Notice2026-05623
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Advisory Committees
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
March 23, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with certain FDA advisory committee activities.
Full Text
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<title>Federal Register, Volume 91 Issue 55 (Monday, March 23, 2026)</title>
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[Federal Register Volume 91, Number 55 (Monday, March 23, 2026)]
[Notices]
[Pages 13852-13854]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05623]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-2364]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food and Drug Administration Advisory Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the information collection associated with certain
FDA advisory committee activities.
DATES: Either electronic or written comments on the collection of
information must be submitted by May 22, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 22, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact
[[Page 13853]]
information, or other information that identifies you in the body of
your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2026-N-2364 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food and Drug Administration
Advisory Committees.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Kelly Covington, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-5661,
<a href="/cdn-cgi/l/email-protection#7a2a283b290e1b1c1c3a1c1e1b54121209541d150c"><span class="__cf_email__" data-cfemail="a2f2f0e3f1d6c3c4c4e2c4c6c38ccacad18cc5cdd4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
FDA Advisory Committees--21 CFR Part 14
OMB Control Number 0910-0833--Extension
This information collection supports certain Food and Drug
Administration (FDA, the Agency, us or we) Advisory Committee
administrative activities. FDA Advisory Committees are established to
advise or make recommendations on matters of public health that come
before the Agency. The Federal Advisory Committee Act (5 U.S.C. App. 2
Sec. 3, Pub. L. 92-463) (``FACA'') defines what constitutes an
``advisory committee'' under the Act and provides general procedures to
follow for the operation of advisory committees. In addition, FACA is
designed to assure that the Congress and the public are kept informed
with respect to the purpose, membership, and activities of advisory
committees. Public advisory committee regulations in part 14 set forth
requirements governing the administrative procedures to follow for the
operation of advisory committees. Agency regulations in part 14,
subpart A (Sec. Sec. 14.1 through 14.15) identify scope of coverage,
applicable definitions, and establish general provisions. The
regulations in part 14, subpart B (Sec. Sec. 14.20 through 14.39) set
forth content and format requirements along with required schedules for
submission of information. The regulations in part 14 subparts C, D,
and E (Sec. Sec. 14.40 through 14.95) set forth requirements governing
advisory committee establishment, recordkeeping, and maintenance,
respectively.
FACA does not specify the manner in which advisory committee
members and staff must be appointed. (See generally 5 U.S.C. App. 2.
See also, 41 CFR 102-3.105, 102-3.130(a)). FDA's regulations, however,
specify that the Commissioner ``will publish one or more notices in the
Federal Register each year requesting nominations for voting members of
all existing standing advisory committees.'' (21 CFR 14.82(a)).
Nominations must specify the committee for which the nominee is
recommended, include a complete curriculum vitae (CV), state that the
nominee is aware of the nomination and willing to serve, and state that
the nominee appears to have no conflict of interest that would preclude
membership. (21 CFR 14.82(c)). In an effort to promote transparency,
consistent with FDA and General Services Administration
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(``GSA'') policy (See, GSA regulations encouraging agencies to
``practice openness'' and suggesting that ``agencies may wish to
explore the use of the internet to post advisory committee information
. . .'' 41 CFR 102-3.95(b)), and pursuant to a settlement agreement in
the case Public Citizen Foundation, Inc. v. Food & Drug Administration,
et al., No. 16-cv-781 (D.D.C.), FDA is also seeking consent from
nominees for FDA to publicly post their CVs in the event they are
selected to serve on an FDA advisory committee.
We therefore estimate the burden of this collection of information
as follows:
Table 1--Estimated Annual Reporting Burden \1\ \2\
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Number of
21 CFR part 14; subpart E--members of Number of responses per Total annual Average burden per response Total hours
advisory committees respondents respondent responses
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Advisory Committee Membership Nominations.... 407 1 407 0.25 (15 mins.).......................... 102
Member Submission of Updated Information..... 359 1 359 0.25 (15 mins.).......................... 90
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Total.................................... .............. .............. .............. ......................................... 192
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Sums may not total due to rounding.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-05623 Filed 3-20-26; 8:45 am]
BILLING CODE 4164-01-P
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