[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Pages 73487-73490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0575]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Expedited Programs for Serious Conditions--Drugs and 
Biologics

AGENCY: Food and Drug Administration, HHS.

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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 revision 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 January 19, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 19, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 19, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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-2013-D-0575 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Guidance for Industry on 
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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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: 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, 
PRAStaff@fda.hhs.gov.

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 revision 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.

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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 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 
(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 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.
    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

[[Page 73490]]

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.

    Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25414 Filed 11-17-20; 8:45 am]
BILLING CODE 4164-01-P


