## SEC. 602. UPDATING DEFINITIONS OF OTHER TRANSACTIONS. 

Section 319L (42 U.S.C. 247d–7e) is amended— 

(1) in subsection (a)(3), by striking ‘‘, such as’’ and all that follows through ‘‘Code’’; and 

## SEC. 603. MEDICAL COUNTERMEASURE MASTER FILES. 

(a) IN GENERAL.—The purpose of this section (including section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b)) is to support and advance the development or manu- facture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products by facilitating and encour- aging submission of data and information to support the develop- ment of such products, and through clarifying the authority to cross-reference to data and information previously submitted to the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), including data and information sub- mitted to medical countermeasure master files or other master files. 

(b) MEDICAL COUNTERMEASURE MASTER FILES.—Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 565A the following: 

## ‘‘SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES. 

‘‘(a) APPLICABILITY OF REFERENCE.— 

‘‘(1) IN GENERAL.—A person may submit data and informa- tion in a master file to the Secretary with the intent to ref- erence, or to authorize, in writing, another person to reference, such data or information to support a medical countermeasure submission (including a supplement or amendment to any such submission), without requiring the master file holder to disclose the data and information to any such persons authorized to reference the master file. Such data and information shall be available for reference by the master file holder or by a person authorized by the master file holder, in accordance with applicable privacy and confidentiality protocols and regula- tions. 

(2) in subsection (c)(5)(A)— 

(A) in clause (i), by striking ‘‘under this subsection’’ and all that follows through ‘‘Code’’ and inserting ‘‘(as defined in subsection (a)(3)) under this subsection’’; and 

(B) in clause (ii)— 

(i) by amending subclause (I) to read as follows: 

‘‘(I) IN GENERAL.—To the maximum extent practicable, competitive procedures shall be used when entering into transactions to carry out projects under this subsection.’’; and (ii) in subclause (II)— 

(I) by striking ‘‘$20,000,000’’ and inserting ‘‘$100,000,000’’; 

(II) by striking ‘‘senior procurement executive for the Department (as designated for purpose of section 16(c) of the Office of Federal Procurement Policy Act (41 U.S.C. 414(c)))’’ and inserting ‘‘Assistant Secretary for Financial Resources’’; and 

(III) by striking ‘‘senior procurement executive under’’ and inserting ‘‘Assistant Secretary for Financial Resources under’’. 

21 USC 360bbb–4b note. 

21 USC 360bbb–4b. 

