[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.


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    Dated: February 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03244 Filed 2-17-21; 8:45 am]
BILLING CODE 4164-01-P