Notice2024-17518
Advisory Committee; Blood Products Advisory Committee; Renewal
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 8, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 153 (Thursday, August 8, 2024)</title>
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[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64930-64931]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#aeedc6dcc7dddac7c0cf80f8cbdcdaeec8cacf80c6c6dd80c9c1d8"><span class="__cf_email__" data-cfemail="52113a203b21263b3c337c04372026123436337c3a3a217c353d24">[email protected]</span></a>.
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 <a href="https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/blood-products-advisory-committee">https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/blood-products-advisory-committee</a> 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 <a href="http://www.fda.gov/AdvisoryCommittees/default.htm">http://www.fda.gov/AdvisoryCommittees/default.htm</a>.
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
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