Document ID: FDA-2022-N-0008-0008
Agency: fda
Document Type: Notice
Title: Advisory Committee; Blood Products Advisory Committee; Renewal
Posted Date: 2022-08-03T04:00Z

[Federal Register Volume 87, Number 148 (Wednesday, August 3, 2022)]
[Notices]
[Pages 47427-47428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16577]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0008]

Advisory Committee; Blood Products Advisory Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Blood Products Advisory Committee by the Commissioner of 
Food and Drugs (the Commissioner). The Commissioner has determined that 
it is in the public interest to renew the Blood Products Advisory 
Committee for an additional 2 years beyond the charter expiration date. 
The new charter will be in effect until the May 13, 2024, expiration 
date.

DATES: Authority for the Blood Products Advisory Committee will expire 
on May 13, 2024, unless the Commissioner formally determines that 
renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Christina Vert, Division of Scientific 
Advisors and Consultants, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
1244, Silver Spring, MD 20993-0002, 240-402-8054, 
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services and by the General Services 
Administration, FDA is announcing the renewal of the Blood Products 
Advisory Committee (the Committee). The Committee is a discretionary 
Federal advisory committee established to provide advice to the 
Commissioner. The Committee advises the Commissioner or designee in 
discharging responsibilities as they relate to helping to ensure safe 
and effective drugs for human use and, as required, any other product 
for which FDA has regulatory responsibility.
    The Committee reviews and evaluates available data concerning the 
safety, effectiveness, and appropriate use of blood, products derived 
from blood and serum or biotechnology which are intended for use in the 
diagnosis, prevention, or treatment of human diseases, and, as 
required, any other product for which the Food and Drug Administration 
has regulatory responsibility. The Committee also advises the 
Commissioner of Food and Drugs of its findings regarding screening and 
testing (to determine eligibility) of donors and labeling of the 
products, on clinical and laboratory studies involving such products, 
on the affirmation or revocation of biological products licenses, and 
on the quality and relevance of FDA's research program which provides 
the scientific support for regulating these agents. The Committee will 
function at times as a medical device panel under the Federal Food, 
Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the 
Committee: (1) recommends classification of devices subject to its 
review into regulatory categories; (2) recommends the assignment of a 
priority for the application of regulatory requirements for devices 
classified in the standards or premarket approval category; (3) advises 
on formulation of product development protocols and reviews premarket 
approval applications for those devices to recommend changes in 
classification as appropriate; (4) recommends exemption of certain 
devices from the application of portions of the Medical Device 
Amendments of 1976; (5) advises on the necessity to ban a device; and 
(6) responds to requests from the Agency to review and make 
recommendations on specific issues or problems concerning the safety 
and effectiveness of devices.
    The Committee shall consist of a core of 17 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of clinical and administrative medicine, hematology, immunology, 
blood banking, surgery, internal medicine, biochemistry, engineering, 
biological and physical sciences, biotechnology, computer technology, 
statistics, epidemiology, sociology/ethics, and other related 
professions. Members will be invited to serve for overlapping terms of 
up to 4 years. Non-Federal members of this committee will serve as 
Special Government Employees, representatives, or Ex-Officio members. 
Federal members will serve as Regular Government Employees or Ex-
Officios. The core of voting members may include one technically 
qualified member, selected by the Commissioner or designee, who is 
identified with consumer interests and is recommended by either a 
consortium of consumer-oriented organizations or other interested 
persons. In addition to the voting members, the Committee may include 
one non-voting representative member who is identified with industry

[[Page 47428]]

interests. There may also be an alternate industry representative.
    The Commissioner or designee shall have the authority to select 
members of other scientific and technical FDA advisory committees 
(normally not to exceed 10 members) to serve temporarily as voting 
members and to designate consultants to serve temporarily as voting 
members when: (1) expertise is required that is not available among 
current voting standing members of the Committee (when additional 
voting members are added to the Committee to provide needed expertise, 
a quorum will be based on the combined total of regular and added 
members); or (2) to comprise a quorum when, because of unforeseen 
circumstances, a quorum is or will be lacking. Because of the size of 
the Committee and the variety in the types of issues that it will 
consider, FDA may, in connection with a particular committee meeting, 
specify a quorum that is less than most of the current voting members. 
The Agency's regulations (21 CFR 14.22(d)) authorize a committee 
charter to specify quorum requirements.
    If functioning as a medical device panel, an additional non-voting 
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in 
addition to the voting members.
    Further information regarding the most recent charter and other 
information can be found at https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/blood-products-advisory-committee or 
by contacting the Designated Federal Officer (see FOR FURTHER 
INFORMATION CONTACT). In light of the fact that no change has been made 
to the committee name or description of duties, no amendment will be 
made to 21 CFR 14.100.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. App.). For general information related to FDA advisory 
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: July 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16577 Filed 8-2-22; 8:45 am]
BILLING CODE 4164-01-P