82 FR 13816 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 49 (March 15, 2017)

The Food and Drug Administration (FDA or we) 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.

[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13816-13817]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05104]


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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 or we) 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 April 
14, 2017.

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:

[[Page 13817]]

202-395-7285, or emailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0765. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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 (GFI) on Expedited Programs for Serious 
Conditions--Drugs and Biologics

OMB Control Number 0910-0765--Extension

    The FDA has established four programs intended to facilitate and 
expedite development and review of new drugs to address unmet medical 
needs in the treatment of serious or life-threatening conditions: (1) 
Fast track designation including rolling review, (2) Breakthrough 
therapy designation, (3) Accelerated approval, and (4) Priority review 
designation. In support of these, the Agency has developed the guidance 
document, ``GFI: Expedited Programs for Serious Conditions--Drugs and 
Biologics.'' The guidance outlines the programs' policies and 
procedures and describes applicable threshold criteria, including when 
to submit information to FDA. Respondents to the information collection 
are sponsors of drug and biological products appropriate for these 
expedited programs.
    Priority Review Designation Request. The guidance describes that a 
sponsor may expressly request priority review of an application. Based 
on information from FDA's databases and information available to FDA, 
we estimate that approximately 48 sponsors will prepare and submit 
approximately 1.7 priority review designation submissions that receive 
a priority review in accordance with the guidance and that the added 
burden for each submission will be approximately 30 hours to develop 
and submit to FDA as part of the application (totaling 2,400 hours).
    Breakthrough Therapy Designation Request. The guidance describes 
the process for sponsors to request breakthrough therapy designation in 
an application. Based on information from FDA's databases and 
information available to FDA, we estimate that approximately 87 
sponsors will prepare approximately 1.29 breakthrough therapy 
designation submissions in accordance with the guidance and that the 
added burden for each submission will be approximately 70 hours to 
prepare and submit (totaling 7,910 hours).
    In the Federal Register of November 29, 2016 (81 FR 85973), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received 
in response to the notice.
    FDA estimates the burden of this collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
 Guidance on expedited programs      Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Priority Review Designation                   48             1.7              80              30           2,400
 Request........................
Breakthrough Therapy Designation              87            1.29             113              70           7,910
 Request........................
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    Total.......................  ..............  ..............  ..............  ..............          10,310
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\1\ There are no capital costs or operating and maintenance costs associated with the information collection.

    The guidance also refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
21 CFR parts 202.1, 314, and 601; sections 505(a), 506(a)(1), 735, and 
736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a), 
356(a)(1), 379(g), and 379(h)) have been approved under OMB control 
numbers 0910-0686, 0910-0001, 0910-0338, 0910-0014, and 0910-0297.

    Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05104 Filed 3-14-17; 8:45 am]
 BILLING CODE 4164-01-P