Notice2026-02386
Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions-Accelerated Approval of Drugs and Biologics
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Published
February 6, 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 This notice solicits comments on information collection relating to the draft guidance, "Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics."
Full Text
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<title>Federal Register, Volume 91 Issue 25 (Friday, February 6, 2026)</title>
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[Federal Register Volume 91, Number 25 (Friday, February 6, 2026)]
[Notices]
[Pages 5491-5494]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02386]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-2033]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Expedited Programs for Serious Conditions--Accelerated
Approval of Drugs and Biologics
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 relating to the
draft guidance, ``Expedited Program for Serious Conditions--Accelerated
Approval of Drugs and Biologics.''
DATES: Either electronic or written comments on the collection of
information must be submitted by April 7, 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 April 7, 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-2024-D-2033 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Expedited Programs for Serious
Conditions--Accelerated Approval of Drugs and Biologics.'' 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
[[Page 5492]]
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: Anne Taylor, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-5683,
<a href="/cdn-cgi/l/email-protection#29797b686b5b48474a41694f4d480741415a074e465f"><span class="__cf_email__" data-cfemail="9acac8dbd8e8fbf4f9f2dafcfefbb4f2f2e9b4fdf5ec">[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.
Expedited Programs for Serious Conditions--Accelerated Approval of
Drugs and Biologics
OMB Control Number 0910-0765--Revision
This information collection supports the implementation of section
506 of the FD&C Act (21 U.S.C. 356) and agency guidance. In the
Consolidated Appropriations Act, 2023 (CAA), Congress amended section
506(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 356(c)), to provide FDA additional authorities and to impose on
FDA additional obligations regarding the accelerated approval pathway.
In the Federal Register of December 6, 2024 (89 FR 97011), FDA
announced the availability of a draft guidance for industry entitled
``Expedited Program for Serious Conditions--Accelerated Approval of
Drugs and Biologics.'' The guidance is available from our website at
<a href="https://www.fda.gov/media/184120/download">https://www.fda.gov/media/184120/download</a>. The guidance provides
information on FDA's policies and procedures for the accelerated
approval program. FDA issued this guidance to satisfy a mandate under
the CAA. This guidance discusses which products may be candidates for
accelerated approval, the standards for granting accelerated approval,
and the procedures for withdrawing accelerated approval. Statutory
requirements in section 506(c) of the FD&C Act are discussed in the
draft guidance document, including the recently added procedures for
the expedited withdrawal of approval of a product approved under
accelerated approval (guidance Section V).
The expedited procedures for withdrawing accelerated approval
require FDA to provide the sponsor with (1) due notice, (2) an
explanation for the proposed withdrawal, (3) an opportunity to meet
with the Commissioner or a designee of the Commissioner (Commissioner/
designee), (4) an opportunity for written appeal to the Commissioner,
or to a designee who has not participated in the proposed withdrawal of
approval and is not a subordinate of an individual (other than the
Commissioner) who participated in such proposed withdrawal, and (5) the
opportunity for an advisory committee meeting on issues related to the
proposed withdrawal if requested by the sponsor and an advisory
committee has not previously advised FDA on such issues with respect to
the withdrawal of the product prior to the sponsor's request. In
addition, FDA must provide an opportunity for public comment on the
proposal to withdraw approval and publish on FDA's website a summary of
public comments received and FDA's response to such comments. We
anticipate there will be information collection burdens associated with
participating in an advisory committee meeting or submitting a written
appeal.
If FDA is considering whether to propose withdrawing approval of a
drug that has been granted accelerated approval, in general, FDA should
convene an advisory committee to request the committee's advice on
whether one or more of the criteria for withdrawal in section 506(c) of
the FD&C Act has been met and any other issues that may be relevant to
whether approval should be withdrawn. The guidance recommends that a
sponsor submit, if it had not already, any data and evidence and any
objections to withdrawal that the sponsor considers relevant so that
they may be considered at this stage (guidance Section V.C). Sponsors
should follow the submission requirements specified in the meeting
notice for the advisory committee using the appropriate docket number,
or submit via email or postal mail if specified in the Federal Register
notice.
In the event that FDA utilizes the expedited procedures for
withdrawing accelerated approval and the sponsor seeks to submit a
written appeal of the proposed withdrawal of approval, the guidance
recommends that the sponsor should present its objections to the
proposal to withdraw approval and may submit any supporting data,
information, or evidence on which the sponsor relies for its appeal.
With respect to such information, the guidance notes that the sponsor
may seek to incorporate by reference any data, information, or evidence
submitted to the new drug application (NDA) or biologics license
application (BLA) file or presented in briefing materials to an
advisory committee convened to provide advice to the Agency on whether
to withdraw the accelerated approval (guidance Section V.C.3.a). The
appeal and any other response, including supporting materials, should
be submitted to the docket opened for the written notice, with a copy
provided to the Center. Additional instructions, for example, on
submitting redacted materials, will
[[Page 5493]]
come from the Commissioner/designee should the sponsor elect to pursue
its opportunity for an appeal or meeting.
The information that respondents submit to us in preparation for an
Advisory Committee meeting and in a written appeal is needed to allow
us to efficiently administer the expedited withdrawal procedures in
section 506(c)(3) of the FD&C Act and to support our efforts to protect
the health of users of drugs approved under accelerated approval. We
use the information collected in preparation for an Advisory Committee
meeting to facilitate discussion among the advisory committee members.
We use the information collected in a written appeal to evaluate
whether the Center's proposal to withdraw approval should be finalized.
We are requesting approval to revise the statutory authority reference
in approved OMB control number 0910-0765 to include section 3210 of the
CAA and to revise the burden estimates approved in that control number
to include the following burden hours.
Description of Respondents: Respondents to this information
collection are sponsors of drugs and biologics that have been granted
accelerated approval designations.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
Activity Number of responses per annual burden per Total
respondents respondent responses response hours
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Advisory Committee meeting; Draft Guidance, 2 1 2 400 800
section V.B...................................
Appeal to the Commissioner; Draft Guidance, 1 1 1 40 40
section V.C.3.a...............................
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Total...................................... ............ .............. 3 ........... 840
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We base our estimates of the number of respondents and the average
burden per response on our experience with Advisory Committee meetings
and written appeals to the Commissioner. We estimate that, on average
over the next three years, two sponsors will request Advisory
Committees per year, across the entire Agency. As discussed, the
sponsors will submit data and evidence and any objections to withdrawal
that the sponsor considers relevant. Part of the information submitted
will have been developed for the NDA or BLA file. Based on our
experience, we estimate that it will take approximately 400 hours for
the sponsor to prepare the submission for the Advisory Committee.
We estimate that, on average over the next three years, one or
fewer sponsors will submit a written appeal of the proposed withdrawal
of approval, across the entire Agency. As discussed, we expect that
each sponsor will present its objections to the proposal to withdraw
approval and will submit any supporting data, information, or evidence
on which the sponsor relies for its appeal. Part of the information
submitted will have been developed for the NDA or BLA file or presented
in briefing materials to an advisory committee. Based on our
experience, we estimate that it will take approximately 40 hours for
the sponsor to prepare the submission for the written appeal.
The draft guidance ``Expedited Program for Serious Conditions--
Accelerated Approval of Drugs and Biologics'' also refers to previously
approved FDA collections of information. The collections of information
in 21 CFR parts 10, 12-16, and 19 relating to administrative practice
and procedures have been approved under OMB control number 0910-0191.
The collections of information in 21 CFR part 312 relating to clinical
trials associated with accelerated approval pathways have been approved
under OMB control number 0910-0014. The collections of information in
21 CFR part 314 relating to the submission of new drug applications,
including accelerated approval of new drugs for serious or life-
threatening conditions, have been approved under OMB control number
0910-0001. The collections of information in 21 CFR part 601 relating
to the submission of biologics license applications have been approved
under OMB control number 0910-0338.
In addition, section 3210 of the CAA provides statutory authority
to help ensure timely completion of confirmatory trials of accelerated
approval products, including that FDA may require as appropriate, a
confirmatory study or studies to be underway prior to approval or
within a specified time period after the date of approval of the
product. The CAA also requires sponsors to submit postmarketing reports
to FDA on the progress of required confirmatory trials approximately
every 180 days. The draft guidance, ``Accelerated Approval and
Considerations for Determining Whether a Confirmatory Trial is
Underway'' (January 2025) describes FDA's policies for implementing
this statutory authority. As described in the Notice of Availability
for that guidance, published January 7, 2025 (90 FR 1171), FDA will use
the reports to monitor the progress of confirmatory trials and take
action, if necessary.
With regard to information collection relating to postmarketing
study commitments, we reviewed the statutory authority granted by
section 3210 of the CAA as well as our existing statutory authority and
regulations. Section 506B of the FD&C Act (21 U.S.C. 356b), and
implementing regulations in Sec. Sec. 312.20, 314.81 and 601.70 (21
CFR 312.20, 314.81 and 601.70), provide for the submission of
postmarket study reports, requiring sponsors of approved drugs and
biological products to report to FDA on the progress of their
postmarketing study commitments, including reports on required studies,
clinical trials, and agreed upon commitments. We tentatively concluded
that the change in our statutory authority with regard to postmarketing
study commitments adds no further information collection requirements
and imposes no further burden beyond what is already required in our
statutes and regulations and included in the approved ICRs for
reporting the status of postmarketing study commitments (90 FR 1171, at
1173).
Our estimated burden for the revised information collection
reflects an overall increase of 840 hours and a corresponding increase
of three responses, which we attribute to the proposed reporting
provisions in the draft guidance ``Expedited Program for
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Serious Conditions--Accelerated Approval of Drugs and Biologics.''
Brian Fahey,
Associate Commissioner for Legislation.
[FR Doc. 2026-02386 Filed 2-5-26; 8:45 am]
BILLING CODE 4164-01-P
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