Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings

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Published

April 7, 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 information collection associated with general FDA administrative practices and procedures, including requests for formal hearings.

Full Text

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<title>Federal Register, Volume 91 Issue 66 (Tuesday, April 7, 2026)</title>
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[Federal Register Volume 91, Number 66 (Tuesday, April 7, 2026)]
[Notices]
[Pages 17658-17660]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06719]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-2431]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Administrative Practices and Procedures; Formal
Hearings

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 information collection associated with
general FDA administrative practices and procedures, including requests
for formal hearings.

DATES: Either electronic or written comments on the collection of
information must be submitted by June 8, 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 June 8, 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 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-2431 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Administrative Practices and
Procedures; Formal Hearings.'' 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 in 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

[[Page 17659]]

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#fdadafbcae899c9b9bbd9b999cd395958ed39a928b"><span class="__cf_email__" data-cfemail="f3a3a1b2a087929595b3959792dd9b9b80dd949c85">[email&#160;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.

Administrative Practices and Procedures; Formal Hearings--21 CFR Parts
10, 12-16, and 19

OMB Control Number 0910-0191--Extension

This information collection supports Food and Drug Administration
(FDA, the agency, us or we) regulations found in 21 CFR part 10, 21 CFR
parts 12 through 16, and 21 CFR part 19 (21 CFR 10, 12-16, and 19),
which implement general provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act). The regulations were promulgated in accordance
with the Administrative Procedures Act and establish administrative
practice and procedures to give instructions to those conducting
business with FDA. Regulations in part 10 (21 CFR part 10) describe
general administrative practices and include content and format
instructions on submitting information to the agency, petitions for
agency action, and other topics such as the public calendar.
Regulations in 21 CFR parts 12 through 16 cover formal evidentiary,
public, and regulatory hearings. We also account for burden associated
with waiver requests under 21 CFR part 10.19. Unless a waiver,
suspension, or modification submitted under Sec. 10.19 (21 CFR 10.19)
is granted by the Commissioner of Food and Drugs (the Commissioner),
the regulations in 21 CFR part 10 apply to all petitions, hearings, and
other administrative proceedings and activities conducted by FDA.
Although we have not received requests under Sec. 10.19, to reflect
the attendant burden resulting from submitting such a request, we
provide an estimate of 1 response and 1 burden hour annually, as
reflected in Question-12 of this supporting statement. Also, because
most information associated with regulations in parts 12-16 is obtained
during the conduct of an official administrative action as described
under 5 CFR 1320.4, we only include burden associated with initiating
hearings pursuant to the applicable regulations.
The information collection also includes activities and burden
associated with general meeting requests and correspondence submitted
under section 10.65 (21 CFR 10.65), as well and general submissions
associated with section 10.115--which provides for public participation
in the development of agency guidance documents through requests to our
Dockets Management Staff. Although most submissions and attendant
burden associated with recommendations found in FDA guidance documents
is accounted for in topic-specific and approved ICRs, here we account
for burden associated with general public submissions as described in
Sec. 10.115(f)(3).
The information collection also includes burden associated with
recommendations discussed in the guidance document entitled, ``Citizen
Petitions and Petitions for Stay of Action Subject to Section 505(q) of
the Federal Food, Drug, and Cosmetic Act.'' The guidance document
communicates FDA's interpretation of section 505(q) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(q)): Petitions
and Civil Actions Regarding Approval of Certain Applications. The
guidance identifies and discusses submission elements including
certification, as well as verification of supplemental information. It
also addresses the relationship between the review of petitions and
pending ANDAs, 505(b)(2) applications, and 351(k) applications for
which a decision on approvability has not yet made.
The information collection also includes burden associated with
requests for FDA speakers. FDA receives thousands of requests each year
from trade associations and industry-based groups for speakers to
participate in external meetings, conferences, and workshops. To
facilitate the processing of these requests and determine
participation, we have designated contacts throughout the agency and
have developed web-based request templates which can be found on our
website at <a href="https://www.fda.gov/training-and-continuing-education/contacts-requesting-fda-speaker">https://www.fda.gov/training-and-continuing-education/contacts-requesting-fda-speaker</a>.
We estimate the burden of this collection of information as
follows:

[[Page 17660]]

Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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10.19--request for waiver, suspension, or 2 1 2 1........................................ 2
modification of requirements.
10.30 and 10.31--citizen petitions and 330 1 330 24....................................... 7,920
petitions related to ANDAs \2\ certain
NDAs,\3\ or certain BLAs \4\.
10.33--administrative reconsideration of 13 1 13 10....................................... 130
action.
10.35--administrative stay of action......... 28 1 28 10....................................... 280
10.65--meetings and correspondence........... 18 1 18 5........................................ 90
10.85--requests for Advisory opinions........ 3 1 3 16....................................... 48
10.115(f)(3)--submitting draft guidance 1 1 1 4........................................ 4
proposals.
12.22--Filing objections and requests for a 15 1 15 20....................................... 300
hearing on a regulation or order.
12.45--Notice of participation............... 1 1 1 3........................................ 3
External requests for FDA speakers........... 3,900 1 3,900 0.17 (10 minutes)........................ 663
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Total.................................... .............. .............. 4,311 ......................................... 9,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Abbreviated New Drug Applications.
\3\ New Drug Applications.
\4\ Biologics License Applications.

Based on submissions to FDA's Division of Dockets Management since
our last evaluation of the information collection, we have adjusted
burden estimates associated with the individual activities that
correspond to the applicable provisions. As a result, the information
collection reflects an increase of 3,080 annual burden hours.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-06719 Filed 4-6-26; 8:45 am]
BILLING CODE 4164-01-P

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