SEC. 2. DISCLOSURE OF NON-EXEMPT DATA REQUIRED 
FOR CERTAIN BIOLOGICAL PRODUCTS AND 
OTHER DRUGS. 
Section 319F–3 of the Public Health Service Act (42 
U.S.C. 247d–6b) is amended by adding at the end the fol-
lowing: 
‘‘(j) DISCLOSURE
OF
NON-EXEMPT
DATA
RE-
QUIRED.— 
‘‘(1) COVERED PRODUCTS.—In this subsection, 
the term ‘covered product’ means a covered counter-
measure that— 
‘‘(A) is a biological product or other drug; 
and 
‘‘(B) is authorized for emergency use 
under section 564 of the Federal Food, Drug, 
and Cosmetic Act on or after the date of enact-
ment of the Consumer Vaccine Safety and Pro-
tection Act of 2023, irrespective of whether the 
biological product or drug later receives ap-
proval or licensure under section 505 of the 
Federal Food, Drug, and Cosmetic Act or sec-
tion 351 of this Act. 
‘‘(2) DISCLOSURE BY SPONSORS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (C), the sponsor of a covered product 
shall disclose to the public, in an easily acces-
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sible location on the website of the sponsor of 
the covered product— 
‘‘(i) in the case of a biological prod-
uct, all data and information available for 
public disclosure under section 601.51(e) 
of title 21, Code of Federal Regulations (or 
successor regulations); and 
‘‘(ii) in the case of another drug, all 
data and information available for public 
disclosure under section 314.430 of title 
21, Code of Federal Regulations (or suc-
cessor regulations). 
‘‘(B) TIMING.—The sponsor of a covered 
product shall, with respect to any data or infor-
mation required to be disclosed by subpara-
graph (A), make the disclosure not later than 
10 days after the later of— 
‘‘(i) the date on which the Food and 
Drug Administration authorizes the emer-
gency use of the covered product under 
section 564 of the Federal Food, Drug, 
and Cosmetic Act; and 
‘‘(ii) the date on which the data or in-
formation becomes available to the spon-
sor. 
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‘‘(C) EXCEPTIONS.—The disclosure re-
quirement in subparagraph (A) does not apply 
with respect to— 
‘‘(i) a trade secret or confidential 
commercial or financial information as de-
fined in section 20.61 of title 21, Code of 
Federal Regulations (or successor regula-
tions); or 
‘‘(ii) personally identifiable informa-
tion. 
‘‘(3) DISCLOSURE BY HHS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the Secretary shall— 
‘‘(i) not later than 10 days after the 
Food and Drug Administration authorizes 
the emergency use of a covered product 
under section 564 of the Federal Food, 
Drug, and Cosmetic Act or approves or li-
censes a covered product under section 505 
of such Act or section 351 of this Act, dis-
close to the public, in an easily accessible 
location on the website of the Department 
of Health and Human Services, all data 
and information required by paragraph (2) 
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to be disclosed by the sponsor of the prod-
uct; and 
‘‘(ii) not later than 30 days after re-
ceiving any additional such data and infor-
mation, so disclose such data and informa-
tion. 
‘‘(B) EXCEPTION.—The disclosure require-
ment in subparagraph (A) does not apply with 
respect to data and information exempted from 
disclosure by paragraph (2)(C). 
‘‘(4) ENFORCEMENT
AGAINST
SPONSORS
FOR 
FAILURE TO DISCLOSE.— 
‘‘(A) EXCLUSION
FROM
DEFINITION
OF 
‘COVERED
COUNTERMEASURE’.—Notwith-
standing subsection (i)(1), a covered product is 
deemed to be excluded from the definition of a 
‘covered countermeasure’ for purposes of the 
provisions of this section (other than this sub-
section) and section 319F–4 if— 
‘‘(i) the covered product is adminis-
tered on or after the date of enactment of 
the Consumer Vaccine Safety and Protec-
tion Act of 2023; and 
‘‘(ii) the sponsor of the covered prod-
uct is determined by the Secretary to have 
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knowingly failed to make a disclosure re-
quired by paragraph (2) with respect to 
the covered product. 
‘‘(B) INELIGIBILITY
FOR
FDA
AWARDS, 
FUNDS, OR OTHER BENEFITS.—If the sponsor 
of a covered product is determined by the Sec-
retary to have knowingly failed to make a dis-
closure required by paragraph (2) with respect 
to the covered product, such sponsor shall be 
treated as ineligible for the award of any grant, 
cooperative agreement, or loan or for any new 
grant of emergency use authorization, expanded 
access, or approval or licensure of any product 
under section 351 of this Act or any provision 
of the Federal Food, Drug, and Cosmetic Act 
so long as such sponsor continues to be in viola-
tion of such requirement. 
‘‘(5) ENFORCEMENT AGAINST HHS FOR FAIL-
URE TO DISCLOSE.—A party injured by a covered 
product with respect to which the Secretary failed to 
carry out the Secretary’s duties under paragraph (3) 
may bring an action in the appropriate district court 
of the United States for appropriate relief, including 
damages.’’. 
Æ 
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