Exemption of the Advanced Research Projects Agency for Health (ARPA-H) From Policies and Requirements of the National Institutes of Health (NIH), 19157 [2023-06620]

Download as PDF Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Notices investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: March 23, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–06580 Filed 3–29–23; 8:45 am] BILLING CODE 4164–01–P 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) Advanced Research Projects Agency for Health, Department of Health and Human Services. ACTION: Notice. AGENCY: 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, 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 lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:22 Mar 29, 2023 Jkt 259001 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. PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 19157 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] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Oncology. Date: April 27, 2023. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Nywana Sizemore, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6189, MSC 7804, Bethesda, MD 20892, 301–408– 9916, sizemoren@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) E:\FR\FM\30MRN1.SGM 30MRN1

Agencies

[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.

-----------------------------------------------------------------------

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">[email protected]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]
BILLING CODE 4140-01-P
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