Notice2026-09108
Advisory Committee; Blood Products Advisory Committee; Renewal
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Published
May 7, 2026
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, 2028, expiration date.
Full Text
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<title>Federal Register, Volume 91 Issue 88 (Thursday, May 7, 2026)</title>
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[Federal Register Volume 91, Number 88 (Thursday, May 7, 2026)]
[Notices]
[Pages 24880-24882]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09108]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-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, 2028, 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: Advisory Committee Oversight and
Management Staff, Office of the Chief Scientist, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3215, Silver
Spring, MD 20993-0002, (301) 796-8220, <a href="/cdn-cgi/l/email-protection#d79694989a8484a2b5babea4a4beb8b9a497b1b3b6f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="a1e0e2eeecf2f2d4c3ccc8d2d2c8cecfd2e1c7c5c08fc9c9d28fc6ced7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 21 CFR 14.40(b) and 41 CFR 102-
3.65 and following approval by the Department of Health and Human
Services and review 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 and informs the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
drug and biological products for human use, as well as, when required,
any other product under the regulatory authority of FDA. 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 products 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. The Committee may consider the quality and relevance
of FDA's research program, which provides scientific support for the
regulation of these products, and makes appropriate recommendations to
the Commissioner.
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 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 at least thirteen voting
members including the Chair. Subject to legal and regulatory
requirements, members and the Chair are selected by and serve at the
discretion of the Commissioner or designee. Each member, including the
Chair, will be selected 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 related specialties.
Members will be invited to serve for terms of up to four years, or
for less time at the discretion of the Commissioner or designee. Non-
Federal members of this committee will serve either as Special
Government Employees or representatives. Federal members will serve as
Regular Government Employees or Ex-Officios.
In addition to the voting members, the Commissioner or designee may
identify consumer and/or industry representatives to join the Committee
(or serve as alternate representatives) as non-voting representative
member(s), via a process consistent with legal and regulatory
requirements. Individuals currently employed at FDA-regulated
companies, such as pharmaceutical and medical device manufacturers,
shall not be selected to serve as members of the Committee unless this
Committee is expected to address issues for which inclusion of an
industry representative is required by statute. If this Committee
includes an industry representative, the Commissioner or designee will
determine whether to invite them to participate in meetings on a case-
by-case basis, according to applicable legal and regulatory
requirements.
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees 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.
A quorum for the Committee is a majority of the current voting
members present at the time, provided that FDA may specify a quorum
that is less than a majority of the current voting
[[Page 24881]]
members because of the size of the Committee and the variety in the
types of issues that it will consider, or other reason determined
appropriate in accordance with legal and regulatory requirements. 21
CFR 14.22(d).
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.
Members appointed to an advisory committee serve for the duration
of the committee, or until their terms expire, they resign, or they are
removed from membership by the Commissioner or designee. Committee
members' terms may end prior to their date of expiration, for reasons
determined to be good cause. Good cause includes excessive absenteeism
from committee meetings, a demonstrated bias that interferes with the
ability to render objective advice, failure to abide by established
procedures, or violation of other applicable rules and regulations.
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 Advisory Committee Oversight and Management Staff
(see FOR FURTHER INFORMATION CONTACT). Because the committee's name and
description of duties remain unchanged, 21 CFR 14.100 will not be
amended.
Renewal Requirements and Justification: The Commissioner has
determined that renewal of the Blood Products Advisory Committee is in
the public interest. This determination is based on the Committee's
essential role in providing independent expert advice on complex
scientific and regulatory matters related to blood products, the
continued need for specialized expertise in this therapeutic area, and
the Committee's demonstrated value in supporting FDA's regulatory
mission. The following information supports this determination in
accordance with applicable legal and regulatory requirements.
Public Interest Determination
Pursuant to 41 U.S.C. 102-3.60(a), to establish, renew,
reestablish, or merge a discretionary (agency discretion) advisory
committee, an agency must first consult with the General Services
Administration's Committee Management Secretariat (the Secretariat)
and, as part of the consultation, provide a written public interest
determination approved by the head of the agency to the Secretariat
with a copy to the Office of Management and Budget. In addition,
pursuant to 41 U.S.C. 102-3.35, an agency shall follow the same
consultation process and document in writing the same determination of
need before creating a subcommittee under a discretionary committee
that is not made up entirely of members of a parent advisory committee.
Information on the following factors for the committee is provided
to the Secretariat to demonstrate that renewing the committee is in the
public interest:
1. Annual budget.
The overall annual budget for this committee is $131,660.
a. Federal personnel on a full-time equivalent (FTE) basis.
The estimated person years of Federal staff support required is
0.50 at an estimated cost of $76,713.
b. Other Federal internal costs.
The anticipated total value in dollars of other internal costs,
such as costs associated with IT and supplies for meetings, is $26,452.
c. Proposed payments to members.
The estimated annual payment to members is $9,299.
d. Proposed number of members.
The anticipated number of members is 13.
e. Reimbursable costs.
The estimated annual reimbursable costs, including travel and
related expenses for members, is $19,196.
2. If applicable, the total dollar value of grants expected to be
recommended during the fiscal year.
N/A.
3. Criteria for selecting members to ensure the committee has the
necessary expertise and fairly balanced membership.
Ensuring Necessary Expertise:
Members must have background, education, and experience
commensurate with the committee's function of advising FDA on the
safety, effectiveness, and appropriate use of blood, blood-derived
products, and biotechnology products intended for the diagnosis,
prevention, or treatment of human diseases, including donor screening
and eligibility, product labeling, clinical and laboratory studies, and
the approval or revocation of biological product licenses, as well as
the quality and relevance of FDA's supporting research programs.
Scientific and technical competence is critical. Nominees should be
acknowledged experts with demonstrated skills in critical evaluation of
data and effective communication. As outlined in the committee charter,
the membership should include 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
specialties, as well as needed consumer and industry representation.
FDA also follows the requirements in section 505(n)(3) regarding
membership of drug or biological product advisory committees. (21
U.S.C. 355(n)(3)). Because the BPAC will function at times as a medical
device panel, FDA also considers the membership requirements in 21
U.S.C. 360(c).
Ensuring Fair Balance:
Appointments are made without discrimination. The committee is
reviewed in totality for balance, characterized by inclusion of
necessary knowledge, insight, and scientific perspective from the
relevant community or expertise area. Nominations are sought from all
geographic locations within the United States and its territories, and
from diverse sources including professional and scientific societies,
academia, government agencies, industry and trade associations,
consumer and patient organizations, and current Agency staff.
4. List of all other Federal advisory committees of the agency.
FDA maintains the following Federal advisory committees:
<bullet> Anesthetic and Analgesic Drug Products Advisory Committee
<bullet> Antimicrobial Drugs Advisory Committee
<bullet> Cardiovascular and Renal Drugs Advisory Committee
<bullet> Cellular Tissue and Gene Therapies Advisory Committee
<bullet> Dermatologic and Ophthalmic Drugs Advisory Committee
<bullet> Device Good Manufacturing Practice Advisory Committee
<bullet> Digital Health Advisory Committee
<bullet> Drug Safety and Risk Management Advisory Committee
<bullet> Endocrinologic and Metabolic Drugs Advisory Committee
<bullet> Gastrointestinal Drugs Advisory Committee
<bullet> Genetic and Metabolic Disease Advisory Committee
<bullet> Medical Devices Advisory Committee
<bullet> National Mammography Quality Assurance Advisory Committee
(Administratively Inactive)
<bullet> Nonprescription Drugs Advisory Committee
<bullet> Obstetrics, Reproductive and Urologic Drug Advisory Committee
<bullet> Oncologic Drugs Advisory Committee
[[Page 24882]]
<bullet> Patient Engagement Advisory Committee
<bullet> Pediatrics Advisory Committee
<bullet> Peripheral and Central Nervous System Advisory Committee
<bullet> Pharmacy Compounding Advisory Committee
<bullet> Pharmacy Compounding Drugs AC
<bullet> Psychopharmacologic Drugs Advisory Committee
<bullet> Pulmonary-Allergy Drugs Advisory Committee
<bullet> Risk Communication Advisory Committee (Administratively
Inactive)
<bullet> Science Board to the Food and Drug Administration
<bullet> Technical and Electronic Product Safety Standards AC
<bullet> Technical and Electronic Products Safety Standards Advisory
Committee
<bullet> Tobacco Products Advisory Committee
5. Justification that the information or advice provided by the
Federal advisory committee or subcommittee is not available from
another Federal advisory committee, another Federal Government source,
or any other more cost-effective and less burdensome source.
The Blood Products Advisory Committee (BPAC) was established to
review and evaluate 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 make
appropriate recommendations to the Commissioner of Food and Drugs. The
Committee also advises the Commissioner of Food and Drugs of its
findings regarding donor screening and testing, product labeling,
clinical and laboratory studies involving such products, and the
affirmation or revocation of biological product licenses.
No other FDA advisory committee is specifically focused on whole
blood, blood components, plasma-derived products, and related
biologics. These products raise unique scientific, technical, and
public health issues involving donor eligibility and screening,
transfusion-transmitted infectious disease risk, manufacturing
controls, and clinical use that require the specialized expertise BPAC
provides. At times, the Committee also functions as a medical device
panel to address related device issues within its area of expertise.
6. If the consultation is a committee renewal, a summary of the
previous accomplishments of the committee and the reasons it needs to
continue.
Summary of Previous Accomplishments:
On May 9, 2024, the Committee met in open session to discuss
strategies to reduce the risk of transfusion-transmitted malaria by
testing blood donations from donors at risk of malaria exposure.
Agency Action: In January 2025, FDA issued a draft guidance for
industry proposing a selective testing strategy to reduce the risk of
transfusion-transmitted malaria (TTM). The draft guidance outlines
testing strategies for blood donations that considers:
Testing donations from donors with a history of malaria.
<bullet> One-time testing of donors who resided in a malaria-
endemic country.
<bullet> Testing donors who traveled to a malaria-endemic region in
the past 12 months.
<bullet> Testing donations collected in U.S. regions identified by
FDA as having local malaria transmission.
The guidance document for blood establishments is now in the public
comment phase. The guidance reflects the scientific and operational
considerations discussed at the committee meeting and is intended to
help blood establishments reduce the risk of malaria transmission
through tailored testing.
The committee is critical for the review and evaluation of data on
the safety and effectiveness, and appropriate use of blood products
intended for use in the diagnosis, prevention, or treatment of human
diseases.
7. Explanation of why the committee/subcommittee is essential to
the conduct of agency business.
Reasons for Continuation:
The Committee plays a critical role in enabling FDA to meet the
requirements of section 505(n)(1) and (s)(1) of the Federal Food, Drug,
and Cosmetic Act by providing expert scientific advice and
recommendations. The BPAC is the only FDA advisory committee that
provides specialized expertise in whole blood, blood components,
plasma-derived products, and related biologics. These products raise
unique scientific, technical, and public health issues involving donor
eligibility and screening, transfusion-transmitted infectious disease
risk, manufacturing controls, and clinical use.
In conclusion, this public interest determination documents that
renewing the committee is in the public interest, essential to the
conduct of agency business, and that the information to be obtained is
not already available through another advisory committee or source
within the Federal Government.
This notice is issued under the Federal Advisory Committee Act as
amended (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>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09108 Filed 5-6-26; 8:45 am]
BILLING CODE 4164-01-P
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