Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Fair And Immediate Release of
Generic Drugs Act'' or the ``FAIR Generics Act''.

SEC. 2. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING FIRST APPLICANT
              STATUS.

    (a) Amendments to Federal Food, Drug, and Cosmetic Act.--
            (1) In general.--Section 505(j)(5)(B) of the Federal Food,
        Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) is amended--
                    (A) in clause (iv)(II)--
                            (i) by striking item (bb); and
                            (ii) by redesignating items (cc) and (dd)
                        as items (bb) and (cc), respectively; and
                    (B) by adding at the end the following:
    ``(v) First Applicant Defined.--As used in this subsection, the
term `first applicant' means an applicant--
            ``(I)(aa) that, on the first day on which a substantially
        complete application containing a certification described in
        paragraph (2)(A)(vii)(IV) is submitted for approval of a drug,
        submits a substantially complete application that contains and
        lawfully maintains a certification described in paragraph
        (2)(A)(vii)(IV) for the drug; and
            ``(bb) that has not entered into a disqualifying agreement
        described under clause (vii)(II); or
            ``(II)(aa) for the drug that is not described in subclause
        (I) and that, with respect to the applicant and drug, each
        requirement described in clause (vi) is satisfied; and
            ``(bb) that has not entered into a disqualifying agreement
        described under clause (vii)(II).
    ``(vi) Requirement.--The requirements described in this clause are
the following:
            ``(I) The applicant described in clause (v)(II) submitted
        and lawfully maintains a certification described in paragraph
        (2)(A)(vii)(IV) or a statement described in paragraph
        (2)(A)(viii) for each unexpired patent for which a first
        applicant described in clause (v)(I) had submitted a
        certification described in paragraph (2)(A)(vii)(IV) on the
        first day on which a substantially complete application
        containing such a certification was submitted.
            ``(II) With regard to each such unexpired patent for which
        the applicant described in clause (v)(II) submitted a
        certification described in paragraph (2)(A)(vii)(IV), no action
        for patent infringement was brought against such applicant
        within the 45 day period specified in paragraph (5)(B)(iii); or
        if an action was brought within such time period, such an
        action was withdrawn or dismissed by a court (including a
        district court) without a decision that the patent was valid
        and infringed; or if an action was brought within such time
        period and was not withdrawn or so dismissed, such applicant
        has obtained the decision of a court (including a district
        court) that the patent is invalid or not infringed (including
        any substantive determination that there is no cause of action
        for patent infringement or invalidity, and including a
        settlement order or consent decree signed and entered by the
        court stating that the patent is invalid or not infringed).
            ``(III) If an applicant described in clause (v)(I) has
        begun commercial marketing of such drug, the applicant
        described in clause (v)(II) does not begin commercial marketing
        of such drug until the date that is 30 days after the date on
        which the applicant described in clause (v)(I) began such
        commercial marketing.''.
            (2) Conforming amendment.--Section 505(j)(5)(D)(i)(IV) of
        such Act (21 U.S.C. 355(j)(5)(D)(i)(IV)) is amended by striking
        ``The first applicant'' and inserting ``The first applicant, as
        defined in subparagraph (B)(v)(I),''.
    (b) Applicability.--The amendments made by subsection (a) shall
apply only with respect to an application filed under section 505(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) to which
the amendments made by section 1102(a) of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173)
apply.

SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING AGREEMENTS TO
              DEFER COMMERCIAL MARKETING.

    (a) Amendments to Federal Food, Drug, and Cosmetic Act.--
            (1) Limitations on agreements to defer commercial marketing
        date.--Section 505(j)(5)(B) of the Federal Food, Drug, and
        Cosmetic Act (21 U.S.C. 355(j)(5)(B)), as amended by section 2,
        is further amended by adding at the end the following:
            ``(vii) Agreement by first applicant to defer commercial
        marketing; limitation on acceleration of deferred commercial
        marketing date.--
                    ``(I) Agreement to defer approval or commercial
                marketing date.--An agreement described in this
                subclause is an agreement between a first applicant and
                the holder of the application for the listed drug or an
                owner of one or more of the patents as to which any
                applicant submitted a certification qualifying such
                applicant for the 180-day exclusivity period whereby
                that applicant agrees, directly or indirectly, (aa) not
                to seek an approval of its application that is made
                effective on the earliest possible date under this
                subparagraph, subparagraph (F) of this paragraph,
                section 505A, or section 527, (bb) not to begin the
                commercial marketing of its drug on the earliest
                possible date after receiving an approval of its
                application that is made effective under this
                subparagraph, subparagraph (F) of this paragraph,
                section 505A, or section 527, or (cc) to both items
                (aa) and (bb).
                    ``(II) Agreement that disqualifies applicant from
                first applicant status.--An agreement described in this
                subclause is an agreement between an applicant and the
                holder of the application for the listed drug or an
                owner of one or more of the patents as to which any
                applicant submitted a certification qualifying such
                applicant for the 180-day exclusivity period whereby
                that applicant agrees, directly or indirectly, not to
                seek an approval of its application or not to begin the
                commercial marketing of its drug until a date that is
                after the expiration of the 180-day exclusivity period
                awarded to another applicant with respect to such drug
                (without regard to whether such 180-day exclusivity
                period is awarded before or after the date of the
                agreement).
            ``(viii) Limitation on acceleration.--If an agreement
        described in clause (vii)(I) includes more than 1 possible date
        when an applicant may seek an approval of its application or
        begin the commercial marketing of its drug--
                    ``(I) the applicant may seek an approval of its
                application or begin such commercial marketing on the
                date that is the earlier of--
                            ``(aa) the latest date set forth in the
                        agreement on which that applicant can receive
                        an approval that is made effective under this
                        subparagraph, subparagraph (F) of this
                        paragraph, section 505A, or section 527, or
                        begin the commercial marketing of such drug,
                        without regard to any other provision of such
                        agreement pursuant to which the commercial
                        marketing could begin on an earlier date; or
                            ``(bb) 180 days after another first
                        applicant begins commercial marketing of such
                        drug; and
                    ``(II) the latest date set forth in the agreement
                on which that applicant can receive an approval that is
                made effective under this subparagraph, subparagraph
                (F) of this paragraph, section 505A, or section 527, or
                begin the commercial marketing of such drug, without
                regard to any other provision of such agreement
                pursuant to which commercial marketing could begin on
                an earlier date, shall be the date used to determine
                whether an applicant is disqualified from first
                applicant status pursuant to clause (vii)(II).''.
            (2) Notification of fda.--Section 505(j) of such Act (21
        U.S.C. 355(j)) is amended by adding at the end the following:
    ``(11)(A) The holder of an abbreviated application under this
subsection shall submit to the Secretary a notification that includes--
            ``(i)(I) the text of any agreement entered into by such
        holder described under paragraph (5)(B)(vii)(I); or
            ``(II) if such an agreement has not been reduced to text, a
        written detailed description of such agreement that is
        sufficient to disclose all the terms and conditions of the
        agreement; and
            ``(ii) the text, or a written detailed description in the
        event of an agreement that has not been reduced to text, of any
        other agreements that are contingent upon, provide a contingent
        condition for, or are otherwise related to an agreement
        described in clause (i).
    ``(B) The notification described under subparagraph (A) shall be
submitted not later than 10 business days after execution of the
agreement described in subparagraph (A)(i). Such notification is in
addition to any notification required under section 1112 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
    ``(C) Any information or documentary material filed with the
Secretary pursuant to this paragraph shall be exempt from disclosure
under section 552 of title 5, United States Code, and no such
information or documentary material may be made public, except as may
be relevant to any administrative or judicial action or proceeding.
Nothing in this paragraph is intended to prevent disclosure to either
body of the Congress or to any duly authorized committee or
subcommittee of the Congress.''.
            (3) Prohibited acts.--Section 301(e) of such Act (21 U.S.C.
        331(e)) is amended by striking ``505 (i) or (k)'' and inserting
        ``505 (i), (j)(11), or (k)''.
    (b) Infringement of Patent.--Section 271(e) of title 35, United
States Code, is amended by adding at the end the following:
    ``(7) The exclusive remedy under this section for an infringement
of a patent for which the Secretary of Health and Human Services has
published information pursuant to subsection (b)(1) or (c)(2) of
section 505 of the Federal Food, Drug, and Cosmetic Act shall be an
action brought under this subsection within the 45-day period described
in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of the Federal
Food, Drug, and Cosmetic Act.''.
    (c) Applicability.--
            (1) Limitations on acceleration of deferred commercial
        marketing date.--The amendment made by subsection (a)(1) shall
        apply only with respect to--
                    (A) an application filed under section 505(j) of
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
                355(j)) to which the amendments made by section 1102(a)
                of the Medicare Prescription Drug, Improvement, and
                Modernization Act of 2003 (Public Law 108-173) apply;
                and
                    (B) an agreement described under section
                505(j)(5)(B)(vii)(I) of the Federal Food, Drug, and
                Cosmetic Act (as added by subsection (a)(1)) executed
                after the date of enactment of this Act.
            (2) Notification of fda.--The amendments made by paragraphs
        (2) and (3) of subsection (a) shall apply only with respect to
        an agreement described under section 505(j)(5)(B)(vii)(I) of
        the Federal Food, Drug, and Cosmetic Act (as added by
        subsection (a)(1)) executed after the date of enactment of this
        Act.

Output:
Fair And Immediate Release of Generic Drugs Act or the FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patentholder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant).

Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decided that the patent was invalid or not infringed; and (3) the applicant does not begin commercial marketing of such drug until 30 days after the first applicant began such commercial marketing.

Prohibits a party that enters an agreement to delay seeking approval of its generic drug application or to delay the commercial marketing of a generic drug from seeking approval of its application or beginning commercial marketing before the earlier of: (1) the latest date set forth in the agreement to seek approval or market the drug without regard to any earlier date under the agreement when commercial marketing could begin, or (2) 180 days after another first applicant begins commercial marketing of such drug.

Requires notice to the Secretary of the Health and Human Services (HHS) of the details of any agreement under this Act not later than ten business days after execution of the agreement.

Declares that the exclusive remedy for an infringement of a patent included within a new drug application shall be an action brought under the FFDCA within the 45-day period prescribed.


Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Public Health Equity Act''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) all communities and individuals are entitled to
        protection from occupational and other exposure to substances
        that are hazardous to the public health;
            (2) hazardous substances have had a disproportionate impact
        on the public health of poor and ethnic minority communities
        and individuals, resulting in exclusion from participation in,
        denial of benefits under, and discrimination under, programs
        and activities receiving Federal financial assistance; and
            (3) each Federal agency has an obligation to ensure that
        all federally assisted programs and activities that affect
        human health do not directly or through contractual
        arrangements use criteria, methods, or practices that cause
        discrimination on the ground of race, color, or national
        origin.

SEC. 3. PUBLIC HEALTH EQUITY.

    The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by
adding at the end thereof the following new title:

                  ``TITLE XXVII--PUBLIC HEALTH EQUITY

``SEC. 2701. DEFINITIONS.

    ``As used in this title:
            ``(1) Activity; program.--The term `program or activity'
        means any operation of--
                    ``(A)(i) a department, agency, special purpose
                district, or other instrumentality of a State or of a
                local government; or
                    ``(ii) the entity of such State or local government
                that distributes such assistance and each such
                department or agency (and each other State or local
                government entity) to which the assistance is extended,
                in the case of assistance to a State or local
                government;
                    ``(B)(i) a college, university, or other
                postsecondary institution, or a public system of higher
                education; or
                    ``(ii) a local educational agency (as defined in
                section 198(a)(10) of the Elementary and Secondary
                Education Act of 1965), system of vocational education,
                or other school system;
                    ``(C)(i) an entire corporation, partnership, or
                other private organization, or an entire sole
                proprietorship--
                            ``(I) if assistance is extended to such
                        corporation, partnership, private organization,
                        or sole proprietorship as a whole; or
                            ``(II) which is principally engaged in the
                        business of providing education, health care,
                        housing, social services, or parks and
                        recreation; or
                    ``(ii) the entire plant or other comparable,
                geographically separate facility to which Federal
                financial assistance is extended, in the case of any
                other corporation, partnership, private organization,
                or sole proprietorship; or
                    ``(D) any other entity which is established by two
                or more of the entities described in subparagraph (A),
                (B), or (C);
        any part of which is extended Federal financial assistance
        relating to a covered substance.
            ``(2) Administrator.--The term `Administrator' has the
        meaning given the term in section 511(7) of the Education for
        Economic Security Act (20 U.S.C. 4020(7)).
            ``(3) Covered substance.--The term `covered substance'
        means--
                    ``(A) any material subject to the requirements
                concerning material safety data sheets for chemicals
                under the Occupational and Safety and Health Act of
                1970 (29 U.S.C. 651 et seq.);
                    ``(B) any contaminant identified in title XIV;
                    ``(C) any substance described in section 201(q) of
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
                321(q)), and any material registered pursuant to the
                Act referred to in such section;
                    ``(D) any chemical listed by the National
                Toxicology Program of the Department of Health and
                Human Services as a known or probable human carcinogen;
                and
                    ``(E) any substance defined in section 101(14) of
                the Comprehensive Environmental Response, Compensation,
                and Liability Act of 1980 (42 U.S.C. 9601(14)) and any
                chemical subject to section 313 of the Emergency
                Planning and Community Right-To-Know Act of 1986 (42
                U.S.C. 11023).

``SEC. 2702. NONDISCRIMINATION.

    ``(a) Prohibition of Discrimination.--The President shall ensure
that no person shall be excluded from participation in, be denied the
benefits of, or be subject to discrimination under, any program or
activity, on the ground of race, color, or national origin.
    ``(b) Promulgation of Regulations.--
            ``(1) Subject.--Subject to paragraph (2), the Secretary of
        Labor, the Secretary of Health and Human Services, the
        Administrator, and any other head of a Federal agency with
        responsibility for providing Federal financial assistance to a
        program or activity shall issue regulations implementing the
        nondiscrimination requirements described in subsection (a) in
        accordance with any applicable law. The regulations shall bar
        acts with discriminatory effects as well as intentionally
        discriminatory acts. The regulations shall address actions of
        programs or activities that result in disproportionate exposure
        to a covered substance on the basis of race, color, or national
        origin.
            ``(2) Timetable.--In issuing regulations under paragraph
        (1)--
                    ``(A) not later than 180 days after the date of
                enactment of this Act, each individual described in
                paragraph (1) shall publish a notice of proposed
                rulemaking in the Federal Register;
                    ``(B) each individual described in paragraph (1)
                shall provide a public comment period, subject to
                section 553 of title 5, United States Code, of 60 days
                after the publication of the notice of proposed
                rulemaking required under subparagraph (A); and
                    ``(C) not later than 45 days after the close of the
                public comment period required under subparagraph (B),
                each individual described in paragraph (1) shall
                publish final regulations.''.

Output: Public Health Equity Act - Amends the Public Health Service Act to add a new title, title XXVII:  Public Health Equity.  Prohibits, under such title, acts with discriminatory effect as well as intentionally discriminatory acts that result in disproportionate exposure to a covered substance on the basis of race, color, or national origin. Defines a covered substance to include certain hazardous materials, substances, contaminants, or chemicals listed, identified, or defined in specified laws.


Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Brownfield Cleanup and Redevelopment
Revolving Loan Fund Pilot Project Act of 1996''.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--The Congress finds the following:
            (1) Contaminated and underused or abandoned industrial
        sites in distressed communities are, economically, at a
        competitive disadvantage relative to greenfield sites, as
        capital for their cleanup and redevelopment may not be
        available.
            (2) Contaminated and underused and abandoned industrial
        properties located in distressed areas, owned by private,
        public, or nonprofit entities, often with significant economic
        development potential once cleaned up, are unable to secure
        initial financing for site remediation.
            (3) Considerable public benefits can accrue from such sites
        once cleaned up and brought back to productive reuse,
        especially those devoted to industrial purposes that employ
        environmentally sound practices.
            (4) Voluntary cleanup programs spur private sector cleanups
        when the property value is sufficient and its location
        favorable enough to make the additional costs of cleanup
        economically feasible, but this approach does not resolve the
        problems facing properties with little or no value, common
        among sites located in economically distressed areas.
            (5) Because of their experience in administering targeted
        loan assistance programs, States are in a good position to use
        Federal funds to capitalize revolving loan funds to support
        local cleanup and redevelopment projects.
    (b) Purpose.--The purpose of this Act is to establish a pilot
project to revitalize distressed communities by providing loans for
cleanup of certain industrial properties that have the potential to
attract private investment, foster clean manufacturing, and create jobs
for local residents.

SEC. 3. PILOT PROJECT PROVIDING REVOLVING LOAN FUND FOR CLEANUPS UNDER
              STATE VOLUNTARY CLEANUP PROGRAMS.

    (a) Establishment of Loan Program.--The Administrator of the
Environmental Protection Agency (hereinafter in this Act referred to as
the ``Administrator'') shall establish a pilot project to provide a
capitalization loan to one or more States that submit applications to
the Administrator to establish or expand a State revolving loan fund
for purposes of providing loans for voluntary environmental cleanups of
eligible facilities.
    (b) Application for Loan.--An application for a capitalization loan
under this section shall be in such form as the Administrator considers
appropriate. At a minimum, the application shall include each of the
following:
            (1) Evidence that the State is carrying out a voluntary
        cleanup program for eligible facilities. The Administrator
        shall ensure that the State voluntary program provides, at a
        minium, adequate opportunities for public participation,
        sufficient technical assistance, and oversight to ensure that
        cleanups comply with Federal and State laws, and certification
        to the owner and prospective purchaser that the cleanup is
        complete.
            (2) Evidence that the State will provide a matching share
        of at least 20 percent of the costs of such cleanup from either
        new or existing sources of State funding.
            (3) A description of the State's proposed revolving loan
        program and of the State's capability to manage the program.
        States may use interest income or loan repayments (in an amount
        equal to not more than 10 percent of their revolving loan fund
        amount) for program administrative purposes. At a minimum, the
        State's revolving loan program shall--
                    (A) provide loans to both public and private
                parties conducting voluntary cleanups under the State's
                voluntary cleanup program
                 who are unable to secure loans from private lending
institutions or other means of financing;
                    (B) require that borrowers demonstrate credit
                worthiness and the ability to carry out the cleanup;
                and
                    (C) give priority to loans for the purpose of
                cleaning up--
                            (i) facilities that are planned to be
                        reused for industrial purposes that employ
                        environmentally sound practices; and
                            (ii) facilities that will generate jobs for
                        contractors whose principal place of business
                        is the political subdivision in which the
                        facility is located or for laborers who reside
                        in such political subdivisions.
            (4) A statement that the State will begin repayment of the
        loan within 5 years after receipt of the loan, and evidence of
        the State's ability to repay the loan.
            (5) A statement that a loan from the revolving loan fund
        will not be used to pay for any of the following:
                    (A) New construction.
                    (B) Environmental fines or penalties.
                    (C) Speculative assessments or speculative
                rehabilitation at facilities with little or no
                potential for economic development.
            (6) Such other elements as the Administrator considers
        appropriate.
    (c) Amount of Loan.--The Administrator shall determine the
distribution of funds among the eligible States. The amount of a
capitalization loan made by the Administrator under this Act to a State
may not exceed 15 percent of the amount available each year to all the
eligible States.
    (d) Authorization.--There are authorized to be appropriated to the
Administrator for purposes of making capitalization loans to States
under the pilot project established by this section the sum of
$5,000,000 for fiscal year 1996 and $7,500,000 for each of the fiscal
years 1997 and 1998.

SEC. 4. DEFINITIONS.

    For purposes of this Act the term ``eligible facility'' means a
facility or property in a State that is determined by the State to have
environmental contamination that--
            (1) could prevent the timely use, development, or reuse of
        the facility or property; and
            (2) is limited in scope and can be comprehensively and
        readily evaluated.
        Such term shall not include any of the following:
            (A) A facility that is eligible for abatement action under
        section 106 of the Comprehensive Environmental Response,
        Compensation, and Liability Act of 1980.
            (B) A facility that, as of the date of the enactment of
        this Act, is subject to Federal enforcement action under the
        Comprehensive Environmental Response, Compensation, and
        Liability Act of 1980 (42 U.S.C. 9601 et seq.).
            (C) A facility included, or proposed for inclusion, on the
        National Priorities List or on the comprehensive environmental
        response, compensation, and liability inventory system
        (``CERCLIS'') that has been evaluated as high priority under
        the hazard ranking system.
            (D) A facility required to have a permit under section 3005
        of the Solid Waste Disposal Act that does not have a permit
        under that section and does not qualify for authorization to
        operate in interim status under subsection (e) of that section.
            (E) A land disposal unit with respect to which a closure
        notification under subtitle C of the Solid Waste Disposal Act
        (42 U.S.C. 6921 et seq.) is submitted and closure requirements
        are specified in a closure plan or permit.
            (F) A facility subject to corrective action under section
        3004(u) or 3008(h) of the Solid Waste Disposal Act (42 U.S.C.
        5924(u) or 6928(h)) that is evaluated as high priority under
        the Environmental Protection Agency's National Corrective
        Action Priority System as set forth in regulations under
        subtitle C of the Solid Waste Disposal Act.
            (G) A facility at which assistance for response activities
        may be obtained pursuant to subtitle I of the Solid Waste
        Disposal Act (42 U.S.C. 6991 et seq.) from the Leaking
        Underground Storage Tank Trust Fund established under section
        9508 of the Internal Revenue Code of 1986.
            (H) A facility owned or operated by a department, agency,
        or instrumentality of the United States.

Output:
Brownfield Cleanup and Redevelopment Revolving Loan Fund Pilot Project Act of 1996 - Directs the Administrator of the Environmental Protection Agency to establish a pilot project to provide capitalization loans to States to establish or expand revolving loan funds that provide loans for voluntary environmental cleanups of eligible facilities (those determined by the State to have limited environmental contamination that can be readily and comprehensively evaluated and that could prevent the timely use, development, or reuse of the facility or property).
Authorizes appropriations.
Makes ineligible for such assistance facilities that are:  (1) eligible for abatement actions, or subject to Federal enforcement action, under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980; (2) on or proposed for inclusion on the National Priorities List or evaluated as high priority under the hazard ranking system; (3) subject to certain actions, or unqualified to conduct certain hazardous waste disposal activities, under the Solid Waste Disposal Act; or (4) owned or operated by the United States.


Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Smith-Mundt Modernization Act of
2012''.

SEC. 2. DISSEMINATION ABROAD OF INFORMATION ABOUT THE UNITED STATES.

    (a) United States Information and Educational Exchange Act of
1948.--Section 501 of the United States Information and Educational
Exchange Act of 1948 (22 U.S.C. 1461) is amended to read as follows:

                        ``general authorization

    ``Sec. 501.  (a) The Secretary and the Broadcasting Board of
Governors are authorized to use funds appropriated or otherwise made
available for public diplomacy information programs to provide for the
preparation, dissemination, and use of information intended for foreign
audiences abroad about the United States, its people, and its policies,
through press, publications, radio, motion pictures, the Internet, and
other information media, including social media, and through
information centers, instructors, and other direct or indirect means of
communication.
    ``(b)(1) Except as provided in paragraph (2), the Secretary and the
Broadcasting Board of Governors may, upon request and reimbursement of
the reasonable costs incurred in fulfilling such a request, make
available, in the United States, motion pictures, films, video, audio,
and other materials prepared for dissemination abroad or disseminated
abroad pursuant to this Act, the United States International
Broadcasting Act of 1994 (22 U.S.C. 6201 et seq.), the Radio
Broadcasting to Cuba Act (22 U.S.C. 1465 et seq.), or the Television
Broadcasting to Cuba Act (22 U.S.C. 1465aa et seq.). The Secretary and
the Broadcasting Board of Governors shall issue necessary regulations--
            ``(A) to establish procedures to maintain such material;
            ``(B) for reimbursement of the reasonable costs incurred in
        fulfilling requests for such material; and
            ``(C) to ensure that the persons seeking release of such
        material have secured and paid for necessary United States
        rights and licenses.
    ``(2) With respect to material prepared for dissemination abroad or
disseminated abroad before the effective date of the Smith-Mundt
Modernization Act of 2012--
            ``(A) the Secretary and the Broadcasting Board of Governors
        shall make available to the Archivist of the United States, for
        domestic distribution, motion pictures, films, videotapes, and
        other material 12 years after the initial dissemination of the
        material abroad; and
            ``(B) the Archivist shall be the official custodian of the
        material and shall issue necessary regulations to ensure that
        persons seeking its release in the United States have secured
        and paid for necessary United States rights and licenses and
        that all costs associated with the provision of the material by
        the Archivist shall be paid by the persons seeking its release,
        in accordance with paragraph (3).
    ``(3) The Archivist may charge fees to recover the costs described
in paragraph (2), in accordance with section 2116(c) of title 44. Such
fees shall be paid into, administered, and expended as part of the
National Archives Trust Fund.
    ``(c) Nothing in this section may be construed to require the
Secretary or the Broadcasting Board of Governors to make material
disseminated abroad available in any format other than in the format
disseminated abroad.''.
    (b) Rule of Construction.--Nothing in this section may be construed
to affect the allocation of funds appropriated or otherwise made
specifically available for public diplomacy.
    (c) Foreign Relations Authorization Act, Fiscal Years 1986 and
1987.--Section 208 of the Foreign Relations Authorization Act, Fiscal
Years 1986 and 1987 (22 U.S.C. 1461-1a) is amended to read as follows:

``SEC. 208. CLARIFICATION ON DOMESTIC DISTRIBUTION OF PROGRAM MATERIAL.

    ``(a) In General.--No funds authorized to be appropriated to the
Department of State or the Broadcasting Board of Governors shall be
used to influence public opinion in the United States. This section
shall apply only to programs carried out pursuant to the United States
Information and Educational Exchange Act of 1948 (22 U.S.C. 1431 et
seq.), the United States International Broadcasting Act of 1994 (22
U.S.C. 6201 et seq.), the Radio Broadcasting to Cuba Act (22 U.S.C.
1465 et seq.), and the Television Broadcasting to Cuba Act (22 U.S.C.
1465aa et seq.). This section shall not prohibit or delay the
Department of State or the Broadcasting Board of Governors from
providing information about its operations, policies, programs, or
program material, or making such available, to the media, public, or
Congress, in accordance with other applicable law.
    ``(b) Rule of Construction.--Nothing in this section shall be
construed to prohibit the Department of State or the Broadcasting Board
of Governors from engaging in any medium or form of communication,
either directly or indirectly, because a United States domestic
audience is or may be thereby exposed to program material, or based on
a presumption of such exposure. Such material may be made available
within the United States and disseminated, when appropriate, pursuant
to sections 502 and 1005 of the United States Information and
Educational Exchange Act of 1948 (22 U.S.C. 1462 and 1437), except that
nothing in this section may be construed to authorize the Department of
State or the Broadcasting Board of Governors to disseminate within the
United States any program material prepared for dissemination abroad on
or before the effective date of the Smith-Mundt Modernization Act of
2012.
    ``(c) Application.--The provisions of this section shall apply only
to the Department of State and the Broadcasting Board of Governors and
to no other department or agency of the Federal Government.''.
    (d) Conforming Amendments.--The United States Information and
Educational Exchange Act of 1948 is amended--
            (1) in section 502 (22 U.S.C. 1462)--
                    (A) by inserting ``and the Broadcasting Board of
                Governors'' after ``Secretary''; and
                    (B) by inserting ``or the Broadcasting Board of
                Governors'' after ``Department''; and
            (2) in section 1005 (22 U.S.C. 1437), by inserting ``and
        the Broadcasting Board of Governors'' after ``Secretary'' each
        place it appears.
    (e) Effective Date.--This Act shall take effect and apply on the
date that is 180 days after the date of the enactment of this Act.

Output:
Smith-Mundt Modernization Act of 2012 - Amends the United States Information and Educational Exchange Act of 1948 to authorize the Secretary of State and the Broadcasting Board of Governors to provide for the preparation and dissemination of information intended for foreign audiences abroad about the United States, including about its people, its history, and the federal government's policies, through press, publications, radio, motion pictures, the Internet, and other information media, including social media, and through information centers and instructors. (Under current law such authority is restricted to information disseminated abroad, with a limited domestic exception.)

Authorizes the Secretary and the Board to make available in the United States motion pictures, films, video, audio, and other materials prepared for dissemination abroad or disseminated abroad pursuant to such Act, the United States International Broadcasting Act of 1994, the Radio Broadcasting to Cuba Act, or the Television Broadcasting to Cuba Act.

Amends the Foreign Relations Authorization Act, Fiscal Years 1986 and 1987 to prohibit funds for the Department of State or the Board from being used to influence public opinion or propagandizing in the United States. (Under current law such provision applies to the United States Information Agency [USIA].)

Applies such prohibition only to programs carried out pursuant to the United States Information and Educational Exchange Act of 1948, the United States International Broadcasting Act of 1994, the Radio Broadcasting to Cuba Act, and the Television Broadcasting to Cuba Act.

States that such provision shall: (1) not prohibit the Department or the Board from providing information about its operations, policies, programs, or program material, or making such information available to members of the media, public, or Congress; (2) not be construed to prohibit the Department from engaging in any medium of information on a presumption that a U.S. domestic audience may be exposed to program material; and (3) apply only to the Department and the Board and to no other federal department or agency.


Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Access to Obstetric Care Act of
1993''.

SEC. 2. MEDICAID DEMONSTRATION PROJECTS TO IMPROVE ACCESS IN
              UNDERSERVED AREAS TO OBSTETRIC SERVICES.

    (a) In General.--The Secretary of Health and Human Services shall
provide under this section for demonstration projects by States that
seek to reduce infant mortality by improving access in urban and rural
underserved areas to obstetric services for eligible pregnant women
under title XIX of the Social Security Act.
    (b) Nature of Projects.--Demonstration projects under this section
shall incorporate innovative approaches for increasing the
participation of obstetric providers under title XIX of the Social
Security Act, such as--
            (1) expediting reimbursement and using innovative payment
        mechanisms, including global fees for obstetric services with
        guaranteed periodic payments;
            (2) special or enhanced reimbursement for early prenatal
        care, risk-assessment, and high-risk services;
            (3) patient distribution or referral systems;
            (4) subsidizing medical liability insurance premiums, in
        whole or in part, for selected obstetric providers;
            (5) paying for all or a portion of payments made in
        settlement of malpractice claims by patients of obstetric
        providers who meet certain criteria; and
            (6) providing professional liability coverage under the
        State tort claims act for certain obstetric providers while
        treating a specified category of patients.
Demonstration projects addressing reimbursement must provide for
integrated prenatal, delivery and postpartum services.
    (c) Supplemental Funding.--(1) With respect to the additional
expenditures for medical assistance made under the State plan under
title XIX of the Social Security Act to carry out a demonstration
project under this section, the Federal medical assistance percentage
(otherwise determined under section 1905(b) of such Act) shall be
increased by 25 percentage points (but in no case to a percentage
greater than 95 percent).
    (2) The amount of funds that may be expended as medical assistance
to carry out the purposes of this section shall be such sums as may be
appropriated during the 5-fiscal-year period beginning with fiscal year
1994.
    (d) Waiver Authority.--(1) Except as provided under paragraphs (2)
and (3), the Secretary is authorized to waive the requirements of title
XIX of the Social Security Act to the extent necessary to implement
demonstration projects under this section.
    (2) Except as permitted under section 1915(b)(1) of the Social
Security Act, the Secretary may not waive under paragraph (1) the
requirement of sections 1902(a)(23) and 1916 of such Act.
    (3) The Secretary may not approve a demonstration project under
this section, or a waiver under paragraph (1), that reduces the amount,
duration, or scope of medical assistance made available under title XIX
of the Social Security Act or that results in a loss of eligibility for
individuals otherwise eligible for such assistance.
    (e) Timely Action on Applications.--A request to the Secretary by a
State for approval of a demonstration project under this section (and
any accompanying waiver of a requirement of title XIX of the Social
Security Act) shall be deemed granted unless the Secretary, within 90
days after the date of its submission to the Secretary, either denies
such request in writing or informs the State in writing with respect to
any additional information which is needed in order to make a final
determination with respect to the request. After the date the Secretary
receives such additional information, the request shall be deemed
granted unless the Secretary, within 90 days of such date, denies the
request.
    (f) Duration.--A demonstration project under this section may be
conducted for any portion of the period beginning after the date of
enactment of this Act and ending December 31, 1997.
    (g) Evaluation.--Such projects must include a plan for evaluating
the effects of the demonstration projects on provider participation.
    (h) Report.--The Secretary shall report to Congress, not later than
March 1, 1998, on the demonstration projects carried out under this
section and on how the results of such projects may be used to
implement programs to lower infant mortality and morbidity through
improving the access of pregnant women to obstetric services in urban
and rural underserved areas.
    (i) Obstetric Provider Defined.--In this section, the term
``obstetric provider'' means an obstetrician, obstetrician-
gynecologist, family practitioner, certified nurse midwife, or
certified family nurse practitioner.

SEC. 3. ANNUAL COMPENDIUM ON STATE INITIATIVES.

    (a) In General.--The Secretary of Health and Human Services, in
consultation with the Office of Rural Health Policy, shall develop and
make available to the public each year a compendium of the various
State initiatives undertaken to address the obstetric access crisis in
urban and rural areas.
    (b) Nature of Compendium.--The compendium shall include information
on State laws, regulations, programs and other initiatives undertaken
to increase access to obstetric care in underserved areas. The
compendium shall include information on activities addressing liability
problems, efforts to retain and place providers of pregnancy-related
services in underserved areas, and efforts to recruit and retain
providers of obstetric services under the Medicaid program. The
compendium shall also include information on the results on any
evaluations that have been conducted on such initiatives.

SEC. 4. STUDY OF OBSTETRICAL MALPRACTICE CLAIMS.

    (a) Study.--The Secretary of Health and Human Services shall
provide a grant to a public or private nonprofit organization to
conduct a study on the rate of medical malpractice actions or claims
relating to obstetrical care for patients whose care is paid for by
title XIX of the Social Security Act as compared to those whose care is
paid for by private insurance. Such study shall include a review of
medical records at selected hospitals, including rural hospitals, to
determine the rates for each group.
    (b) Report.--By not later than 2 years after the date of the
enactment of this Act, the Secretary shall submit to Congress a report
on the study conducted under subsection (a).
    (c) Medical Malpractice Action or Claim Defined.--In this section,
the term ``medical malpractice action or claim'' has the meaning given
such term in section 431(7) of the Health Care Quality Improvement Act
of 1986 (42 U.S.C. 11151(7)).

Output: Access to Obstetric Care Act of 1993 - Directs the Secretary of Health and Human Services to:  (1) provide for demonstration projects to improve access to obstetric services in underserved urban and rural areas for eligible pregnant women under title XIX (Medicaid) of the Social Security Act; (2) develop and make public each year a compendium of State initiatives to address the obstetric access crisis; and (3) provide a grant for the study of obstetrical malpractice claims.


Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Student Disciplinary Fairness Act of
2015''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Too many juveniles are introduced to the formal
        criminal justice system for minor behavioral infractions at
        school.
            (2) Common behavioral infractions at school often result in
        suspension, expulsion, or incarceration of the juvenile
        students involved.
            (3) Zero-tolerance school discipline policies increase the
        number of incarcerated juveniles.
            (4) Research shows that juveniles who are incarcerated are
        significantly less likely to complete secondary school,
        experience less human capital development and diminished
        earnings potential, and are more likely to recidivate and be
        incarcerated as adults.

SEC. 3. SCHOOL DISCIPLINE POLICY.

    The Juvenile Justice and Delinquency Prevention Act of 1974 (42
U.S.C. 5601 et seq.) is amended by inserting after title V the
following new title:

                  ``TITLE VI--SCHOOL DISCIPLINE POLICY

``SEC. 601. ESTABLISHMENT OF OFFICE.

    ``(a) In General.--There is hereby established within the Office of
Juvenile Justice and Delinquency Prevention an Office of School and
Discipline Policy (referred to in this title as the `Office'), headed
by a Director appointed by the Administrator of the Office of Juvenile
Justice and Delinquency Prevention.
    ``(b) Purpose.--The purpose of the Office shall be to reduce the
number of juveniles who are incarcerated and develop a criminal record
based on activity that occurs while the juvenile is at school.

``SEC. 602. DUTIES.

    ``The Office shall--
            ``(1) collect and publish data, in collaboration with the
        Office for Civil Rights of the Department of Education,
        relating to the arrest and incarceration of juvenile students
        for violations of school rules or policies;
            ``(2) work with States, units of local government, local
        educational agencies, and non-governmental organizations in
        order to expand the use of alternatives to detention and
        incarceration programming in schools in order to reduce the
        number of juvenile students who are arrested and incarcerated
        for violating school rules or policies; and
            ``(3) collect and publish data, in collaboration with the
        Office of Justice Programs, relating to the relationship
        between the presence of a school resource officer at a school
        and the rate of juvenile students who are arrested and
        incarcerated for violations of school rules or policies.

``SEC. 603. SCHOOL DISCIPLINE POLICY GRANT PROGRAM.

    ``(a) Grants Authorized.--The Director may make grants to States,
units of local government, and local educational agencies in order to
further the purpose described in section 601(b).
    ``(b) Application.--A State, unit of local government, or local
educational agency seeking a grant under this section shall submit an
application to the Director at such time, in such manner, and
containing such information as the Director may reasonably require.
    ``(c) Preference.--The Director shall give preference in awarding
grants to an applicant that demonstrates that it has, at the time of
submitting an application, begun to take steps to further the purpose
described in section 601(b).
    ``(d) Uses of Funds.--A State, unit of local government or local
educational agency that receives a grant under this section shall use
such funds for programs that reduce the rate of juvenile students who
are arrested and incarcerated for violations of school rules or
policies, and any other activity that the Director determines will
further the purpose described in section 601(b).

``SEC. 604. DEFINITIONS.

    ``In this title:
            ``(1) The term `school' means an elementary school or a
        secondary school as such terms are defined in section 9101 of
        the Elementary and Secondary Education Act of 1965 (20 U.S.C.
        7801).
            ``(2) The term `school resource officer' has the meaning
        given such term in section 1709 of the Omnibus Crime Control
        and Safe Streets Act of 1968 (42 U.S.C. 3796dd-8).
            ``(3) The term `local educational agency' has the meaning
        given such term in section 9101 of the Elementary and Secondary
        Education Act of 1965 (20 U.S.C. 7801).
            ``(4) The term `juvenile student' means a juvenile who is
        enrolled in school.

``SEC. 605. AUTHORIZATION OF APPROPRIATIONS.

    ``There is authorized to be appropriated such sums as may be
necessary for fiscal years 2014 and 2015 to carry out this title.''.

SEC. 4. CONDITIONS FOR STATES TO RECEIVE ``COPS ON THE BEAT'' GRANTS.

    Section 1702(c) of the Omnibus Crime Control and Safe Streets Act
of 1968 is amended--
            (1) in paragraph (10), by striking ``and'' at the end;
            (2) in paragraph (11), by striking the period at the end
        and inserting ``; and''; and
            (3) by inserting after paragraph (11), the following new
        paragraph:
            ``(12) in the case of an applicant that is a State or unit
        of local government, provide assurances that--
                    ``(A) the administration of juvenile justice in the
                applicant's jurisdiction is consistent with any
                requirements of the United States Constitution and the
                4th, 5th, and 14th amendments to the Constitution,
                including assurances that--
                            ``(i) before a juvenile is arrested, the
                        arresting law enforcement officer must have
                        probable cause specific to that juvenile; and
                            ``(ii) juveniles who are arrested must
                        receive adequate procedural due process,
                        including--
                                    ``(I) adequate and timely notice to
                                the juvenile and the juvenile's
                                guardian regarding any court
                                proceedings related to the incident for
                                which the juvenile was arrested;
                                    ``(II) representation by an
                                attorney in any court proceeding as a
                                result of which the juvenile could face
                                incarceration;
                                    ``(III) protections against self-
                                incrimination; and
                                    ``(IV) an opportunity to cross-
                                examine any witness testifying against
                                the juvenile; and
                    ``(B) any contract governing the terms of probation
                for a juvenile shall not contain any clauses that--
                            ``(i) the juvenile cannot understand; and
                            ``(ii) in the case of a juvenile student
                        (as such term is defined in section 604 of the
                        Juvenile Justice and Delinquency Prevention Act
                        of 1974), could result in incarceration for
                        violations of school rules or policies.''.

SEC. 5. AUTHORITY FOR THE ATTORNEY GENERAL TO ACCESS CERTAIN RECORDS
              RELATING TO JUVENILE JUSTICE.

    Section 210401 of the Violent Crime Control and Law Enforcement Act
of 1994 (42 U.S.C. 14141) is amended by adding at the end the
following:
    ``(c) Access to Certain Records Relating to Juvenile Justice.--The
Attorney General may issue subpoenas requiring the production of any
documents relating to any matter which the Attorney General is
authorized to investigate under subsection (a).''.

SEC. 6. DEPARTMENT OF EDUCATION GRANT PROGRAM.

    (a) Program Authorized.--From the amounts appropriated to carry out
this section, the Secretary of Education (acting through the Office of
Civil Rights of the Department of Education) shall make grants to
eligible entities to fund training for school personnel in elementary
schools and secondary schools on de-escalation techniques to teach the
personnel procedures and tactics to mitigate delinquent student
behavior which may avoid a referral to law enforcement officials.
    (b) Application.--To receive a grant under this section, an
eligible entity shall submit an application to the Secretary of
Education at such time, in such manner, and containing such information
as the Secretary may require, including information that demonstrates
that the eligible entity--
            (1) is fully compliant with all applicable Federal school
        discipline data reporting requirements, including, if
        applicable, the reporting requirements of section 618 of the
        Individuals with Disabilities Education Act of 1965 (20 U.S.C.
        1418(a)); and
            (2) has provided complete information to all applicable
        data surveys of Department of Education, including the Office
        for Civil Rights.
    (c) Limitation.--An elementary school or secondary school may only
receive assistance under this section during a grant period from 1
eligible entity receiving a grant under this section during the grant
period.
    (d) Definitions.--For purposes of this section:
            (1) Eligible entity.--The term ``eligible entity'' means a
        State, unit of general local government, or juvenile justice
        agency.
            (2) General esea terms.--The terms ``elementary schools'',
        ``secondary schools'', and ``State'' have the meanings given
        the terms in section 9101 of the Elementary and Secondary
        Education Act of 1965 (20 U.S.C. 7801).
            (3) School personnel.--The term ``school personnel'' has
        the meaning given the term in section 4151 of the Elementary
        and Secondary Education Act of 1965 (20 U.S.C. 7161).
    (e) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary for fiscal years 2014 and
2015 to carry out this section.

Output: Student Disciplinary Fairness Act of 2015 This bill amends the Juvenile Justice and Delinquency Prevention Act of 1974 to establish an Office of School and Discipline Policy within the Department of Justice (DOJ). The Office must collect and publish data on the arrests or incarceration of juvenile students for violations of school rules or policies. It must also collaborate with states and local governments to expand alternatives to juvenile detention and incarceration.  The legislation amends the Omnibus Crime Control and Streets Act of 1968 to require state or local governments that apply for public safety and community policing grants to provide assurances that the administration of juvenile justice in their jurisdictions is consistent with constitutional guarantees, including due process and equal protection, and that probation terms for a juvenile meet certain conditions.  This bill amends the Violent Crime Control and Law Enforcement Act of 1994 to authorize DOJ to issue subpoenas during investigations of law enforcement agencies for alleged patterns or practices of conduct that violate constitutional rights.  The Office of Civil Rights of the Department of Education must make grants to states, local governments, and juvenile justice agencies to train elementary and secondary school teachers and administrators on de-escalation techniques to mitigate delinquent student behavior.


Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicare Certified Registered Nurse
First Assistant Direct Reimbursement Act of 2001''.

SEC. 2. MEDICARE COVERAGE OF SURGICAL FIRST ASSISTING SERVICES OF
              CERTIFIED REGISTERED NURSE FIRST ASSISTANTS.

    (a) Services Covered.--Section 1861(s)(2) of the Social Security
Act (42 U.S.C. 1395x(s)(2)), as amended by sections 102(a) and 105(a)
of the Medicare, Medicaid, and SCHIP Benefits Improvement and
Protection Act of 2000, as enacted into law by section 1(a)(6) of
Public Law 106-554, is amended--
            (1) by striking ``and'' at the end of subparagraph (U);
            (2) by inserting ``and'' at the end of subparagraph (V);
        and
            (3) by adding at the end the following new subparagraph:
            ``(W) surgical first assisting services (as defined in
        subsection (ww)(1)) furnished by a certified registered nurse
        first assistant (as defined in subsection (ww)(2));''.
    (b) Services Described.--Section 1861 of the Social Security Act
(42 U.S.C. 1395x) , as amended by sections 102(b) and 105(b) of the
Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act
of 2000, as enacted into law by section 1(a)(6) of Public Law 106-554,
is amended by adding at the end the following new subsection:

 ``Surgical First Assisting Services; Certified Registered Nurse First
                               Assistant

    ``(ww)(1) The term `surgical first assisting services' means
services consisting of first assisting a physician with surgery and
related preoperative, intraoperative, and postoperative care (as
determined by the Secretary) furnished by a certified registered nurse
first assistant (as defined in paragraph (2)) which the certified
registered nurse first assistant is legally authorized to perform by
the State in which the services are performed.
    ``(2) The term `certified registered nurse first assistant' means
an individual who--
            ``(A) is a registered nurse and is licensed to practice
        nursing in the State in which the surgical first assisting
        services are performed;
            ``(B) has completed a minimum of 2,000 hours of first
        assisting a physician with surgery and related preoperative,
        intraoperative, and postoperative care; and
            ``(C) is certified as a registered nurse first assistant by
        an organization recognized by the Secretary.''.
    (c) Payment Amount.--Section 1833(a)(1) of the Social Security Act
(42 U.S.C. 1395l(a)(1)), as amended by sections 105(c) and 223(c) of
the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection
Act of 2000, as enacted into law by section 1(a)(6) of Public Law 106-
554, is amended--
            (1) by striking ``and'' before ``(U)''; and
            (2) by inserting before the semicolon at the end the
        following: ``, and (V) with respect to surgical first assisting
        services (as defined in section 1861(ww)(1)) furnished by a
        certified registered nurse first assistant (as defined in
        section 1861(ww)(2)), the amount paid shall be 80 percent of
        the lesser of the actual charge for the services or 85 percent
        of the amount determined under the fee schedule established
        under section 1848(b) for the same services if furnished by a
        physician''.
    (d) Payments to Employers.--
            (1) In general.--Section 1833(r) of the Social Security Act
        (42 U.S.C. 1395l(r)) is amended--
                    (A) in paragraph (1), by inserting ``or section
                1861(s)(2)(W) (relating to surgical first assisting
                services)'' after ``clinical nurse specialist
                services)''; and
                    (B) in paragraph (2), by striking
                ``1861(s)(2)(K)(ii)'' and inserting ``1861(s)(2)(K)(ii)
                or 1861(s)(2)(W)''.
            (2) Application of mandatory assignment rules.--Section
        1842(b)(18)(C)(i) of such Act (42 U.S.C. 1395u(b)(18)(C)(i)) is
        amended by striking ``physician assistant, nurse practitioner,
        clinical nurse specialist'' and inserting ``physician
        assistant, nurse practitioner, clinical nurse specialist, or
        certified registered nurse first assistant''.
            (3) Exclusion from bundled payments for covered skilled
        nursing facility services.--Section 1888(e)(2)(A)(ii) of such
        Act (42 U.S.C. 1395yy(e)(2)(A)(ii)) is amended by inserting
        ``surgical first assisting services of a certified registered
        nurse first assistant,'' after ``services of a certified
        registered nurse anesthetist,''.
    (e) Reduction in Payments To Avoid Duplicate Payment.--
Notwithstanding any other provision of law, the Secretary of Health and
Human Services may reduce the amount of payments otherwise made to
hospitals under title XVIII of the Social Security Act (42 U.S.C. 1395
et seq.) to eliminate estimated duplicate payments for historical or
current costs attributable to surgical first assisting services
furnished by certified registered nurse first assistants as described
in section 1861(ww) of such Act (as added by subsection (a)).
    (f) Effective Date.--The amendments made by this section shall
apply to services furnished on or after the date of the enactment of
this Act.

SEC. 3. STUDY OF PAYMENT RATES.

    Not later than 180 days after the date of the enactment of this
Act, the Secretary of Health and Human Services shall submit to
Congress a report containing recommendations for adjustments to the
payment amounts established under part B of title XVIII of the Social
Security Act for surgical first assisting services furnished by
certified registered nurse first assistants (as described in section
1861(ww) of such Act (as added by section 1(a)) to ensure that the
payment amounts reflect the approximate costs of furnishing such
services, taking into account the costs of compensation, overhead, and
supervision attributable to certified registered nurse first
assistants.

Output: Medicare Certified Registered Nurse First Assistant Direct Reimbursement Act of 2001 - Amends title XVIII (Medicare) of the Social Security Act to provide for coverage of surgical first assisting services furnished by certified registered nurse first assistants.


Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Generating Antibiotic Incentives Now
Act of 2011''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Extension of exclusivity period for drugs.
Sec. 4. Additional extension of exclusivity period for qualified
                            infectious disease products for which a
                            companion diagnostic test is cleared or
                            approved.
Sec. 5. Priority review.
Sec. 6. Fast track product.
Sec. 7. Study on incentives for qualified infectious disease biological
                            products.
Sec. 8. Clinical trials.

SEC. 3. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 505D (21 U.S.C. 355e) the following:

``SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED
              INFECTIOUS DISEASE PRODUCTS.

    ``(a) Extension.--If, prior to approval of a drug pursuant to an
application submitted under section 505(b), the Secretary determines
that the drug is a qualified infectious disease product, then the four-
and five-year periods described in subsections (c)(3)(E)(ii) and
(j)(5)(F)(ii) of section 505, the three-year periods described in
clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and
(iv) of subsection (j)(5)(F) of section 505, or the seven-year period
described in section 527, as applicable, shall be extended by five
years.
    ``(b) Relation to Pediatric Exclusivity.--Any extension under
subsection (a) of a period shall be in addition to any extension of the
period under section 505A with respect to the drug.
    ``(c) Limitations.--Subsection (a) does not apply to the approval
of--
            ``(1) a supplement to an application under section 505(b)
        for any qualified infectious disease product for which an
        extension described in subsection (a) is in effect or has
        expired; or
            ``(2) a subsequent application filed by the same sponsor or
        manufacturer of a qualified infectious disease product
        described in paragraph (1) (or a licensor, predecessor in
        interest, or other related entity) for--
                    ``(A) a change (not including a modification to the
                structure of the qualified infectious disease product)
                that results in a new indication, route of
                administration, dosing schedule, dosage form, delivery
                system, delivery device, or strength; or
                    ``(B) a modification to the structure of the
                qualified infectious disease product that does not
                result in a change in safety or effectiveness.
    ``(d) Determination.--The manufacturer or sponsor of a drug may
request the Secretary to designate a drug as a qualified infectious
disease product. Such a request for designation shall be made at least
45 days before the submission of an application under section 505(b)
for such drug. The Secretary shall, not later than 30 days after the
submission of such request, determine whether the drug is a qualified
infectious disease product.
    ``(e) Regulations.--The Secretary shall promulgate regulations for
carrying out this section. The Secretary shall promulgate the initial
regulations for carrying out this section not later than 12 months
after the date of the enactment of this section.
    ``(f) Definitions.--In this section:
            ``(1) Qualified infectious disease product.--The term
        `qualified infectious disease product' means an antibiotic drug
        for treating, detecting, preventing, or identifying a
        qualifying pathogen.
            ``(2) Qualifying pathogen.--The term `qualifying pathogen'
        means--
                    ``(A) resistant gram positive pathogens, including
                methicillin-resistant Staphylococcus aureus (MRSA),
                vancomycin-resistant Staphylococcus aureus (VRSA), and
                vancomycin-resistant enterococcus (VRE);
                    ``(B) multi-drug resistant gram negative bacteria,
                including Acinetobacter, Klebsiella, Pseudomonas, and
                E. coli species;
                    ``(C) multi-drug resistant tuberculosis; or
                    ``(D) any other infectious pathogen identified for
                purposes of this section by the Secretary.''.
    (b) Application.--Section 505E of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), applies only with respect to
a drug that is first approved under section 505(c) of such Act (21
U.S.C. 355(c)) on or after the date of the enactment of this Act.

SEC. 4. ADDITIONAL EXTENSION OF EXCLUSIVITY PERIOD FOR QUALIFIED
              INFECTIOUS DISEASE PRODUCTS FOR WHICH A COMPANION
              DIAGNOSTIC TEST IS CLEARED OR APPROVED.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
as amended by section 3, is further amended by inserting after section
505E the following:

``SEC. 505E-1. ADDITIONAL EXTENSION OF EXCLUSIVITY FOR QUALIFIED
              INFECTIOUS DISEASE PRODUCTS FOR WHICH A COMPANION
              DIAGNOSTIC TEST IS CLEARED OR APPROVED.

    ``(a) In General.--If the sponsor or manufacturer of a qualified
infectious disease product identifies in accordance with subsection (b)
a companion diagnostic test described in subsection (c), any period
extended under section 505E(a) with respect to such product shall be
further extended by 6 months.
    ``(b) Identification Requirements.--For purposes of subsection (a),
the identification of a companion diagnostic test shall--
            ``(1) be made in such manner as the Secretary may require;
        and
            ``(2) occur before the expiration of the period to be
        extended under subsection (a), not counting any extension to
        such period under section 505E(a) or 505A.
    ``(c) Companion Diagnostic Test.--For purposes of subsection (a), a
device is a companion diagnostic test with respect to a qualified
infectious disease product if each of the following is met:
            ``(1) The device is determined by the Secretary under
        subsection (f) to be a test for diagnosis of a qualifying
        pathogen.
            ``(2) The qualified infectious disease product has been
        determined under section 505E(d) to be for treating, detecting,
        preventing, or identifying such qualifying pathogen.
            ``(3) The device is cleared under section 510(k) or
        approved under section 515.
            ``(4) The sponsor or manufacturer, as applicable, of the
        qualified infectious disease product has the exclusive rights
        to submit an identification under subsection (a) with respect
        to the device.
    ``(d) Relation to Pediatric Exclusivity.--Any extension under
subsection (a) of a period with respect to a qualified infectious
disease product shall be in addition to any extension of the period
under section 505A of this Act with respect to the product.
    ``(e) Limitations.--After the extension of any period under
subsection (a) with respect to a qualified infectious disease product
pursuant to the identification of a device as a companion diagnostic
test, subsection (a) does not authorize--
            ``(1) any subsequent extension with respect to such
        product; or
            ``(2) any extension with respect to any other product
        pursuant to identification of such device.
    ``(f) Determination.--The sponsor or manufacturer of a drug may
request the Secretary to determine that a device is a test for
diagnosis of a qualifying pathogen. Such a request shall be made at
least 45 days before the submission of a notification under section
510(k) or an application under section 515 for such device. The
Secretary shall, not later than 30 days after the submission of such
request, determine whether the device is a test for diagnosis of a
qualifying pathogen.
    ``(g) Definitions.--In this section:
            ``(1) The term `qualified infectious disease product' means
        a drug that is determined to be a qualified infectious disease
        product under section 505E.
            ``(2) The term `qualifying pathogen' has the meaning given
        to such term in section 505E.''.

SEC. 5. PRIORITY REVIEW.

    (a) Amendment.--Chapter V of the Federal Food, Drug, and Cosmetic
Act is amended by inserting after section 524 (21 U.S.C. 360n) the
following:

``SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.

    ``(a) In General.--If the Secretary makes a determination under
section 505E(c) that a drug is a qualified infectious disease product,
then the Secretary shall give priority review to any application
submitted for approval for such drug under section 505(b).
    ``(b) Definition.--In this section, the term `priority review',
with respect to an application described in subsection (a), means
review and action by the Secretary on such application not later than 6
months after receipt by the Secretary of such application.''.
    (b) Application.--Section 524A of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), applies only with respect to
an application that is submitted under section 505(b) (21 U.S.C.
355(b)) on or after the date of the enactment of this Act.

SEC. 6. FAST TRACK PRODUCT.

    Paragraph (1) of section 506(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356(a)) is amended by inserting after ``if it
is intended for the treatment of a serious or life-threatening
condition and it demonstrates the potential to address unmet medical
needs for such a condition'' the following: ``or if the Secretary
determines under section 505E that the drug is a qualified infectious
disease product''.

SEC. 7. STUDY ON INCENTIVES FOR QUALIFIED INFECTIOUS DISEASE BIOLOGICAL
              PRODUCTS.

    (a) In General.--The Comptroller General of the United States
shall--
            (1) conduct a study on the need for incentives to encourage
        the research, development, and marketing of qualified
        infectious disease biological products; and
            (2) not later than 1 year after the date of the enactment
        of this Act, submit a report to the Congress on the results of
        such study, including any recommendations of the Comptroller
        General on appropriate incentives for addressing such need.
    (b) Definitions.--In this section:
            (1) The term ``biological product'' has the meaning given
        to such term in section 351 of the Public Health Service Act
        (42 U.S.C. 262).
            (2) The term ``qualified infectious disease biological
        product'' means a biological product for treating, detecting,
        preventing, or identifying a qualifying pathogen.
            (3) The term ``qualifying pathogen'' has the meaning given
        to such term in section 505E of the Federal Food, Drug, and
        Cosmetic Act, as added by section 3 of this Act.

SEC. 8. CLINICAL TRIALS.

    (a) Review and Revision of Guidelines.--
            (1) In general.--Not later than 1 year after the date of
        the enactment of this Act, and not later than 4 years
        thereafter, the Secretary shall--
                    (A) review the guidelines of the Food and Drug
                Administration for the conduct of clinical trials with
                respect to antibiotic drugs; and
                    (B) as appropriate, revise such guidelines to
                reflect developments in scientific and medical
                information and technology and to ensure clarity
                regarding the procedures and requirements for approval
                of an antibiotic drug under chapter V of the Federal
                Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.).
            (2) Issues for review.--At a minimum, the review under
        paragraph (1) shall address the appropriate animal models of
        infection, in vitro techniques, valid micro-biological
        surrogate markers, the use of non-inferiority versus
        superiority trials, and appropriate delta values for non-
        inferiority trials.
            (3) Rule of construction.--Except to the extent to which
        the Secretary of Health and Human Services makes revisions
        under paragraph (1)(B), nothing in this section shall be
        construed to repeal or otherwise affect the guidelines of the
        Food and Drug Administration.
    (b) Recommendations for Investigations.--
            (1) Request.--The sponsor of a drug intended to be used to
        treat, detect, prevent, or identify a qualifying pathogen may
        request that the Secretary provide written recommendations for
        nonclinical and clinical investigations which may be conducted
        with the drug before it may be approved for such use under
        section 505 of the Federal Food, Drug, and Cosmetic Act (21
        U.S.C. 355).
            (2) Recommendations.--If the Secretary has reason to
        believe that a drug for which a request is made under this
        subsection is a qualified infections disease product, the
        Secretary shall provide the person making the request written
        recommendations for the nonclinical and clinical investigations
        which the Secretary believes, on the basis of information
        available to the Secretary at the time of the request, would be
        necessary for approval under section 505 of the Federal Food,
        Drug, and Cosmetic Act (21 U.S.C. 355) of such drug for the use
        described in paragraph (1).
    (c) Definitions.--In this section:
            (1) The term ``drug'' has the meaning given to such term in
        section 201 of the Federal Food, Drug, and Cosmetic Act (21
        U.S.C. 321).
            (2) The term ``qualifying pathogen'' has the meaning given
        to such term in section 505E of the Federal Food, Drug, and
        Cosmetic Act, as added by section 3 of this Act.
            (3) The term ``Secretary'' means the Secretary of Health
        and Human Services, acting through the Commissioner of Food and
        Drugs.

Output:
Generating Antibiotic Incentives Now Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for a new prescription drug by five years for a drug that the Secretary of Health and Human Services (HHS) determines to be a qualified infectious disease product. Defines "qualified infectious disease product" to mean an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen (certain pathogens that are resistant to antibiotics). Excludes drugs that are: (1) a supplement to a new drug application for which an extension is in effect or has expired; or (2) a subsequent application for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or a modification to the structure of the product that does not result in a change in safety or effectiveness.

Extends such period of exclusivity an additional six months for a sponsor or manufacturer of a qualified infectious disease product that identifies a companion diagnostic test.

Requires the Secretary to give priority review to any drug determined to be a qualified infectious disease product.

Includes qualified infectious disease products as fast track products for which the Secretary shall facilitate development and expedite review.

Directs the Comptroller General to study the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products.

Requires the Secretary to: (1) review Food and Drug Administration (FDA) guidelines for clinical trials of antibiotic drugs; and (2) revise such guidelines, as appropriate, to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of an antibiotic drug.


Input:
SECTION 1. EXTENSION OF MEDICARE PRESCRIPTION DRUG INITIAL ENROLLMENT
              PERIODS FOR 2006 AND 2007; SUSPENSION OF LATE ENROLLMENT
              PENALTY THROUGH DECEMBER 31, 2007.

    (a) Extension of Medicare Prescription Drug Initial Enrollment
Periods for 2006 and 2007.--Section 1860D-1(b)(1) of the Social
Security Act (42 U.S.C. 1395w-101(b)(1)) is amended--
            (1) in subparagraph (B)(iii), by inserting ``subparagraph
        (D) and'' after ``Subject to''; and
            (2) by adding at the end the following new subparagraph:
            ``(D) Extension of initial enrollment periods.--For
        purposes of subparagraph (B)(iii), in applying section
        1851(e)(1), with respect to the annual, coordinated election
        period--
                    ``(i) for 2006, such period shall begin on November
                15, 2005, and end on November 14, 2006; and
                    ``(ii) for 2007, such period shall begin on
                November 15, 2006, and end on November 14, 2007.''.
    (b) Suspension of Late Enrollment Penalty Through December 31,
2007.--Section 1860D-13(b)(3)(B) of such Act (42 U.S.C. 1395w-
113(b)(3)(B)) is amended by inserting ``(after December 2007)'' after
``any month''.

SEC. 2. OPEN ENROLLMENT AND DISENROLLMENT IN PRESCRIPTION DRUG PLANS
              ALLOWED DURING FIRST 12 MONTHS OF ENROLLMENT.

    Section 1860D-1(b)(1) of the Social Security Act (42 U.S.C. 1395w-
101(b)(1)) is amended by adding at the end the following new
subparagraph:
                    ``(D) Open enrollment and disenrollment period for
                first 12 months of enrollment.--In establishing the
                process under subparagraph (A), in the case of a part D
                eligible individual who initially enrolls under section
                1860D-1(a) in a prescription drug plan on or after the
                date of enactment of this paragraph, the Secretary
                shall permit such individual to change such enrollment
                into another prescription drug plan once at any time
                during the first 12 months of such initial enrollment
                (other than during an annual, coordinated election
                period referred to in section 1860D-
                1(b)(1)(B)(iii)).''.

SEC. 3. LIMITATIONS ON CHANGING PRESCRIPTION DRUG PLAN FORMULARIES;
              NOTICE OF CHANGE IN FORMULARY.

    (a) Limitation on Removal or Change of Covered Part D Drugs From
the Prescription Drug Plan Formulary.--Section 1860D-4(b)(3)(E) of the
Social Security Act (42 U.S.C. 1395w-104(b)(3)(E)) is amended to read
as follows:
                    ``(E) Removing a drug from formulary or imposing a
                restriction or limitation on coverage.--
                            ``(i) Limitation on removal, limitation, or
                        restriction.--
                                    ``(I) In general.--Subject to
                                subclause (II) and clause (ii),
                                beginning with 2006, the PDP sponsor of
                                a prescription drug plan may not remove
                                a covered part D drug from the plan
                                formulary or impose a restriction or
                                limitation on the coverage of such a
                                drug (such as through the application
                                of a preferred status, usage
                                restriction, step therapy, prior
                                authorization, or quantity limitation)
                                other than at the beginning of each
                                plan year except as the Secretary may
                                permit to take into account new
                                therapeutic uses and newly covered part
                                D drugs.
                                    ``(II) Special rule for newly
                                enrolled individuals.--Subject to
                                clause (ii), in the case of an
                                individual who enrolls in a
                                prescription drug plan on or after the
                                date of enactment of this subparagraph,
                                the PDP sponsor of such plan may not
                                remove a covered part D drug from the
                                plan formulary or impose a restriction
                                or limitation on the coverage of such a
                                drug (such as through the application
                                of a preferred status, usage
                                restriction, step therapy, prior
                                authorization, or quantity limitation)
                                during the period beginning on the date
                                of such enrollment and ending on
                                December 31 of the immediately
                                succeeding plan year except as the
                                Secretary may permit to take into
                                account new therapeutic uses and newly
                                covered part D drugs.
                            ``(ii) Exceptions to limitation on
                        removal.--Clause (i) shall not apply with
                        respect to a covered part D drug that--
                                    ``(I) is a brand name drug for
                                which there is a generic drug approved
                                under section 505(j) of the Food and
                                Drug Cosmetic Act (21 U.S.C. 355(j))
                                that is placed on the market during the
                                period in which there are limitations
                                on removal or change in the formulary
                                under subclause (I) or (II) of clause
                                (i);
                                    ``(II) is a brand name drug that
                                goes off-patent during such period;
                                    ``(III) is a drug for which the
                                Commissioner of Food and Drugs issues a
                                clinical warning that imposes a
                                restriction or limitation on the drug
                                during such period; or
                                    ``(IV) has been determined to be
                                ineffective during such period.
                            ``(iii) Notice of removal under application
                        of exception to limitation.--The PDP sponsor of
                        a prescription drug plan shall provide
                        appropriate notice (such as under subsection
                        (a)(3)) of any removal or change under clause
                        (ii) to the Secretary, affected enrollees,
                        physicians, pharmacies, and pharmacists.''.
    (b) Notice of Change in Formulary and Other Restrictions or
Limitations on Coverage.--
            (1) In general.--Section 1860D-4(a) of such Act (42 U.S.C.
        1395w-104(a)) is amended by adding at the end the following new
        paragraph:
            ``(5) Annual notice of changes in formulary and other
        restrictions or limitations on coverage.--Each PDP sponsor
        offering a prescription drug plan shall furnish to each
        enrollee at the time of each annual coordinated election period
        (referred to in section 1860D-1(b)(1)(B)(iii)) for a plan year
        a notice of any changes in the formulary or other restrictions
        or limitations on coverage of a covered part D drug under the
        plan that will take effect for the plan year.''.
            (2) Effective date.--The amendment made by paragraph (1)
        shall apply to annual coordinated election periods beginning
        after the date of the enactment of this Act.

Output:
Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to: (1) extend the 2006 and 2007 initial enrollment periods for the Medicare prescription drug benefit; (2) suspend the late enrollment penalty through December 31, 2007; and (3) permit Medicare beneficiaries to change enrollment in a prescription drug plan during the first 12 months of enrollment.

Prohibits a PDP sponsor, beginning with 2006, from removing a covered part D drug from the plan formulary, or imposing a restriction or limitation on the coverage of such a drug, other than at the beginning of each plan year, except as the Secretary may permit to take into account new therapeutic uses and newly covered part D drugs.

Requires each PDP sponsor to furnish to each plan enrollee, at the time of each annual coordinated election period, a notice of any changes in the formulary or other part D drug coverage restrictions or limitations that will take effect for the upcoming plan year.