SEC. 2. ENSURING ACCESS OF PRIMARY RECIPIENT TO IN-
FORMATION RELATED TO RESEARCH. 
Part H of title IV of the Public Health Service Act 
(42 U.S.C. 289 et seq.) is amended by inserting after sec-
tion 493A (42 U.S.C. 289b–1) the following: 
‘‘SEC. 493B. ENSURING ACCESS OF PRIMARY RECIPIENT TO 
INFORMATION RELATED TO RESEARCH. 
‘‘(a) IN GENERAL.—The Secretary shall require, by 
regulation, that, as a condition of the receipt of a covered 
grant, a primary recipient shall ensure that each agree-
ment entered into by such primary recipient with a foreign 
secondary recipient provides for such primary recipient to 
have access to all supporting information related to the 
research carried out by the foreign secondary recipient, 
including access to— 
‘‘(1) raw data; 
‘‘(2) databases; 
‘‘(3) notes; 
‘‘(4) progress reports; and 
‘‘(5) other information the Secretary determines 
to be relevant. 
‘‘(b) FAILURE TO COMPLY.— 
‘‘(1) DETERMINATION.—Each of the following 
actors may make a determination that a primary re-
cipient has failed to comply with the regulations 
issued under subsection (a): 
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‘‘(A) The Secretary. 
‘‘(B) The Inspector General of the Depart-
ment of Health and Human Services. 
‘‘(C) The Director of the Office of Man-
agement and Budget. 
‘‘(2) PENALTIES.— 
‘‘(A) INITIAL RESPONSE.—If a determina-
tion that a primary recipient has failed to com-
ply is made under paragraph (1), the Secretary 
shall— 
‘‘(i) 
withhold 
undistributed 
grant 
amounts from the relevant primary recipi-
ent until the date on which such recipient 
comes into compliance, as determined by 
an appropriate authority; and 
‘‘(ii) change the status of the relevant 
primary recipient in the System for Award 
Management (or successor system) admin-
istered by the General Services Adminis-
tration, and other relevant Federal data-
bases, to a status that prevents Federal 
funds from being provided to such recipi-
ent until the date on which such recipient 
comes into compliance, as determined by 
an appropriate authority. 
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‘‘(B) FAILURE
TO
COME
INTO
COMPLI-
ANCE.—A primary recipient determined to have 
failed to comply under paragraph (1) and who 
does not come into compliance, as determined 
by an appropriate authority, during the 180-day 
period beginning on the date of the initial de-
termination of a failure to comply, shall return 
all grant amounts related to the relevant cov-
ered grant to the agency that provided such 
amounts. 
‘‘(c) DEFINITIONS.—In this section, the following 
definitions apply: 
‘‘(1) APPROPRIATE AUTHORITY.—The term ‘ap-
propriate authority’ means— 
‘‘(A) the Secretary; or 
‘‘(B) the Director of the Office of Manage-
ment and Budget. 
‘‘(2) COVERED
GRANT.—The term ‘covered 
grant’ means a grant awarded under a Department 
of Health and Human Services program to fund an 
activity that involves biomedical or behavioral re-
search. 
‘‘(3) FOREIGN
SECONDARY
RECIPIENT.—The 
term ‘foreign secondary recipient’ means an entity 
that— 
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‘‘(A) conducts activities— 
‘‘(i) under an agreement with a pri-
mary recipient; and 
‘‘(ii) to facilitate an activity for which 
the primary recipient received a covered 
grant; and 
‘‘(B) is a foreign entity as that term is de-
fined in section 3 of the Lobbying Disclosure 
Act of 1995 (2 U.S.C. 1602). 
‘‘(4) PRIMARY RECIPIENT.—The term ‘primary 
recipient’ means an entity that receives a covered 
grant.’’. 
Æ 
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