I 
117TH CONGRESS 
1ST SESSION H. R. 4211 
To amend the Public Health Service Act to require full inspection, and 
complete transparency, with respect to entities receiving financial assist-
ance from the National Institutes of Health, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 28, 2021 
Mr. TURNER introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to require full 
inspection, and complete transparency, with respect to 
entities receiving financial assistance from the National 
Institutes of Health, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Enabling More Pene-
trating Oversight When Examining Research for NIH Act 
of 2021’’ or the ‘‘EMPOWER NIH Act of 2021’’. 
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SEC. 2. ONSITE INSPECTIONS REQUIRED OF NIH AWARD 
RECIPIENTS. 
Part A of title IV of the Public Health Service Act 
(42 U.S.C. 281 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 404O. ONSITE INSPECTIONS OF AWARD RECIPIENTS. 
‘‘(a) SCOPE.— 
‘‘(1) IN GENERAL.—This section applies with 
respect to any financial assistance from the National 
Institutes of Health to any non-Federal entity for 
research-related activities, whether the assistance is 
made available directly or indirectly, including 
through the award of a subgrant or other subaward. 
‘‘(2) SPECIAL RULE.—This section applies even 
where an entity described in paragraph (1) is located 
or operates at— 
‘‘(A) a site that is in a foreign country 
whose government— 
‘‘(i) prevents inspectors from reaching 
the site; 
‘‘(ii) impedes or impairs inspection; or 
‘‘(B) a site that restricts or delays the 
entry of the inspectors for any reason. 
‘‘(b) CONDITION ON RECEIPT.—As a condition on re-
ceipt of any financial assistance described in subsection 
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(a), an entity shall agree to undergo an annual in-person 
inspection pursuant to this section. 
‘‘(c) INSPECTION REQUIREMENTS.—The Director of 
NIH shall conduct an annual inspection of each entity re-
ceiving financial assistance described in subsection (a) in 
accordance with the following: 
‘‘(1) The inspection shall be unannounced. 
‘‘(2) The timing of the inspection shall vary 
each year. 
‘‘(3) The inspection shall take place at all the 
sites at which activities are being funded through 
the financial assistance. 
‘‘(4) The inspection shall examine— 
‘‘(A) whether the funded research is con-
sistent with the description and assurances in 
the relevant proposal; 
‘‘(B) whether each site at which the re-
search is conducted, and the research itself, is 
in compliance with all applicable standards and 
requirements of the National Institutes of 
Health; and 
‘‘(C) whether each entity receiving the fi-
nancial assistance keeps detailed and updated 
records of the research conducted. 
‘‘(5) The inspection shall include— 
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‘‘(A) the facility at the research site; 
‘‘(B) the materials used to conduct the re-
search; 
‘‘(C) any electronic or hard-copy materials 
relevant to the research; and 
‘‘(D) photographic and video evidence of 
the inspection. 
‘‘(6) Each team of inspectors shall consist of at 
least three individuals, each of whom shall have no 
affiliation with any of the entities receiving the fi-
nancial assistance. 
‘‘(7) Each team of inspectors shall certify in 
writing that they have no financial conflict of inter-
est with respect to the operations, researchers, or 
potential findings involved. 
‘‘(8) Each inspector upon arrival at the site to 
be inspected shall present officials of the entity to be 
inspected with credentials confirming the inspector’s 
identity and authority to inspect the entity. 
‘‘(d) PENALTIES.— 
‘‘(1) IN GENERAL.—If an entity fails an inspec-
tion under this section— 
‘‘(A) the entities receiving the financial as-
sistance involved shall, collectively, return the 
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full amount of such assistance to the Treasury; 
and 
‘‘(B) each entity receiving the financial as-
sistance involved, including each entity that re-
ceives the assistance directly from the National 
Institutes of Health and each entity that re-
ceives the assistance indirectly, shall be ineli-
gible to receive financial assistance from the 
National Institutes of Health for a period of— 
‘‘(i) not less than 5 years; and 
‘‘(ii) in the case of an entity that is 
determined by the Director of NIH to have 
failed the inspection for a violation de-
scribed in paragraph (2), not less than 15 
years. 
‘‘(2) VIOLATIONS DESCRIBED.—A violation re-
ferred to in paragraph (1)(B)(ii) is— 
‘‘(A) without regard to whether the con-
duct is knowing or not— 
‘‘(i) denial of entry by the entity to in-
spectors; 
‘‘(ii) maintaining incomplete or fal-
sified research records; 
‘‘(iii) damaging or destroying research 
records; 
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‘‘(iv) withholding research records 
from inspectors; or 
‘‘(v) relocating research materials to 
alternate sites to avoid inspection; or 
‘‘(B) any action taken knowingly to pre-
vent a full and complete inspection. 
‘‘(3) RELATION
TO
OTHER
PENALTIES.—The 
penalties specified in this subsection are in addition 
to any other penalties applicable to an act or omis-
sion causing an entity to fail an inspection under 
this section. 
‘‘(e) ANNUAL REPORT TO CONGRESS.— 
‘‘(1) IN GENERAL.—Not later than October 1, 
2024, and annually thereafter, The Director of NIH 
shall submit an annual report on the implementation 
of this section to the following congressional commit-
tees: 
‘‘(A) The Committee on Homeland Secu-
rity and Governmental Affairs of the Senate. 
‘‘(B) The Committee on Finance of the 
Senate. 
‘‘(C) The Select Committee on Intelligence 
of the Senate. 
‘‘(D) The Committee on Oversight and Re-
form of the House of Representatives. 
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‘‘(E) The Committee on Energy and Com-
merce of the House of Representatives. 
‘‘(F) The Permanent Select Committee on 
Intelligence of the House of Representatives. 
‘‘(2) CONTENTS.—Each report under para-
graph (1) shall, with respect to the period covered 
by the report, include— 
‘‘(A) the full text of each proposal receiv-
ing financial assistance from the National Insti-
tutes of Health; 
‘‘(B) data regarding whether research con-
ducted using financial assistance from the Na-
tional Institutes of Health is consistent with the 
substance of the corresponding proposal; 
‘‘(C) data regarding whether each site at 
which research is conducted using financial as-
sistance from the National Institutes of Health, 
and the research itself, is in compliance with all 
applicable standards and requirements of the 
National Institutes of Health; 
‘‘(D) data regarding whether each entity 
receiving financial assistance from the National 
Institutes of Health keeps detailed and updated 
records of the research conducted; 
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‘‘(E) a final assessment of whether each 
entity receiving financial assistance from the 
National Institutes of Health remains eligible to 
continue receiving such assistance; and 
‘‘(F) a plan for the National Institutes of 
Health to enforce the penalties under sub-
section (d) with respect to each entity fails an 
inspection under this section. 
‘‘(3) PUBLICATION.—The Director of NIH shall 
post each report under paragraph (1) in its entirety 
on the public website of the National Institutes of 
Health. 
‘‘(f) APPLICABILITY.—This section applies beginning 
on October 1, 2023, irrespective of whether the financial 
assistance involved is awarded before or after such date.’’. 
Æ 
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