Notice2024-00217
Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions-Drugs and Biologics
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Published
January 9, 2024
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 pertaining to "Expedited Programs for Serious Conditions--Drugs and Biologics."
Full Text
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<title>Federal Register, Volume 89 Issue 6 (Tuesday, January 9, 2024)</title>
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[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1101-1103]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00217]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4804]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Expedited Programs for Serious Conditions--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 pertaining to
``Expedited Programs for Serious Conditions--Drugs and Biologics.''
DATES: Submit either electronic or written comments on the collection
of information by March 11, 2024.
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 March 11, 2024. 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-2023-N-4804 for ``Expedited Programs for Serious Conditions--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 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
[[Page 1102]]
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#1f4f4d5e4c6b7e79795f797b7e3177776c31787069"><span class="__cf_email__" data-cfemail="035351425077626565436567622d6b6b702d646c75">[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--Drugs and Biologics
OMB Control Number 0910-0765--Extension
This information collection supports regulations governing FDA
expedited programs for serious conditions. These provisions are set
forth in 21 CFR part 312, subpart E and are intended to speed the
availability of new therapies to patients with serious conditions,
especially when there are no satisfactory alternative therapies, while
preserving appropriate standards for safety and effectiveness. The
regulations call for earlier attention to drugs that have promise in
treating such conditions, including early consultation with FDA for
sponsors of such products. Respondents to the information collection
are sponsors of drug or biologic product applications submitted to FDA.
To assist respondents with the information collection, we developed
Agency guidance entitled ``Guidance for Industry Expedited Programs for
Serious Conditions--Drugs and Biologics'' (May 2014). The guidance is a
resource for information on FDA's policies and procedures related to
the following expedited programs for serious conditions: (1) fast track
designation, (2) breakthrough therapy designation, (3) accelerated
approval, and (4) priority review designation, and describes threshold
criteria generally applicable to expedited programs, including what is
meant by serious condition, unmet medical need, and available therapy.
The guidance addresses the applicability of expedited programs to rare
diseases, clarification on available therapy, and additional detail on
possible flexibility in manufacturing and product quality. It also
clarifies the qualifying criteria for breakthrough therapy designation,
provides examples of surrogate endpoints and intermediate clinical
endpoints used to support accelerated approval, and priority review.
In addition, we developed Agency guidance entitled ``Expedited
Programs for Regenerative Medicine Therapies for Serious Conditions,''
(February 2019) describing the criteria for participation in the
Regenerative Medicine Advanced Therapy (RMAT) program. The RMAT
expedited program was approved as part of the 21st Century CURES Act,
signed December 13, 2016. An RMAT product is intended to treat, modify,
reverse, or cure serious or life-threatening diseases or conditions,
and preliminary clinical evidence indicate that the drug has the
potential to address unmet medical needs for such diseases or
conditions. This is a Center Biologics Evaluation and Research (CBER)
program and is included as an expedited program available for serious
conditions.
For a sponsor or applicant who seeks fast track, priority,
breakthrough, RMAT or accelerated approval designation review, approval
is required to submit a request showing that the drug product: (1) is
intended for a serious or life-threatening condition and (2) has the
potential to (a) address an unmet medical need, (b) demonstrate
substantial improvement over available therapy, or (c) fill an unmet
need to be approved based on a surrogate endpoint. We expect that most
information to support a designation request will have been gathered
under existing requirements for preparing an investigational new drug
(IND), new drug application (NDA), or biologics license application
(BLA). If such information has already been submitted to us, the
information may be summarized in the designation request. A designation
request should include, where applicable, additional information not
specified elsewhere by statute or regulation. For example, additional
information may be needed to show that a product has the potential to
address an unmet medical need where an approved therapy exists for the
serious or life-threatening condition to be treated. Such information
may include clinical data, published reports, summaries of data and
reports, and a list of references. The amount of information and
discussion in a designation request should be sufficient to permit a
reviewer to assess whether the criteria for fast track, priority,
breakthrough, RMAT or accelerated approval designation have been met.
After we make an expedited programs designation, a sponsor or
applicant may submit a premeeting package that may include additional
information supporting a request to participate in certain expedited
programs. The premeeting package serves as background information for
the meeting and should support the intended objectives of the meeting.
As with the request for expedited programs designation, we expect that
most sponsors or applicants will have gathered such information to meet
existing requirements for preparing an IND, NDA, or BLA. These may
include descriptions of clinical safety and efficacy trials not
conducted under an IND (e.g., foreign studies) and information to
support a request for accelerated approval. If such information has
already been submitted to us, the information may be summarized in the
premeeting package.
The guidance documents are available on our website at <a href="http://www.fda.gov/regulatory-information/search-fda-guidance-documents">www.fda.gov/regulatory-information/search-fda-guidance-documents</a> and were issued
consistent with our good guidance practice regulations in 21 CFR
10.115, which provide for public comment at any time.
We estimate the burden of this collection of information as
follows:
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Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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CDER
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Priority Review Designation 81 1.53 124 30 3,720
Requests (Expedited Programs
for Serious Conditions Guidance
(EPSC) Section VIII)...........
Breakthrough Therapy Designation 71 1.08 77 70 5,390
Requests (EPSC Section VI).....
Fast Track Designation Requests 235 1.18 277 60 16,620
(EPSC Section V)...............
Accelerated Approval Designation 26 1.27 33 100 3,300
(EPSC Section VII).............
Premeeting Packages (21 CFR 163 1.01 165 100 16,500
312.82)........................
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CDER Subtotal............... .............. .............. 676 .............. 45,530
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CBER
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Priority Review Designation 8 1 8 30 240
Request (EPSC Section VIII)....
Breakthrough Therapy Designation 15 1.1 17 70 1,190
Request (EPSC Section VI)......
Fast Track Designation Requests 64 1.2 77 60 4,620
(EPSC Section VII).............
RMAT Designation Requests 33 1.1 36 60 2,160
(Regenerative Medicine
Therapies for Serious
Conditions Guidance (RMAT)
Section III)...................
Guidance p 6)...................
Premeeting Packages (RMAT 146 1.9 277 100 27,700
Section V).....................
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CBER Subtotal............... .............. .............. 415 .............. 35,910
Total................... .............. .............. 1,091 .............. 81,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on FY 2022 receipts, we estimate that for Center for Drug
Evaluation and Research (CDER) products, 81 respondents will submit 124
requests for priority review designation annually, and we assume 30
hours are needed to prepare such a request. We estimate 71 respondents
will submit 77 requests for breakthrough designation annually, and we
assume 70 hours are needed to prepare such a request. We estimate that
235 respondents will submit 277 requests for fast-track designation
requests annually, and we assume 60 hours are required to prepare such
a request. We estimate 26 respondents will submit 33 accelerated
approval designation requests annually and we assume 100 hours are
required to prepare such a request. Finally, CDER received 165 pre-
meeting package submissions from 163 respondents. We assume 100 hours
are needed to prepare a pre-meeting package.
Similarly, also based on FY 2022 receipts, we estimate that for
CBER products, 8 applicants will submit 8 requests for priority review
designation annually, and we assume 30 hours are required to prepare
such a request. We estimate 15 respondents will submit 17 requests for
breakthrough designation annually, and we assume 70 hours are needed to
prepare such a request. We estimate that 64 respondents will submit 78
requests for fast-track designation annually, and we assume 60 hours is
required to prepare such a request. We also estimate 33 respondents
will submit 35 requests for RMAT designation annually and assume that
60 hours are needed to prepare each RMAT designation request. Finally,
CBER received 283 pre-meeting package submissions from 146 respondents.
We assume 100 hours are needed to prepare a pre-meeting package.
Based on a review of the information collection since our last
request for OMB approval, we have increased our burden estimate by 143
responses and 10,350 hours to reflect actual submissions we have
received. We attribute these changes to increased interest in the
expedited programs, new expedited programs, and an increase in the
number of submissions we received over the last few years.
Dated: January 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00217 Filed 1-8-24; 8:45 am]
BILLING CODE 4164-01-P
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