[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64930-64931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17518]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-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, 2026, expiration 
date.

DATES: Authority for the Blood Products Advisory Committee will expire 
on May 13, 2026, 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, 
Silver Spring, MD 20993-0002, 240-731-3544, [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 FDA 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 recommends

[[Page 64931]]

classification of devices subject to its review into regulatory 
categories; recommends the assignment of a priority for the application 
of regulatory requirements for devices classified in the standards or 
premarket approval category; advises on formulation of product 
development protocols and reviews premarket approval applications for 
those devices to recommend changes in classification as appropriate; 
recommends exemption of certain devices from the application of 
portions of the Act; advises on the necessity to ban a device; and 
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 15 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 either 
as Special Government Employees or non-voting representatives. 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 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. 1001 et seq.). For general information related to FDA advisory 
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: August 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17518 Filed 8-7-24; 8:45 am]
BILLING CODE 4164-01-P