Title: EMPOWER NIH Act of 2021
Policy area: Health

Summary:
Enabling More Penetrating Oversight When Examining Research for NIH Act of 2021 or the EMPOWER NIH Act of 2021
This bill requires annual, unannounced, in-person inspections of all nonfederal entities that receive funding, including through subawards, from the National Institutes of Health (NIH) to assess whether the funded research is consistent with the research proposal and otherwise meets record-keeping requirements and NIH standards.
The inspections are required even when an entity is located in a foreign country with a government that interferes with the inspection; entities that fail an inspection must return the full amount of NIH funding and lose eligibility for future NIH funding for at least five years.
The bill is effective on October 1, 2023, and applies to NIH funding awarded both before and after that date.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4211 Introduced in House (IH)]

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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 
   assistance 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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Enabling More Penetrating Oversight 
When Examining Research for NIH Act of 2021'' or the ``EMPOWER NIH Act 
of 2021''.

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 receipt of any 
financial assistance described in subsection (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 receiving 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 consistent 
                with the description and assurances in the relevant 
                proposal;
                    ``(B) whether each site at which the research 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 financial 
                assistance keeps detailed and updated records of the 
                research conducted.
            ``(5) The inspection shall include--
                    ``(A) the facility at the research site;
                    ``(B) the materials used to conduct the research;
                    ``(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 financial assistance.
            ``(7) Each team of inspectors shall certify in writing that 
        they have no financial conflict of interest 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 inspection under 
        this section--
                    ``(A) the entities receiving the financial 
                assistance involved shall, collectively, return the 
                full amount of such assistance to the Treasury; and
                    ``(B) each entity receiving the financial 
                assistance involved, including each entity that 
                receives the assistance directly from the National 
                Institutes of Health and each entity that receives the 
                assistance indirectly, shall be ineligible 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 described 
                        in paragraph (2), not less than 15 years.
            ``(2) Violations described.--A violation referred to in 
        paragraph (1)(B)(ii) is--
                    ``(A) without regard to whether the conduct is 
                knowing or not--
                            ``(i) denial of entry by the entity to 
                        inspectors;
                            ``(ii) maintaining incomplete or falsified 
                        research records;
                            ``(iii) damaging or destroying research 
                        records;
                            ``(iv) withholding research records from 
                        inspectors; or
                            ``(v) relocating research materials to 
                        alternate sites to avoid inspection; or
                    ``(B) any action taken knowingly to prevent 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 omission 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 committees:
                    ``(A) The Committee on Homeland Security 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 Reform of the 
                House of Representatives.
                    ``(E) The Committee on Energy and Commerce of the 
                House of Representatives.
                    ``(F) The Permanent Select Committee on 
                Intelligence of the House of Representatives.
            ``(2) Contents.--Each report under paragraph (1) shall, 
        with respect to the period covered by the report, include--
                    ``(A) the full text of each proposal receiving 
                financial assistance from the National Institutes of 
                Health;
                    ``(B) data regarding whether research conducted 
                using financial assistance from the National 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 assistance 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;
                    ``(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 subsection (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.''.
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