Notice2022-16577
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 3, 2022
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, 2024, expiration date.
Full Text
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<title>Federal Register, Volume 87 Issue 148 (Wednesday, August 3, 2022)</title>
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[Federal Register Volume 87, Number 148 (Wednesday, August 3, 2022)]
[Notices]
[Pages 47427-47428]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#e8ab809a819b9c818689c6be8d9a9ca88e8c89c680809bc68f879e"><span class="__cf_email__" data-cfemail="07446f756e74736e6966295162757347616366296f6f7429606871">[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 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
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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. App.). 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: 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
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