[Federal Register Volume 85, Number 34 (Thursday, February 20, 2020)]
[Notices]
[Pages 9785-9786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03302]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


HHS Notice of Committee Establishment, Notice of Intent To 
Convene, and Call for Nominations for the NIH Human Fetal Tissue 
Research Ethics Advisory Board for Fiscal Year 2020

AGENCY: Department of Health and Human Services.

ACTION: Notice.

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SUMMARY: The U.S. Department of Health and Human Services (HHS) 
announces the establishment of, and intent to convene, the National 
Institutes of Health (NIH) Human Fetal Tissue Research Ethics Advisory 
Board--FY 2020 (Ethics Board or Board), as authorized by section 492A 
of the Public Health Service (PHS) Act, as amended. HHS is soliciting 
nominations of individuals for appointment to the Ethics Board for 
fiscal year 2020. Nominations for qualified individuals for appointment 
to the Ethics Board are currently being accepted.

DATES: Nominations must be received no later than 5:00 p.m. ET 30 days 
after the publication of this Federal Register notice.

ADDRESSES: Nomination packages must be submitted to the Executive 
Secretary, NIH Human Fetal Tissue Research Ethics Advisory Board--FY 
2020, Office of Science Policy, NIH, 6705 Rockledge Drive, Suite 750 
Bethesda, MD 20892. Federal Express, Airborne, UPS, etc., mail delivery 
should be addressed to Executive Secretary, NIH Human Fetal Tissue 
Research Ethics Advisory Board--FY 2020, Office of Science Policy, NIH, 
at the above address, or sent via email to: [email protected]

FOR FURTHER INFORMATION CONTACT: Inquiries may be directed to Cari 
Young, Office of Science Policy, 6705 Rockledge Drive, Suite 750 
Bethesda, MD 20892, Telephone: 301-496-9838, or 
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to section 492A of the Public 
Health Service (PHS) Act, 42 U.S.C. 289a-1, as amended, and in 
accordance with the policy announced on June 5, 2019, the Secretary 
announces (1) his

[[Page 9786]]

determination that an advisory board should be convened to recommend 
whether, with respect to research involving human fetal tissue (HFT) 
proposed in NIH grant and cooperative agreement applications and R&D 
contract proposals, described in the NIH Guide Notice NOT-OD-19-128, 
the Secretary should withhold funds or not withhold funds because of 
ethical considerations; (2) his intent to convene such an advisory 
board; and (3) the establishment of the NIH Human Fetal Tissue Ethics 
Advisory Board--FY 2020. NIH Human Fetal Tissue Ethics Advisory Board--
FY 2020 is governed by the Federal Advisory Committee Act (5 U.S.C. 
App.), which sets forth standards for the formation and use of advisory 
committees. The number of meetings to be held by the Board will depend 
on the number of relevant NIH grant and cooperative agreement 
applications and R&D contract proposals pending the Board's 
consideration. Meetings will be open to the public except as determined 
otherwise by the Secretary in accordance with subsection (c) of section 
552b of Title 5 U.S.C. Notice of all meetings will be given to the 
public.
    In accordance with section 492A(5)(B)(ii) of the PHS Act, no later 
than 180 days after the date on which this notice is published in the 
Federal Register, the Board will submit to the Secretary, the Committee 
on Energy and Commerce of the House of Representatives, and the 
Committee on Health, Education, Labor and Pensions of the Senate, a 
report describing the findings of the Board regarding the project(s) of 
research involved and recommendations regarding whether the Secretary 
should or should not withhold funds for the project(s). As required by 
section 492A(b)(5)(K) of the PHS Act, the Ethics Board will terminate 
30 days after the date on which the required report is submitted to the 
Secretary, the Committee on Energy and Commerce of the House of 
Representatives, and the Committee on Health, Education, Labor and 
Pensions of the Senate.
    Notice of Establishment: Pursuant to the Federal Advisory Committee 
Act, as amended (5 U.S.C. App.), the Secretary of Health and Human 
Services (HHS), announces the establishment of the NIH Human Fetal 
Tissue Research Ethics Advisory Board--FY 2020, as authorized by 
section 492A of the Public Health Service (PHS) Act, 42 U.S.C. 289a-1, 
as amended.
    The Ethics Board will advise, consult with, and make 
recommendations to, the Secretary of Health and Human Services 
(Secretary) regarding the ethics of research involving human fetal 
tissue (HFT) proposed in NIH grant and cooperative agreement 
applications and R&D contract proposals, described in the NIH Guide 
Notice NOT-OD-19-128. Recommendations will address whether the 
Secretary should withhold funds or not withhold funds from a proposed 
project because of ethical considerations. In providing advice and 
recommendations on these matters, the Ethics Board will consider, among 
other things, the use of alternative models, and review and verify the 
core ethical principles and procedures used in the process to obtain 
written voluntary informed consent for the donation of the tissue. The 
ethical considerations the Ethics Board should consider are those 
related to whether the nature of the research involved is such that it 
is unethical to conduct or support the research.
    Notice of Intent To Convene: Consistent with section 492A of the 
PHS Act, this announcement outlines the intention of the HHS Secretary 
to convene the Ethics Board and solicits nominations for the 
individuals who should be considered for appointment to the Board. The 
Secretary will consider such recommendations in making appointments to 
the Board.
    Call for Nominations: The Board will be composed of 15 individuals 
who are not federal employees. Section 492A(b)(5)(C) of the PHS Act 
establishes certain requirements for the composition of the Board. The 
appointed members of the Board will include no fewer than one attorney; 
no fewer than one ethicist; no fewer than one practicing physician; and 
no fewer than one theologian. No fewer than one-third, and no more than 
one-half of the appointed members will be scientists with substantial 
accomplishments in biomedical or behavioral research.
    Interested individuals may self-nominate or be nominated by another 
individual or organization. The following information may be included 
in the package of materials submitted for each individual being 
nominated for consideration: (1) A letter of nomination stating the 
name, affiliation, and contact information for the nominee, the basis 
for the nomination (i.e., the specific attributes, perspectives, and/or 
skills the individual possesses that would benefit the workings of the 
Ethics Board), and the nominee's field(s) of expertise; (2) a 
biographical sketch of the nominee; (3) the name, address, daytime 
telephone number, and email address at which the nominator can be 
contacted; (4) a current copy of the nominee's curriculum vitae; and 
(5) the category of Board member the nominee would fill (i.e., 
attorney, ethicist, practicing physician, theologian, or scientist with 
substantial accomplishments in biomedical or behavioral research). 
Nomination packages may be submitted directly by the individual being 
nominated or by the person/organization recommending the candidate.

    Dated: February 12, 2020.
Alex M. Azar II,
Secretary.
[FR Doc. 2020-03302 Filed 2-19-20; 8:45 am]
BILLING CODE 4140-01-P