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, 9785-9786 [2020-03302]

Download as PDF lotter on DSKBCFDHB2PROD with NOTICES Federal Register / Vol. 85, No. 34 / Thursday, February 20, 2020 / Notices ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. 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FOR FURTHER INFORMATION CONTACT: David McMillan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6387, Silver Spring, MD 20993, 240–402– 1009; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 VerDate Sep<11>2014 19:48 Feb 19, 2020 Jkt 250001 9785 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. Dated: February 11, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: [FR Doc. 2020–03426 Filed 2–19–20; 8:45 am] BILLING CODE 4164–01–P I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.’’ This guidance provides consistent recommendations for the nonclinical assessments of immune endpoints and supplements the recommendations provided in other guidances, most notably the ICH guidance for industry ‘‘S8 Immunotoxicity Studies for Human Pharmaceuticals.’’ This guidance replaces the withdrawn guidance entitled ‘‘Immunotoxicology Evaluation of Investigational New Drugs’’ issued November 1, 2002 (67 FR 66647). The topics addressed include multiple aspects of immune suppression, modulation, and stimulation, including carcinogenicity assessment, dermal sensitization, adjuvanted vaccine development, and developmental and juvenile animal studies. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved FDA collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). The information collection has been approved under OMB control numbers 0910–0001 and 0910–0014. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https:// www.regulations.gov. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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 Department of Health and Human Services. ACTION: Notice. AGENCY: 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: SciencePolicy@ od.nih.gov SUMMARY: 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 SciencePolicy@od.nih.gov. 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 E:\FR\FM\20FEN1.SGM 20FEN1 lotter on DSKBCFDHB2PROD with NOTICES 9786 Federal Register / Vol. 85, No. 34 / Thursday, February 20, 2020 / Notices 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 VerDate Sep<11>2014 19:48 Feb 19, 2020 Jkt 250001 (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 onethird, and no more than one-half of the appointed members will be scientists with substantial accomplishments in biomedical or behavioral research. Interested individuals may selfnominate 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 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; 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: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; ZAI1–EC–D–M1, NIAID Research Education Program (R25) Mar 31, 2020. Date: March 31, 2020. Time: 10:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Eleazar Cohen, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institute of Health, 5601 Fishers Lane, Room 3G62A, Bethesda, MD 20892, (240) 669–5081, ecohen@ niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) E:\FR\FM\20FEN1.SGM 20FEN1

Agencies

[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.

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

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

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