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Notice: 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
Federal Register: Volume 78, Number 216 (Thursday, November 7, 2013)
        Pages 66939-66940
AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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 
December 9, 2013.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--New and 
title ``Guidance for Industry on Expedited Programs for Serious 
Conditions--Drugs and Biologics.'' 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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 on Expedited Programs for Serious Conditions--
Drugs and Biologics--(OMB Control Number 0910-New)

    Description of Respondents: Respondents to this collection of

[[Page 66940]]

information are sponsors that develop drugs and biological products.
    Burden Estimate: This guidance outlines FDA's policies and 
procedures related to the following expedited programs for serious 
conditions: (1) Fast track designation including rolling review, (2) 
breakthrough therapy designation, (3) accelerated approval, and (4) 
priority review designation. In addition, this guidance describes 
threshold criteria generally applicable to these expedited programs.
    This guidance refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
21 CFR parts 202.1, 314, and 601, and sections 505(a), 506(a)(1), 735, 
and 736 of the Federal Food, Drug, and Cosmetic Act (FD&C 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.
    This guidance proposes the following new collections of 
information:
    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 47 sponsors will prepare and submit 
approximately 1 priority review designation submission 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 1,410 hours).
    Breakthrough Therapy Designation Request. The guidance describes 
the process for sponsors to request breakthrough therapy designation in 
an application. Based on information available to FDA, we estimate that 
approximately 24 sponsors will prepare approximately 1 breakthrough 
therapy designation submission in accordance with the guidance and that 
the added burden for each submission will be approximately 70 hours to 
prepare and submit (totaling 1,680 hours).
    Promotional Materials for Accelerated Approval Under Part 314. The 
guidance describes section 506(b)(2)(B) of the FD&C Act and FDA's 
accelerated approval regulations (Sec. Sec.  314.550 and 601.45). These 
provisions authorize FDA to require sponsors to submit copies of all 
promotional materials to the Agency for consideration prior to their 
dissemination. The regulations provide that copies of all promotional 
materials including promotional labeling as well as advertisements 
intended for dissemination or publication within 120 days following 
marketing approval must be submitted to FDA during the preapproval 
period. The regulations further provide that after 120 days following 
marketing approval, unless otherwise informed by the Agency, the 
applicant must submit promotional materials at least 30 days prior to 
the intended time of initial dissemination of the labeling or initial 
publication of the advertisement. Currently, FDA has OMB approval for 
the submission of copies of all promotional materials under part 601 
(OMB control number 0910-0338) but does not have approval for the 
submission of copies of all promotional materials under part 314.
    Based on information from FDA's databases and information available 
to FDA, we estimate that approximately 20 sponsors will submit 
promotional materials for accelerated approval 7 times annually in 
accordance with Sec.  314.550 and that the burden for each submission 
will be approximately 120 hours (a total of 16,800 hours).
    In the Federal Register of June 26, 2013 (78 FR 38349), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received 26 comments. However, these 
comments did not address the information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Guidance on expedited programs      Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Priority Review Designation                   47               1              47              30           1,410
 Request........................
Breakthrough Therapy Designation              24               1              24              70           1,680
 Request........................
Promotional Materials for                     20               7             140             120          16,800
 Accelerated Approval Under Sec.
   314.550......................
���������������������������������
    Total hours.................  ..............  ..............  ..............  ..............          19,890
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: November 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26695 Filed 11-6-13; 8:45 am]
BILLING CODE 4160-01-P


 
 
 

 
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