--- tags: - sentence-transformers - sentence-similarity - feature-extraction - generated_from_trainer - dataset_size:216 - loss:MatryoshkaLoss - loss:MultipleNegativesRankingLoss base_model: Snowflake/snowflake-arctic-embed-l widget: - source_sentence: Are foreign organizations eligible to apply for the intervention research grant mentioned in the context? sentences: - "PAR-25-379: Intervention Research to Improve Native American Health (R01 Clinical\ \ Trial Optional) Section III. Eligibility Information\n \n \n \n \n 1.\ \ Eligible Applicants\n \n \n \n Eligible Organizations\n \n Higher\ \ Education Institutions\n \n \n \n Public/State Controlled Institutions\ \ of Higher Education\n \n \n Private Institutions of Higher Education\n\ \ \n \n \n The following types of Higher Education Institutions are always\ \ encouraged to apply for NIH support as Public or Private Institutions of Higher\ \ Education:\n \n \n \n Hispanic-serving Institutions\n \n \n Historically\ \ Black Colleges and Universities (HBCUs)\n \n \n Tribally Controlled\ \ Colleges and Universities (TCCUs)\n \n \n Alaska Native and Native Hawaiian\ \ Serving Institutions\n \n \n Asian American Native American Pacific\ \ Islander Serving Institutions (AANAPISIs)\n \n \n \n Nonprofits Other\ \ Than Institutions of Higher Education\n \n \n \n Nonprofits with 501(c)(3)\ \ IRS Status (Other than Institutions of Higher Education)\n \n \n Nonprofits\ \ without 501(c)(3) IRS Status (Other than Institutions of Higher Education)\n\ \ \n \n \n For-Profit Organizations\n \n \n \n Small Businesses\n\ \ \n \n For-Profit Organizations (Other than Small Businesses)\n \n\ \ \n \n Local Governments\n \n \n \n State Governments\n \n \n \ \ County Governments\n \n \n City or Township Governments\n \n\ \ \n Special District Governments\n \n \n Indian/Native American Tribal\ \ Governments (Federally Recognized)\n \n \n Indian/Native American Tribal\ \ Governments (Other than Federally Recognized).\n \n \n \n \n \n Federal\ \ Government\n \n \n \n Eligible Agencies of the Federal Government\n \ \ \n \n U.S. Territory or Possession\n \n \n \n \n \n Other\n \ \ \n \n \n Independent School Districts\n \n \n Public Housing Authorities/Indian\ \ Housing Authorities\n \n \n Native American Tribal Organizations (other\ \ than Federally recognized tribal governments)\n \n \n Faith-based or\ \ Community-based Organizations\n \n \n Regional Organizations\n \n\ \ \n \n \n Foreign Organizations\n \n \n \n Non-domestic (non-U.S.) Entities\ \ (Foreign Organizations)\n \n are not\n \n eligible to apply.\n\ \ \n \n \n \n Non-domestic (non-U.S.) components of U.S. Organizations\n\ \ \n are not\n \n eligible to apply.\n \n \n \n \n Foreign\ \ components, as\n \n defined in the\n \n NIH Grants Policy\ \ Statement\n \n \n ,\n \n are\n \n allowed.\n \n \n\ \ \n Required Registrations\n \n \n Applicant Organizations\n \n\ \ \n \n Applicant organizations must complete and maintain the following registrations\ \ as described in the How to Apply-Application Guide to be eligible to apply for\ \ or receive an award. All registrations must be completed prior to the application\ \ being submitted. Registration can take 6 weeks or more, so applicants should\ \ begin the registration process as soon as possible. Failure to complete registrations\ \ in advance of  a due date is not a valid reason for a late submission, please\ \ reference the\n \n NIH Grants Policy Statement Section 2.3.9.2 Electronically\ \ Submitted Applications\n \n .\n \n \n \n \n System for Award\ \ Management (SAM) –\n \n Applicants must complete and maintain an active\ \ registration,\n \n which requires renewal at least annually\n \ \ \n . The renewal process may require as much time as the initial registration.\ \ SAM registration includes the assignment of a Commercial and Government Entity\ \ (CAGE) Code for domestic organizations which have not already been assigned\ \ a CAGE Code.\n \n \n \n NATO Commercial and Government Entity (NCAGE)\ \ Code\n \n – Foreign organizations must obtain an NCAGE code (in\ \ lieu of a CAGE code) in order to register in SAM.\n \n \n Unique\ \ Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration\ \ process. The same UEI must be used for all registrations, as well as on the\ \ grant application.\n \n \n \n \n \n eRA Commons\n \n - Once\ \ the unique organization identifier is established, organizations can register\ \ with eRA Commons in tandem with completing their Grants.gov registration; all\ \ registrations must be in place by time of submission. eRA Commons requires organizations\ \ to identify at least one Signing Official (SO) and at least one Program Director/Principal\ \ Investigator (PD/PI) account in order to submit an application.\n \n \n\ \ \n Grants.gov\n \n – Applicants must have an active SAM registration\ \ in order to complete the Grants.gov registration.\n \n \n \n \n Program\ \ Directors/Principal Investigators (PD(s)/PI(s))\n \n \n \n All PD(s)/PI(s)\ \ must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational\ \ officials to either create a new account or to affiliate their existing account\ \ with the applicant organization in eRA Commons. If the PD/PI is also the organizational\ \ Signing Official, they must have two distinct eRA Commons accounts, one for\ \ each role. Obtaining an eRA Commons account can take up to 2 weeks.\n \n\ \ \n \n Eligible Individuals (Program Director/Principal Investigator)\n \ \ \n Any individual(s) with the skills, knowledge, and resources necessary\ \ to carry out the proposed research as the Program Director(s)/Principal Investigator(s)\ \ (PD(s)/PI(s)) is invited to work with their organization to develop an application\ \ for support. Individuals from diverse backgrounds, including underrepresented\ \ racial and ethnic groups, individuals with disabilities, and women are always\ \ encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement\ \ of Applications Supporting Individuals from Underrepresented Ethnic and Racial\ \ Groups as well as Individuals with Disabilities,\n \n NOT-OD-22-019\n\ \ \n and Notice of NIH's Interest in Diversity,\n \n NOT-OD-20-031\n\ \ \n .\n \n \n For institutions/organizations proposing multiple\ \ PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and\ \ submission details in the Senior/Key Person Profile (Expanded) Component of\ \ the How to Apply- Application Guide.\n \n \n \n \n Foreign components,\ \ as\n \n defined in the\n \n NIH Grants Policy Statement\n\ \ \n \n ,\n \n are\n \n allowed only when the ancestral\ \ catchment area(s) of tribe(s) cross(es) U.S. national boundary.\n \n \n \n\ \ \n 2. Cost Sharing\n \n \n This NOFO does not require cost sharing\ \ as defined in the\n \n NIH Grants Policy Statement Section 1.2 Definition\ \ of Terms\n \n .\n \n \n \n \n 3. Additional Information on Eligibility\n\ \ \n \n Number of Applications\n \n \n \n \n Applicant organizations\ \ may submit more than one application, provided that each application is scientifically\ \ distinct.\n \n \n The NIH will not accept duplicate or highly overlapping\ \ applications under review at the same time, per\n \n NIH Grants Policy\ \ Statement Section 2.3.7.4 Submission of Resubmission Application\n \n \ \ . This means that the NIH will not accept:\n \n \n \n A new (A0) application\ \ that is submitted before issuance of the summary statement from the review of\ \ an overlapping new (A0) or resubmission (A1) application.\n \n \n A\ \ resubmission (A1) application that is submitted before issuance of the summary\ \ statement from the review of the previous new (A0) application.\n \n \n\ \ An application that has substantial overlap with another application pending\ \ appeal of initial peer review (see\n \n NIH Grants Policy Statement\ \ 2.3.9.4 Similar, Essentially Identical, or Identical Applications\n \n\ \ )." - "RFA-HL-26-010: Limited Competition: Data Analysis and Sharing Center (DASC) for\ \ the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trials Not Allowed)\ \ Section II. Award Information\n \n \n \n Funding Instrument\n \n \ \ Cooperative Agreement: A financial assistance mechanism used when there will\ \ be substantial Federal scientific or programmatic involvement. Substantial involvement\ \ means that, after award, NIH scientific or program staff will assist, guide,\ \ coordinate, or participate in project activities. See Section VI.2 for additional\ \ information about the substantial involvement for this NOFO.\n \n \n \n \ \ Application Types Allowed\n New\n \n Renewal\n \n \n \n \n The\n\ \ \n OER Glossary\n \n and the How to Apply Application Guide provide\ \ details on these application types. Only those application types listed here\ \ are allowed for this NOFO.\n \n \n \n Clinical Trial?\n \n Not Allowed:\ \ Only accepting applications that do not propose clinical trials.\n \n \n\ \ \n \n \n Need help determining whether you are doing a clinical trial?\n\ \ \n \n \n \n Funds Available and Anticipated Number of Awards\n \n \ \ The following NIH components intend to commit an estimated total of $3 million\ \ to fund a single award in FY 2026:\n \n \n NHLBI, $0.97 million\n \n\ \ \n NIAID, $0.30 million\n \n \n NIMH, $0.30 million\n \n \n NCI,\ \ $0.75 million\n \n \n NIA, $0.19 million\n \n \n NIDA, $0.15 million\n\ \ \n \n NICHD, $0.13 million\n \n \n NIDCR, $0.07 million\n \n\ \ \n NIMHD, $0.04 million\n \n \n NIAAA, $0.03 million\n \n \n \ \ NINR, $0.03 million\n \n \n ORWH, $0.03 million\n \n \n NIDCD, $0.02\ \ million\n \n \n \n Award Budget\n \n Application budgets may not\ \ exceed direct costs of $2 million per year in Fiscal Years 2026 through 2031.\n\ \ \n \n \n Award Project Period\n \n 6 years\n \n This variable\ \ defines that we need to start a new row. \n \n \n \n NIH grants policies\ \ as described in the\n \n NIH Grants Policy Statement\n \n will\ \ apply to the applications submitted and awards made from this NOFO." - 'PAR-25-378: Intervention Research to Improve Native American Health (R34 Clinical Trial Optional) Part 2. Full Text of Announcement' - source_sentence: What are the sections of the Public Health Service Act under which the awards for the intervention research are made? sentences: - "PAR-25-379: Intervention Research to Improve Native American Health (R01 Clinical\ \ Trial Optional) Section VIII. Other Information\n \n \n \n \n Recently\ \ issued trans-NIH\n \n policy notices\n \n may affect your application\ \ submission. A full list of policy notices published by NIH is provided in the\n\ \ \n NIH Guide for Grants and Contracts\n \n . All awards are subject\ \ to the terms and conditions, cost principles, and other considerations described\ \ in the\n \n NIH Grants Policy Statement\n \n .\n \n \n \n\ \ Authority and Regulations\n \n Awards are made under the authorization\ \ of Sections 301 and 405 of the Public Health Service Act as amended (42 USC\ \ 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.\n\ \ \n end row \n \n \n \n \n Weekly TOC for this Announcement\n \n \n\ \ \n NIH Funding Opportunities and Notices\n \n \n \n \n \n \n \n \n \n\ \ \n \n \n \n Department of Health\n \n and Human Services (HHS)\n \n \n\ \ \n \n NIH... Turning Discovery Into Health\n \n ®" - "RFA-DK-26-007: Collaborative Research Using Biosamples and/or Data from Type\ \ 1 Diabetes Clinical Studies (R01 - Clinical Trial Not Allowed) Part 1. Overview\ \ Information\n \n \n \n Participating Organization(s)\n \n National\ \ Institutes of Health (\n \n NIH\n \n )\n \n \n \n Components\ \ of Participating Organizations\n \n National Institute of Diabetes and\ \ Digestive and Kidney Diseases (\n \n NIDDK\n \n )\n \n \n\ \ Office of The Director, National Institutes of Health (\n \n OD\n\ \ \n )\n \n \n \n Funding Opportunity Title\n \n Collaborative\ \ Research Using Biosamples and/or Data from Type 1 Diabetes Clinical Studies\ \ (R01 - Clinical Trial Not Allowed)\n \n \n \n Activity Code\n \n \n\ \ R01\n \n Research Project Grant\n \n \n \n Announcement Type\n\ \ Reissue of\n \n RFA-DK-22-021\n \n \n \n \n Related Notices\n \ \ \n \n \n April 4, 2024\n \n - Overview of Grant Application\ \ and Review Changes for Due Dates on or after January 25, 2025. See Notice\n\ \ \n NOT-OD-24-084\n \n .\n \n \n \n August 31, 2022\n\ \ \n - Implementation Changes for Genomic Data Sharing Plans Included\ \ with Applications Due on or after January 25, 2023. See Notice\n \n \ \ NOT-OD-22-198\n \n .\n \n \n \n August 5, 2022\n \n\ \ - Implementation Details for the NIH Data Management and Sharing Policy.\ \ See Notice\n \n NOT-OD-22-189\n \n .\n \n \n \n \n \ \ Funding Opportunity Number (FON)\n \n RFA-DK-26-007\n \n \n \n Companion\ \ Funding Opportunity\n None\n \n \n Number of Applications\n \n \ \ See\n \n Section III. 3. Additional Information on Eligibility\n \ \ \n .\n \n \n \n Assistance Listing Number(s)\n 93.847\n \n \n\ \ Funding Opportunity Purpose\n \n This Notice of Funding Opportunity\ \ (NOFO) invites applications for studies of type 1 diabetes etiology and pathogenesis\ \ using data and samples from clinical trials and studies. This opportunity is\ \ intended to fund investigative teams collaborating to answer important questions\ \ about disease mechanisms leading to improved delay and durable prevention of\ \ type 1 diabetes. This NOFO is associated with the Special Diabetes Program (\n\ \ \n https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program\n\ \ \n ) which funds research on the prevention, treatment, and cure of type\ \ 1 diabetes and its complications, including unique, innovative, and collaborative\ \ research consortia and clinical trials networks.\n \n \n \n \n \n \n \n \ \ Funding Opportunity Goal(s)\n \n To promote extramural basic and clinical\ \ biomedical research that improves the understanding of the mechanisms underlying\ \ disease and leads to improved preventions, diagnosis, and treatment of diabetes,\ \ digestive, and kidney diseases. Programmatic areas within the National Institute\ \ of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine,\ \ hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic\ \ diseases.\n \n This variable defines that we need to start a new row." - "RFA-HL-26-010: Limited Competition: Data Analysis and Sharing Center (DASC) for\ \ the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trials Not Allowed)\ \ Section VI. Award Administration Information\n \n \n \n \n 1. Award Notices\n\ \ \n \n A Notice of Award (NoA) is the official authorizing document notifying\ \ the applicant that an award has been made and that funds may be requested from\ \ the designated HHS payment system or office. The NoA is signed by the Grants\ \ Management Officer and emailed to the recipient’s business official.\n \n\ \ \n In accepting the award, the recipient agrees that any activities under\ \ the award are subject to all provisions currently in effect or implemented during\ \ the period of the award, other Department regulations and policies in effect\ \ at the time of the award, and applicable statutory provisions.\n \n \n \ \ Recipients must comply with any funding restrictions described in\n \n\ \ Section IV.6. Funding Restrictions\n \n . Any pre-award costs incurred\ \ before receipt of the NoA are at the applicant's own risk.  For more information\ \ on the Notice of Award, please refer to the\n \n NIH Grants Policy Statement\ \ Section 5. The Notice of Award\n \n and NIH Grants & Funding website,\ \ see\n \n Award Process.\n \n \n \n \n \n Institutional Review\ \ Board or Independent Ethics Committee Approval: Recipient institutions must\ \ ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety\ \ of participants enrolled in NIH-funded studies, the recipient must provide NIH\ \ copies of documents related to all major changes in the status of ongoing protocols.\n\ \ \n \n \n \n 2. Administrative and National Policy Requirements\n \n\ \ \n The following Federal wide and HHS-specific policy requirements apply\ \ to awards funded through NIH:\n \n \n \n The rules listed at\n \n\ \ 2 CFR Part 200\n \n , Uniform Administrative Requirements, Cost\ \ Principles, and Audit Requirements for Federal Awards.\n \n \n All NIH\ \ grant and cooperative agreement awards include the\n \n NIH Grants\ \ Policy Statement\n \n as part of the terms and conditions in the Notice\ \ of Award (NoA). The NoA includes the requirements of this NOFO. For these terms\ \ of award, see the\n \n NIH Grants Policy Statement Part II: Terms\ \ and Conditions of NIH Grant Awards, Subpart A: General\n \n and\n \ \ \n Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms\ \ and Conditions for Specific Types of Grants, Recipients, and Activities\n \ \ \n .\n \n \n If a recipient receives an award, the recipient\ \ must follow all applicable nondiscrimination laws. The recipient agrees to this\ \ when registering in SAM.gov. The recipient must also submit an Assurance of\ \ Compliance (\n \n HHS-690\n \n ). To learn more, see the\n\ \ \n Laws and Regulations Enforced by the HHS Office for Civil Rights\ \ website\n \n .\n \n \n HHS recognizes that NIH research\ \ projects are often limited in scope for many reasons that are nondiscriminatory,\ \ such as the principal investigator’s scientific interest, funding limitations,\ \ recruitment requirements, and other considerations. Thus, criteria in research\ \ protocols that target or exclude certain populations are warranted where nondiscriminatory\ \ justifications establish that such criteria are appropriate with respect to\ \ the health or safety of the subjects, the scientific study design, or the purpose\ \ of the research. For additional guidance regarding how the provisions apply\ \ to NIH grant programs, please contact the Scientific/Research Contact that is\ \ identified in Section VII under Agency Contacts of this NOFO.\n \n \n\ \ \n \n \n All federal statutes and regulations relevant to federal financial\ \ assistance, including those highlighted in\n \n NIH Grants Policy Statement\ \ Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.\n\ \ \n \n \n Recipients are responsible for ensuring that their activities\ \ comply with all applicable federal regulations.  NIH may terminate awards under\ \ certain circumstances.  See\n \n 2 CFR Part 200.340 Termination\n \ \ \n and\n \n NIH Grants Policy Statement Section 8.5.2 Remedies\ \ for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding\ \ of Support\n \n .\n \n \n Successful recipients under this NOFO\ \ agree that:\n \n \n Where the award funding involves implementing, acquiring,\ \ or upgrading health IT for activities by any funded entity, recipients and subrecipient(s)\ \ are required to: Use health IT that meets standards and implementation specifications\ \ adopted in 45 CFR part 170, Subpart B, if such standards and implementation\ \ specifications can support the activity.  Visit\n \n https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B\n\ \ \n to learn more.\n \n \n Where the award funding involves implementing,\ \ acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory\ \ settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the\ \ HITECH Act, use health IT certified under the ONC Health IT Certification Program\ \ if certified technology can support the activity. Visit\n \n https://www.healthit.gov/topic/certification-ehrs/certification-health-it\n\ \ \n to learn more.\n \n \n Pursuant to the Cybersecurity Act of\ \ 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has\ \ established a common set of voluntary, consensus-based, and industry-led guidelines,\ \ best practices, methodologies, procedures, and processes.\n \n \n Successful\ \ recipients under this NOFO agree that:\n \n \n When recipients, subrecipients,\ \ or third-party entities have:\n \n \n \n ongoing and consistent access\ \ to HHS owned or operated information or operational technology systems; and\n\ \ \n \n receive, maintain, transmit, store, access, exchange, process,\ \ or utilize personal identifiable information (PII) or personal health information\ \ (PHI) obtained from the awarding HHS agency for the purposes of executing the\ \ award.\n \n \n \n Recipients shall develop plans and procedures, modeled\ \ after the\n \n NIST Cybersecurity framework\n \n , to protect\ \ HHS systems and data. Please refer to\n \n NIH Post-Award Monitoring\ \ and Reporting\n \n for additional information.\n \n \n \n Cooperative\ \ Agreement Terms and Conditions of Award\n \n The following special terms\ \ of award are in addition to, and not in lieu of, otherwise applicable U.S. Office\ \ of Management and Budget (OMB) administrative guidelines, U.S. Department of\ \ Health and Human Services (HHS) grant administration regulations at 2 CFR Part\ \ 200, and other HHS, PHS, and NIH grant administration policies.\n \n \n \ \ The administrative and funding instrument used for this program will be the\ \ cooperative agreement, an \"assistance\" mechanism (rather than an \"acquisition\"\ \ mechanism), in which substantial NIH programmatic involvement with the recipients\ \ is anticipated during the performance of the activities. Under the cooperative\ \ agreement, the NIH purpose is to support and stimulate the recipients' activities\ \ by involvement in and otherwise working jointly with the recipients in a partnership\ \ role; it is not to assume direction, prime responsibility, or a dominant role\ \ in the activities. Consistent with this concept, the dominant role and prime\ \ responsibility resides with the recipients for the project as a whole, although\ \ specific tasks and activities may be shared among the recipients and NIH as\ \ defined below.\n \n \n \n Each U01 CRS project, the U01 (DASC, and the\ \ U01 LACC will receive a separate award, and the mPIs of each respective award\ \ will have control over their project's operating budget.\n \n \n All\ \ recipients will be required to attend annual cohort meetings and participate\ \ in the cooperative nature of the cohort.\n \n \n \n \n The Clinical\ \ Research Sites will have primary responsibility for:\n \n \n \n \n The\ \ CRS mPI(s) will be responsible for the scientific and technical direction of\ \ the project and agree to abide by cohort policies and guidance. This includes\ \ accepting the actions and recommendations approved by the Steering Committee,\ \ the Executive Committee, and the Observational Study Monitoring Board. In addition,\ \ each CRS mPI must agree to accept participation of and close coordination and\ \ cooperation with the following stakeholders: NIH Program Staff, the LACC, and\ \ the DASC in those aspects of management of the project as described below.\n\ \ \n \n Specific responsibilities of the CRS include but are not limited\ \ to:\n \n \n Collaboratively defining objectives and approaches of\ \ specific research protocols\n \n \n Providing leadership in protocol\ \ development for specific research protocol(s), and/or serving as an expert Reading\ \ Center or Laboratory for specific research protocol(s) as needed\n \n\ \ \n Participating fully in required activities and responsibilities of\ \ the MWCCS Executive Committee\n \n \n Accepting and implementing\ \ the policies approved by the MWCCS Executive Committee consistent with applicable\ \ grant regulations\n \n \n Monitoring CRS staff and investigator\ \ adherence to clinical and laboratory protocols\n \n \n Obtaining\ \ all requisite study and protocol IRB approvals\n \n \n Scheduling\ \ participant clinic visits, capturing study-specified outcomes, and completion\ \ of study visit components including consent, questionnaires, in-person examinations,\ \ and collection of biospecimens\n \n \n Tracking retention and follow-up\ \ of participants at the CRS and making these data available to the LACC and the\ \ DASC on a monthly basis\n \n \n Close monitoring of participant\ \ safety and unexpected adverse outcomes\n \n \n Collaborating closely\ \ with the LACC and the DASC to establish and implement quality assurance and\ \ control processes in all study activities, including data analyses led by the\ \ CRS\n \n \n Participating in all relevant staff trainings and ongoing\ \ evaluation of CRS personnel interview skills, HIV counseling, and examination\ \ techniques\n \n \n Implementing training, ongoing evaluation, and\ \ quality control for all CRS laboratory staff and procedures for handling and\ \ testing of participant specimens, including web-based tracking of delivery to\ \ central repository\n \n \n Implementation and maintenance of strict\ \ data security procedures for the collection, storage, analysis, and archiving\ \ of participants' personal health information\n \n \n Taking rapid\ \ corrective actions for all supported activities when deficits or problems are\ \ identified\n \n \n Cooperating fully with the LACC, the DASC, and\ \ NIH programmatic, technical, and administrative staff\n \n \n Providing\ \ research opportunities and mentorship to early career investigators, including\ \ those at the pre-doctoral, post-doctoral, and early independent career stages\n\ \ \n \n Developing and supporting collaborations with external investigators,\ \ as appropriate\n \n \n All other specific required activities described\ \ in RFA HL-26-009 but not listed here\n \n \n \n \n Recipients will\ \ retain custody of, and have primary rights to, the data developed under these\ \ awards, subject to Government rights of access consistent with current HHS,\ \ PHS, and NIH policies. However, recipients will implement the approved Data\ \ Management and Sharing Plan (see Submitting an Application), which will be incorporated\ \ as an additional term of award and will be expected to share (make available)\ \ these data both within the consortium and with the scientific community. Recipients\ \ should comply with their institutional intellectual property policies and practices\ \ as approved in the award.\n \n \n \n \n The Leadership and Coordination\ \ Center will have primary responsibility for:\n \n \n \n \n Clinical\ \ and scientific guidance and oversight of the MWCCS as a whole, including scientific\ \ leadership, scientific working group support, operational working group support,\ \ training pertaining to the clinical protocol and participant interactions, operational\ \ accountability, community and participant engagement, and promotion of the cohort\ \ to external stakeholders\n \n \n Establishing and maintaining congenial,\ \ respectful, and productive working relationships with each of the CRS, the DASC,\ \ the NCAB, and NIH Program Staff\n \n \n Collaborating closely with the\ \ mPIs of the DASC to ensure clear delineation of responsibilities, frequent communications,\ \ and smooth central functioning of various aspects of cohort management and support\ \ of the CRS for both cohort operational specific aims and scientific investigational\ \ aims\n \n \n Serving as permanent co-chair(s) of the MWCCS Executive\ \ Committee, with an additional co-chair elected or selected by the CRS mPIs,\ \ in order to facilitate leadership continuity over time, accountability, and\ \ timely communications\n \n \n Developing and leading a consensus process\ \ for finalizing and implementing the Joint Unified Modular Protocol (JUMP)\n\ \ \n \n Collecting and tracking study and protocol approvals, including\ \ IRB approvals, ancillary studies, and renewals\n \n \n Providing clinical,\ \ scientific, and operational leadership, accountability, and technical assistance\ \ to the cohort-wide efforts to ascertain and adjudicate significant clinical\ \ events and outcomes for all ever-enrolled participants (e.g. major adverse cardiovascular\ \ events (MACE), incident cancers, HIV/AIDS-related comorbidities, hospitalizations,\ \ deaths), as allowable per participant consents\n \n \n Coordinating,\ \ facilitating, and monitoring clinical review committees' efforts to adjudicate\ \ all significant clinical events in a timely fashion\n \n \n Actively\ \ participating in specific scientific investigations when appropriate\n \n\ \ \n Working collaboratively with investigators proposing ancillary study\ \ components\n \n \n Providing summary tracking of submitted site-specific\ \ and MACS/WIHS-wide concept sheets\n \n \n Establishing a process for\ \ annual strategic planning of scientific and management priorities to ensure\ \ that resources are allocated to meet local and cohort-wide aims\n \n \n\ \ Arranging, conducting, and distributing documentation for regular conference\ \ calls for Scientific Work Groups (SWG), Executive Committee (EC) and other committees,\ \ and annual meetings of cohort investigators\n \n \n Ensure high-fidelity\ \ adherence and quality outcomes for all clinical and laboratory protocols, via\ \ development of enhanced resources for staff training, guidelines for credentialing,\ \ regular monitoring and oversight for quality control purposes, and additional\ \ approaches as proposed by the LACC mPIs\n \n \n Coordinating implementation\ \ of new or modified protocols approved by the Executive Committee\n \n \n\ \ Consult and coordinate with the DASC on all areas of protocol implementation,\ \ tracking, quality control, and data collection which involve overlapping areas\ \ of responsibility (e.g. the overlap between clinical techniques and collection\ \ of clinical data). Providing teaching and training to cohort personnel at the\ \ CRSs to assure that the questionnaires continue to be administered in a uniform,\ \ standardized fashion\n \n \n Providing a forum for posting, circulating\ \ and consolidating input on draft manuscripts to co-authors, NIH co-funding ICO\ \ Project Scientists and Program Officers\n \n \n Planning and hosting\ \ an annual symposium or workshop to inform the broader research community about\ \ scientific progress of the MWCCS and provide an opportunity for development\ \ of collaborations with outside investigators\n \n \n All other specific\ \ required activities described in RFA HL-26-011 but not listed here\n \n\ \ \n \n \n The Data Analysis and Sharing Center will have primary responsibility\ \ for:\n \n \n \n \n Modernizing and maintaining all data collection systems\ \ for the MWCCS, with continual quality-improvement updates to facilitate CRS\ \ data collection activities.\n \n \n Preparing and updating operations\ \ manuals, data collection forms, coordinating the revision of existing questionnaires\ \ and development and testing of new questionnaires for use in the cohort, including\ \ the standardization of procedures for data collection\n \n \n Implementing\ \ uniform methods to capture participant data on vital and health status, risk\ \ factors, and other personal information\n \n \n Developing data linkages\ \ with health information exchanges, clinics, and medical centers to ascertain\ \ events of clinical significance, ideally through automated data collection.\n\ \ \n \n Performing centralized data analyses to support MWCCS scientific\ \ investigations\n \n \n Developing innovative approaches to statistical\ \ analysis of prospective observational cohort data\n \n \n Tracking recruitment\ \ and retention of participants at each CRS and making these figures available\ \ to the Executive Committee (EC) and representatives of co-funding institutes\ \ in annual progress reports\n \n \n Collecting, editing, cleaning, and\ \ storing data collected from CRSs; providing centralized storage, security, processing\ \ and retrieval of cohort data; providing quality control of the data management\ \ system and addressing evolving data needs of the cohort study\n \n \n \ \ Preparing a final annotated dataset for delivery to NIH or an NIH designated\ \ repository of the complete cohort dataset (all data included in the cohort dataset)\n\ \ \n \n Performing data audit site visits on a routine basis at a minimum\ \ of once every three years\n \n \n Collaborate with the biorepository\ \ to ensure accurate inventory of specimens in the repository; train and provide\ \ updates on the web-based tracking system; manage requests for specimens from\ \ investigators; prioritize requests for samples; facilitate timely delivery of\ \ samples to investigators\n \n \n Releasing clinical and GWAS data to\ \ the scientific community in a timely manner, consistent with NIH and NHLBI policies\n\ \ \n \n Producing an annual study progress report to be distributed at\ \ the annual EC meeting in collaboration with the LACC.\n \n \n Maintaining\ \ the system for tracking cohort research and providing study progress reports\ \ at the semi-annual investigator meeting\n \n \n Maintaining an ongoing,\ \ up-to-date web-based searchable list of all MWCCS publications, manuscripts\ \ in progress and presentations using cohort data\n \n \n Maintaining\ \ internal and public websites, posting study documents on internal website\n\ \ \n \n All other specific required activities described in RFA HL-26-010\ \ but not listed here\n \n \n \n \n NIH staff have substantial programmatic\ \ involvement that is above and beyond the normal stewardship role in awards,\ \ as described below:\n \n \n \n The NHLBI Project Collaborator will have\ \ substantial involvement in the conduct of this activity through technical assistance,\ \ advice, and coordination above and beyond normal program stewardship for grants.\ \ In addition to the NHLBI Project Collaborator, other NHLBI Program Officials\ \ and Grants Management Officers will oversee the normal program stewardship of\ \ the cooperative agreements. Final decision-making authority on matters of budgetary\ \ and funding actions, grants management actions, and management of intellectual\ \ property will reside with Senior Institute management, separate organizational\ \ components, and/or oversight committees. Other NHLBI staff members such as direct\ \ line supervisor or other Senior NHLBI Program management staff may serve as\ \ agency Program Officials as needed with responsibility for the normal scientific\ \ and programmatic stewardship of the award.\n \n \n In addition, each co-sponsoring\ \ institute will nominate at least one Project Collaborator, Scientist, or Program\ \ Officer to provide scientific oversight, technical assistance, and coordination\ \ aligned with their institute’s scientific priorities for the MWCCS. NIH Program\ \ Staff activities will include but may not be limited to:\n \n \n \n Participating\ \ in the NIH Scientific Oversight Committee (N-SOC) which will be comprised of\ \ representatives from all MWCCS co-funding ICOs, the Office of AIDS Research\ \ (OAR), and other NIH stakeholders as appropriate\n \n \n Participating\ \ in study leadership via voting membership in the MWCCS Executive Committee,\ \ close and regular consultations with the LACC and the DASC, and regular communication\ \ with NIH stakeholders in the MWCCS\n \n \n Reviewing all relevant study\ \ protocols and data\n \n \n Monitoring study progress, results and quality\ \ assurance across all sites\n \n \n Participating in selected Scientific\ \ Working Groups and Operational Working Groups as appropriate\n \n \n \ \ Providing technical assistance and advice to the recipients as appropriate\n\ \ \n \n Providing mentoring and counseling to MWCCS investigators, including\ \ trainees and early stage investigators, as appropriate and needed\n \n \n\ \ Assisting with the development of research protocols\n \n \n Ensuring\ \ disclosure of conflicts of interest and adherence to NIH policies\n \n \n\ \ Facilitating collaborations between the recipients and other NIH-sponsored\ \ programs investigators, or organizations that may contribute to the study's\ \ goals\n \n \n Assisting in the interaction between the recipients and\ \ investigators at other institutions, as appropriate for the cohort\n \n\ \ \n Promoting collaborative research efforts that involve interactions with\ \ other NIH-supported projects, programs, and centers and helping with the coordination\ \ of such efforts\n \n \n \n \n Areas of Joint Responsibility include,\ \ but may not be limited to:\n \n \n \n \n MWCCS Executive Committee\n\ \ \n \n \n The EC is the primary decision-making body for this multi-site\ \ collaborative research study. All MWCCS stakeholders will have representation\ \ on the EC and participate in sharing decision-making on all topics of broad\ \ important to cohort operations. One or more of the LACC mPIs will serve as permanent\ \ EC Chair, with an additional EC Chair chosen by the CRS mPIs.\n \n \n \ \ As an explicit condition of their NIH cooperative agreement awards, all recipients\ \ must agree to both actively participate in the EC and to collegially abide by\ \ its decisions and policies pertaining to all aspects of study operations.\n\ \ \n \n Specific areas of responsibility for EC members include but may\ \ not be limited to:\n \n \n \n Protection of participant safety via regular\ \ monitoring and responsive corrective action when needed\n \n \n Promotion\ \ of scientific integrity, validity, and excellence in all areas of study operations\ \ and scientific investigations\n \n \n Facilitation of rapid and regular\ \ data sharing with the broader scientific community to increase the pace, significance,\ \ and impact of MWCCS HIV populomics research.\n \n \n Participation in\ \ regular EC video calls, annual cohort meetings, and ad-hoc trainings, research\ \ meetings, and other gatherings as needed\n \n \n Assistance to and support\ \ of the NCAB\n \n \n Substantive contributions to, and participation\ \ in, Scientific Working Groups and Operational Working Groups as appropriate\ \ for individual areas of expertise.\n \n \n Cooperation and collaboration\ \ with the LACC and the DASC on relevant areas of study operations and scientific\ \ investigations\n \n \n \n \n MWCCS Steering Committee\n \n \n \n\ \ The SC is a subset of the EC which meets more frequently than the full EC\ \ and advises the EC on important operational and scientific issues. All MWCCS\ \ stakeholders (CRS mPIs, CRS Project Directors, LACC mPIs, DASC mPIs, NIH Program\ \ Staff, NCAB members) should have at least one representative on the SC. The\ \ EC Co-Chairs will also serve as SC Co-Chairs.\n \n \n \n Scientific Work\ \ Groups\n \n \n \n SWGs are comprised of subject-matter scientific experts\ \ from the CRS, the LACC, the DASC, and NIH who collaborate on new and continuing\ \ scientific investigations which will result in public presentations and peer-reviewed\ \ publications. SWGs should also include and provide mentorship opportunities\ \ for early-stage investigators, including pre-doctoral and post-doctoral trainees.\ \ The LACC will provide scientific leadership and coordination of operations (e.g.\ \ scheduling of meetings, maintenance of records, facilitation of communications),\ \ while the DASC will monitor SWG productivity and outputs via monitoring of agreed-upon\ \ productivity metrics and regular reporting to the EC. The number and topic areas\ \ of the SWG will be determined by the MWCCS investigators (LACC and EC); however\ \ NIH expects that these topic areas will be well-aligned with the NIH scientific\ \ priority areas detailed in Section 1 of this NOFO. Furthermore, NIH expects\ \ that there will be no gaps in coverage – in other words there should be no NIH\ \ priority area which is not covered by at least one SWG.\n \n \n \n Operational\ \ Work Groups\n \n \n \n OWGs have the purpose of bringing together scientific\ \ and methodological experts from among MWCCS investigators and staff, as well\ \ as NIH staff as appropriate, to consider and advise the LACC, the DASC, and\ \ the EC on topics of significance to cohort operations. For example, a Laboratory\ \ Measures Working Group might have the mandate of reviewing and ensuring quality\ \ and high-fidelity adherence to study protocol in the collection, processing,\ \ storage, and analysis of participant biospecimens. The number and topic areas\ \ of the OWGs will be proposed by the LACC and the DASC and agreed to by the EC.\ \ Coordination, administrative support, and monitoring of the OWGs will be the\ \ responsibility of either the LACC or the DASC, depending on the specific topic\ \ area.\n \n \n \n National Community Advisory Board\n \n \n \n \ \ MWCCS investigators and staff from the CRS, LACC, and DASC and NIH staff will\ \ collaborate to support the NCAB, its members, and its planned activities as\ \ requested by NCAB leadership. The LACC will provide leadership and coordination\ \ for cohort support of the NCAB, including centralized administration and payment\ \ of stipends and travel reimbursements to NCAB members for required annual national\ \ meetings.\n \n \n \n Observational Study Monitoring Board\n \n \n\ \ \n The OSMB is an independent board of scientific, clinical care, and bioethics\ \ experts who monitor MWCCS progress and advise the Director of NHLBI on matters\ \ of study performance, participant safety, return of clinical results, informed\ \ consent, participant burden, and overall study success. All MWCCS stakeholders\ \ collaborate to support the OSMB through provision of any requested data or information\ \ about study operations and scientific investigations, including making presentations\ \ and/or preparing topic-specific reports as requested by the OSMB members.\n\ \ \n \n \n Violations of Terms and Conditions of Cooperative Agreement\ \ Awards\n \n \n \n The NHLBI and NIH reserve the right to withhold funding\ \ or curtail the study if any of the following occur:\n \n \n \n Human\ \ participant ethical issues that may dictate a premature end of the award\n \ \ \n \n Substantial shortfall in participant recruitment, follow-up, data\ \ reporting, data sharing, or quality control\n \n \n Failure to develop\ \ or implement a mutually agreeable protocol\n \n \n Major breach of the\ \ protocol or substantive changes in the agreed-upon protocol, methodologies,\ \ and/or tools with which the NHLBI/NIH cannot concur\n \n \n \n \n Dispute\ \ Resolution:\n \n \n \n Any disagreements that may arise in scientific\ \ or programmatic matters (within the scope of the award) between recipients and\ \ NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed\ \ of three members will be convened: a designee of the Steering Committee chosen\ \ without NIH staff voting, one NIH designee, and a third designee with expertise\ \ in the relevant area who is chosen by the other two; in the case of individual\ \ disagreement, the first member may be chosen by the individual recipient. This\ \ special dispute resolution procedure does not alter the recipient's right to\ \ appeal an adverse action that is otherwise appealable in accordance with PHS\ \ regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.\n \ \ \n \n \n 3. Data Management and Sharing\n \n Consistent with the 2023\ \ NIH Policy for Data Management and Sharing, when data management and sharing\ \ is applicable to the award, recipients will be required to adhere to the Data\ \ Management and Sharing requirements as outlined in the\n \n NIH Grants\ \ Policy Statement\n \n . Upon the approval of a Data Management and Sharing\ \ Plan, it is required for recipients to implement the plan as described.\n \ \ \n \n \n \n 4. Reporting\n \n \n When multiple years are involved,\ \ recipients will be required to submit the\n \n Research Performance\ \ Progress Report (RPPR)\n \n annually and financial statements as required\ \ in the\n \n NIH Grants Policy Statement Section 8.4.1 Reporting.\n \ \ \n To learn more about post-award monitoring and reporting, see the NIH\ \ Grants & Funding website, see\n \n Post-Award Monitoring and Reporting\n\ \ \n .\n \n \n \n \n A final RPPR, invention statement, and the expenditure\ \ data portion of the Federal Financial Report are required for closeout of an\ \ award, as described in the\n \n NIH Grants Policy Statement Section\ \ 8.6 Closeout\n \n . NIH NOFOs outline intended research goals and objectives.\ \ Post award, NIH will review and measure performance based on the details and\ \ outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301." - source_sentence: What is the maximum allowable direct costs for application budgets per year for the award period from Fiscal Years 2026 through 2031? sentences: - "RFA-HL-26-011: Leadership and Coordination Center (LACC) for the MACS/WIHS Combined\ \ Cohort Study (MWCCS) (U01 Clinical Trials Not Allowed) Section II. Award Information\n\ \ \n \n \n Funding Instrument\n \n Cooperative Agreement: A financial\ \ assistance mechanism used when there will be substantial Federal scientific\ \ or programmatic involvement. Substantial involvement means that, after award,\ \ NIH scientific or program staff will assist, guide, coordinate, or participate\ \ in project activities. See Section VI.2 for additional information about the\ \ substantial involvement for this NOFO.\n \n \n \n Application Types Allowed\n\ \ New\n \n \n \n \n The\n \n OER Glossary\n \n and the\ \ How to Apply Application Guide provide details on these application types. Only\ \ those application types listed here are allowed for this NOFO.\n \n \n \n\ \ Clinical Trial?\n \n Not Allowed: Only accepting applications that do\ \ not propose clinical trials.\n \n \n \n \n \n Need help determining whether\ \ you are doing a clinical trial?\n \n \n \n \n Funds Available and Anticipated\ \ Number of Awards\n \n The following NIH components intend to commit an\ \ estimated total of $3 million to fund a single award in FY 2026:\n \n \n\ \ NHLBI, $1.37 million\n \n \n NIAID, $0.30 million\n \n \n NIMH, $0.30\ \ million\n \n \n NCI, $0.35 million\n \n \n NIA, $0.19 million\n\ \ \n \n NIDA, $0.15 million\n \n \n NICHD, $0.13 million\n \n \n\ \ NIDCR, $0.07 million\n \n \n NIMHD, $0.04 million\n \n \n NIAAA, $0.03\ \ million\n \n \n NINR, $0.03 million\n \n \n ORWH, $0.03 million\n\ \ \n \n NIDCD, $0.02 million\n \n \n \n Award Budget\n \n Application\ \ budgets may not exceed direct costs of $2 million per year in Fiscal Years 2026\ \ through 2031.\n \n \n \n Award Project Period\n \n 6 years\n \n\ \ This variable defines that we need to start a new row. \n \n \n \n NIH grants\ \ policies as described in the\n \n NIH Grants Policy Statement\n \ \ \n will apply to the applications submitted and awards made from this NOFO." - "PAR-25-379: Intervention Research to Improve Native American Health (R01 Clinical\ \ Trial Optional) Section III. Eligibility Information\n \n \n \n \n 1.\ \ Eligible Applicants\n \n \n \n Eligible Organizations\n \n Higher\ \ Education Institutions\n \n \n \n Public/State Controlled Institutions\ \ of Higher Education\n \n \n Private Institutions of Higher Education\n\ \ \n \n \n The following types of Higher Education Institutions are always\ \ encouraged to apply for NIH support as Public or Private Institutions of Higher\ \ Education:\n \n \n \n Hispanic-serving Institutions\n \n \n Historically\ \ Black Colleges and Universities (HBCUs)\n \n \n Tribally Controlled\ \ Colleges and Universities (TCCUs)\n \n \n Alaska Native and Native Hawaiian\ \ Serving Institutions\n \n \n Asian American Native American Pacific\ \ Islander Serving Institutions (AANAPISIs)\n \n \n \n Nonprofits Other\ \ Than Institutions of Higher Education\n \n \n \n Nonprofits with 501(c)(3)\ \ IRS Status (Other than Institutions of Higher Education)\n \n \n Nonprofits\ \ without 501(c)(3) IRS Status (Other than Institutions of Higher Education)\n\ \ \n \n \n For-Profit Organizations\n \n \n \n Small Businesses\n\ \ \n \n For-Profit Organizations (Other than Small Businesses)\n \n\ \ \n \n Local Governments\n \n \n \n State Governments\n \n \n \ \ County Governments\n \n \n City or Township Governments\n \n\ \ \n Special District Governments\n \n \n Indian/Native American Tribal\ \ Governments (Federally Recognized)\n \n \n Indian/Native American Tribal\ \ Governments (Other than Federally Recognized).\n \n \n \n \n \n Federal\ \ Government\n \n \n \n Eligible Agencies of the Federal Government\n \ \ \n \n U.S. Territory or Possession\n \n \n \n \n \n Other\n \ \ \n \n \n Independent School Districts\n \n \n Public Housing Authorities/Indian\ \ Housing Authorities\n \n \n Native American Tribal Organizations (other\ \ than Federally recognized tribal governments)\n \n \n Faith-based or\ \ Community-based Organizations\n \n \n Regional Organizations\n \n\ \ \n \n \n Foreign Organizations\n \n \n \n Non-domestic (non-U.S.) Entities\ \ (Foreign Organizations)\n \n are not\n \n eligible to apply.\n\ \ \n \n \n \n Non-domestic (non-U.S.) components of U.S. Organizations\n\ \ \n are not\n \n eligible to apply.\n \n \n \n \n Foreign\ \ components, as\n \n defined in the\n \n NIH Grants Policy\ \ Statement\n \n \n ,\n \n are\n \n allowed.\n \n \n\ \ \n Required Registrations\n \n \n Applicant Organizations\n \n\ \ \n \n Applicant organizations must complete and maintain the following registrations\ \ as described in the How to Apply-Application Guide to be eligible to apply for\ \ or receive an award. All registrations must be completed prior to the application\ \ being submitted. Registration can take 6 weeks or more, so applicants should\ \ begin the registration process as soon as possible. Failure to complete registrations\ \ in advance of  a due date is not a valid reason for a late submission, please\ \ reference the\n \n NIH Grants Policy Statement Section 2.3.9.2 Electronically\ \ Submitted Applications\n \n .\n \n \n \n \n System for Award\ \ Management (SAM) –\n \n Applicants must complete and maintain an active\ \ registration,\n \n which requires renewal at least annually\n \ \ \n . The renewal process may require as much time as the initial registration.\ \ SAM registration includes the assignment of a Commercial and Government Entity\ \ (CAGE) Code for domestic organizations which have not already been assigned\ \ a CAGE Code.\n \n \n \n NATO Commercial and Government Entity (NCAGE)\ \ Code\n \n – Foreign organizations must obtain an NCAGE code (in\ \ lieu of a CAGE code) in order to register in SAM.\n \n \n Unique\ \ Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration\ \ process. The same UEI must be used for all registrations, as well as on the\ \ grant application.\n \n \n \n \n \n eRA Commons\n \n - Once\ \ the unique organization identifier is established, organizations can register\ \ with eRA Commons in tandem with completing their Grants.gov registration; all\ \ registrations must be in place by time of submission. eRA Commons requires organizations\ \ to identify at least one Signing Official (SO) and at least one Program Director/Principal\ \ Investigator (PD/PI) account in order to submit an application.\n \n \n\ \ \n Grants.gov\n \n – Applicants must have an active SAM registration\ \ in order to complete the Grants.gov registration.\n \n \n \n \n Program\ \ Directors/Principal Investigators (PD(s)/PI(s))\n \n \n \n All PD(s)/PI(s)\ \ must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational\ \ officials to either create a new account or to affiliate their existing account\ \ with the applicant organization in eRA Commons. If the PD/PI is also the organizational\ \ Signing Official, they must have two distinct eRA Commons accounts, one for\ \ each role. Obtaining an eRA Commons account can take up to 2 weeks.\n \n\ \ \n \n Eligible Individuals (Program Director/Principal Investigator)\n \ \ \n Any individual(s) with the skills, knowledge, and resources necessary\ \ to carry out the proposed research as the Program Director(s)/Principal Investigator(s)\ \ (PD(s)/PI(s)) is invited to work with their organization to develop an application\ \ for support. Individuals from diverse backgrounds, including underrepresented\ \ racial and ethnic groups, individuals with disabilities, and women are always\ \ encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement\ \ of Applications Supporting Individuals from Underrepresented Ethnic and Racial\ \ Groups as well as Individuals with Disabilities,\n \n NOT-OD-22-019\n\ \ \n and Notice of NIH's Interest in Diversity,\n \n NOT-OD-20-031\n\ \ \n .\n \n \n For institutions/organizations proposing multiple\ \ PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and\ \ submission details in the Senior/Key Person Profile (Expanded) Component of\ \ the How to Apply- Application Guide.\n \n \n \n \n Foreign components,\ \ as\n \n defined in the\n \n NIH Grants Policy Statement\n\ \ \n \n ,\n \n are\n \n allowed only when the ancestral\ \ catchment area(s) of tribe(s) cross(es) U.S. national boundary.\n \n \n \n\ \ \n 2. Cost Sharing\n \n \n This NOFO does not require cost sharing\ \ as defined in the\n \n NIH Grants Policy Statement Section 1.2 Definition\ \ of Terms\n \n .\n \n \n \n \n 3. Additional Information on Eligibility\n\ \ \n \n Number of Applications\n \n \n \n \n Applicant organizations\ \ may submit more than one application, provided that each application is scientifically\ \ distinct.\n \n \n The NIH will not accept duplicate or highly overlapping\ \ applications under review at the same time, per\n \n NIH Grants Policy\ \ Statement Section 2.3.7.4 Submission of Resubmission Application\n \n \ \ . This means that the NIH will not accept:\n \n \n \n A new (A0) application\ \ that is submitted before issuance of the summary statement from the review of\ \ an overlapping new (A0) or resubmission (A1) application.\n \n \n A\ \ resubmission (A1) application that is submitted before issuance of the summary\ \ statement from the review of the previous new (A0) application.\n \n \n\ \ An application that has substantial overlap with another application pending\ \ appeal of initial peer review (see\n \n NIH Grants Policy Statement\ \ 2.3.9.4 Similar, Essentially Identical, or Identical Applications\n \n\ \ )." - Department of Health and Human Services - source_sentence: What is the purpose of the Notice of Award (NoA) in the context of NIH funding? sentences: - "RFA-HL-26-011: Leadership and Coordination Center (LACC) for the MACS/WIHS Combined\ \ Cohort Study (MWCCS) (U01 Clinical Trials Not Allowed) Section III. Eligibility\ \ Information\n \n \n \n \n 1. Eligible Applicants\n \n \n \n Eligible\ \ Organizations\n \n Higher Education Institutions\n \n \n \n Public/State\ \ Controlled Institutions of Higher Education\n \n \n Private Institutions\ \ of Higher Education\n \n \n \n The following types of Higher Education\ \ Institutions are always encouraged to apply for NIH support as Public or Private\ \ Institutions of Higher Education:\n \n \n \n Hispanic-serving Institutions\n\ \ \n \n Historically Black Colleges and Universities (HBCUs)\n \n\ \ \n Tribally Controlled Colleges and Universities (TCCUs)\n \n \n \ \ Alaska Native and Native Hawaiian Serving Institutions\n \n \n Asian\ \ American Native American Pacific Islander Serving Institutions (AANAPISIs)\n\ \ \n \n \n Nonprofits Other Than Institutions of Higher Education\n \ \ \n \n \n Nonprofits with 501(c)(3) IRS Status (Other than Institutions of\ \ Higher Education)\n \n \n Nonprofits without 501(c)(3) IRS Status (Other\ \ than Institutions of Higher Education)\n \n \n \n For-Profit Organizations\n\ \ \n \n \n Small Businesses\n \n \n For-Profit Organizations (Other\ \ than Small Businesses)\n \n \n \n Local Governments\n \n \n \n \ \ State Governments\n \n \n County Governments\n \n \n City or\ \ Township Governments\n \n \n Special District Governments\n \n \n\ \ Indian/Native American Tribal Governments (Federally Recognized)\n \n\ \ \n Indian/Native American Tribal Governments (Other than Federally Recognized).\n\ \ \n \n \n \n \n Federal Governments\n \n \n \n Eligible Agencies\ \ of the Federal Government\n \n \n U.S. Territory or Possession\n \ \ \n \n \n \n \n Other\n \n \n \n Independent School Districts\n \ \ \n \n Public Housing Authorities/Indian Housing Authorities\n \n \n\ \ Native American Tribal Organizations (other than Federally recognized tribal\ \ governments)\n \n \n Faith-based or Community-based Organizations\n\ \ \n \n Regional Organizations\n \n \n \n \n Foreign Organizations\n\ \ \n \n \n Non-domestic (non-U.S.) Entities (Foreign Organizations)\n \ \ \n are not\n \n eligible to apply.\n \n \n \n \n Non-domestic\ \ (non-U.S.) components of U.S. Organizations\n \n are not\n \n \ \ eligible to apply.\n \n \n \n \n Foreign components, as\n \n \ \ defined in the NIH Grants Policy Statement\n \n ,\n \n are not\n\ \ \n allowed.\n \n \n \n Required Registrations\n \n \n Applicant\ \ Organizations\n \n \n \n Applicant organizations must complete and maintain\ \ the following registrations as described in the How to Apply- Application Guide\ \ to be eligible to apply for or receive an award. All registrations must be completed\ \ prior to the application being submitted. Registration can take 6 weeks or more,\ \ so applicants should begin the registration process as soon as possible. Failure\ \ to complete registrations in advance of a due date is not a valid reason for\ \ a late submission, please reference the\n \n NIH Grants Policy Statement\ \ Section 2.3.9.2 Electronically Submitted Applications\n \n for additional\ \ information.\n \n \n \n \n System for Award Management (SAM) –\n \ \ \n Applicants must complete and maintain an active registration,\n \ \ \n which requires renewal at least annually\n \n . The renewal\ \ process may require as much time as the initial registration. SAM registration\ \ includes the assignment of a Commercial and Government Entity (CAGE) Code for\ \ domestic organizations which have not already been assigned a CAGE Code.\n \ \ \n \n \n NATO Commercial and Government Entity (NCAGE) Code\n \ \ \n – Foreign organizations must obtain an NCAGE code (in lieu of a\ \ CAGE code) in order to register in SAM.\n \n \n Unique Entity Identifier\ \ (UEI) - A UEI is issued as part of the SAM.gov registration process. The same\ \ UEI must be used for all registrations, as well as on the grant application.\n\ \ \n \n \n \n \n eRA Commons\n \n - Once the unique organization\ \ identifier is established, organizations can register with eRA Commons in tandem\ \ with completing their Grants.gov registrations; all registrations must be in\ \ place by time of submission. eRA Commons requires organizations to identify\ \ at least one Signing Official (SO) and at least one Program Director/Principal\ \ Investigator (PD/PI) account in order to submit an application.\n \n \n\ \ \n Grants.gov\n \n – Applicants must have an active SAM registration\ \ in order to complete the Grants.gov registration.\n \n \n \n \n Program\ \ Directors/Principal Investigators (PD(s)/PI(s))\n \n \n \n All PD(s)/PI(s)\ \ must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational\ \ officials to either create a new account or to affiliate their existing account\ \ with the applicant organization in eRA Commons. If the PD/PI is also the organizational\ \ Signing Official, they must have two distinct eRA Commons accounts, one for\ \ each role. Obtaining an eRA Commons account can take up to 2 weeks.\n \n\ \ \n \n Eligible Individuals (Program Director/Principal Investigator)\n \ \ \n Any individual(s) with the skills, knowledge, and resources necessary\ \ to carry out the proposed research as the Program Director(s)/Principal Investigator(s)\ \ (PD(s)/PI(s)) is invited to work with their organization to develop an application\ \ for support.\n \n \n For institutions/organizations proposing multiple\ \ PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and\ \ submission details in the Senior/Key Person Profile (Expanded) Component of\ \ the How to Apply-Application Guide.\n \n \n \n \n A multiple PI (mPI)\ \ leadership structure is required. The LACC mPI team should include individuals\ \ with demonstrated deep knowledge of, and familiarity with, the MWCCS. In addition,\ \ the team should include at least one clinician with experience in clinical care\ \ of patients living with HIV and/or relevant comorbidities, as well as one or\ \ more individuals with epidemiologic cohort study leadership experience.Individuals\ \ may not apply to be an mPI of both the LACC and Data Analysis and Sharing Center\ \ (DASC) (\n \n RFA-HL-26-010\n \n ). Applications without an mPI\ \ leadership structure will be considered incomplete and will not proceed to peer\ \ review.\n \n \n \n \n 2. Cost Sharing\n \n \n This NOFO does not\ \ require cost sharing as defined in the\n \n NIH Grants Policy Statement\ \ Section 1.2 Definition of Terms\n \n .\n \n \n \n \n 3. Additional\ \ Information on Eligibility\n \n \n Number of Applications\n \n \n \n\ \ \n Applicant organizations may submit more than one application, provided\ \ that each application is scientifically distinct.\n \n \n The NIH will\ \ not accept duplicate or highly overlapping applications under review at the\ \ same time, per\n \n NIH Grants Policy Statement Section 2.3.7.4 Submission\ \ of Resubmission Application\n \n . This means that the NIH will not accept:\n\ \ \n \n \n A new (A0) application that is submitted before issuance of\ \ the summary statement from the review of an overlapping new (A0) or resubmission\ \ (A1) application.\n \n \n A resubmission (A1) application that is submitted\ \ before issuance of the summary statement from the review of the previous new\ \ (A0) application.\n \n \n An application that has substantial overlap\ \ with another application pending appeal of initial peer review (see\n \n\ \ NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or\ \ Identical Applications\n \n )." - 'RFA-HL-26-011: Leadership and Coordination Center (LACC) for the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trials Not Allowed) Part 2. Full Text of Announcement' - "RFA-AI-24-079: Asthma and Allergic Diseases Cooperative Research Centers (U19\ \ Clinical Trial Optional) Section VI. Award Administration Information\n \n\ \ \n \n \n 1. Award Notices\n \n \n A Notice of Award (NoA) is the official\ \ authorizing document notifying the applicant that an award has been made and\ \ that funds may be requested from the designated HHS payment system or office.\ \ The NoA is signed by the Grants Management Officer and emailed to the recipient’s\ \ business official.\n \n \n In accepting the award, the recipient agrees\ \ that any activities under the award are subject to all provisions currently\ \ in effect or implemented during the period of the award, other Department regulations\ \ and policies in effect at the time of the award, and applicable statutory provisions.\n\ \ \n \n Recipients must comply with any funding restrictions described in\n\ \ \n Section IV.6. Funding Restrictions\n \n . Any pre-award costs\ \ incurred before receipt of the NoA are at the applicant's own risk.  For more\ \ information on the Notice of Award, please refer to the\n \n NIH Grants\ \ Policy Statement Section 5. The Notice of Award\n \n and NIH Grants &\ \ Funding website, see\n \n Award Process.\n \n \n \n \n \n Individual\ \ awards are based on the application submitted to, and as approved by, the NIH\ \ and are subject to the IC-specific terms and conditions identified in the NoA.\n\ \ \n \n ClinicalTrials.gov: If an award provides for one or more clinical\ \ trials. By law (Title VIII, Section 801 of Public Law 110-85), the \"responsible\ \ party\" must register and submit results information for certain “applicable\ \ clinical trials” on the ClinicalTrials.gov Protocol Registration and Results\ \ System Information Website (\n \n https://register.clinicaltrials.gov\n\ \ \n ). NIH expects registration and results reporting of all trials whether\ \ required under the law or not. For more information, see\n \n https://grants.nih.gov/policy/clinical-trials/reporting/index.htm\n\ \ \n \n \n Institutional Review Board or Independent Ethics Committee Approval:\ \ Grantee institutions must ensure that all protocols are reviewed by their IRB\ \ or IEC. To help ensure the safety of participants enrolled in NIH-funded studies,\ \ the recipient must provide NIH copies of documents related to all major changes\ \ in the status of ongoing protocols.\n \n \n Data and Safety Monitoring\ \ Requirements: The NIH policy for data and safety monitoring requires oversight\ \ and monitoring of all NIH-conducted or -supported human biomedical and behavioral\ \ intervention studies (clinical trials) to ensure the safety of participants\ \ and the validity and integrity of the data. Further information concerning these\ \ requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm\ \ and in the application instructions (SF424 (R&R) and PHS 398).\n \n \n \ \ Investigational New Drug or Investigational Device Exemption Requirements:\ \ Consistent with federal regulations, clinical research projects involving the\ \ use of investigational therapeutics, vaccines, or other medical interventions\ \ (including licensed products and devices for a purpose other than that for which\ \ they were licensed) in humans under a research protocol must be performed under\ \ a Food and Drug Administration (FDA) investigational new drug (IND) or investigational\ \ device exemption (IDE).\n \n \n \n \n Prior Approval of Pilot Projects\n\ \ \n \n Recipient-selected projects that involve {clinical trials or studies\ \ involving greater than minimal risk to human subjects} require prior approval\ \ by NIH prior to initiation.\n \n \n \n The recipient institution will\ \ comply with the NIH\n \n Guidance on Changes That Involve Human Subjects\ \ in Active Awards and That Will Require Prior NIH Approval\n \n .\n\ \ \n \n The recipient institution will provide NIH with specific plans\ \ for data and safety monitoring, and will notify the IRB and NIH of serious adverse\ \ events and unanticipated problems, consistent with\n \n NIH DSMP policies\n\ \ \n .\n \n \n \n \n \n 2. Administrative and National Policy\ \ Requirements\n \n \n The following Federal wide and HHS-specific policy\ \ requirements apply to awards funded through NIH:\n \n \n \n The rules\ \ listed at\n \n 2 CFR Part 200\n \n , Uniform Administrative\ \ Requirements, Cost Principles, and Audit Requirements for Federal Awards.\n\ \ \n \n All NIH grant and cooperative agreement awards include the\n \ \ \n NIH Grants Policy Statement\n \n as part of the terms and\ \ conditions in the Notice of Award (NoA). The NoA includes the requirements of\ \ this NOFO. For these terms of award, see the\n \n NIH Grants Policy\ \ Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General\n\ \ \n and\n \n Part II: Terms and Conditions of NIH Grant Awards,\ \ Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and\ \ Activities\n \n .\n \n \n If a recipient receives an award,\ \ the recipient must follow all applicable nondiscrimination laws. The recipient\ \ agrees to this when registering in SAM.gov. The recipient must also submit an\ \ Assurance of Compliance (\n \n HHS-690\n \n ). To learn more,\ \ see the\n \n Laws and Regulations Enforced by the HHS Office for Civil\ \ Rights website\n \n .\n \n \n HHS recognizes that NIH research\ \ projects are often limited in scope for many reasons that are nondiscriminatory,\ \ such as the principal investigator’s scientific interest, funding limitations,\ \ recruitment requirements, and other considerations. Thus, criteria in research\ \ protocols that target or exclude certain populations are warranted where nondiscriminatory\ \ justifications establish that such criteria are appropriate with respect to\ \ the health or safety of the subjects, the scientific study design, or the purpose\ \ of the research. For additional guidance regarding how the provisions apply\ \ to NIH grant programs, please contact the Scientific/Research Contact that is\ \ identified in Section VII under Agency Contacts of this NOFO.\n \n \n\ \ \n \n \n All federal statutes and regulations relevant to federal financial\ \ assistance, including those highlighted in\n \n NIH Grants Policy Statement\ \ Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.\n\ \ \n \n \n Recipients are responsible for ensuring that their activities\ \ comply with all applicable federal regulations.  NIH may terminate awards under\ \ certain circumstances.  See\n \n 2 CFR Part 200.340 Termination\n \ \ \n and\n \n NIH Grants Policy Statement Section 8.5.2 Remedies\ \ for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding\ \ of Support\n \n .\n \n \n Successful recipients under this NOFO\ \ agree that:\n \n \n Where the award funding involves implementing, acquiring,\ \ or upgrading health IT for activities by any funded entity, recipients and subrecipient(s)\ \ are required to: Use health IT that meets standards and implementation specifications\ \ adopted in 45 CFR part 170, Subpart B, if such standards and implementation\ \ specifications can support the activity.  Visit\n \n https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B\n\ \ \n to learn more.\n \n \n Where the award funding involves implementing,\ \ acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory\ \ settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the\ \ HITECH Act, use health IT certified under the ONC Health IT Certification Program\ \ if certified technology can support the activity. Visit\n \n https://www.healthit.gov/topic/certification-ehrs/certification-health-it\n\ \ \n to learn more.\n \n \n Pursuant to the Cybersecurity Act of\ \ 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has\ \ established a common set of voluntary, consensus-based, and industry-led guidelines,\ \ best practices, methodologies, procedures, and processes.\n \n \n Successful\ \ recipients under this NOFO agree that:\n \n \n When recipients, subrecipients,\ \ or third-party entities have:\n \n \n \n ongoing and consistent access\ \ to HHS owned or operated information or operational technology systems; and\n\ \ \n \n receive, maintain, transmit, store, access, exchange, process,\ \ or utilize personal identifiable information (PII) or personal health information\ \ (PHI) obtained from the awarding HHS agency for the purposes of executing the\ \ award.\n \n \n \n Recipients shall develop plans and procedures, modeled\ \ after the\n \n NIST Cybersecurity framework\n \n , to protect\ \ HHS systems and data. Please refer to\n \n NIH Post-Award Monitoring\ \ and Reporting\n \n for additional information.\n \n \n \n Cooperative\ \ Agreement Terms and Conditions of Award\n \n The following special terms\ \ of award are in addition to, and not in lieu of, otherwise applicable U.S. Office\ \ of Management and Budget (OMB) administrative guidelines, U.S. Department of\ \ Health and Human Services (HHS) grant administration regulations at 2 CFR Part\ \ 200, and other HHS, PHS, and NIH grant administration policies.\n \n \n \ \ The administrative and funding instrument used for this program will be the\ \ cooperative agreement, an \"assistance\" mechanism (rather than an \"acquisition\"\ \ mechanism), in which substantial NIH programmatic involvement with the recipients\ \ is anticipated during the performance of the activities. Under the cooperative\ \ agreement, the NIH purpose is to support and stimulate the recipients' activities\ \ by involvement in and otherwise working jointly with the recipients in a partnership\ \ role; it is not to assume direction, prime responsibility, or a dominant role\ \ in the activities. Consistent with this concept, the dominant role and prime\ \ responsibility resides with the recipients for the project as a whole, although\ \ specific tasks and activities may be shared among the recipients and NIH as\ \ defined below.\n \n \n \n The PD(s)/PI(s) will have the primary responsibility\ \ for:\n \n \n \n \n Determining and coordinating the scientific and administrative\ \ activities of the approved projects;\n \n \n Setting project goals and\ \ timelines;\n \n \n Serving on the AADCRC Steering Committee and participating\ \ in all Steering Committee activities;\n \n \n Accepting and implementing\ \ common guidelines approved by the Steering Committee;\n \n \n For clinical\ \ trials and other human subject research, implementing current Good Clinical\ \ Practice guidelines and complying with the\n \n NIAID Clinical Terms\ \ of Award\n \n ;\n \n \n For clinical trials in which the PD(s)/PI(s)\ \ is the IND/IDE Sponsor, having responsibilty for the development, assembly,\ \ and submission of all required regulatory documents, providing NIAID all required\ \ information in accordance to NIH clinical research guidance. This includes,\ \ but is not limited to, all communications with the FDA (or other regulatory\ \ authority) and the Institutional Review Board (IRB). If NIAID is the IND/IDE\ \ Sponsor, providing access to all necessary data and documentation to NIAID to\ \ fulfill its role.\n \n \n Sharing reagents and resources with other\ \ investigators funded under this NOFO as appropriate, including any scientists\ \ added via IOF support;\n \n \n Making data available for external checking\ \ against the original source documentation;\n \n \n Recipients will retain\ \ custody of and have primary rights to the data and software developed under\ \ these awards, subject to Government rights of access consistent with current\ \ HHS, PHS, and NIH policies.\n \n \n \n \n NIH staff have substantial\ \ programmatic involvement that is above and beyond the normal stewardship role\ \ in awards, as described below:\n \n \n \n \n NIAID may assign one or\ \ more Project Scientist(s) to the AADCRC program. The Project Scientist(s) will:\n\ \ \n \n Provide guidance and support in the design of research activities;\n\ \ \n \n Provide guidance and support in the execution of studies;\n\ \ \n \n Contribute to the analysis and publication of data;\n \ \ \n \n Advise in the selection of sources or resources;\n \n \n\ \ Advise in management and technical performance;\n \n \n In\ \ AADCRC centers that include clinical trials, and in some cases clinical studies,\ \ the NIAID-assigned Project Scientist will be a Medical Officer;\n \n \n\ \ Assist in planning of the meetings and teleconferences of the Steering\ \ Committee and subcommittees, and ensure coordination of Steering Committee activities\ \ and implementation of its recommendations, decisions, and policies.\n \ \ \n \n All NIAID staff will be non-voting members of the Steering Committee.\n\ \ \n \n \n \n \n \n Clinical Research Oversight\n \n \n \n \n \n\ \ Protocol Development, Review and Approval:\n \n The NIAID Project\ \ Scientist will participate in the development, review and approval of all clinical\ \ research protocols supported by this NOFO.\n \n \n In some cases, the\ \ NIAID-assigned Project Scientist will be a physician who may also assume the\ \ role of Medical Monitor of a clinical study or trial.\n \n \n \n IND/IDE:\n\ \ \n NIAID retains the right to have NIAID serve as the IND/IDE sponsor\ \ for trials involving the use of investigational products.\n \n \n \n \ \ Monitoring Boards and Safety Reporting:\n \n NIAID Project Scientists\ \ will facilitate and provide oversight of the review and reporting of data to\ \ DAIT monitoring committees and Data Safety and Monitoring Boards.\n \n \n\ \ \n Study Termination:\n \n NIAID reserves the right to terminate\ \ or curtail a clinical study or clinical trial for any of the following reasons:\n\ \ \n \n risk to subject safety;\n \n \n the scientific\ \ question is no longer relevant, or the objectives will not be met;\n \n\ \ \n failure to comply with Good Clinical Practices, Federal Regulations,\ \ or Terms and Conditions of Award;\n \n \n occurrence of unforeseen\ \ drug safety issues or data from preclinical studies indicate a presence of unanticipated\ \ toxicity;\n \n \n risks that cannot be adequately quantified;\n\ \ \n \n failure to remedy deficiencies identified through site monitoring;\n\ \ \n \n substandard data; inadequate progress in fulfilling the research\ \ agenda;\n \n \n slow accrual; or\n \n \n reaching a\ \ major study endpoint substantially before schedule with persuasive statistical\ \ significance.\n \n \n \n \n \n Access to Data:\n \n The\ \ NIAID Project Scientist or designee will have access to all data generated under\ \ this cooperative agreement and may review the data as recorded on the case report\ \ forms or in a database. NIAID staff may use information obtained from the data\ \ for the preparation of internal reports on the activities of the study.\n \ \ \n \n Additionally, an agency program official or IC program director\ \ will be responsible for the normal scientific and programmatic stewardship of\ \ the award and will be named in the award notice.\n \n \n \n \n Areas\ \ of Joint Responsibility include:\n \n \n \n \n Establishing a Steering\ \ Committee consisting of the PD(s)/PI(s) of each AADCRC and NIH Project Scientists\ \ from NIAID. The NIH Program Officer will be an optional attendee. The Steering\ \ Committee’s responsibilities include facilitating collaborative projects, organizing\ \ the yearly IOF competition (establishing goals, guidelines and evaluation criteria,\ \ evaluating proposed projects, and proposing funding plans), setting the agenda\ \ for an annual face-to-face AADCRC scientific meeting, establishing an AADCRC\ \ policy to promote resource sharing among AADCRCs and outside collaborators,\ \ and proposing AADCRC-centered sessions for national and international scientific\ \ meetings.\n \n \n \n Each AADCRC Center will have one voting member on\ \ the Steering Committee; in the case of multi-PI centers, all PIs/PDs will be\ \ Steering Committee members, but must share one vote. NIAID Project Scientists\ \ and the NIH Program Officer will be non-voting members of the Steering Committee\ \ and participate in all Steering Committee activities. A chair will be elected\ \ by the majority of vote among the voting members of the Steering Committee.\ \ The Steering Committee will make decisions by majority vote. The Steering Committee\ \ will meet by teleconference twice a year and at a face-to-face meeting once\ \ a year.\n \n \n \n Collaboratively facilitating the conduct, progress\ \ and monitoring of the studies supported by the award.\n \n \n Fostering\ \ collaborations between AADCRCs.\n \n \n \n \n Dispute Resolution:\n\ \ \n \n \n Any disagreements that may arise in scientific or programmatic\ \ matters (within the scope of the award) between recipients and NIH may be brought\ \ to Dispute Resolution. A Dispute Resolution Panel composed of three members\ \ will be convened: a designee of the Steering Committee chosen without NIH staff\ \ voting, one NIH designee, and a third designee with expertise in the relevant\ \ area who is chosen by the other two; in the case of individual disagreement,\ \ the first member may be chosen by the individual recipient. This special dispute\ \ resolution procedure does not alter the recipient's right to appeal an adverse\ \ action that is otherwise appealable in accordance with PHS regulation 42 CFR\ \ Part 50, Subpart D and HHS regulation 45 CFR Part 16.\n \n \n \n \n 3.\ \ Data Management and Sharing\n \n \n Consistent with the 2023 NIH Policy\ \ for Data Management and Sharing, when data management and sharing is applicable\ \ to the award, recipients will be required to adhere to the Data Management and\ \ Sharing requirements as outlined in the\n \n NIH Grants Policy Statement\n\ \ \n . Upon the approval of a Data Management and Sharing Plan, it is required\ \ for recipients to implement the plan as described.\n \n \n \n 4. Reporting\n\ \ \n \n When multiple years are involved, recipients will be required to\ \ submit the\n \n Research Performance Progress Report (RPPR)\n \ \ \n annually and financial statements as required in the\n \n \ \ NIH Grants Policy Statement Section 8.4.1 Reporting\n \n . To learn\ \ more about post-award monitoring and reporting, see the NIH Grants & Funding\ \ website, see\n \n Post-Award Monitoring and Reporting\n \n \ \ .\n \n \n \n \n \n Progress reports should briefly describe status\ \ of pilot projects, including data and safety monitoring, and should notify NIH\ \ of serious adverse events and unanticipated problems.\n \n \n \n \n A\ \ final RPPR, invention statement, and the expenditure data portion of the Federal\ \ Financial Report are required for closeout of an award, as described in the\n\ \ \n NIH Grants Policy Statement Section 8.6 Closeout\n \n . NIH\ \ NOFOs outline intended research goals and objectives. Post award, NIH will review\ \ and measure performance based on the details and outcomes that are shared within\ \ the RPPR, as described at 2 CFR Part 200.301." - source_sentence: What are the responsibilities of the PD(s)/PI(s) in managing the activities of the approved projects under the cooperative agreement? sentences: - "RFA-DK-26-007: Collaborative Research Using Biosamples and/or Data from Type\ \ 1 Diabetes Clinical Studies (R01 - Clinical Trial Not Allowed) Part 1. Overview\ \ Information\n \n \n \n Participating Organization(s)\n \n National\ \ Institutes of Health (\n \n NIH\n \n )\n \n \n \n Components\ \ of Participating Organizations\n \n National Institute of Diabetes and\ \ Digestive and Kidney Diseases (\n \n NIDDK\n \n )\n \n \n\ \ Office of The Director, National Institutes of Health (\n \n OD\n\ \ \n )\n \n \n \n Funding Opportunity Title\n \n Collaborative\ \ Research Using Biosamples and/or Data from Type 1 Diabetes Clinical Studies\ \ (R01 - Clinical Trial Not Allowed)\n \n \n \n Activity Code\n \n \n\ \ R01\n \n Research Project Grant\n \n \n \n Announcement Type\n\ \ Reissue of\n \n RFA-DK-22-021\n \n \n \n \n Related Notices\n \ \ \n \n \n April 4, 2024\n \n - Overview of Grant Application\ \ and Review Changes for Due Dates on or after January 25, 2025. See Notice\n\ \ \n NOT-OD-24-084\n \n .\n \n \n \n August 31, 2022\n\ \ \n - Implementation Changes for Genomic Data Sharing Plans Included\ \ with Applications Due on or after January 25, 2023. See Notice\n \n \ \ NOT-OD-22-198\n \n .\n \n \n \n August 5, 2022\n \n\ \ - Implementation Details for the NIH Data Management and Sharing Policy.\ \ See Notice\n \n NOT-OD-22-189\n \n .\n \n \n \n \n \ \ Funding Opportunity Number (FON)\n \n RFA-DK-26-007\n \n \n \n Companion\ \ Funding Opportunity\n None\n \n \n Number of Applications\n \n \ \ See\n \n Section III. 3. Additional Information on Eligibility\n \ \ \n .\n \n \n \n Assistance Listing Number(s)\n 93.847\n \n \n\ \ Funding Opportunity Purpose\n \n This Notice of Funding Opportunity\ \ (NOFO) invites applications for studies of type 1 diabetes etiology and pathogenesis\ \ using data and samples from clinical trials and studies. This opportunity is\ \ intended to fund investigative teams collaborating to answer important questions\ \ about disease mechanisms leading to improved delay and durable prevention of\ \ type 1 diabetes. This NOFO is associated with the Special Diabetes Program (\n\ \ \n https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program\n\ \ \n ) which funds research on the prevention, treatment, and cure of type\ \ 1 diabetes and its complications, including unique, innovative, and collaborative\ \ research consortia and clinical trials networks.\n \n \n \n \n \n \n \n \ \ Funding Opportunity Goal(s)\n \n To promote extramural basic and clinical\ \ biomedical research that improves the understanding of the mechanisms underlying\ \ disease and leads to improved preventions, diagnosis, and treatment of diabetes,\ \ digestive, and kidney diseases. Programmatic areas within the National Institute\ \ of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine,\ \ hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic\ \ diseases.\n \n This variable defines that we need to start a new row." - "RFA-AI-24-079: Asthma and Allergic Diseases Cooperative Research Centers (U19\ \ Clinical Trial Optional) Section VI. Award Administration Information\n \n\ \ \n \n \n 1. Award Notices\n \n \n A Notice of Award (NoA) is the official\ \ authorizing document notifying the applicant that an award has been made and\ \ that funds may be requested from the designated HHS payment system or office.\ \ The NoA is signed by the Grants Management Officer and emailed to the recipient’s\ \ business official.\n \n \n In accepting the award, the recipient agrees\ \ that any activities under the award are subject to all provisions currently\ \ in effect or implemented during the period of the award, other Department regulations\ \ and policies in effect at the time of the award, and applicable statutory provisions.\n\ \ \n \n Recipients must comply with any funding restrictions described in\n\ \ \n Section IV.6. Funding Restrictions\n \n . Any pre-award costs\ \ incurred before receipt of the NoA are at the applicant's own risk.  For more\ \ information on the Notice of Award, please refer to the\n \n NIH Grants\ \ Policy Statement Section 5. The Notice of Award\n \n and NIH Grants &\ \ Funding website, see\n \n Award Process.\n \n \n \n \n \n Individual\ \ awards are based on the application submitted to, and as approved by, the NIH\ \ and are subject to the IC-specific terms and conditions identified in the NoA.\n\ \ \n \n ClinicalTrials.gov: If an award provides for one or more clinical\ \ trials. By law (Title VIII, Section 801 of Public Law 110-85), the \"responsible\ \ party\" must register and submit results information for certain “applicable\ \ clinical trials” on the ClinicalTrials.gov Protocol Registration and Results\ \ System Information Website (\n \n https://register.clinicaltrials.gov\n\ \ \n ). NIH expects registration and results reporting of all trials whether\ \ required under the law or not. For more information, see\n \n https://grants.nih.gov/policy/clinical-trials/reporting/index.htm\n\ \ \n \n \n Institutional Review Board or Independent Ethics Committee Approval:\ \ Grantee institutions must ensure that all protocols are reviewed by their IRB\ \ or IEC. To help ensure the safety of participants enrolled in NIH-funded studies,\ \ the recipient must provide NIH copies of documents related to all major changes\ \ in the status of ongoing protocols.\n \n \n Data and Safety Monitoring\ \ Requirements: The NIH policy for data and safety monitoring requires oversight\ \ and monitoring of all NIH-conducted or -supported human biomedical and behavioral\ \ intervention studies (clinical trials) to ensure the safety of participants\ \ and the validity and integrity of the data. Further information concerning these\ \ requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm\ \ and in the application instructions (SF424 (R&R) and PHS 398).\n \n \n \ \ Investigational New Drug or Investigational Device Exemption Requirements:\ \ Consistent with federal regulations, clinical research projects involving the\ \ use of investigational therapeutics, vaccines, or other medical interventions\ \ (including licensed products and devices for a purpose other than that for which\ \ they were licensed) in humans under a research protocol must be performed under\ \ a Food and Drug Administration (FDA) investigational new drug (IND) or investigational\ \ device exemption (IDE).\n \n \n \n \n Prior Approval of Pilot Projects\n\ \ \n \n Recipient-selected projects that involve {clinical trials or studies\ \ involving greater than minimal risk to human subjects} require prior approval\ \ by NIH prior to initiation.\n \n \n \n The recipient institution will\ \ comply with the NIH\n \n Guidance on Changes That Involve Human Subjects\ \ in Active Awards and That Will Require Prior NIH Approval\n \n .\n\ \ \n \n The recipient institution will provide NIH with specific plans\ \ for data and safety monitoring, and will notify the IRB and NIH of serious adverse\ \ events and unanticipated problems, consistent with\n \n NIH DSMP policies\n\ \ \n .\n \n \n \n \n \n 2. Administrative and National Policy\ \ Requirements\n \n \n The following Federal wide and HHS-specific policy\ \ requirements apply to awards funded through NIH:\n \n \n \n The rules\ \ listed at\n \n 2 CFR Part 200\n \n , Uniform Administrative\ \ Requirements, Cost Principles, and Audit Requirements for Federal Awards.\n\ \ \n \n All NIH grant and cooperative agreement awards include the\n \ \ \n NIH Grants Policy Statement\n \n as part of the terms and\ \ conditions in the Notice of Award (NoA). The NoA includes the requirements of\ \ this NOFO. For these terms of award, see the\n \n NIH Grants Policy\ \ Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General\n\ \ \n and\n \n Part II: Terms and Conditions of NIH Grant Awards,\ \ Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and\ \ Activities\n \n .\n \n \n If a recipient receives an award,\ \ the recipient must follow all applicable nondiscrimination laws. The recipient\ \ agrees to this when registering in SAM.gov. The recipient must also submit an\ \ Assurance of Compliance (\n \n HHS-690\n \n ). To learn more,\ \ see the\n \n Laws and Regulations Enforced by the HHS Office for Civil\ \ Rights website\n \n .\n \n \n HHS recognizes that NIH research\ \ projects are often limited in scope for many reasons that are nondiscriminatory,\ \ such as the principal investigator’s scientific interest, funding limitations,\ \ recruitment requirements, and other considerations. Thus, criteria in research\ \ protocols that target or exclude certain populations are warranted where nondiscriminatory\ \ justifications establish that such criteria are appropriate with respect to\ \ the health or safety of the subjects, the scientific study design, or the purpose\ \ of the research. For additional guidance regarding how the provisions apply\ \ to NIH grant programs, please contact the Scientific/Research Contact that is\ \ identified in Section VII under Agency Contacts of this NOFO.\n \n \n\ \ \n \n \n All federal statutes and regulations relevant to federal financial\ \ assistance, including those highlighted in\n \n NIH Grants Policy Statement\ \ Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.\n\ \ \n \n \n Recipients are responsible for ensuring that their activities\ \ comply with all applicable federal regulations.  NIH may terminate awards under\ \ certain circumstances.  See\n \n 2 CFR Part 200.340 Termination\n \ \ \n and\n \n NIH Grants Policy Statement Section 8.5.2 Remedies\ \ for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding\ \ of Support\n \n .\n \n \n Successful recipients under this NOFO\ \ agree that:\n \n \n Where the award funding involves implementing, acquiring,\ \ or upgrading health IT for activities by any funded entity, recipients and subrecipient(s)\ \ are required to: Use health IT that meets standards and implementation specifications\ \ adopted in 45 CFR part 170, Subpart B, if such standards and implementation\ \ specifications can support the activity.  Visit\n \n https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B\n\ \ \n to learn more.\n \n \n Where the award funding involves implementing,\ \ acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory\ \ settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the\ \ HITECH Act, use health IT certified under the ONC Health IT Certification Program\ \ if certified technology can support the activity. Visit\n \n https://www.healthit.gov/topic/certification-ehrs/certification-health-it\n\ \ \n to learn more.\n \n \n Pursuant to the Cybersecurity Act of\ \ 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has\ \ established a common set of voluntary, consensus-based, and industry-led guidelines,\ \ best practices, methodologies, procedures, and processes.\n \n \n Successful\ \ recipients under this NOFO agree that:\n \n \n When recipients, subrecipients,\ \ or third-party entities have:\n \n \n \n ongoing and consistent access\ \ to HHS owned or operated information or operational technology systems; and\n\ \ \n \n receive, maintain, transmit, store, access, exchange, process,\ \ or utilize personal identifiable information (PII) or personal health information\ \ (PHI) obtained from the awarding HHS agency for the purposes of executing the\ \ award.\n \n \n \n Recipients shall develop plans and procedures, modeled\ \ after the\n \n NIST Cybersecurity framework\n \n , to protect\ \ HHS systems and data. Please refer to\n \n NIH Post-Award Monitoring\ \ and Reporting\n \n for additional information.\n \n \n \n Cooperative\ \ Agreement Terms and Conditions of Award\n \n The following special terms\ \ of award are in addition to, and not in lieu of, otherwise applicable U.S. Office\ \ of Management and Budget (OMB) administrative guidelines, U.S. Department of\ \ Health and Human Services (HHS) grant administration regulations at 2 CFR Part\ \ 200, and other HHS, PHS, and NIH grant administration policies.\n \n \n \ \ The administrative and funding instrument used for this program will be the\ \ cooperative agreement, an \"assistance\" mechanism (rather than an \"acquisition\"\ \ mechanism), in which substantial NIH programmatic involvement with the recipients\ \ is anticipated during the performance of the activities. Under the cooperative\ \ agreement, the NIH purpose is to support and stimulate the recipients' activities\ \ by involvement in and otherwise working jointly with the recipients in a partnership\ \ role; it is not to assume direction, prime responsibility, or a dominant role\ \ in the activities. Consistent with this concept, the dominant role and prime\ \ responsibility resides with the recipients for the project as a whole, although\ \ specific tasks and activities may be shared among the recipients and NIH as\ \ defined below.\n \n \n \n The PD(s)/PI(s) will have the primary responsibility\ \ for:\n \n \n \n \n Determining and coordinating the scientific and administrative\ \ activities of the approved projects;\n \n \n Setting project goals and\ \ timelines;\n \n \n Serving on the AADCRC Steering Committee and participating\ \ in all Steering Committee activities;\n \n \n Accepting and implementing\ \ common guidelines approved by the Steering Committee;\n \n \n For clinical\ \ trials and other human subject research, implementing current Good Clinical\ \ Practice guidelines and complying with the\n \n NIAID Clinical Terms\ \ of Award\n \n ;\n \n \n For clinical trials in which the PD(s)/PI(s)\ \ is the IND/IDE Sponsor, having responsibilty for the development, assembly,\ \ and submission of all required regulatory documents, providing NIAID all required\ \ information in accordance to NIH clinical research guidance. This includes,\ \ but is not limited to, all communications with the FDA (or other regulatory\ \ authority) and the Institutional Review Board (IRB). If NIAID is the IND/IDE\ \ Sponsor, providing access to all necessary data and documentation to NIAID to\ \ fulfill its role.\n \n \n Sharing reagents and resources with other\ \ investigators funded under this NOFO as appropriate, including any scientists\ \ added via IOF support;\n \n \n Making data available for external checking\ \ against the original source documentation;\n \n \n Recipients will retain\ \ custody of and have primary rights to the data and software developed under\ \ these awards, subject to Government rights of access consistent with current\ \ HHS, PHS, and NIH policies.\n \n \n \n \n NIH staff have substantial\ \ programmatic involvement that is above and beyond the normal stewardship role\ \ in awards, as described below:\n \n \n \n \n NIAID may assign one or\ \ more Project Scientist(s) to the AADCRC program. The Project Scientist(s) will:\n\ \ \n \n Provide guidance and support in the design of research activities;\n\ \ \n \n Provide guidance and support in the execution of studies;\n\ \ \n \n Contribute to the analysis and publication of data;\n \ \ \n \n Advise in the selection of sources or resources;\n \n \n\ \ Advise in management and technical performance;\n \n \n In\ \ AADCRC centers that include clinical trials, and in some cases clinical studies,\ \ the NIAID-assigned Project Scientist will be a Medical Officer;\n \n \n\ \ Assist in planning of the meetings and teleconferences of the Steering\ \ Committee and subcommittees, and ensure coordination of Steering Committee activities\ \ and implementation of its recommendations, decisions, and policies.\n \ \ \n \n All NIAID staff will be non-voting members of the Steering Committee.\n\ \ \n \n \n \n \n \n Clinical Research Oversight\n \n \n \n \n \n\ \ Protocol Development, Review and Approval:\n \n The NIAID Project\ \ Scientist will participate in the development, review and approval of all clinical\ \ research protocols supported by this NOFO.\n \n \n In some cases, the\ \ NIAID-assigned Project Scientist will be a physician who may also assume the\ \ role of Medical Monitor of a clinical study or trial.\n \n \n \n IND/IDE:\n\ \ \n NIAID retains the right to have NIAID serve as the IND/IDE sponsor\ \ for trials involving the use of investigational products.\n \n \n \n \ \ Monitoring Boards and Safety Reporting:\n \n NIAID Project Scientists\ \ will facilitate and provide oversight of the review and reporting of data to\ \ DAIT monitoring committees and Data Safety and Monitoring Boards.\n \n \n\ \ \n Study Termination:\n \n NIAID reserves the right to terminate\ \ or curtail a clinical study or clinical trial for any of the following reasons:\n\ \ \n \n risk to subject safety;\n \n \n the scientific\ \ question is no longer relevant, or the objectives will not be met;\n \n\ \ \n failure to comply with Good Clinical Practices, Federal Regulations,\ \ or Terms and Conditions of Award;\n \n \n occurrence of unforeseen\ \ drug safety issues or data from preclinical studies indicate a presence of unanticipated\ \ toxicity;\n \n \n risks that cannot be adequately quantified;\n\ \ \n \n failure to remedy deficiencies identified through site monitoring;\n\ \ \n \n substandard data; inadequate progress in fulfilling the research\ \ agenda;\n \n \n slow accrual; or\n \n \n reaching a\ \ major study endpoint substantially before schedule with persuasive statistical\ \ significance.\n \n \n \n \n \n Access to Data:\n \n The\ \ NIAID Project Scientist or designee will have access to all data generated under\ \ this cooperative agreement and may review the data as recorded on the case report\ \ forms or in a database. NIAID staff may use information obtained from the data\ \ for the preparation of internal reports on the activities of the study.\n \ \ \n \n Additionally, an agency program official or IC program director\ \ will be responsible for the normal scientific and programmatic stewardship of\ \ the award and will be named in the award notice.\n \n \n \n \n Areas\ \ of Joint Responsibility include:\n \n \n \n \n Establishing a Steering\ \ Committee consisting of the PD(s)/PI(s) of each AADCRC and NIH Project Scientists\ \ from NIAID. The NIH Program Officer will be an optional attendee. The Steering\ \ Committee’s responsibilities include facilitating collaborative projects, organizing\ \ the yearly IOF competition (establishing goals, guidelines and evaluation criteria,\ \ evaluating proposed projects, and proposing funding plans), setting the agenda\ \ for an annual face-to-face AADCRC scientific meeting, establishing an AADCRC\ \ policy to promote resource sharing among AADCRCs and outside collaborators,\ \ and proposing AADCRC-centered sessions for national and international scientific\ \ meetings.\n \n \n \n Each AADCRC Center will have one voting member on\ \ the Steering Committee; in the case of multi-PI centers, all PIs/PDs will be\ \ Steering Committee members, but must share one vote. NIAID Project Scientists\ \ and the NIH Program Officer will be non-voting members of the Steering Committee\ \ and participate in all Steering Committee activities. A chair will be elected\ \ by the majority of vote among the voting members of the Steering Committee.\ \ The Steering Committee will make decisions by majority vote. The Steering Committee\ \ will meet by teleconference twice a year and at a face-to-face meeting once\ \ a year.\n \n \n \n Collaboratively facilitating the conduct, progress\ \ and monitoring of the studies supported by the award.\n \n \n Fostering\ \ collaborations between AADCRCs.\n \n \n \n \n Dispute Resolution:\n\ \ \n \n \n Any disagreements that may arise in scientific or programmatic\ \ matters (within the scope of the award) between recipients and NIH may be brought\ \ to Dispute Resolution. A Dispute Resolution Panel composed of three members\ \ will be convened: a designee of the Steering Committee chosen without NIH staff\ \ voting, one NIH designee, and a third designee with expertise in the relevant\ \ area who is chosen by the other two; in the case of individual disagreement,\ \ the first member may be chosen by the individual recipient. This special dispute\ \ resolution procedure does not alter the recipient's right to appeal an adverse\ \ action that is otherwise appealable in accordance with PHS regulation 42 CFR\ \ Part 50, Subpart D and HHS regulation 45 CFR Part 16.\n \n \n \n \n 3.\ \ Data Management and Sharing\n \n \n Consistent with the 2023 NIH Policy\ \ for Data Management and Sharing, when data management and sharing is applicable\ \ to the award, recipients will be required to adhere to the Data Management and\ \ Sharing requirements as outlined in the\n \n NIH Grants Policy Statement\n\ \ \n . Upon the approval of a Data Management and Sharing Plan, it is required\ \ for recipients to implement the plan as described.\n \n \n \n 4. Reporting\n\ \ \n \n When multiple years are involved, recipients will be required to\ \ submit the\n \n Research Performance Progress Report (RPPR)\n \ \ \n annually and financial statements as required in the\n \n \ \ NIH Grants Policy Statement Section 8.4.1 Reporting\n \n . To learn\ \ more about post-award monitoring and reporting, see the NIH Grants & Funding\ \ website, see\n \n Post-Award Monitoring and Reporting\n \n \ \ .\n \n \n \n \n \n Progress reports should briefly describe status\ \ of pilot projects, including data and safety monitoring, and should notify NIH\ \ of serious adverse events and unanticipated problems.\n \n \n \n \n A\ \ final RPPR, invention statement, and the expenditure data portion of the Federal\ \ Financial Report are required for closeout of an award, as described in the\n\ \ \n NIH Grants Policy Statement Section 8.6 Closeout\n \n . NIH\ \ NOFOs outline intended research goals and objectives. Post award, NIH will review\ \ and measure performance based on the details and outcomes that are shared within\ \ the RPPR, as described at 2 CFR Part 200.301." - "RFA-AI-24-079: Asthma and Allergic Diseases Cooperative Research Centers (U19\ \ Clinical Trial Optional) Section IV. Application and Submission Information\n\ \ \n \n \n \n 1. Requesting an Application Package\n \n \n The application\ \ forms package specific to this opportunity must be accessed through ASSIST or\ \ an institutional system-to-system solution. A button to apply using ASSIST is\ \ available in Part 1 of this NOFO. See the administrative office for instructions\ \ if planning to use an institutional system-to-system solution.\n \n \n \n\ \ \n 2. Content and Form of Application Submission\n \n \n It is critical\ \ that applicants follow the Multi-Project (M) Instructions in the\n \n \ \ How to Apply - Application Guide\n \n , except where instructed in\ \ this notice of funding opportunity to do otherwise and where instructions in\ \ the\n \n How to Apply - Application Guide\n \n are directly related\ \ to the Grants.gov downloadable forms currently used with most NIH opportunities.\ \ Conformance to the requirements in the\n \n How to Apply - Application\ \ Guide\n \n is required and strictly enforced. Applications that are out\ \ of compliance with these instructions may be delayed or not accepted for review.\n\ \ \n \n \n \n Letter of Intent\n \n \n Although a letter of intent\ \ is not required, is not binding, and does not enter into the review of a subsequent\ \ application, the information that it contains allows IC staff to estimate the\ \ potential review workload and plan the review.\n \n \n By the date listed\ \ in\n \n Part 1. Overview Information\n \n , prospective applicants\ \ are asked to submit a letter of intent that includes the following information:\n\ \ \n \n \n Descriptive title of proposed activity\n \n \n Name(s),\ \ address(es), and telephone number(s) of the PD(s)/PI(s)\n \n \n Names\ \ of other key personnel\n \n \n Participating institution(s)\n \n\ \ \n Number and title of this funding opportunity\n \n \n \n The letter\ \ of intent should be sent to:\n \n \n Poonam Tewary, PhD\n \n Telephone:\ \ 240-532-9777\n \n Email:\n \n \n [email protected]\n \n\ \ \n \n \n \n \n \n Page Limitations\n \n \n All page limitations described\ \ in the\n \n How to Apply- Application Guide\n \n and the\n \ \ \n Table of Page Limits\n \n must be followed.\n \n \n \n \n\ \ \n \n \n Component\n \n \n Component Type for Submission\n\ \ \n \n Page Limit\n \n \n Required/Optional\n \n\ \ \n Minimum\n \n \n Maximum\n \n \n \n \n \n \n \ \ Overall\n \n \n Overall\n \n \n 12\n \n \n \ \ Required\n \n \n 1\n \n \n 1\n \n \n \n \n\ \ Admin Core\n \n \n Admin Core\n \n \n 6\n \ \ \n \n Required\n \n \n 1\n \n \n 1\n \n\ \ \n \n \n Data Stewardship Core\n \n \n Data Core\n \n\ \ \n 6\n \n \n Required\n \n \n 1\n \n \n\ \ 1\n \n \n \n \n Clinical Core\n \n \n Clinical\ \ Core\n \n \n 6\n \n \n Optional\n \n \n \ \ 0\n \n \n 1\n \n \n \n \n Scientific Core\n \n\ \ \n Scientific Core\n \n \n 6\n \n \n Optional\n\ \ \n \n 0\n \n \n 2\n \n \n \n \n Research\ \ Project\n \n \n Project\n \n \n 12\n \n \n \ \ Required\n \n \n 2\n \n \n NA\n \n \n \n \n\ \ \n \n \n Instructions for the Submission of Multi-Component Applications\n\ \ \n \n \n \n The following section supplements the instructions found in\n\ \ \n How to Apply- Application Guide\n \n and should be used for\ \ preparing a multi-component application.\n \n \n \n \n The application\ \ should consist of the following components:\n \n \n Overall: required,\ \ 1\n \n \n \n Administrative Core: required, 1\n \n \n Data Stewardship\ \ Core: required: 1, the Data Stewardship Core must support all Research Projects,\ \ and will support other Scientific/Clinical Core(s), as needed\n \n \n \ \ Clinical Core: optional, maximum 1, the Clinical Core must support at least\ \ two Research Projects\n \n \n Scientific Core: optional, maximum 2,\ \ each Scientific Core must support at least two Research Projects\n \n \n\ \ Research Projects: required, minimum 2, no maximum\n \n \n \n \n \n\ \ Overall Component\n \n \n When preparing the application, use Component\ \ Type ‘Overall’.\n \n \n All instructions in the\n \n How to Apply\ \ - Application Guide\n \n must be followed, with the following additional\ \ instructions, as noted.\n \n \n \n \n SF424(R&R) Cover (Overall)\n \ \ \n \n Complete entire form.\n \n \n \n \n PHS 398 Cover Page Supplement\ \ (Overall)\n \n \n Note: Human Embryonic Stem Cell lines from other components\ \ should be repeated in cell line table in Overall component.\n \n \n \n \n\ \ Research & Related Other Project Information (Overall)\n \n \n Follow\ \ standard instructions.\n \n \n \n \n Project/Performance Site Locations\ \ (Overall)\n \n \n Enter primary site only.\n \n \n \n \n \n A summary\ \ of Project/Performance Sites in the Overall section of the assembled application\ \ image in eRA Commons compiled from data collected in the other components will\ \ be generated upon submission.\n \n \n \n \n \n Research and Related Senior/Key\ \ Person Profile (Overall)\n \n \n Include only the Project Director/Principal\ \ Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for\ \ the entire application.\n \n \n \n \n \n A summary of Senior/Key Persons\ \ followed by their Biographical Sketches in the Overall section of the assembled\ \ application image in eRA Commons will be generated upon submission.\n \n\ \ \n \n \n \n Budget (Overall)\n \n \n The only budget information included\ \ in the Overall component is the Estimated Project Funding section of the SF424\ \ (R&R) Cover.\n \n \n \n \n \n A budget summary in the Overall section\ \ of the assembled application image in eRA Commons compiled from detailed budget\ \ data collected in the other components will be generated upon submission.\n\ \ \n \n \n \n \n PHS 398 Research Plan (Overall)\n \n \n \n \n \n \ \ Specific Aims:\n \n List in priority order, the broad, long-range objectives\ \ and goals of the proposed Center. Concisely describe the hypothesis or hypotheses\ \ to be tested.\n \n \n \n \n \n Research Strategy:\n \n Describe\ \ the focus of the research Center. This narrative section should summarize the\ \ overall research strategy for the multi-component application. The multi-component\ \ application should be viewed as a confederation of interrelated Research Projects,\ \ each capable of standing on its own scientific merit, but complementary to one\ \ another. This is an important section, for it provides the group of investigators\ \ an opportunity to give conceptual wholeness to the overall Center by giving\ \ a statement of the general problem area and by laying out a broad strategy for\ \ attacking the problem. As the strategy develops, each Research Project and Core\ \ should be cited briefly as to its place in the overall scheme. To help achieve\ \ the NOFO’s objective, it is recommended, but not required, to draft the applications\ \ along the lines of either of the two models: the Pathway Focus (Model A) or\ \ Clinical Intervention/Observation Focus (Model B) as described under Part 2,\ \ Section I.\n \n \n To highlight Center synergy, describe how the individual\ \ components will be coordinated and work together to address the overall goals\ \ and aims of the Center. Include a schematic overview of the interactions and\ \ collaborations among the components and indicate collaborations among members\ \ and relevant publications co-authored by members of the Center. Center synergy\ \ may also be addressed in other sections of the application, as appropriate.\ \ Discuss the role of all Research Projects and Cores in the Overall Research\ \ Strategy of the application. Describe how the integration of the individual\ \ Research Projects into a single Center benefits the objectives more than pursuing\ \ each project independently. For renewal applications, describe the impact that\ \ the Center’s prior accomplishments have had on the field of asthma and/or allergic\ \ disease.\n \n \n For individual Research Projects and Cores that will\ \ be continued as part of a renewal application, additional details of progress\ \ made during the prior funding period should be provided in the Research Strategy\ \ within each Research Project and/or Core.\n \n \n \n \n \n \n \n \n \n \ \ Resource Sharing Plan\n \n :\n \n Individuals are required to\ \ comply with the instructions for the Resource Sharing Plans as provided in the\n\ \ \n How to Apply - Application Guide\n \n .\n \n \n \n \n \n\ \ Other Plan(s):\n \n \n \n All instructions in the\n \n How\ \ to Apply- Application Guide\n \n must be followed, with the following\ \ additional instructions:\n \n \n \n \n \n All applicants planning research\ \ (funded or conducted in whole or in part by NIH) that results in the generation\ \ of scientific data are required to comply with the instructions for the Data\ \ Management and Sharing Plan. All applications, regardless of the amount of direct\ \ costs requested for any one year, must address a Data Management and Sharing\ \ Plan.\n \n \n Recipients are encouraged to deposit data into the\n \ \ \n ImmPort database\n \n .\n \n \n \n \n \n \n Appendix:\n\ \ \n \n \n Only limited items are allowed in the Appendix. Follow all instructions\ \ for the Appendix as described in\n \n How to Apply- Application Guide\n\ \ \n ; any instructions provided here are in addition to the\n \n \ \ How to Apply - Application Guide\n \n instructions.\n \n \n \n\ \ \n PHS Human Subjects and Clinical Trials Information (Overall)\n \n \n\ \ When involving human subjects research, clinical research, and/or NIH-defined\ \ clinical trials follow all instructions for the PHS Human Subjects and Clinical\ \ Trials Information form in the\n \n How to Apply - Application Guide\n\ \ \n , with the following additional instructions:\n \n \n If you\ \ answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other\ \ Project Information form, there must be at least one human subjects study record\ \ using the\n \n Study Record: PHS Human Subjects and Clinical Trials\ \ Information\n \n form or a\n \n Delayed Onset Study\n \n\ \ record within the application. The study record(s) must be included in the\ \ component(s) where the work is being done, unless the same study spans multiple\ \ components. To avoid the creation of duplicate study records, a single study\ \ record with sufficient information for all involved components must be included\ \ in the Overall component when the same study spans multiple components.\n \ \ \n \n \n Study Record: PHS Human Subjects and Clinical Trials Information\n\ \ \n \n \n All instructions in the\n \n How to Apply - Application\ \ Guide\n \n must be followed.\n \n \n \n \n \n Delayed Onset Study\n\ \ \n \n \n Note:\n \n Delayed onset\n \n does NOT apply\ \ to a study that can be described but will not start immediately (i.e., delayed\ \ start). All instructions in the\n \n How to Apply- Application Guide\n\ \ \n must be followed.\n \n \n \n \n PHS Assignment Request Form\ \ (Overall)\n \n \n All instructions in the\n \n How to Apply- Application\ \ Guide\n \n must be followed.\n \n \n \n \n \n Administrative Core\n\ \ \n \n \n When preparing your application, use Component Type ‘Admin Core.’\n\ \ \n \n All instructions in the\n \n How to Apply- Application Guide\n\ \ \n must be followed, with the following additional instructions, as noted.\n\ \ \n \n \n SF424 (R&R) Cover (Administrative Core)\n \n \n \n Complete\ \ only the following fields:\n \n \n \n Applicant Information\n \n\ \ \n Type of Applicant (optional)\n \n \n Descriptive Title of Applicant’s\ \ Project\n \n \n Proposed Project Start/Ending Dates\n \n \n \n \n\ \ PHS 398 Cover Page Supplement (Administrative Core)\n \n \n \n Enter\ \ Human Embryonic Stem Cells in each relevant component.\n \n \n \n Research\ \ & Related Other Project Information (Administrative Core)\n \n \n \n \n\ \ Human Subjects:\n \n Answer only the ‘Are Human Subjects Involved?’\ \ and 'Is the Project Exempt from Federal regulations?’ questions.\n \n \n\ \ \n Vertebrate Animals:\n \n Answer only the ‘Are Vertebrate Animals\ \ Used?’ question.\n \n \n \n Project Narrative:\n \n Do not complete.\ \ Note: ASSIST screens will show an asterisk for this attachment indicating it\ \ is required. However, eRA systems only enforce this requirement in the Overall\ \ component and applications will not receive an error if omitted in other components.\n\ \ \n \n \n Project/Performance Site Location(s) (Administrative Core)\n\ \ \n \n \n List all performance sites that apply to the specific component.\n\ \ \n \n \n Note: The Project Performance Site form allows up to 300 sites,\ \ prior to using additional attachment for additional entries.\n \n \n \n\ \ \n Research & Related Senior/Key Person Profile (Administrative Core)\n\ \ \n \n \n \n In the Project Director/Principal Investigator section of\ \ the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide\ \ a valid eRA Commons ID in the Credential field.\n \n \n In the additional\ \ Senior/Key Profiles section, list Senior/Key persons that are working in the\ \ component.\n \n \n Include a single Biographical Sketch for each Senior/Key\ \ person listed in the application regardless of the number of components in which\ \ they participate. When a Senior/Key person is listed in multiple components,\ \ the Biographical Sketch can be included in any one component.\n \n \n \ \ If more than 100 Senior/Key persons are included in a component, the Additional\ \ Senior Key Person attachments should be used.\n \n \n For institutions/organizations\ \ proposing a single PD/PI, the PD/PI will serve as the Administrative Core Lead.\ \ For institutions/organizations proposing multiple PD(s)/PI(s), the Contact PD/PI\ \ must serve as the Administrative Core Lead.\n \n \n \n \n Budget (Administrative\ \ Core)\n \n \n \n Budget forms appropriate for the specific component\ \ will be included in the application package.\n \n \n In the budget, include\ \ funding for the overall administrative efforts, administrative services, expenses\ \ for publications demonstrating collaborative efforts, and communication expenses.\n\ \ \n \n \n Infrastructure and Opportunity Fund (IOF)\n \n : Propose\ \ funds for the IOF within the Administrative Core component; the IOF budget is\ \ not expected to exceed $350K in direct costs. This will be awarded to one recipient\ \ organization that will be selected by NIAID post-award to manage the fund. Include\ \ IOF costs as a single line item in the Other Direct Costs Category of the Administrative\ \ Core Budget. A part of the IOF budget, direct costs proposed for an IOF administrator\ \ may be requested in the Personnel category for a maximum of 0.5 person months\ \ and must comply with NIH grants policy. F&A Costs will be applied in accordance\ \ with NIH grants policy.\n \n \n Include travel funds for the PD(s)/PI(s)\ \ and subproject PD(s)/PI(s) to attend an annual AADCRC Scientific and Steering\ \ Committee meeting. The two-day meeting will be held each year in or near Rockville,\ \ Maryland.\n \n \n \n Note: The R&R Budget form included in many of the\ \ component types allows for up to 100 Senior/Key Persons in section A and 100\ \ Equipment Items in section C prior to using attachments for additional entries.\ \ All other SF424 (R&R) instructions apply.\n \n \n \n \n PHS 398 Research\ \ Plan (Administrative Core)\n \n \n \n \n Specific Aims:\n \n \ \ List in priority order the proposed activities and services of the Administrative\ \ Core. Describe the work to be completed to address issues of Center coordination,\ \ communication, management, and administering the IOF. Testing of scientific\ \ hypotheses should not be proposed within a Core.\n \n \n \n Research\ \ Strategy:\n \n A fully developed and well-described Administrative Core\ \ plan is required.\n \n \n Describe and justify the operational plan and\ \ organizational structure of the proposed multi-component application. Include\ \ plans on how the PD(s)/PI(s) will interact and coordinate with Project/Core\ \ Leaders to identify and resolve problems and establish a strong collaborative\ \ environment for the Center. Provide an administrative plan that includes a discussion\ \ of the structure and roles of administrative staff, including the functions\ \ to be performed; how fiscal and other resources will be prioritized, allocated,\ \ and managed; how communications, group meetings, and teleconferences will be\ \ facilitated; how conflict resolution will be attained; and how research related\ \ travel and training will be managed. Describe how the Core’s administrative,\ \ management, and leadership capabilities provide for: internal quality control\ \ of on-going research, management of day-to-day program activities, management\ \ of contractual agreements, fair communication and cooperation among program\ \ leaders and/or program investigators, and development of scientific meetings,\ \ as applicable. Present a leadership succession plan.\n \n \n Provide a\ \ plan to administer the AADCRC Infrastructure and Opportunity Fund (IOF), including\ \ fund disbursement, administration, and reports. Within the plan, address the\ \ following: establishing an administrative structure to manage the IOF; disbursing\ \ and tracking IOF funds under the direction of the Steering Committee; implementing\ \ plans for interacting with the institutions that will receive IOF funds, including\ \ establishing consortium agreements when applicable; and establishing procedures,\ \ formats, and timelines for reporting on the status of IOF projects and expenditures\ \ to the NIAID and the AADCRC Steering Committee.\n \n \n \n External Advisory\ \ Group (optional)\n \n : If an EAG is proposed for an individual Center,\ \ then describe the expertise and responsibilities of the potential members. Discuss\ \ how the individual Center Research Projects will be supported by the EAG.\n\ \ \n \n For a new application,\n \n do not\n \n contact\ \ or name potential members in the application\n \n .\n \n For\ \ a renewal application with an EAG already established, provide the names only\ \ of current EAG members in the application.\n \n \n \n Resource Sharing\ \ Plan:\n \n Individuals are required to comply with the instructions for\ \ the Resource Sharing Plans as provided in the\n \n How to Apply - Application\ \ Guide\n \n .\n \n \n \n Appendix:\n \n \n \n Only limited\ \ items are allowed in the Appendix. Follow all instructions for the\n \n\ \ How to Apply - Application Guide\n \n ; any instructions provided\ \ here are in addition to those in the\n \n How to Apply - Application\ \ Guide\n \n instructions.\n \n \n \n PHS Human Subjects and Clinical\ \ Trials Information (Administrative Core)\n \n \n \n When involving human\ \ subjects research, clinical research, and/or NIH-defined clinical trials follow\ \ all instructions for the PHS Human Subjects and Clinical Trials Information\ \ form in the\n \n How to Apply - Application Guide,\n \n with\ \ the following additional instructions:\n \n \n If you answered “Yes” to\ \ the question “Are Human Subjects Involved?” on the R&R Other Project Information\ \ form, you must include at least one human subjects study record using the\n\ \ \n Study Record: PHS Human Subjects and Clinical Trials Information\n\ \ \n form or a\n \n Delayed Onset Study\n \n record.\n \ \ \n \n \n Study Record: PHS Human Subjects and Clinical Trials Information\n\ \ \n \n \n All instructions in the\n \n How to Apply - Application\ \ Guide\n \n must be followed.\n \n \n \n Delayed Onset Study\n\ \ \n \n \n Note:\n \n Delayed onset\n \n does NOT apply\ \ to a study that can be described but will not start immediately (i.e., delayed\ \ start). All instructions in the\n \n How to Apply - Application Guide\n\ \ \n must be followed.\n \n \n \n Data Stewardship Core\n \n\ \ \n \n When preparing your application, use Component Type ‘Data Core.’\n\ \ \n \n All instructions in the\n \n How to Apply - Application\ \ Guide\n \n must be followed, with the following additional instructions,\ \ as noted.\n \n \n \n SF424 (R&R) Cover (Data Stewardship Core)\n \ \ \n \n \n Complete only the following fields:\n \n \n \n Applicant\ \ Information\n \n \n Type of Applicant (optional)\n \n \n Descriptive\ \ Title of Applicant’s Project\n \n \n Proposed Project Start/Ending Dates\n\ \ \n \n \n \n PHS 398 Cover Page Supplement (Data Stewardship Core)\n\ \ \n \n \n Enter Human Embryonic Stem Cells in each relevant component.\n\ \ \n \n \n Research & Related Other Project Information (Data Stewardship\ \ Core)\n \n \n \n \n Human Subjects:\n \n Answer only the ‘Are\ \ Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’\ \ questions.\n \n \n \n Vertebrate Animals:\n \n Answer only the\ \ ‘Are Vertebrate Animals Used?’ question.\n \n \n \n Project Narrative:\n\ \ \n Do not complete. Note: ASSIST screens will show an asterisk for this\ \ attachment indicating it is required. However, eRA systems only enforce this\ \ requirement in the Overall component and applications will not receive an error\ \ if omitted in other components.\n \n \n \n Facilities & Other Resources:\n\ \ \n Describe the facilities provided by the Core, as applied to procedures\ \ and techniques provided, as well as quality control.\n \n \n \n Project/Performance\ \ Site Location(s) (Data Stewardship Core)\n \n \n \n List all performance\ \ sites that apply to the specific component.\n \n \n \n Note: The Project\ \ Performance Site form allows up to 300 sites, prior to using additional attachment\ \ for additional entries.\n \n \n \n \n Research & Related Senior/Key\ \ Person Profile (Data Stewardship Core)\n \n \n \n \n In the Project\ \ Director/Principal Investigator section of the form, use Project Role of ‘Other’\ \ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential\ \ field.\n \n \n In the additional Senior/Key Profiles section, list Senior/Key\ \ persons that are working in the component.\n \n \n Include a single\ \ Biographical Sketch for each Senior/Key person listed in the application regardless\ \ of the number of components in which they participate. When a Senior/Key person\ \ is listed in multiple components, the Biographical Sketch can be included in\ \ any one component.\n \n \n If more than 100 Senior/Key persons are included\ \ in a component, the Additional Senior Key Person attachments should be used.\n\ \ \n \n \n \n Budget (Data Stewardship Core)\n \n \n \n Budget\ \ forms appropriate for the specific component will be included in the application\ \ package.\n \n \n Request funds to support central data management (database\ \ establishment, data management and cleaning, data storage, database security)\ \ for the entire awarded U19 Cooperative Agreement to all researchers within the\ \ applicant group.\n \n \n In case the statistical design and analysis of\ \ data for at least two Research Projects is to be conducted by this Core, request\ \ funds to support appropriate biostatistical personnel and equipment use effort.\n\ \ \n \n Request funds to support the required timely submission of data,\ \ meta-data and data analyses to the ImmPort database or other public databases\ \ as appropriate.\n \n \n The percentage of total funds that will be required\ \ to support each component Research Project or Core that will utilize the Data\ \ Stewardship Core should also be presented. This information should be included\ \ in the Core’s budget justification for Year 1.\n \n \n For all clinical\ \ trials, NIAID will provide a Data and Safety Monitoring Board (DSMB). Therefore,\ \ the applicant does not need to include or budget for DSMB expenses.\n \n\ \ \n \n Note: The R&R Budget form included in many of the component types\ \ allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items\ \ in section C prior to using attachments for additional entries. All other SF424\ \ (R&R) instructions apply.\n \n \n \n \n PHS 398 Research Plan (Data\ \ Stewardship Core)\n \n \n \n \n Specific Aims:\n \n List in priority\ \ order the broad, long-range activities and services of the proposed Core. In\ \ addition, state the Core’s relationship to the Center’s goals and how the Core\ \ relates to all the activities of individual Research Projects in the application.\ \ Testing of scientific hypotheses should not be proposed within a Core.\n \ \ \n \n \n Research Strategy:\n \n \n \n Describe and justify the overall\ \ function of the required Data Stewardship Core. Describe how the services of\ \ this Core (including procedures, techniques and quality control) will support\ \ all proposed Research Projects and Scientific and/or Clinical Cores, and advance\ \ the outcomes from the proposed research Center.\n \n \n Describe how the\ \ Data Stewardship Core will facilitate the harmonization of data collection and\ \ analysis services across all Research Projects and Scientific/Clinical Cores,\ \ as needed.\n Discuss how the Core will support data management by providing\ \ appropriate team expertise. Describe the plans for development of harmonized\ \ protocols, including selection and use of common data elements, if applicable.\ \ Explain the processes, procedures, methods and plans to provide bioinformatics\ \ infrastructure support for Center-wide database establishment, data cleaning\ \ and tracking, information management, curation, data monitoring, data storage\ \ and quality control. Outline how the Core will promote the exchange of information\ \ among all recipients of this NOFO.\n \n \n If the Data Stewardship Core\ \ will support the statistical design and data analyses for Research Projects\ \ and/or a Clinical or Scientific Core, provide general descriptions of statistical\ \ approaches to be used. However, specific statistical analyses addressing scientific\ \ hypotheses should be described within each of the Research Projects or within\ \ the Clinical or Scientific Core, whichever is applicable.\n \n \n Note\ \ that information requested here for this Core should not duplicate the information\ \ provided in the Data Management and Sharing Plan. Place information regarding\ \ plans to comply with the NIH Data Management and Sharing Policy in the Data\ \ Management and Sharing Plan attachment in the “Other Plan(s)” section of the\ \ Overall component.\n \n \n \n Note\n \n : Specific details for\ \ clinical trials and studies will be captured using the PHS Human Subjects and\ \ Clinical Trials Information Form. Do not duplicate information requested under\ \ the PHS Human Subjects and Clinical Trials Information Forms.\n \n \n \n\ \ Resource Sharing Plan:\n \n Individuals are required to comply with\ \ the instructions for the Resource Sharing Plans as provided in the\n \n\ \ How to Apply - Application Guide\n \n .\n \n \n \n Appendix:\n\ \ \n \n \n Only limited items are allowed in the Appendix. Follow all instructions\ \ for the\n \n How to Apply- Application Guide\n \n ; any instructions\ \ provided here are in addition to those in the\n \n How to Apply- Application\ \ Guide\n \n instructions.\n \n \n \n PHS Human Subjects and Clinical\ \ Trials Information (Data Stewardship Core)\n \n \n \n When involving\ \ human subjects research, clinical research, and/or NIH-defined clinical trials\ \ follow all instructions for the PHS Human Subjects and Clinical Trials Information\ \ form in the\n \n How to Apply- Application Guide,\n \n with the\ \ following additional instructions:\n \n \n If you answered “Yes” to the\ \ question “Are Human Subjects Involved?” on the R&R Other Project Information\ \ form, you must include at least one human subjects study record using the\n\ \ \n Study Record: PHS Human Subjects and Clinical Trials Information\n\ \ \n form or a\n \n Delayed Onset Study\n \n record.\n \ \ \n \n \n Study Record: PHS Human Subjects and Clinical Trials Information\n\ \ \n \n \n All instructions in the\n \n How to Apply- Application\ \ Guide\n \n must be followed.\n \n \n \n Delayed Onset Study\n\ \ \n \n \n Note:\n \n Delayed onset\n \n does NOT apply\ \ to a study that can be described but will not start immediately (i.e., delayed\ \ start). All instructions in the\n \n How to Apply- Application Guide\n\ \ \n must be followed.\n \n \n \n Clinical Core\n \n \n \n \ \ When preparing your application, use Component Type ‘Clinical Core.’\n \ \ \n \n All instructions in the\n \n How to Apply- Application Guide\n\ \ \n must be followed, with the following additional instructions, as noted.\n\ \ \n \n \n SF424 (R&R) Cover (Clinical Core)\n \n \n \n Complete\ \ only the following fields:\n \n \n \n Applicant Information\n \n\ \ \n Type of Applicant (optional)\n \n \n Descriptive Title of Applicant’s\ \ Project\n \n \n Proposed Project Start/Ending Dates\n \n \n \n \n\ \ PHS 398 Cover Page Supplement (Clinical Core)\n \n \n \n Enter Human\ \ Embryonic Stem Cells in each relevant component.\n \n \n \n Research\ \ & Related Other Project Information (Clinical Core)\n \n \n \n \n Human\ \ Subjects:\n \n Answer only the ‘Are Human Subjects Involved?’ and 'Is\ \ the Project Exempt from Federal regulations?’ questions.\n \n \n \n Vertebrate\ \ Animals:\n \n Answer only the ‘Are Vertebrate Animals Used?’ question.\n\ \ \n \n \n Project Narrative:\n \n Do not complete. Note: ASSIST\ \ screens will show an asterisk for this attachment indicating it is required.\ \ However, eRA systems only enforce this requirement in the Overall component\ \ and applications will not receive an error if omitted in other components.\n\ \ \n \n \n Facilities & Other Resources:\n \n Describe the facilities\ \ provided by the Core, as applied to procedures and techniques provided, as well\ \ as quality control.\n \n \n \n Project/Performance Site Location(s) (Clinical\ \ Core)\n \n \n \n List all performance sites that apply to the specific\ \ component.\n \n \n \n Note: The Project Performance Site form allows\ \ up to 300 sites, prior to using additional attachment for additional entries.\n\ \ \n \n \n \n Research & Related Senior/Key Person Profile (Clinical Core)\n\ \ \n \n \n \n In the Project Director/Principal Investigator section of\ \ the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide\ \ a valid eRA Commons ID in the Credential field.\n \n \n In the additional\ \ Senior/Key Profiles section, list Senior/Key persons that are working in the\ \ component.\n \n \n Include a single Biographical Sketch for each Senior/Key\ \ person listed in the application regardless of the number of components in which\ \ they participate. When a Senior/Key person is listed in multiple components,\ \ the Biographical Sketch can be included in any one component.\n \n \n \ \ If more than 100 Senior/Key persons are included in a component, the Additional\ \ Senior Key Person attachments should be used.\n \n \n Within the biosketches,\ \ highlight the expertise of the Clinical Core Lead to guide and/or assist in\ \ the development and preparation of documentation required for clinical research,\ \ as well as experience with regulatory activities, including IND/IDE submissions\ \ (if applicable), recruitment and retention of study participants, medical monitoring,\ \ and safety oversight and reporting.\n \n \n \n \n Budget (Clinical Core)\n\ \ \n \n \n Budget forms appropriate for the specific component will be\ \ included in the application package.\n \n \n For Year 1, outline the percentage\ \ of total funds that will be required to support each component Research Project\ \ that will utilize the Clinical Core\n \n \n If a clinical trial is proposed,\ \ include costs for a medical monitor.\n \n \n For all clinical trials,\ \ NIAID will provide a Data and Safety Monitoring Board (DSMB). Therefore, do\ \ not include or budget for DSMB expenses.\n \n \n \n Note: The R&R Budget\ \ form included in many of the component types allows for up to 100 Senior/Key\ \ Persons in section A and 100 Equipment Items in section C prior to using attachments\ \ for additional entries. All other SF424 (R&R) instructions apply.\n \n \n\ \ \n \n PHS 398 Research Plan (Clinical Core)\n \n \n \n \n Specific\ \ Aims:\n \n List in priority order the broad, long-range activities and\ \ services of the proposed Clinical Core. In addition, state the Core’s relationship\ \ to the Center’s goals and how the Core relates to two or more individual Research\ \ Projects in the application. Testing of scientific hypotheses should not be\ \ proposed within a Core.\n \n \n \n Research Strategy:\n \n \n \n\ \ Describe how the Clinical Core will support at least one of two purposes:\ \ 1) recruit and characterize human subjects and collect appropriate biosamples\ \ in support of at least two Research Project(s), and/or 2) conduct one or more\ \ single-site pilot clinical trials or clinical studies in support of at least\ \ two Research Projects.\n \n \n \n Describe how the proposed Clinical\ \ Core activities will contribute to meeting the Center’s goals and objectives\ \ and explain why the Core resources are not otherwise available.\n \n \n\ \ Describe how resource utilization will be allocated and/or prioritized,\ \ if applicable, to support the Center. Indicate the specific projects to be supported\ \ by the Clinical Core.\n \n \n Describe the services provided by the\ \ Core (including procedures, techniques, and quality control).\n \n \n \n\ \ If the Clinical Core proposes single site pilot clinical trials and/or studies\ \ designed only to collect and provide samples for two or more Research Projects,\ \ describe the following aspects of the proposed trial(s)/study(ies):\n \n\ \ \n \n Discuss the rationale and process for the selection, recruitment and\ \ retention of the participant population, choice of intervention (if applicable),\ \ choice of study sites, duration, plans for trial management and schedule of\ \ events.\n \n \n Discuss the trial/study's feasibility, difficulties\ \ that may be encountered, and offer alternative approaches to be implemented,\ \ if needed, include general concepts for sample size determinations and statistical\ \ methodologies, but, particularly for pilot clinical trials, provide study-specific\ \ details in the PHS Human Subjects and Clinical Trial Information Forms.\n \ \ \n \n \n \n Note:\n \n If a clinical trial/study is included in\ \ a Research Project (and not as a Clinical Core), then the above information\ \ should appear as part of that Research Project.\n \n \n \n Note:\n \ \ \n Specific details for trials and studies will be captured using the PHS\ \ Human Subjects and Clinical Trials Information Form. Do not duplicate information\ \ requested under the PHS Human Subjects and Clinical Trials Information Forms.\n\ \ \n \n \n Resource Sharing Plan:\n \n Individuals are required\ \ to comply with the instructions for the Resource Sharing Plans as provided in\ \ the\n \n How to Apply- Application Guide\n \n .\n \n \n \n\ \ Appendix:\n \n \n \n Only limited items are allowed in the Appendix.\ \ Follow all instructions for the\n \n How to Apply- Application Guide\n\ \ \n ; any instructions provided here are in addition to those in the\n\ \ \n How to Apply- Application Guide\n \n instructions.\n \n\ \ \n \n PHS Human Subjects and Clinical Trials Information (Clinical Core)\n\ \ \n \n \n When involving human subjects research, clinical research, and/or\ \ NIH-defined clinical trials follow all instructions for the PHS Human Subjects\ \ and Clinical Trials Information form in the\n \n How to Apply- Application\ \ Guide,\n \n with the following additional instructions:\n \n \n \ \ If you answered “Yes” to the question “Are Human Subjects Involved?” on the\ \ R&R Other Project Information form, you must include at least one human subjects\ \ study record using the\n \n Study Record: PHS Human Subjects and Clinical\ \ Trials Information\n \n form or a\n \n Delayed Onset Study\n\ \ \n record.\n \n \n \n Study Record: PHS Human Subjects and Clinical\ \ Trials Information\n \n \n \n All instructions in the\n \n How\ \ to Apply- Application Guide\n \n must be followed.\n \n \n \n \ \ Delayed Onset Study\n \n \n \n Note:\n \n Delayed onset\n \ \ \n does NOT apply to a study that can be described but will not start immediately\ \ (i.e., delayed start). All instructions in the\n \n How to Apply- Application\ \ Guide\n \n must be followed.\n \n \n \n Scientific Core\n \ \ \n \n \n When preparing your application, use Component Type ‘Scientific\ \ Core.’\n \n \n All instructions in the\n \n How to Apply- Application\ \ Guide\n \n must be followed, with the following additional instructions,\ \ as noted.\n \n \n \n SF424 (R&R) Cover (Scientific Core)\n \n \n\ \ \n Complete only the following fields:\n \n \n \n Applicant Information\n\ \ \n \n Type of Applicant (optional)\n \n \n Descriptive Title\ \ of Applicant’s Project\n \n \n Proposed Project Start/Ending Dates\n\ \ \n \n \n \n PHS 398 Cover Page Supplement (Scientific Core)\n \n\ \ \n \n Enter Human Embryonic Stem Cells in each relevant component.\n \n\ \ \n \n Research & Related Other Project Information (Scientific Core)\n \ \ \n \n \n \n Human Subjects:\n \n Answer only the ‘Are Human Subjects\ \ Involved?’ and ‘Is the Project Exempt from Federal regulations?’ questions.\n\ \ \n \n \n Vertebrate Animals:\n \n Answer only the ‘Are Vertebrate\ \ Animals Used?’ question.\n \n \n \n Project Narrative:\n \n Do\ \ not complete. Note: ASSIST screens will show an asterisk for this attachment\ \ indicating it is required. However, eRA systems only enforce this requirement\ \ in the Overall component and applications will not receive an error if omitted\ \ in other components.\n \n \n \n Facilities & Other Resources:\n \n\ \ Describe the facilities provided by the Core, as applied to procedures and\ \ techniques provided, as well as quality control.\n \n \n \n Project/Performance\ \ Site Location(s) (Scientific Core)\n \n \n \n List all performance sites\ \ that apply to the specific component.\n \n \n \n Note: The Project Performance\ \ Site form allows up to 300 sites, prior to using additional attachment for additional\ \ entries.\n \n \n \n \n Research & Related Senior/Key Person Profile\ \ (Scientific Core)\n \n \n \n \n In the Project Director/Principal Investigator\ \ section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’\ \ and provide a valid eRA Commons ID in the Credential field.\n \n \n \ \ In the additional Senior/Key Profiles section, list Senior/Key persons that\ \ are working in the component.\n \n \n Include a single Biographical\ \ Sketch for each Senior/Key person listed in the application regardless of the\ \ number of components in which they participate. When a Senior/Key person is\ \ listed in multiple components, the Biographical Sketch can be included in any\ \ one component.\n \n \n If more than 100 Senior/Key persons are included\ \ in a component, the Additional Senior Key Person attachments should be used.\n\ \ \n \n \n \n Budget (Scientific Core)\n \n \n \n Budget forms\ \ appropriate for the specific component will be included in the application package.\n\ \ \n \n For Year 1, outline the percentage of total funds that will be required\ \ to support each component Research Project that will utilize the Scientific\ \ Core.\n \n \n \n Note: The R&R Budget form included in many of the component\ \ types allows for up to 100 Senior/Key Persons in section A and 100 Equipment\ \ Items in section C prior to using attachments for additional entries. All other\ \ SF424 (R&R) instructions apply.\n \n \n \n \n PHS 398 Research Plan\ \ (Scientific Core)\n \n \n \n \n Specific Aims:\n \n \n \n \n \ \ Discuss the Core’s relationship to the Center’s goals and how the Core relates\ \ to two or more individual Research Projects in the application. Testing of scientific\ \ hypotheses should not be proposed within a Core.\n \n \n \n \n Research\ \ Strategy:\n \n \n \n \n Describe how the proposed Scientific Core activities\ \ (including procedures, techniques and quality control) will contribute to meeting\ \ the Center’s goals and objectives and explain why the Core resources are not\ \ otherwise available.\n \n \n Describe how resource utilization will\ \ be allocated and/or prioritized, if applicable, to support the Center.\n \ \ \n \n \n Indicate the specific Research Projects to be supported by the\ \ Scientific Core. Describe the interactions of the Core with each of the Research\ \ Projects.\n \n \n \n Resource Sharing Plan:\n \n Individuals are\ \ required to comply with the instructions for the Resource Sharing Plans as provided\ \ in the\n \n How to Apply- Application Guide\n \n .\n \n \n\ \ \n Appendix:\n \n \n \n Only limited items are allowed in the Appendix.\ \ Follow all instructions for the\n \n How to Apply- Application Guide\n\ \ \n ; any instructions provided here are in addition to those in the\n\ \ \n How to Apply- Application Guide\n \n instructions.\n \n\ \ \n \n PHS Human Subjects and Clinical Trials Information (Scientific Core)\n\ \ \n \n \n When involving human subjects research, clinical research, and/or\ \ NIH-defined clinical trials follow all instructions for the PHS Human Subjects\ \ and Clinical Trials Information form in the\n \n How to Apply- Application\ \ Guide,\n \n with the following additional instructions:\n \n \n \ \ If you answered “Yes” to the question “Are Human Subjects Involved?” on the\ \ R&R Other Project Information form, you must include at least one human subjects\ \ study record using the\n \n Study Record: PHS Human Subjects and Clinical\ \ Trials Information\n \n form or a\n \n Delayed Onset Study\n\ \ \n record.\n \n \n \n Study Record: PHS Human Subjects and Clinical\ \ Trials Information\n \n \n \n All instructions in the\n \n How\ \ to Apply- Application Guide\n \n must be followed.\n \n \n \n \ \ Delayed Onset Study\n \n \n \n Note:\n \n Delayed onset\n \ \ \n does NOT apply to a study that can be described but will not start immediately\ \ (i.e., delayed start). All instructions in the\n \n How to Apply- Application\ \ Guide\n \n must be followed.\n \n \n \n Research Project\n \ \ \n \n \n When preparing your application, use Component Type ‘Project.’\n\ \ \n \n All instructions in the\n \n How to Apply- Application Guide\n\ \ \n must be followed, with the following additional instructions, as noted.\n\ \ \n \n \n SF424 (R&R) Cover (Research Project)\n \n \n \n Complete\ \ only the following fields:\n \n \n \n Applicant Information\n \n\ \ \n Type of Applicant (optional)\n \n \n Descriptive Title of Applicant’s\ \ Project\n \n \n Proposed Project Start/Ending Dates\n \n \n \n \n\ \ PHS 398 Cover Page Supplement (Research Project)\n \n \n \n Enter\ \ Human Embryonic Stem Cells in each relevant component.\n \n \n \n Research\ \ & Related Other Project Information (Research Project)\n \n \n \n \n \ \ Human Subjects:\n \n Answer only the ‘Are Human Subjects Involved?’\ \ and 'Is the Project Exempt from Federal regulations?’ questions.\n \n \n\ \ \n Vertebrate Animals:\n \n Answer only the ‘Are Vertebrate Animals\ \ Used?’ question.\n \n \n \n Project Narrative:\n \n Do not complete.\ \ Note: ASSIST screens will show an asterisk for this attachment indicating it\ \ is required. However, eRA systems only enforce this requirement in the Overall\ \ component and applications will not receive an error if omitted in other components.\n\ \ \n \n \n Project/Performance Site Location(s) (Research Project)\n \ \ \n \n \n List all performance sites that apply to the specific component.\n\ \ \n \n \n Note: The Project Performance Site form allows up to 300 sites,\ \ prior to using additional attachment for additional entries.\n \n \n \n\ \ \n Research & Related Senior/Key Person Profile (Research Project)\n \ \ \n \n \n \n In the Project Director/Principal Investigator section of the\ \ form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide\ \ a valid eRA Commons ID in the Credential field.\n \n \n In the additional\ \ Senior/Key Profiles section, list Senior/Key persons that are working in the\ \ component.\n \n \n Include a single Biographical Sketch for each Senior/Key\ \ person listed in the application regardless of the number of components in which\ \ they participate. When a Senior/Key person is listed in multiple components,\ \ the Biographical Sketch can be included in any one component.\n \n \n \ \ If more than 100 Senior/Key persons are included in a component, the Additional\ \ Senior Key Person attachments should be used.\n \n \n Within the biosketches,\ \ highlight the experience and expertise of the Research Project Lead and key\ \ personnel in regulatory activities, including IND/IDE submissions, safety oversight\ \ and reporting.\n \n \n \n \n Budget (Research Project)\n \n \n \n\ \ Budget forms appropriate for the specific component will be included in the\ \ application package.\n \n \n In single PD/PI applications, the PD/PI must\ \ also lead at least one Research Project and is required to commit an overall\ \ minimum of 2 person months in AADCRC activities. In multi-PD/PI applications,\ \ every PD/PI must lead a Research Project or Core, with at least one of the PD(s)/PI(s)\ \ leading a Research Project and committing an overall minimum of 2 person months\ \ to AADCRC activities.\n \n \n Include costs to support statistical design/support,\ \ data collection and analysis if those are not included in one of the Cores.\n\ \ \n \n If the Research Project involves a pilot clinical trial or a clinical\ \ observational study:\n \n \n \n Include costs for clinical site monitoring,\ \ medical monitoring, project management, and quality assurance of the proposed\ \ pilot clinical trials or observational clinical studies in the application budget.\ \ Alternatively, these costs can be incorporated into the budget of a Clinical\ \ Core, provided that specific cross-references are made to clarify how these\ \ necessary functions will be supported.\n \n \n \n Note: For all clinical\ \ trials, NIAID will provide a Data and Safety Monitoring Board (DSMB). Therefore,\ \ do not include or budget for DSMB expenses.\n \n \n \n Note: The R&R\ \ Budget form included in many of the component types allows for up to 100 Senior/Key\ \ Persons in section A and 100 Equipment Items in section C prior to using attachments\ \ for additional entries. All other SF424 (R&R) instructions apply.\n \n \n\ \ \n \n PHS 398 Research Plan (Research Project)\n \n \n \n \n Specific\ \ Aims:\n \n \n \n \n List, in priority order, the objectives and goals\ \ of the proposed project.\n \n \n Concisely describe the hypothesis or\ \ hypotheses to be tested. In addition, state the individual Research Project's\ \ relationship to the Center’s goals and how it relates to other projects or Cores.\n\ \ \n \n \n \n Research Strategy:\n \n \n \n \n Describe how the\ \ proposed research will contribute to meeting the Center’s goals and objectives\ \ and indicate the project's relevance to the primary theme of the application.\n\ \ \n \n Explain the rationale for selecting the methods to accomplish\ \ the specific aims of the Research Project.\n \n \n Provide a detailed\ \ timeline for the study supporting completion within the funding period.\n \ \ \n \n \n \n Clinical Trials\n \n \n \n The Approach section of\ \ a pilot clinical trial project should address the following aspects of the proposed\ \ trial(s):\n \n \n \n Discuss the rationale for the proposed approach\ \ for the problems being studied.\n \n \n Describe the design of the proposed\ \ trial, include rationale for the selection of the participant population, choice\ \ of intervention (if applicable), duration, and schedule of events.\n \n\ \ \n Discuss each trial’s feasibility.\n \n \n Include a plan for\ \ the management of the pilot clinical trial that offers description of personnel\ \ involved in 1) conducting the trial, and 2) data entry and interactions with\ \ the activities of the Data Stewardship Core.\n \n \n Include general\ \ concepts for sample size determinations and statistical methodologies, but provide\ \ trial-specific details in the PHS Human Subjects and Clinical Trial Information\ \ Forms.\n \n \n \n Note: Specific details for each trial will be captured\ \ using the PHS Human Subjects and Clinical Trials Information Forms. Do not duplicate\ \ information requested under the PHS Human Subjects and Clinical Trials Information\ \ Forms.\n \n \n \n Clinical studies\n \n \n \n For applications\ \ proposing one or more clinical studies (observational studies with no interventions\ \ and involving only minimal risk procedures or cross-sectional studies), the\ \ Approach section of the clinical study project should address the following\ \ aspects of the study:\n \n \n \n Describe the design of the proposed\ \ study, include rationale for the selection of the participant population, choice\ \ of outcomes, duration, and schedule of events.\n \n \n Discuss each\ \ study's feasibility. Include a plan for the management of the clinical study\ \ that offers description of personnel involved in conducting the study, personnel\ \ involved in data entry, and the personnel involved in statistical analysis.\ \ Describe the interactions between these teams and the Data Stewardship Core.\n\ \ \n \n Include general concepts for sample size determinations and statistical\ \ methodologies, but provide study-specific details in the PHS Human Subjects\ \ Information Forms.\n \n \n Describe the timeline for protocol development,\ \ the plan for study implementation, the plan for evaluation of proposed study\ \ site(s), and plans for management and analysis of study data.\n \n \n \ \ For observational or cross-sectional clinical studies, describe the data analyses\ \ and statistical approach for the proposed study design and methods used to assign\ \ participants.\n \n \n \n Note: Specific details for each study will be\ \ captured using the PHS Human Subjects Information Form. Do not duplicate information\ \ requested under the PHS Human Subjects Information Forms.\n \n \n \n \ \ Projects obtaining human samples from non-AADCRC-supported clinical studies\ \ or trials:\n \n \n \n For projects that plan to obtain human samples\ \ derived from clinical studies or clinical trials that are planned, ongoing,\ \ or completed and are or have been sponsored by sources other than the AADCRC,\ \ the information in the Approach section should include the following:\n \n\ \ \n \n Study title\n \n \n Study objectives (primary and secondary)\n\ \ \n \n Study population(s) with clear description of clinical phenotypes\n\ \ \n \n Key design features, including primary and secondary endpoints,\ \ comparison/control groups\n \n \n Sample size calculations and statistical\ \ analysis plans as they pertain to the questions posed by the AADCRC study that\ \ will utilize the parent study/trial samples\n \n \n Study duration and\ \ timeline (if a planned or an ongoing study)\n \n \n \n \n Non-clinical\ \ research\n \n \n \n \n Describe the research design conceptual procedures\ \ and analyses to be used to accomplish the specific aims of the project.\n \ \ \n \n In the rare instances where animal models are proposed, justify\ \ the models and describe how the findings could be translated into human research\ \ and how they associate with the proposed clinical project(s).\n \n \n \ \ Provide a tentative timetable for the project.\n \n \n If animal studies\ \ are included, describe the relevance of the proposed animal model(s) to human\ \ asthma and/or allergic diseases. Describe the scientific potential for findings\ \ in animals to translate to human disease and appropriately justify the use of\ \ animal models if similar data could be obtained from human studies.\n \n\ \ \n \n \n Letters of Support:\n \n For Projects obtaining human samples\ \ from non-AADCRC-supported clinical studies or trials, include documentation\ \ of the ability to acquire human samples, including written agreements between\ \ the PD(s)/PI(s), the applicant institution, the clinical study/trial sponsor(s),\ \ including drug companies, if applicable, and the IND/IDE sponsor (if not one\ \ of the above) to be used in the studies proposed by the application is required.\ \ A statement is required that the subjects from whom samples were obtained from\ \ the parent clinical study/trial not supported by the proposed AADCRC project\ \ have given informed consent/assent and the material they have provided can be\ \ used by the AADCRC project.\n \n \n \n Resource Sharing Plan:\n \n\ \ Individuals are required to comply with the instructions for the Resource\ \ Sharing Plans as provided in the\n \n How to Apply- Application Guide\n\ \ \n .\n \n \n \n Appendix:\n \n \n \n Only limited items\ \ are allowed in the Appendix. Follow all instructions for the\n \n How\ \ to Apply- Application Guide\n \n ; any instructions provided here are\ \ in addition to those in the\n \n How to Apply- Application Guide\n \ \ \n instructions.\n \n \n \n PHS Human Subjects and Clinical Trials\ \ Information (Research Project)\n \n \n \n When involving human subjects\ \ research, clinical research, and/or NIH-defined clinical trials follow all instructions\ \ for the PHS Human Subjects and Clinical Trials Information form in the\n \ \ \n How to Apply- Application Guide,\n \n with the following additional\ \ instructions:\n \n \n If you answered “Yes” to the question “Are Human\ \ Subjects Involved?” on the R&R Other Project Information form, you must include\ \ at least one human subjects study record using the\n \n Study Record:\ \ PHS Human Subjects and Clinical Trials Information\n \n form or a\n \ \ \n Delayed Onset Study\n \n record.\n \n \n \n Study Record:\ \ PHS Human Subjects and Clinical Trials Information\n \n \n \n All instructions\ \ in the\n \n How to Apply- Application Guide\n \n must be followed\ \ with the following additional instructions:\n \n \n \n Section 2 - Study\ \ Population Characteristics\n \n \n \n \n 2.5 - Recruitment and Retention\ \ Plan\n \n \n \n Describe actions to be taken to address problems with\ \ recruitment of study participants.\n \n \n \n Section 4 - Protocol Synopsis\n\ \ \n \n \n \n 4.1 Study Design\n \n \n \n \n 4.1.a Detailed Description\n\ \ \n \n \n For multi-visit studies, provide a description of the study\ \ design including the procedures and activities that can occur at each visit\ \ (schedule of events).\n \n \n \n Section 5 - Other Clinical Trial-related\ \ Attachments\n \n \n \n \n 5.1 Other Clinical Trial-related Attachments\n\ \ \n \n \n Describe the plan to obtain required investigational agent(s).\n\ \ \n \n IND applications required by the FDA for any investigational agents\ \ should be obtained by applicants prior to submission of applications. Provide\ \ the IND documents with other clinical trial related attachments.\n \n \n\ \ \n Delayed Onset Study\n \n \n \n Note:\n \n Delayed onset\n\ \ \n does NOT apply to a study that can be described but will not start\ \ immediately (i.e., delayed start). All instructions in the\n \n How\ \ to Apply- Application Guide\n \n must be followed.\n \n \n \n \n \ \ 3. Unique Entity Identifier and System for Award Management (SAM)\n \n\ \ \n See Part 2. Section III.1 for information regarding the requirement for\ \ obtaining a unique entity identifier and for completing and maintaining active\ \ registrations in System for Award Management (SAM), NATO Commercial and Government\ \ Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov\n \n \n\ \ \n \n 4. Submission Dates and Times\n \n \n Part I. contains information\ \ about Key Dates and times. Applicants are encouraged to submit applications\ \ before the due date to ensure they have time to make any application corrections\ \ that might be necessary for successful submission. When a submission date falls\ \ on a weekend or\n \n Federal holiday\n \n , the application deadline\ \ is automatically extended to the next business day.\n \n \n Organizations\ \ must submit applications to\n \n Grants.gov\n \n (the online\ \ portal to find and apply for grants across all Federal agencies) using ASSIST\ \ or other electronic submission systems. Applicants must then complete the submission\ \ process by tracking the status of the application in the\n \n eRA Commons\n\ \ \n , NIH’s electronic system for grants administration. NIH and Grants.gov\ \ systems check the application against many of the application instructions upon\ \ submission. Errors must be corrected and a changed/corrected application must\ \ be submitted to Grants.gov on or before the application due date and time. If\ \ a Changed/Corrected application is submitted after the deadline, the application\ \ will be considered late. Applications that miss the due date and time are subjected\ \ to the\n \n NIH Grants Policy Statement Section 2.3.9.2 Electronically\ \ Submitted Applications\n \n .\n \n \n \n Applicants are responsible\ \ for viewing their application before the due date in the eRA Commons to ensure\ \ accurate and successful submission.\n \n \n \n Information on the submission\ \ process and a definition of on-time submission are provided in\n \n \ \ How to Apply- Application Guide.\n \n \n \n \n \n 5. Intergovernmental\ \ Review (E.O. 12372)\n \n \n This initiative is not subject to\n \n\ \ intergovernmental review\n \n .\n \n \n \n \n 6. Funding Restrictions\n\ \ \n \n All NIH awards are subject to the terms and conditions, cost principles,\ \ and other considerations described in the\n \n NIH Grants Policy Statement\n\ \ \n .\n \n \n Pre-award costs are allowable only as described in\ \ the\n \n NIH Grants Policy Statement\n \n \n Section 7.9.1 Selected\ \ Items of Cost.\n \n \n \n \n \n 7. Other Submission Requirements and\ \ Information\n \n \n Applications must be submitted electronically following\ \ the instructions described in the\n \n How to Apply - Application Guide\n\ \ \n . Paper applications will not be accepted.\n \n \n For information\ \ on how applications will be automatically assembled for review and funding consideration\ \ after submission, refer to:\n \n http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf\n\ \ \n .\n \n \n \n Applicants must complete all required registrations\ \ before the application due date.\n \n Section III. Eligibility Information\ \ contains information about registration.\n \n \n For assistance with your\ \ electronic application or for more information on the electronic submission\ \ process, visit\n \n How to Apply - Application Guide\n \n . If\ \ you encounter a system issue beyond your control that threatens your ability\ \ to complete the submission process on-time, you must follow the\n \n \ \ Dealing with System Issues\n \n guidance. For assistance with application\ \ submission, contact the Application Submission Contacts in Section VII.\n \ \ \n \n \n Important reminders:\n \n \n \n All PD(s)/PI(s) and component\ \ Project Leads must include their eRA Commons ID in the Credential field of the\ \ Senior/Key Person Profile form\n \n .\n \n Failure to register\ \ in the Commons and to include a valid PD/PI Commons ID in the credential field\ \ will prevent the successful submission of an electronic application to NIH.\n\ \ \n \n The applicant organization must ensure that the unique entity identifier\ \ provided on the application is the same identifier used in the organization’s\ \ profile in the eRA Commons and for the System for Award Management. Additional\ \ information may be found in\n \n How to Apply - Application Guide\n\ \ \n .\n \n \n See\n \n more tips\n \n for avoiding\ \ common errors.\n \n \n \n \n Upon receipt, applications will be evaluated\ \ for completeness and compliance with application instructions by the Center\ \ for Scientific Review and responsiveness by the National Institute of Allergy\ \ and Infectious Diseases, NIH. Applications that are incomplete, non-compliant\ \ and/or nonresponsive will not be reviewed.\n \n \n \n Mandatory Disclosure\n\ \ \n Recipients or subrecipients must submit any information related to\ \ violations of federal criminal law involving fraud, bribery, or gratuity violations\ \ potentially affecting the federal award. See Mandatory Disclosures,\n \n\ \ 2 CFR 200.113\n \n and\n \n NIH Grants Policy Statement Section\ \ 4.1.35\n \n .\n \n \n Send written disclosures to the NIH Chief\ \ Grants Management Officer listed on the Notice of Award for the IC that funded\ \ the award and to the\n \n HHS Office of Inspector Grant Self Disclosure\ \ Program\n \n at\n \n \n [email protected]\n \n \n .\n\ \ \n \n \n \n Post Submission Materials\n \n \n Applicants are required\ \ to follow the instructions for post-submission materials, as described in\n\ \ \n the policy\n \n ." pipeline_tag: sentence-similarity library_name: sentence-transformers metrics: - cosine_accuracy@1 - cosine_accuracy@3 - cosine_accuracy@5 - cosine_accuracy@10 - cosine_precision@1 - cosine_precision@3 - cosine_precision@5 - cosine_precision@10 - cosine_recall@1 - cosine_recall@3 - cosine_recall@5 - cosine_recall@10 - cosine_ndcg@10 - cosine_mrr@10 - cosine_map@100 model-index: - name: SentenceTransformer based on Snowflake/snowflake-arctic-embed-l results: - task: type: information-retrieval name: Information Retrieval dataset: name: Unknown type: unknown metrics: - type: cosine_accuracy@1 value: 0.9166666666666666 name: Cosine Accuracy@1 - type: cosine_accuracy@3 value: 1.0 name: Cosine Accuracy@3 - type: cosine_accuracy@5 value: 1.0 name: Cosine Accuracy@5 - type: cosine_accuracy@10 value: 1.0 name: Cosine Accuracy@10 - type: cosine_precision@1 value: 0.9166666666666666 name: Cosine Precision@1 - type: cosine_precision@3 value: 0.3333333333333333 name: Cosine Precision@3 - type: cosine_precision@5 value: 0.20000000000000004 name: Cosine Precision@5 - type: cosine_precision@10 value: 0.10000000000000002 name: Cosine Precision@10 - type: cosine_recall@1 value: 0.9166666666666666 name: Cosine Recall@1 - type: cosine_recall@3 value: 1.0 name: Cosine Recall@3 - type: cosine_recall@5 value: 1.0 name: Cosine Recall@5 - type: cosine_recall@10 value: 1.0 name: Cosine Recall@10 - type: cosine_ndcg@10 value: 0.9692441461309548 name: Cosine Ndcg@10 - type: cosine_mrr@10 value: 0.9583333333333334 name: Cosine Mrr@10 - type: cosine_map@100 value: 0.9583333333333334 name: Cosine Map@100 --- # SentenceTransformer based on Snowflake/snowflake-arctic-embed-l This is a [sentence-transformers](https://www.SBERT.net) model finetuned from [Snowflake/snowflake-arctic-embed-l](https://huggingface.co/Snowflake/snowflake-arctic-embed-l). It maps sentences & paragraphs to a 1024-dimensional dense vector space and can be used for semantic textual similarity, semantic search, paraphrase mining, text classification, clustering, and more. ## Model Details ### Model Description - **Model Type:** Sentence Transformer - **Base model:** [Snowflake/snowflake-arctic-embed-l](https://huggingface.co/Snowflake/snowflake-arctic-embed-l) - **Maximum Sequence Length:** 512 tokens - **Output Dimensionality:** 1024 dimensions - **Similarity Function:** Cosine Similarity ### Model Sources - **Documentation:** [Sentence Transformers Documentation](https://sbert.net) - **Repository:** [Sentence Transformers on GitHub](https://github.com/UKPLab/sentence-transformers) - **Hugging Face:** [Sentence Transformers on Hugging Face](https://huggingface.co/models?library=sentence-transformers) ### Full Model Architecture ``` SentenceTransformer( (0): Transformer({'max_seq_length': 512, 'do_lower_case': False}) with Transformer model: BertModel (1): Pooling({'word_embedding_dimension': 1024, 'pooling_mode_cls_token': True, 'pooling_mode_mean_tokens': False, 'pooling_mode_max_tokens': False, 'pooling_mode_mean_sqrt_len_tokens': False, 'pooling_mode_weightedmean_tokens': False, 'pooling_mode_lasttoken': False, 'include_prompt': True}) (2): Normalize() ) ``` ## Usage ### Direct Usage (Sentence Transformers) First install the Sentence Transformers library: ```bash pip install -U sentence-transformers ``` Then you can load this model and run inference. ```python from sentence_transformers import SentenceTransformer # Download from the 🤗 Hub model = SentenceTransformer("christinemahler/aie5-midterm") # Run inference sentences = [ 'What are the responsibilities of the PD(s)/PI(s) in managing the activities of the approved projects under the cooperative agreement?', 'RFA-AI-24-079: Asthma and Allergic Diseases Cooperative Research Centers (U19 Clinical Trial Optional) Section VI. Award Administration Information\n \n \n \n \n 1. Award Notices\n \n \n A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.\n \n \n In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.\n \n \n Recipients must comply with any funding restrictions described in\n \n Section IV.6. Funding Restrictions\n \n . Any pre-award costs incurred before receipt of the NoA are at the applicant\'s own risk. \xa0For more information on the Notice of Award, please refer to the\n \n NIH Grants Policy Statement Section 5. The Notice of Award\n \n and NIH Grants & Funding website, see\n \n Award Process.\n \n \n \n \n \n Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.\n \n \n ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (\n \n https://register.clinicaltrials.gov\n \n ). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see\n \n https://grants.nih.gov/policy/clinical-trials/reporting/index.htm\n \n \n \n Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.\n \n \n Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).\n \n \n Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).\n \n \n \n \n Prior Approval of Pilot Projects\n \n \n Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.\n \n \n \n The recipient institution will comply with the NIH\n \n Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval\n \n .\n \n \n The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with\n \n NIH DSMP policies\n \n .\n \n \n \n \n \n 2. Administrative and National Policy Requirements\n \n \n The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:\n \n \n \n The rules listed at\n \n 2 CFR Part 200\n \n , Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.\n \n \n All NIH grant and cooperative agreement awards include the\n \n NIH Grants Policy Statement\n \n as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the\n \n NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General\n \n and\n \n Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities\n \n .\n \n \n If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (\n \n HHS-690\n \n ). To learn more, see the\n \n Laws and Regulations Enforced by the\xa0HHS Office for Civil Rights website\n \n .\n \n \n HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.\n \n \n \n \n \n All federal statutes and regulations relevant to federal financial assistance, including those highlighted in\n \n NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.\n \n \n \n Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.\xa0 NIH may terminate awards under certain circumstances.\xa0 See\n \n 2 CFR Part 200.340 Termination\n \n and\n \n NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support\n \n .\n \n \n Successful recipients under this NOFO agree that:\n \n \n Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.\xa0 Visit\n \n https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B\n \n to learn more.\n \n \n Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit\n \n https://www.healthit.gov/topic/certification-ehrs/certification-health-it\n \n to learn more.\n \n \n Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.\n \n \n Successful recipients under this NOFO agree that:\n \n \n When recipients, subrecipients, or third-party entities have:\n \n \n \n ongoing and consistent access to HHS owned or operated information or operational technology systems; and\n \n \n receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.\n \n \n \n Recipients shall develop plans and procedures, modeled after the\n \n NIST Cybersecurity framework\n \n , to protect HHS systems and data. Please refer to\n \n NIH Post-Award Monitoring and Reporting\n \n for additional information.\n \n \n \n Cooperative Agreement Terms and Conditions of Award\n \n The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.\n \n \n The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients\' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.\n \n \n \n The PD(s)/PI(s) will have the primary responsibility for:\n \n \n \n \n Determining and coordinating the scientific and administrative activities of the approved projects;\n \n \n Setting project goals and timelines;\n \n \n Serving on the AADCRC Steering Committee and participating in all Steering Committee activities;\n \n \n Accepting and implementing common guidelines approved by the Steering Committee;\n \n \n For clinical trials and other human subject research, implementing current Good Clinical Practice guidelines and complying with the\n \n NIAID Clinical Terms of Award\n \n ;\n \n \n For clinical trials in which the PD(s)/PI(s) is the IND/IDE Sponsor, having responsibilty for the development, assembly, and submission of all required regulatory documents, providing NIAID all required information in accordance to NIH clinical research guidance. This includes, but is not limited to, all communications with the FDA (or other regulatory authority) and the Institutional Review Board (IRB). If NIAID is the IND/IDE Sponsor, providing access to all necessary data and documentation to NIAID to fulfill its role.\n \n \n Sharing reagents and resources with other investigators funded under this NOFO as appropriate, including any scientists added via IOF support;\n \n \n Making data available for external checking against the original source documentation;\n \n \n Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.\n \n \n \n \n NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:\n \n \n \n \n NIAID may assign one or more Project Scientist(s) to the AADCRC program. The Project Scientist(s) will:\n \n \n Provide guidance and support in the design of research activities;\n \n \n Provide guidance and support in the execution of studies;\n \n \n Contribute to the analysis and publication of data;\n \n \n Advise in the selection of sources or resources;\n \n \n Advise in management and technical performance;\n \n \n In AADCRC centers that include clinical trials, and in some cases clinical studies, the NIAID-assigned Project Scientist will be a Medical Officer;\n \n \n Assist in planning of the meetings and teleconferences of the Steering Committee and subcommittees, and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies.\n \n \n All NIAID staff will be non-voting members of the Steering Committee.\n \n \n \n \n \n \n Clinical Research Oversight\n \n \n \n \n \n Protocol Development, Review and Approval:\n \n The NIAID Project Scientist will participate in the development, review and approval of all clinical research protocols supported by this NOFO.\n \n \n In some cases,\xa0the NIAID-assigned Project Scientist will be a physician who may also assume the role of Medical Monitor of a clinical study or trial.\n \n \n \n IND/IDE:\n \n NIAID retains the right to have NIAID serve as the IND/IDE sponsor for trials involving the use of investigational products.\n \n \n \n Monitoring Boards and Safety Reporting:\n \n NIAID Project Scientists will facilitate and provide oversight of the review and reporting of data to DAIT monitoring committees and Data Safety and Monitoring Boards.\n \n \n \n Study Termination:\n \n NIAID reserves the right to terminate or curtail a clinical study or clinical trial for any of the following reasons:\n \n \n risk to subject safety;\n \n \n the scientific question is no longer relevant, or the objectives will not be met;\n \n \n failure to comply with Good Clinical Practices, Federal Regulations, or Terms and Conditions of Award;\n \n \n occurrence of unforeseen drug safety issues or data from preclinical studies indicate a presence of unanticipated toxicity;\n \n \n risks that cannot be adequately quantified;\n \n \n failure to remedy deficiencies identified through site monitoring;\n \n \n substandard data; inadequate progress in fulfilling the research agenda;\n \n \n slow accrual; or\n \n \n reaching a major study endpoint substantially before schedule with persuasive statistical significance.\n \n \n \n \n \n Access to Data:\n \n The NIAID Project Scientist or designee will have access to all data generated under this cooperative agreement and may review the data as recorded on the case report forms or in a database. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study.\n \n \n Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.\n \n \n \n \n Areas of Joint Responsibility include:\n \n \n \n \n Establishing a Steering Committee consisting of the PD(s)/PI(s) of each AADCRC and NIH Project Scientists from NIAID. The NIH Program Officer will be an optional attendee. The Steering Committee’s responsibilities include facilitating collaborative projects,\xa0organizing the yearly IOF competition (establishing goals, guidelines and evaluation criteria, evaluating proposed projects, and proposing funding plans), setting the agenda for an annual face-to-face AADCRC scientific meeting, establishing an AADCRC policy to promote resource sharing among AADCRCs and outside collaborators, and proposing AADCRC-centered sessions for national and international scientific meetings.\n \n \n \n Each AADCRC Center will have one voting member on the Steering Committee; in the case of multi-PI centers, all PIs/PDs will be Steering Committee members, but must share one vote. NIAID Project Scientists and the NIH Program Officer will be non-voting members of the Steering Committee and participate in all Steering Committee activities. A chair will be elected by the majority of vote among the voting members of the Steering Committee. The Steering Committee will make decisions by majority vote. The Steering Committee will meet by teleconference twice a year and at a face-to-face meeting once a year.\n \n \n \n Collaboratively facilitating the conduct, progress and monitoring of the studies supported by the award.\n \n \n Fostering collaborations between AADCRCs.\n \n \n \n \n Dispute Resolution:\n \n \n \n Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient\'s right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.\n \n \n \n \n 3. Data Management and Sharing\n \n \n Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the\n \n NIH Grants Policy Statement\n \n . Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.\n \n \n \n 4. Reporting\n \n \n When multiple years are involved, recipients will be required to submit the\n \n Research Performance Progress Report (RPPR)\n \n annually and financial statements as required in the\n \n NIH Grants Policy Statement Section 8.4.1 Reporting\n \n . To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see\n \n Post-Award Monitoring and Reporting\n \n .\n \n \n \n \n \n Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.\n \n \n \n \n A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the\n \n NIH Grants Policy Statement Section 8.6 Closeout\n \n . NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.', "RFA-AI-24-079: Asthma and Allergic Diseases Cooperative Research Centers (U19 Clinical Trial Optional) Section IV. Application and Submission Information\n \n \n \n \n 1. Requesting an Application Package\n \n \n The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.\n \n \n \n \n 2. Content and Form of Application Submission\n \n \n It is critical that applicants follow the Multi-Project (M) Instructions in the\n \n How to Apply - Application Guide\n \n , except where instructed in this notice of funding opportunity to do otherwise and where instructions in the\n \n How to Apply - Application Guide\n \n are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the\n \n How to Apply - Application Guide\n \n is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.\n \n \n \n \n Letter of Intent\n \n \n Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.\n \n \n By the date listed in\n \n Part 1. Overview Information\n \n , prospective applicants are asked to submit a letter of intent that includes the following information:\n \n \n \n Descriptive title of proposed activity\n \n \n Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)\n \n \n Names of other key personnel\n \n \n Participating institution(s)\n \n \n Number and title of this funding opportunity\n \n \n \n The letter of intent should be sent to:\n \n \n Poonam Tewary, PhD\n \n Telephone: 240-532-9777\n \n Email:\n \n \n [email\xa0protected]\n \n \n \n \n \n \n \n Page Limitations\n \n \n All page limitations described in the\n \n How to Apply- Application Guide\n \n and the\n \n Table of Page Limits\n \n must be followed.\n \n \n \n \n \n \n \n Component\n \n \n Component Type for Submission\n \n \n Page Limit\n \n \n Required/Optional\n \n \n Minimum\n \n \n Maximum\n \n \n \n \n \n \n Overall\n \n \n Overall\n \n \n 12\n \n \n Required\n \n \n 1\n \n \n 1\n \n \n \n \n Admin Core\n \n \n Admin Core\n \n \n 6\n \n \n Required\n \n \n 1\n \n \n 1\n \n \n \n \n Data Stewardship Core\n \n \n Data Core\n \n \n 6\n \n \n Required\n \n \n 1\n \n \n 1\n \n \n \n \n Clinical Core\n \n \n Clinical Core\n \n \n 6\n \n \n Optional\n \n \n 0\n \n \n 1\n \n \n \n \n Scientific Core\n \n \n Scientific Core\n \n \n 6\n \n \n Optional\n \n \n 0\n \n \n 2\n \n \n \n \n Research Project\n \n \n Project\n \n \n 12\n \n \n Required\n \n \n 2\n \n \n NA\n \n \n \n \n \n \n \n Instructions for the Submission of Multi-Component Applications\n \n \n \n \n The following section supplements the instructions found in\n \n How to Apply- Application Guide\n \n and should be used for preparing a multi-component application.\n \n \n \n \n The application should consist of the following components:\n \n \n Overall: required, 1\n \n \n \n Administrative Core: required, 1\n \n \n Data Stewardship Core: required: 1, the Data Stewardship Core must support all Research Projects, and will support other Scientific/Clinical Core(s), as needed\n \n \n Clinical Core: optional,\xa0maximum 1, the Clinical Core must support at least two Research Projects\n \n \n Scientific Core: optional, maximum 2, each Scientific Core must support at least two Research Projects\n \n \n Research Projects: required, minimum 2, no maximum\n \n \n \n \n \n Overall Component\n \n \n When preparing the application, use Component Type ‘Overall’.\n \n \n All instructions in the\n \n How to Apply - Application Guide\n \n must be followed, with the following additional instructions, as noted.\n \n \n \n \n SF424(R&R) Cover (Overall)\n \n \n Complete entire form.\n \n \n \n \n PHS 398 Cover Page Supplement (Overall)\n \n \n Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.\n \n \n \n \n Research & Related Other Project Information (Overall)\n \n \n Follow standard instructions.\n \n \n \n \n Project/Performance Site Locations (Overall)\n \n \n Enter primary site only.\n \n \n \n \n \n A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.\n \n \n \n \n \n Research and Related Senior/Key Person Profile (Overall)\n \n \n Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.\n \n \n \n \n \n A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.\n \n \n \n \n \n Budget (Overall)\n \n \n The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.\n \n \n \n \n \n A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.\n \n \n \n \n \n PHS 398 Research Plan (Overall)\n \n \n \n \n \n Specific Aims:\n \n List in priority order, the broad, long-range objectives and goals of the proposed Center. Concisely describe the hypothesis or hypotheses to be tested.\n \n \n \n \n \n Research Strategy:\n \n Describe the focus of the research Center. This narrative section should summarize the overall research strategy for the multi-component application. The multi-component application should be viewed as a confederation of interrelated Research Projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section, for it provides the group of investigators an opportunity to give conceptual wholeness to the overall Center\xa0by giving a statement of the general problem area and by laying out a broad strategy for attacking the problem. As the strategy develops, each Research Project and Core should be cited briefly as to its place in the overall scheme. To help achieve the NOFO’s objective, it is recommended, but not required, to draft the applications along the lines of either of the two models: the Pathway Focus (Model A) or Clinical Intervention/Observation Focus (Model B) as described under Part 2, Section I.\n \n \n To highlight Center synergy, describe how the individual components will be coordinated and work together to address the overall goals and aims of the Center. Include a schematic overview of the interactions and collaborations among the components and indicate collaborations among members and relevant publications co-authored by members of the Center. Center synergy may also be addressed in other sections of the application, as appropriate. Discuss the role of all Research Projects and Cores in the Overall Research Strategy of the application. Describe how the integration of the individual Research Projects into a single Center benefits the objectives more than pursuing each project independently. For renewal applications, describe the impact that the Center’s prior accomplishments have had on the field of asthma and/or allergic disease.\n \n \n For individual Research Projects and Cores that will be continued as part of a renewal application, additional details of progress made during the prior funding period should be provided in the Research Strategy within each Research Project and/or Core.\n \n \n \n \n \n \n \n \n \n Resource Sharing Plan\n \n :\n \n Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the\n \n How to Apply - Application Guide\n \n .\n \n \n \n \n \n Other Plan(s):\n \n \n \n All instructions in the\n \n How to Apply- Application Guide\n \n must be followed, with the following additional instructions:\n \n \n \n \n \n All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.\n \n \n Recipients are encouraged to deposit data into\xa0the\n \n ImmPort database\n \n .\n \n \n \n \n \n \n Appendix:\n \n \n \n Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in\n \n How to Apply- Application Guide\n \n ; any instructions provided here are in addition to the\n \n How to Apply - Application Guide\n \n instructions.\n \n \n \n \n PHS Human Subjects and Clinical Trials Information (Overall)\n \n \n When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the\n \n How to Apply - Application Guide\n \n , with the following additional instructions:\n \n \n If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the\n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n form or a\n \n Delayed Onset Study\n \n record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.\n \n \n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n \n \n All instructions in the\n \n How to Apply - Application Guide\n \n must be followed.\n \n \n \n \n \n Delayed Onset Study\n \n \n \n Note:\n \n Delayed onset\n \n does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the\n \n How to Apply- Application Guide\n \n must be followed.\n \n \n \n \n PHS Assignment Request Form (Overall)\n \n \n All instructions in the\n \n How to Apply- Application Guide\n \n must be followed.\n \n \n \n \n \n Administrative Core\n \n \n \n When preparing your application, use Component Type ‘Admin Core.’\n \n \n All instructions in the\n \n How to Apply- Application Guide\n \n must be followed, with the following additional instructions, as noted.\n \n \n \n SF424 (R&R) Cover (Administrative Core)\n \n \n \n Complete only the following fields:\n \n \n \n Applicant Information\n \n \n Type of Applicant (optional)\n \n \n Descriptive Title of Applicant’s Project\n \n \n Proposed Project Start/Ending Dates\n \n \n \n \n PHS 398 Cover Page Supplement (Administrative Core)\n \n \n \n Enter Human Embryonic Stem Cells in each relevant component.\n \n \n \n Research & Related Other Project Information (Administrative Core)\n \n \n \n \n Human Subjects:\n \n Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.\n \n \n \n Vertebrate Animals:\n \n Answer only the ‘Are Vertebrate Animals Used?’ question.\n \n \n \n Project Narrative:\n \n Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.\n \n \n \n Project/Performance Site Location(s) (Administrative Core)\n \n \n \n List all performance sites that apply to the specific component.\n \n \n \n Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.\n \n \n \n \n Research & Related Senior/Key Person Profile (Administrative Core)\n \n \n \n \n In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.\n \n \n In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.\n \n \n Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.\n \n \n If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.\n \n \n For institutions/organizations proposing a single PD/PI, the PD/PI will serve as the Administrative Core Lead. For institutions/organizations proposing multiple PD(s)/PI(s), the Contact PD/PI must serve as the Administrative Core Lead.\n \n \n \n \n Budget (Administrative Core)\n \n \n \n Budget forms appropriate for the specific component will be included in the application package.\n \n \n In the budget, include funding for the overall administrative efforts, administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses.\n \n \n \n Infrastructure and Opportunity Fund (IOF)\n \n : Propose funds for the IOF within the Administrative Core component; the IOF budget is not expected to exceed $350K in direct costs. This will be awarded to one recipient organization that will be selected by NIAID post-award to manage the fund. Include IOF costs as a single line item in the Other Direct Costs Category of the Administrative Core Budget. A part of the IOF budget, direct costs proposed for an IOF administrator may be requested in the Personnel category for a maximum of 0.5 person months and must comply with NIH grants policy. F&A Costs will be applied in accordance with NIH grants policy.\n \n \n Include travel funds for the PD(s)/PI(s) and subproject PD(s)/PI(s) to attend an annual AADCRC Scientific and Steering Committee meeting. The two-day meeting will be held each year in or near Rockville, Maryland.\n \n \n \n Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.\n \n \n \n \n PHS 398 Research Plan (Administrative Core)\n \n \n \n \n Specific Aims:\n \n List in priority order the proposed activities and services of the Administrative Core. Describe the work to be completed to address issues of Center coordination, communication, management, and administering the IOF. Testing of scientific hypotheses should not be proposed within a Core.\n \n \n \n Research Strategy:\n \n A fully developed and well-described Administrative Core plan is required.\n \n \n Describe and justify the operational plan and organizational structure of the proposed multi-component application. Include plans on how the PD(s)/PI(s) will interact and coordinate with Project/Core Leaders to identify and resolve problems and establish a strong collaborative environment for the Center. Provide an administrative plan that includes a discussion of the structure and roles of administrative staff, including the functions to be performed; how fiscal and other resources will be prioritized, allocated, and managed; how communications, group meetings, and teleconferences will be facilitated; how conflict resolution will be attained; and how research related travel and training will be managed. Describe how the Core’s administrative, management, and leadership capabilities provide for: internal quality control of on-going research, management of day-to-day program activities, management of contractual agreements, fair communication and cooperation among program leaders and/or program investigators, and development of scientific meetings, as applicable.\xa0Present a leadership succession plan.\n \n \n Provide a plan to administer the AADCRC Infrastructure and Opportunity Fund (IOF), including fund disbursement, administration, and reports. Within the plan, address the following: establishing an administrative structure to manage the IOF; disbursing and tracking IOF funds under the direction of the Steering Committee; implementing plans for interacting with the institutions that will receive IOF funds, including establishing consortium agreements when applicable; and establishing procedures, formats, and timelines for reporting on the status of IOF projects and expenditures to the NIAID and the AADCRC Steering Committee.\n \n \n \n External Advisory Group (optional)\n \n : If an EAG is proposed for an individual Center, then describe the expertise and responsibilities of the potential members. Discuss how the individual Center Research Projects will be supported by the EAG.\n \n \n For a new application,\n \n do not\n \n contact or name potential members in the application\n \n .\n \n For a renewal application with an EAG already established, provide the names only of current EAG members in the application.\n \n \n \n Resource Sharing Plan:\n \n Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the\n \n How to Apply - Application Guide\n \n .\n \n \n \n Appendix:\n \n \n \n Only limited items are allowed in the Appendix. Follow all instructions for the\n \n How to Apply - Application Guide\n \n ; any instructions provided here are in addition to those in the\n \n How to Apply - Application Guide\n \n instructions.\n \n \n \n PHS Human Subjects and Clinical Trials Information (Administrative Core)\n \n \n \n When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the\n \n How to Apply - Application Guide,\n \n with the following additional instructions:\n \n \n If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the\n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n form or a\n \n Delayed Onset Study\n \n record.\n \n \n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n \n \n All instructions in the\n \n How to Apply - Application Guide\n \n must be followed.\n \n \n \n Delayed Onset Study\n \n \n \n Note:\n \n Delayed onset\n \n does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the\n \n How to Apply - Application Guide\n \n must be followed.\n \n \n \n Data Stewardship Core\n \n \n \n When preparing your application, use Component Type ‘Data Core.’\n \n \n All instructions in the\n \n How to Apply - Application Guide\n \n must be followed, with the following additional instructions, as noted.\n \n \n \n SF424 (R&R) Cover (Data Stewardship Core)\n \n \n \n Complete only the following fields:\n \n \n \n Applicant Information\n \n \n Type of Applicant (optional)\n \n \n Descriptive Title of Applicant’s Project\n \n \n Proposed Project Start/Ending Dates\n \n \n \n \n PHS 398 Cover Page Supplement (Data Stewardship Core)\n \n \n \n Enter Human Embryonic Stem Cells in each relevant component.\n \n \n \n Research & Related Other Project Information (Data Stewardship Core)\n \n \n \n \n Human Subjects:\n \n Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.\n \n \n \n Vertebrate Animals:\n \n Answer only the ‘Are Vertebrate Animals Used?’ question.\n \n \n \n Project Narrative:\n \n Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.\n \n \n \n Facilities & Other Resources:\n \n Describe the facilities provided by the Core, as applied to procedures and techniques provided, as well as quality control.\n \n \n \n Project/Performance Site Location(s) (Data Stewardship Core)\n \n \n \n List all performance sites that apply to the specific component.\n \n \n \n Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.\n \n \n \n \n Research & Related Senior/Key Person Profile (Data Stewardship Core)\n \n \n \n \n In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.\n \n \n In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.\n \n \n Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.\n \n \n If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.\n \n \n \n \n Budget (Data Stewardship Core)\n \n \n \n Budget forms appropriate for the specific component will be included in the application package.\n \n \n Request funds to support central data management (database establishment, data management and cleaning, data storage, database security) for the entire awarded U19 Cooperative Agreement to all researchers within the applicant group.\n \n \n In case the statistical design and analysis of data for at least two Research Projects is to be conducted by this Core, request funds to support appropriate biostatistical personnel and equipment use effort.\n \n \n Request funds to support the required timely submission of data, meta-data and data analyses to the ImmPort database or other public databases as appropriate.\n \n \n The percentage of total funds that will be required to support each component Research Project or Core that will utilize the Data Stewardship Core should also be presented. This information should be included in the Core’s budget justification for Year 1.\n \n \n For all clinical trials, NIAID will provide a Data and Safety Monitoring Board (DSMB). Therefore, the applicant does not need to include or budget for DSMB expenses.\n \n \n \n Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.\n \n \n \n \n PHS 398 Research Plan (Data Stewardship Core)\n \n \n \n \n Specific Aims:\n \n List in priority order the broad, long-range activities and services of the proposed Core. In addition, state the Core’s relationship to the Center’s goals and how the Core relates to all the activities of individual Research Projects in the application. Testing of scientific hypotheses should not be proposed within a Core.\n \n \n \n Research Strategy:\n \n \n \n Describe and justify the overall function of the required Data Stewardship Core. Describe how the services of this Core (including procedures, techniques and quality control) will support all proposed\xa0Research Projects and Scientific and/or Clinical Cores,\xa0and advance the outcomes from the proposed research Center.\n \n \n Describe how the Data Stewardship Core will facilitate the harmonization of data collection and analysis services across all Research Projects and Scientific/Clinical Cores, as needed.\n Discuss how the Core will support data management by providing appropriate team expertise. Describe the plans for development of harmonized protocols, including selection and use of common data elements, if applicable. Explain the processes, procedures, methods and plans to provide bioinformatics infrastructure support for Center-wide database establishment, data cleaning and tracking, information management, curation, data monitoring, data storage and quality control. Outline how the Core will promote the exchange of information among all recipients of this NOFO.\n \n \n If the Data Stewardship Core will support the statistical design and data analyses for Research Projects and/or a Clinical or Scientific Core, provide general descriptions of statistical approaches to be used. However, specific statistical analyses addressing scientific hypotheses should be described within each of the Research Projects or within the Clinical or Scientific Core, whichever is applicable.\n \n \n Note that information requested here for this Core should not duplicate the information provided in the Data Management and Sharing Plan. Place information regarding plans to comply with the NIH Data Management and Sharing Policy in the Data Management and Sharing Plan attachment in the “Other Plan(s)” section of the Overall component.\n \n \n \n Note\n \n : Specific details for clinical trials and studies will be captured using the PHS Human Subjects and Clinical Trials Information Form. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.\n \n \n \n Resource Sharing Plan:\n \n Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the\n \n How to Apply - Application Guide\n \n .\n \n \n \n Appendix:\n \n \n \n Only limited items are allowed in the Appendix. Follow all instructions for the\n \n How to Apply- Application Guide\n \n ; any instructions provided here are in addition to those in the\n \n How to Apply- Application Guide\n \n instructions.\n \n \n \n PHS Human Subjects and Clinical Trials Information (Data Stewardship Core)\n \n \n \n When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the\n \n How to Apply- Application Guide,\n \n with the following additional instructions:\n \n \n If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the\n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n form or a\n \n Delayed Onset Study\n \n record.\n \n \n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n \n \n All instructions in the\n \n How to Apply- Application Guide\n \n must be followed.\n \n \n \n Delayed Onset Study\n \n \n \n Note:\n \n Delayed onset\n \n does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the\n \n How to Apply- Application Guide\n \n must be followed.\n \n \n \n Clinical Core\n \n \n \n When preparing your application, use Component Type ‘Clinical Core.’\n \n \n All instructions in the\n \n How to Apply- Application Guide\n \n must be followed, with the following additional instructions, as noted.\n \n \n \n SF424 (R&R) Cover (Clinical Core)\n \n \n \n Complete only the following fields:\n \n \n \n Applicant Information\n \n \n Type of Applicant (optional)\n \n \n Descriptive Title of Applicant’s Project\n \n \n Proposed Project Start/Ending Dates\n \n \n \n \n PHS 398 Cover Page Supplement (Clinical Core)\n \n \n \n Enter Human Embryonic Stem Cells in each relevant component.\n \n \n \n Research & Related Other Project Information (Clinical Core)\n \n \n \n \n Human Subjects:\n \n Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.\n \n \n \n Vertebrate Animals:\n \n Answer only the ‘Are Vertebrate Animals Used?’ question.\n \n \n \n Project Narrative:\n \n Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.\n \n \n \n Facilities & Other Resources:\n \n Describe the facilities provided by the Core, as applied to procedures and techniques provided, as well as quality control.\n \n \n \n Project/Performance Site Location(s) (Clinical Core)\n \n \n \n List all performance sites that apply to the specific component.\n \n \n \n Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.\n \n \n \n \n Research & Related Senior/Key Person Profile (Clinical Core)\n \n \n \n \n In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.\n \n \n In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.\n \n \n Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.\n \n \n If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.\n \n \n Within the biosketches, highlight the expertise of the Clinical Core Lead to guide and/or assist in the development and preparation of documentation required for clinical research, as well as experience with regulatory activities, including IND/IDE submissions (if applicable), recruitment and retention of study participants, medical monitoring, and safety oversight and reporting.\n \n \n \n \n Budget (Clinical Core)\n \n \n \n Budget forms appropriate for the specific component will be included in the application package.\n \n \n For Year 1, outline the percentage of total funds that will be required to support each component Research Project that will utilize the Clinical Core\n \n \n If a clinical trial is proposed, include costs for a medical monitor.\n \n \n For all clinical trials, NIAID will provide a Data and Safety Monitoring Board (DSMB). Therefore, do not include or budget for DSMB expenses.\n \n \n \n Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.\n \n \n \n \n PHS 398 Research Plan (Clinical Core)\n \n \n \n \n Specific Aims:\n \n List in priority order the broad, long-range activities and services of the proposed Clinical Core. In addition, state the Core’s relationship to the Center’s goals and how the Core relates to two or more individual Research Projects in the application. Testing of scientific hypotheses should not be proposed within a Core.\n \n \n \n Research Strategy:\n \n \n \n Describe how the Clinical Core will support at least one of two purposes: 1) recruit and characterize human subjects and collect appropriate biosamples in support of at least two Research Project(s), and/or 2) conduct one or more single-site pilot clinical trials or clinical studies in support of at least two Research Projects.\n \n \n \n Describe how the proposed Clinical Core activities will contribute to meeting the Center’s goals and objectives and explain why the Core resources are not otherwise available.\n \n \n Describe how resource utilization will be allocated and/or prioritized, if applicable, to support the Center. Indicate the specific projects to be supported by the Clinical Core.\n \n \n Describe the services provided by the Core (including procedures, techniques, and quality control).\n \n \n \n If the Clinical Core proposes single site pilot clinical trials and/or studies designed only to collect and provide samples for two or more Research Projects, describe the following aspects of the proposed trial(s)/study(ies):\n \n \n \n Discuss the rationale and process for the selection, recruitment and retention of the participant population, choice of intervention (if applicable), choice of study sites, duration, plans for trial management and schedule of events.\n \n \n Discuss the trial/study's feasibility, difficulties that may be encountered, and offer alternative approaches to be implemented, if needed, include general concepts for sample size determinations and statistical methodologies, but, particularly for pilot clinical trials, provide study-specific details in the PHS Human Subjects and Clinical Trial Information Forms.\n \n \n \n \n Note:\n \n If a clinical trial/study is included in a Research Project (and not as a Clinical Core), then the above information should appear as part of that Research Project.\n \n \n \n Note:\n \n Specific details for trials and studies will be captured using the PHS Human Subjects and Clinical Trials Information Form. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.\n \n \n \n Resource Sharing Plan:\n \n Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the\n \n How to Apply- Application Guide\n \n .\n \n \n \n Appendix:\n \n \n \n Only limited items are allowed in the Appendix. Follow all instructions for the\n \n How to Apply- Application Guide\n \n ; any instructions provided here are in addition to those in the\n \n How to Apply- Application Guide\n \n instructions.\n \n \n \n PHS Human Subjects and Clinical Trials Information (Clinical Core)\n \n \n \n When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the\n \n How to Apply- Application Guide,\n \n with the following additional instructions:\n \n \n If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the\n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n form or a\n \n Delayed Onset Study\n \n record.\n \n \n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n \n \n All instructions in the\n \n How to Apply- Application Guide\n \n must be followed.\n \n \n \n Delayed Onset Study\n \n \n \n Note:\n \n Delayed onset\n \n does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the\n \n How to Apply- Application Guide\n \n must be followed.\n \n \n \n Scientific Core\n \n \n \n When preparing your application, use Component Type ‘Scientific Core.’\n \n \n All instructions in the\n \n How to Apply- Application Guide\n \n must be followed, with the following additional instructions, as noted.\n \n \n \n SF424 (R&R) Cover (Scientific Core)\n \n \n \n Complete only the following fields:\n \n \n \n Applicant Information\n \n \n Type of Applicant (optional)\n \n \n Descriptive Title of Applicant’s Project\n \n \n Proposed Project Start/Ending Dates\n \n \n \n \n PHS 398 Cover Page Supplement (Scientific Core)\n \n \n \n Enter Human Embryonic Stem Cells in each relevant component.\n \n \n \n Research & Related Other Project Information (Scientific Core)\n \n \n \n \n Human Subjects:\n \n Answer only the ‘Are Human Subjects Involved?’ and ‘Is the Project Exempt from Federal regulations?’ questions.\n \n \n \n Vertebrate Animals:\n \n Answer only the ‘Are Vertebrate Animals Used?’ question.\n \n \n \n Project Narrative:\n \n Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.\n \n \n \n Facilities & Other Resources:\n \n Describe the facilities provided by the Core, as applied to procedures and techniques provided, as well as quality control.\n \n \n \n Project/Performance Site Location(s) (Scientific Core)\n \n \n \n List all performance sites that apply to the specific component.\n \n \n \n Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.\n \n \n \n \n Research & Related Senior/Key Person Profile (Scientific Core)\n \n \n \n \n In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.\n \n \n In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.\n \n \n Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.\n \n \n If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.\n \n \n \n \n Budget (Scientific Core)\n \n \n \n Budget forms appropriate for the specific component will be included in the application package.\n \n \n For Year 1, outline the percentage of total funds that will be required to support each component Research Project that will utilize the Scientific Core.\n \n \n \n Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.\n \n \n \n \n PHS 398 Research Plan (Scientific Core)\n \n \n \n \n Specific Aims:\n \n \n \n \n Discuss the Core’s relationship to the Center’s goals and how the Core relates to two or more individual Research Projects in the application. Testing of scientific hypotheses should not be proposed within a Core.\n \n \n \n \n Research Strategy:\n \n \n \n \n Describe how the proposed Scientific Core activities (including procedures, techniques and quality control) will contribute to meeting the Center’s goals and objectives and explain why the Core resources are not otherwise available.\n \n \n Describe how resource utilization will be allocated and/or prioritized, if applicable, to support the Center.\n \n \n \n Indicate the specific Research Projects to be supported by the Scientific Core. Describe the interactions of the Core with each of the Research Projects.\n \n \n \n Resource Sharing Plan:\n \n Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the\n \n How to Apply- Application Guide\n \n .\n \n \n \n Appendix:\n \n \n \n Only limited items are allowed in the Appendix. Follow all instructions for the\n \n How to Apply- Application Guide\n \n ; any instructions provided here are in addition to those in the\n \n How to Apply- Application Guide\n \n instructions.\n \n \n \n PHS Human Subjects and Clinical Trials Information (Scientific Core)\n \n \n \n When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the\n \n How to Apply- Application Guide,\n \n with the following additional instructions:\n \n \n If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the\n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n form or a\n \n Delayed Onset Study\n \n record.\n \n \n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n \n \n All instructions in the\n \n How to Apply- Application Guide\n \n must be followed.\n \n \n \n Delayed Onset Study\n \n \n \n Note:\n \n Delayed onset\n \n does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the\n \n How to Apply- Application Guide\n \n must be followed.\n \n \n \n Research Project\n \n \n \n When preparing your application, use Component Type ‘Project.’\n \n \n All instructions in the\n \n How to Apply- Application Guide\n \n must be followed, with the following additional instructions, as noted.\n \n \n \n SF424 (R&R) Cover (Research Project)\n \n \n \n Complete only the following fields:\n \n \n \n Applicant Information\n \n \n Type of Applicant (optional)\n \n \n Descriptive Title of Applicant’s Project\n \n \n Proposed Project Start/Ending Dates\n \n \n \n \n PHS 398 Cover Page Supplement (Research Project)\n \n \n \n Enter Human Embryonic Stem Cells in each relevant component.\n \n \n \n Research & Related Other Project Information (Research Project)\n \n \n \n \n Human Subjects:\n \n Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.\n \n \n \n Vertebrate Animals:\n \n Answer only the ‘Are Vertebrate Animals Used?’ question.\n \n \n \n Project Narrative:\n \n Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.\n \n \n \n Project/Performance Site Location(s) (Research Project)\n \n \n \n List all performance sites that apply to the specific component.\n \n \n \n Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.\n \n \n \n \n Research & Related Senior/Key Person Profile (Research Project)\n \n \n \n \n In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.\n \n \n In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.\n \n \n Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.\n \n \n If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.\n \n \n Within the biosketches, highlight the experience and expertise of the Research Project Lead and key personnel in regulatory activities, including IND/IDE submissions, safety oversight and reporting.\n \n \n \n \n Budget (Research Project)\n \n \n \n Budget forms appropriate for the specific component will be included in the application package.\n \n \n In single PD/PI applications, the PD/PI must also lead at least one Research Project and is required to commit an overall minimum of 2 person months in AADCRC activities. In multi-PD/PI applications, every PD/PI must lead a Research Project or Core, with at least one of the PD(s)/PI(s) leading a Research Project and committing an overall minimum of 2 person months to AADCRC activities.\n \n \n Include costs to support statistical design/support, data collection and analysis if those are not included in one of the Cores.\n \n \n If the Research Project involves a pilot clinical trial or a clinical observational study:\n \n \n \n Include costs for clinical site monitoring, medical monitoring, project management, and quality assurance of the proposed pilot clinical trials or observational clinical studies in the application budget. Alternatively, these costs can be incorporated into the budget of a Clinical Core, provided that specific cross-references are made to clarify how these necessary functions will be supported.\n \n \n \n Note: For all clinical trials, NIAID will provide a Data and Safety Monitoring Board (DSMB). Therefore, do not include or budget for DSMB expenses.\n \n \n \n Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.\n \n \n \n \n PHS 398 Research Plan (Research Project)\n \n \n \n \n Specific Aims:\n \n \n \n \n List, in priority order, the objectives and goals of the proposed project.\n \n \n Concisely describe the hypothesis or hypotheses to be tested. In addition, state the individual Research Project's relationship to the Center’s goals and how it relates to other projects or Cores.\n \n \n \n \n Research Strategy:\n \n \n \n \n Describe how the proposed research will contribute to meeting the Center’s goals and objectives and indicate the project's relevance to the primary theme of the application.\n \n \n Explain the rationale for selecting the methods to accomplish the specific aims of the Research Project.\n \n \n Provide a detailed timeline for the study supporting completion within the funding period.\n \n \n \n \n Clinical Trials\n \n \n \n The Approach section of a pilot clinical trial project should address the following aspects of the proposed trial(s):\n \n \n \n Discuss the rationale for the proposed approach for the problems being studied.\n \n \n Describe the design of the proposed trial, include rationale for the\xa0selection of the participant population, choice of intervention (if applicable), duration, and schedule of events.\n \n \n Discuss each trial’s feasibility.\n \n \n Include a plan for the management of the pilot clinical trial that offers description of personnel involved in 1) conducting the trial, and 2) data entry and interactions with the activities of the Data Stewardship Core.\n \n \n Include general concepts for sample size determinations and statistical methodologies, but provide trial-specific details in the PHS Human Subjects and Clinical Trial Information Forms.\n \n \n \n Note: Specific details for each trial will be captured using the PHS Human Subjects and Clinical Trials Information Forms. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.\n \n \n \n Clinical studies\n \n \n \n For applications proposing one or more clinical studies (observational studies with no interventions and involving only minimal risk procedures or cross-sectional studies), the Approach section of the clinical study project should address the following aspects of the study:\n \n \n \n Describe the design of the proposed study, include rationale for the selection of the participant population, choice of outcomes, duration, and schedule of events.\n \n \n Discuss each study's feasibility. Include a plan for the management of the clinical study that offers description of personnel involved in conducting the study, personnel involved in data entry, and the personnel involved in statistical analysis. Describe the interactions between these teams and the Data Stewardship Core.\n \n \n Include general concepts for sample size determinations and statistical methodologies, but provide study-specific details in the PHS Human Subjects Information Forms.\n \n \n Describe the timeline for protocol development, the plan for study implementation, the plan for evaluation of proposed study site(s), and plans for management and analysis of study data.\n \n \n For observational or cross-sectional clinical studies, describe the data analyses and statistical approach for the proposed study design and methods used to assign participants.\n \n \n \n Note: Specific details for each study will be captured using the PHS Human Subjects Information Form. Do not duplicate information requested under the PHS Human Subjects Information Forms.\n \n \n \n Projects obtaining human samples from non-AADCRC-supported clinical studies or trials:\n \n \n \n For projects that plan to obtain human samples derived from clinical studies or clinical trials that are planned, ongoing, or completed and are or have been sponsored by sources other than the AADCRC, the information in the Approach section should include the following:\n \n \n \n Study title\n \n \n Study objectives (primary and secondary)\n \n \n Study population(s) with clear description of clinical phenotypes\n \n \n Key design features, including primary and secondary endpoints, comparison/control groups\n \n \n Sample size calculations and statistical analysis plans as they pertain to the questions posed by the AADCRC study that will utilize the parent study/trial samples\n \n \n Study duration and timeline (if a planned or an ongoing study)\n \n \n \n \n Non-clinical research\n \n \n \n \n Describe the research design conceptual procedures and analyses to be used to accomplish the specific aims of the project.\n \n \n In the rare instances where animal models are proposed, justify the models and describe how the findings could be translated into human research and how they associate with the proposed clinical project(s).\n \n \n Provide a tentative timetable for the project.\n \n \n If animal studies are included, describe the relevance of the proposed animal model(s) to human asthma and/or allergic diseases. Describe the scientific potential for findings in animals to translate to human disease and appropriately justify the use of animal models if similar data could be obtained from human studies.\n \n \n \n \n Letters of Support:\n \n For Projects obtaining human samples from non-AADCRC-supported clinical studies or trials, include documentation of the ability to acquire human samples, including written agreements between the PD(s)/PI(s), the applicant institution, the clinical study/trial sponsor(s), including drug companies, if applicable, and the IND/IDE sponsor (if not one of the above) to be used in the studies proposed by the application is required. A statement is required that the subjects from whom samples were obtained from the parent clinical study/trial not supported by the proposed AADCRC project have given informed consent/assent and the material they have provided can be used by the AADCRC project.\n \n \n \n Resource Sharing Plan:\n \n Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the\n \n How to Apply- Application Guide\n \n .\n \n \n \n Appendix:\n \n \n \n Only limited items are allowed in the Appendix. Follow all instructions for the\n \n How to Apply- Application Guide\n \n ; any instructions provided here are in addition to those in the\n \n How to Apply- Application Guide\n \n instructions.\n \n \n \n PHS Human Subjects and Clinical Trials Information (Research Project)\n \n \n \n When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the\n \n How to Apply- Application Guide,\n \n with the following additional instructions:\n \n \n If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the\n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n form or a\n \n Delayed Onset Study\n \n record.\n \n \n \n Study Record: PHS Human Subjects and Clinical Trials Information\n \n \n \n All instructions in the\n \n How to Apply- Application Guide\n \n must be followed with the following additional instructions:\n \n \n \n Section 2 - Study Population Characteristics\n \n \n \n \n 2.5 - Recruitment and Retention Plan\n \n \n \n Describe actions to be taken to address problems with recruitment of study participants.\n \n \n \n Section 4 - Protocol Synopsis\n \n \n \n \n 4.1 Study Design\n \n \n \n \n 4.1.a Detailed Description\n \n \n \n For multi-visit studies, provide a description of the study design including the procedures and activities that can occur at each visit (schedule of events).\n \n \n \n Section 5 - Other Clinical Trial-related Attachments\n \n \n \n \n 5.1 Other Clinical Trial-related Attachments\n \n \n \n Describe the plan to obtain required investigational agent(s).\n \n \n IND applications required by the FDA for any investigational agents should be obtained by applicants prior to submission of applications. Provide the IND documents with other clinical trial related attachments.\n \n \n \n Delayed Onset Study\n \n \n \n Note:\n \n Delayed onset\n \n does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the\n \n How to Apply- Application Guide\n \n must be followed.\n \n \n \n \n 3. Unique Entity Identifier and System for Award Management (SAM)\n \n \n See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov\n \n \n \n \n 4. Submission Dates and Times\n \n \n Part I. contains information about Key Dates and times. 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Additional information may be found in\n \n How to Apply - Application Guide\n \n .\n \n \n See\n \n more tips\n \n for avoiding common errors.\n \n \n \n \n Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Institute of Allergy and Infectious Diseases, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.\n \n \n \n Mandatory Disclosure\n \n Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures,\n \n 2 CFR 200.113\n \n and\n \n NIH Grants Policy Statement Section 4.1.35\n \n .\n \n \n Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the\n \n HHS Office of Inspector Grant Self Disclosure Program\n \n at\n \n \n [email\xa0protected]\n \n \n .\n \n \n \n \n Post Submission Materials\n \n \n Applicants are required to follow the instructions for post-submission materials, as described in\n \n the policy\n \n .", ] embeddings = model.encode(sentences) print(embeddings.shape) # [3, 1024] # Get the similarity scores for the embeddings similarities = model.similarity(embeddings, embeddings) print(similarities.shape) # [3, 3] ``` ## Evaluation ### Metrics #### Information Retrieval * Evaluated with [InformationRetrievalEvaluator](https://sbert.net/docs/package_reference/sentence_transformer/evaluation.html#sentence_transformers.evaluation.InformationRetrievalEvaluator) | Metric | Value | |:--------------------|:-----------| | cosine_accuracy@1 | 0.9167 | | cosine_accuracy@3 | 1.0 | | cosine_accuracy@5 | 1.0 | | cosine_accuracy@10 | 1.0 | | cosine_precision@1 | 0.9167 | | cosine_precision@3 | 0.3333 | | cosine_precision@5 | 0.2 | | cosine_precision@10 | 0.1 | | cosine_recall@1 | 0.9167 | | cosine_recall@3 | 1.0 | | cosine_recall@5 | 1.0 | | cosine_recall@10 | 1.0 | | **cosine_ndcg@10** | **0.9692** | | cosine_mrr@10 | 0.9583 | | cosine_map@100 | 0.9583 | ## Training Details ### Training Dataset #### Unnamed Dataset * Size: 216 training samples * Columns: sentence_0 and sentence_1 * Approximate statistics based on the first 216 samples: | | sentence_0 | sentence_1 | |:--------|:-----------------------------------------------------------------------------------|:------------------------------------------------------------------------------------| | type | string | string | | details | | | * Samples: | sentence_0 | sentence_1 | |:-------------------------------------------------------------------------------------------------------------------------------------------|:------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | What is the primary role of the Department of Health and Human Services? | Department of Health and Human Services | | Which services are typically provided by the Department of Health and Human Services? | Department of Health and Human Services | | What is the primary purpose of the National Cooperative Drug/Device Discovery/Development Groups (NCDDG) funding opportunity? | PAR-25-353: National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U19 Clinical Trial Optional) Part 1. Overview Information



Participating Organization(s)

National Institutes of Health (

NIH

)



Components of Participating Organizations

National Institute of Mental Health (

NIMH

)



Funding Opportunity Title

National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U19 Clinical Trial Optional)



Activity Code


U19

Research Program – Cooperative Agreements



Announcement Type
Reissue of

PAR-22-144




Related Notices



April 4, 2024

- Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice

NOT-OD-24-084

.



Augus... | * Loss: [MatryoshkaLoss](https://sbert.net/docs/package_reference/sentence_transformer/losses.html#matryoshkaloss) with these parameters: ```json { "loss": "MultipleNegativesRankingLoss", "matryoshka_dims": [ 768, 512, 256, 128, 64 ], "matryoshka_weights": [ 1, 1, 1, 1, 1 ], "n_dims_per_step": -1 } ``` ### Training Hyperparameters #### Non-Default Hyperparameters - `eval_strategy`: steps - `per_device_train_batch_size`: 10 - `per_device_eval_batch_size`: 10 - `num_train_epochs`: 10 - `multi_dataset_batch_sampler`: round_robin #### All Hyperparameters
Click to expand - `overwrite_output_dir`: False - `do_predict`: False - `eval_strategy`: steps - `prediction_loss_only`: True - `per_device_train_batch_size`: 10 - `per_device_eval_batch_size`: 10 - `per_gpu_train_batch_size`: None - `per_gpu_eval_batch_size`: None - `gradient_accumulation_steps`: 1 - `eval_accumulation_steps`: None - `torch_empty_cache_steps`: None - `learning_rate`: 5e-05 - `weight_decay`: 0.0 - `adam_beta1`: 0.9 - `adam_beta2`: 0.999 - `adam_epsilon`: 1e-08 - `max_grad_norm`: 1 - `num_train_epochs`: 10 - `max_steps`: -1 - `lr_scheduler_type`: linear - `lr_scheduler_kwargs`: {} - `warmup_ratio`: 0.0 - `warmup_steps`: 0 - `log_level`: passive - `log_level_replica`: warning - `log_on_each_node`: True - `logging_nan_inf_filter`: True - `save_safetensors`: True - `save_on_each_node`: False - `save_only_model`: False - `restore_callback_states_from_checkpoint`: False - `no_cuda`: False - `use_cpu`: False - `use_mps_device`: False - `seed`: 42 - `data_seed`: None - `jit_mode_eval`: False - `use_ipex`: False - `bf16`: False - `fp16`: False - `fp16_opt_level`: O1 - `half_precision_backend`: auto - `bf16_full_eval`: False - `fp16_full_eval`: False - `tf32`: None - `local_rank`: 0 - `ddp_backend`: None - `tpu_num_cores`: None - `tpu_metrics_debug`: False - `debug`: [] - `dataloader_drop_last`: False - `dataloader_num_workers`: 0 - `dataloader_prefetch_factor`: None - `past_index`: -1 - `disable_tqdm`: False - `remove_unused_columns`: True - `label_names`: None - `load_best_model_at_end`: False - `ignore_data_skip`: False - `fsdp`: [] - `fsdp_min_num_params`: 0 - `fsdp_config`: {'min_num_params': 0, 'xla': False, 'xla_fsdp_v2': False, 'xla_fsdp_grad_ckpt': False} - `fsdp_transformer_layer_cls_to_wrap`: None - `accelerator_config`: {'split_batches': False, 'dispatch_batches': None, 'even_batches': True, 'use_seedable_sampler': True, 'non_blocking': False, 'gradient_accumulation_kwargs': None} - `deepspeed`: None - `label_smoothing_factor`: 0.0 - `optim`: adamw_torch - `optim_args`: None - `adafactor`: False - `group_by_length`: False - `length_column_name`: length - `ddp_find_unused_parameters`: None - `ddp_bucket_cap_mb`: None - `ddp_broadcast_buffers`: False - `dataloader_pin_memory`: True - `dataloader_persistent_workers`: False - `skip_memory_metrics`: True - `use_legacy_prediction_loop`: False - `push_to_hub`: False - `resume_from_checkpoint`: None - `hub_model_id`: None - `hub_strategy`: every_save - `hub_private_repo`: None - `hub_always_push`: False - `gradient_checkpointing`: False - `gradient_checkpointing_kwargs`: None - `include_inputs_for_metrics`: False - `include_for_metrics`: [] - `eval_do_concat_batches`: True - `fp16_backend`: auto - `push_to_hub_model_id`: None - `push_to_hub_organization`: None - `mp_parameters`: - `auto_find_batch_size`: False - `full_determinism`: False - `torchdynamo`: None - `ray_scope`: last - `ddp_timeout`: 1800 - `torch_compile`: False - `torch_compile_backend`: None - `torch_compile_mode`: None - `dispatch_batches`: None - `split_batches`: None - `include_tokens_per_second`: False - `include_num_input_tokens_seen`: False - `neftune_noise_alpha`: None - `optim_target_modules`: None - `batch_eval_metrics`: False - `eval_on_start`: False - `use_liger_kernel`: False - `eval_use_gather_object`: False - `average_tokens_across_devices`: False - `prompts`: None - `batch_sampler`: batch_sampler - `multi_dataset_batch_sampler`: round_robin
### Training Logs | Epoch | Step | cosine_ndcg@10 | |:------:|:----:|:--------------:| | 1.0 | 22 | 0.9023 | | 2.0 | 44 | 0.9455 | | 2.2727 | 50 | 0.9609 | | 3.0 | 66 | 0.9609 | | 4.0 | 88 | 0.9692 | | 4.5455 | 100 | 0.9692 | | 5.0 | 110 | 0.9692 | | 6.0 | 132 | 0.9692 | | 6.8182 | 150 | 0.9692 | | 7.0 | 154 | 0.9692 | | 8.0 | 176 | 0.9638 | | 9.0 | 198 | 0.9692 | | 9.0909 | 200 | 0.9692 | | 10.0 | 220 | 0.9692 | ### Framework Versions - Python: 3.11.11 - Sentence Transformers: 3.3.1 - Transformers: 4.48.3 - PyTorch: 2.5.1+cu124 - Accelerate: 1.3.0 - Datasets: 3.3.2 - Tokenizers: 0.21.0 ## Citation ### BibTeX #### Sentence Transformers ```bibtex @inproceedings{reimers-2019-sentence-bert, title = "Sentence-BERT: Sentence Embeddings using Siamese BERT-Networks", author = "Reimers, Nils and Gurevych, Iryna", booktitle = "Proceedings of the 2019 Conference on Empirical Methods in Natural Language Processing", month = "11", year = "2019", publisher = "Association for Computational Linguistics", url = "https://arxiv.org/abs/1908.10084", } ``` #### MatryoshkaLoss ```bibtex @misc{kusupati2024matryoshka, title={Matryoshka Representation Learning}, author={Aditya Kusupati and Gantavya Bhatt and Aniket Rege and Matthew Wallingford and Aditya Sinha and Vivek Ramanujan and William Howard-Snyder and Kaifeng Chen and Sham Kakade and Prateek Jain and Ali Farhadi}, year={2024}, eprint={2205.13147}, archivePrefix={arXiv}, primaryClass={cs.LG} } ``` #### MultipleNegativesRankingLoss ```bibtex @misc{henderson2017efficient, title={Efficient Natural Language Response Suggestion for Smart Reply}, author={Matthew Henderson and Rami Al-Rfou and Brian Strope and Yun-hsuan Sung and Laszlo Lukacs and Ruiqi Guo and Sanjiv Kumar and Balint Miklos and Ray Kurzweil}, year={2017}, eprint={1705.00652}, archivePrefix={arXiv}, primaryClass={cs.CL} } ```