[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Notices]
[Page 19157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06620]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Exemption of the Advanced Research Projects Agency for Health
(ARPA-H) From Policies and Requirements of the National Institutes of
Health (NIH)
AGENCY: Advanced Research Projects Agency for Health, Department of
Health and Human Services.
ACTION: Notice.
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SUMMARY: The Secretary of the U.S. Department of Health and Human
Services (HHS) has statutory authority to exempt the Advanced Research
Projects Agency for Health (ARPA-H) from certain policies and
requirements of the National Institutes of Health (NIH) as necessary
and appropriate to ensure ARPA-H can most effectively achieve its
statutorily specified goals. Pursuant to such authority, and for the
reasons stated herein, the Secretary is giving notice that he intends
to exempt ARPA-H from all NIH policies and requirements subject to the
limitations and condition stated herein.
FOR FURTHER INFORMATION CONTACT: Thomas Libert, 240-731-3874,
h.gov">tom.libert@arpa-h.gov.
SUPPLEMENTARY INFORMATION: This notice follows 87 FR 32174, published
on May 24, 2022. The Consolidated Appropriations Act, 2023 (Public Law
117-328, enacted on December 29, 2022) includes authorizing language
for ARPA-H. Notably, section 499A of the Public Health Service Act
(PHSA), as added by section 2331(a) of the Consolidated Appropriations
Act, 2023, establishes ARPA-H within NIH and provides that the
Director, ARPA-H, shall report to the Secretary of HHS.
Subparagraph (A) of section 499A(a)(3) provides that the Secretary
may exempt ARPA-H from NIH policies and requirements that are in effect
on the day before the enactment of section 499A as necessary and
appropriate to ensure ARPA-H can most effectively achieve its
statutorily specified goals, except as otherwise provided for in
section 499A and subject to the requirements of subparagraph (B).
Subparagraph (B) of section 499A(a)(3) provides that not later than 90
days after the date of enactment of section 499A, the Secretary shall
publish a notice in the Federal Register describing the specific NIH
policies and requirements from which the Secretary intends to exempt
ARPA-H, including a rationale for such exemptions.
Pursuant to section 499A(a)(3) of the PHSA, notice is hereby given
that I intend to exempt ARPA-H from all policies and requirements of
the NIH that were in effect on the day before the enactment of section
499A, that is, on December 28, 2022.
The exemption is necessary and appropriate to ensure ARPA-H can
most effectively achieve its statutorily specified goals and consistent
with prior actions for the following reasons:
The mission of ARPA-H is complementary to NIH, but its
business model is distinct and separate. To succeed at its mission to
realize transformative health solutions, ARPA-H must establish a unique
culture and distinct and separate business and operations processes,
including its own policies and requirements.
On April 15, 2022, I transferred ARPA-H to NIH as
authorized by title II of division H of the Consolidated Appropriations
Act, 2022 (Pub. L. 117-103, enacted on March 15, 2022) and delegated to
the Director, NIH, certain authorities for the purpose of carrying out
ARPA-H (87 FR 23526). As a condition of the delegation, I specified
that NIH may not subject ARPA-H to NIH policies.
As noted, section 499A of the PHSA establishes ARPA-H
within NIH and provides that the Director, ARPA-H, shall report to the
Secretary. In the Joint Explanatory Statement (168 Cong. Rec. S8895,
2022), Congress signaled its intent for ARPA-H to establish its own
culture, procedures, and policies:
The agreement strongly encourages HHS to collaborate with the
Defense Advanced Research Projects Agency (DARPA) to develop the
foundational policies, procedures, and staff training for ARPA-H
employees. The agreement believes ARPA-H will require a very
different culture and mission than NIH's other 27 Institutes and
Centers.
ARPA-H shall continue to be subject to all policies and
requirements of HHS. All major policy, programmatic, and operational
decisions proposed by ARPA-H shall continue to come to the Secretary
for approval.
The exemption is subject to the following condition:
Where ARPA-H identifies a need to develop a policy or
requirement to fulfill its mission, it shall rely upon NIH policies and
requirements until such time as ARPA-H develops its own policies and
requirements as appropriate.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2023-06620 Filed 3-29-23; 8:45 am]
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