[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5428-5429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02415]


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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; Guidance for Industry 
on 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: Fax written comments on the collection of information by March 
9, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0389. 
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.

Guidance for Industry: ``Expedited Programs for Serious Conditions--
Drugs and Biologics''

OMB Control Numbers 0910-0389 and 0910-0765--Revision

    This information collection supports the previous captioned Agency 
guidance. The guidance provides 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. The guidance 
also clarifies the qualifying criteria for breakthrough therapy 
designation and provides examples of surrogate endpoints and 
intermediate clinical endpoints used to support accelerated approval.

[[Page 5429]]

    In the Federal Register of November 8, 2017 (82 FR 51846), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received. 
We therefore estimate the burden of the information collection as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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Guidance for industry: Expedited                     Number of                        Average
       programs for serious          Number of    responses  per   Total  annual    burden per      Total hours
conditions-- Drugs and biologics    respondents      respondent      responses       response
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Priority review designation                   48             1.7              82              30           2,400
 request (0765).................
Breakthrough therapy designation              87            1.29             113              70           7,910
 request (0765).................
Fast track designation request               140            1.33             187              60          11,220
 (0389).........................
Fast track premeeting packages               107            1.23             132             100          13,200
 (0389).........................
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    Total.......................  ..............  ..............  ..............  ..............          34,730
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The information collection elements regarding priority review 
designation and breakthrough therapy designation requests are reflected 
in rows 1 and 2 of table 1 and are currently approved under OMB control 
number 0910-0765. Meanwhile, fast track designation requests and 
premeeting packages are currently approved under OMB Control No. 0910-
0389. We are therefore revising OMB control number 0910-0389 to include 
all four collection elements. Information collection burden for 
accelerated approval requests is currently approved under OMB control 
numbers 0910-0001 (drugs) and 0910-0338 (biologics). The estimates 
provided are based on our experience with the respective collection 
elements over the past 3 years.
    A sponsor or applicant who seeks fast track designation is required 
to submit a request to the Agency 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. The Agency expects 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 
the Agency, 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 the Agency makes 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, the Agency expects 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 FDA, the information may be summarized in the 
premeeting package.
    The Agency estimates the total annual number of respondents 
submitting requests for fast track designation is approximately 140, 
and the number of requests received is approximately 187 annually. FDA 
estimates that the number of hours needed to prepare a request for fast 
track designation is approximately 60 hours per request (row 3 in table 
1).
    Of the requests for fast track designation made per year, the 
Agency granted approximately 132 requests from 107 respondents, and for 
each of these granted requests, a premeeting package was submitted to 
the Agency. FDA estimates that the preparation hours are approximately 
100 hours per premeeting package (row 4 in table 1). The total burden 
hours for fast track designation and fast track meetings has increased 
due to increased requests; however, the hours per request have remained 
the same.

    Dated: February 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02415 Filed 2-6-18; 8:45 am]
 BILLING CODE 4164-01-P