[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10095-10097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03244]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0575]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by March 22, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0765. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Expedited Programs for Serious Conditions--Drugs and Biologics
OMB Control Number 0910-0765--Extension
This information collection supports Agency regulations and
associated guidance pertaining to expedited programs for serious
conditions. The purpose of our regulations in 21 CFR part 312, subpart
E is to establish procedures designed to expedite the development,
evaluation, and marketing of new therapies intended to treat persons
with life-threatening and severely debilitating illnesses, especially
where no satisfactory alternative therapy exists. While the statutory
standards of safety and effectiveness apply to all drugs, the many
kinds of drugs that are subject to them, and the wide range of uses for
those drugs, demand flexibility in applying the standards.
We have developed the guidance for industry entitled ``Expedited
Programs for Serious Conditions--Drugs and Biologics'' as a single
resource for information on FDA's policies and procedures related to
the following
[[Page 10096]]
expedited programs for serious conditions: (1) Fast track designation,
(2) breakthrough therapy designation, (3) accelerated approval, and (4)
priority review designation. The guidance 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
and provides examples of surrogate endpoints and intermediate clinical
endpoints used to support accelerated approval.
A sponsor or applicant who seeks fast track designation is required
to submit to us a request showing that the drug product: (1) Is
intended for a serious or life-threatening condition and (2) has the
potential to address an unmet medical need. We expect that most
information to support a designation request will have been gathered
under existing requirements for preparing an investigational new drug
application (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 fast track 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 need not be voluminous, but it should be sufficient to permit a
reviewer to assess whether the criteria for fast track designation have
been met.
After we make a fast track designation, a sponsor or applicant may
submit a premeeting package that may include additional information
supporting a request to participate in certain fast track 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 fast track designation, we expect that most sponsors or
applicants will have gathered such information to meet existing
requirements for preparing an IND, an NDA, or a 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.
We also developed the guidance document entitled ``Expedited
Programs for Regenerative Medicine Therapies for Serious Conditions.''
The guidance provides sponsors engaged in the development of
regenerative medicine therapies for serious or life-threatening
diseases or conditions with FDA's recommendations on the expedited
development and review of these therapies. The guidance describes the
expedited programs available to sponsors of regenerative medicine
therapies for serious or life-threatening diseases or conditions,
including those products designated as regenerative advanced therapies
(which FDA refers to as ``regenerative medicine advanced therapy''
(RMAT) designation). The guidance also describes considerations in the
clinical development of regenerative medicine therapies and
opportunities for sponsors of regenerative medicine therapies to
interact with the Center of Biologics Evaluation and Research review
staff.
The guidance documents are available on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents and
were issued consistent with our good guidance practice regulations in
21 CFR 10.115, which provide for public comment at any time.
In the Federal Register of November 18, 2020 (85 FR 73487), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
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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Priority Review Designation 70 1.44 101 30 3,030
Requests.......................
Breakthrough Therapy Designation 119 1.31 156 70 10,920
Requests.......................
Fast Track Designation Requests. 205 1.273 261 60 15,660
RMAT Designation Requests....... 33 1.15 38 60 2,280
Fast Track Premeeting Packages.. 224 1.75 392 100 39,200
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Total....................... .............. .............. 948 .............. 71,090
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have increased our burden estimates by 389
responses and 35,325 hours. As reflected in table 1, we estimate that
70 respondents will submit 101 requests for priority review designation
annually. We assume an average of 30 hours is needed to prepare such a
request.
We estimate that 119 respondents will submit 156 requests for
breakthrough designation annually and assume that an average of 70
hours is needed to prepare such a request.
We estimate 205 respondents will submit 261 requests for fast track
designation requests annually and assume that an average of 60 hours is
needed to prepare such a request.
Of the requests for fast track designation made per year, we
granted approximately 224 requests from 392 respondents, and for each
of these granted requests, a premeeting package was submitted. We
therefore assume an average burden of 100 hours per respondent for
preparing a premeeting package.
Finally, we estimate 33 respondents will submit 38 requests for
RMAT designation and assume that an average of 60 hours is needed to
prepare such a request.
[[Page 10097]]
Dated: February 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03244 Filed 2-17-21; 8:45 am]
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