
[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Notices]
[Pages 7676-7677]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02754]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1394]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Special Protocol Assessment

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 
12, 2014.

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 0910-0470. 
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 Special Protocol Assessment--(OMB Control 
Number 0910-0470)--Extension

    The ``Guidance for Industry on Special Protocol Assessment'' 
describes Agency procedures to evaluate issues related to the adequacy 
(e.g., design, conduct, analysis) of certain proposed studies. The 
guidance describes procedures for sponsors to request special protocol 
assessment and for the Agency to act on such requests. The guidance 
provides information on how the Agency interprets and applies 
provisions of the Food and Drug Administration Modernization Act of 
1997 and the specific Prescription Drug User Fee Act of 1992 (PDUFA) 
goals for special protocol assessment associated with the development 
and review of PDUFA products. The guidance describes the following two 
collections of information: (1) The submission of a notice of intent to 
request special protocol assessment of a carcinogenicity protocol, and 
(2) the submission of a request for special protocol assessment.

Notification for a Carcinogenicity Protocol

    As described in the guidance, a sponsor interested in Agency 
assessment of a carcinogenicity protocol should notify the appropriate 
division in FDA's Center for Drug Evaluation and Research (CDER) or the 
Center for Biologics Evaluation and Research (CBER) of an intent to 
request special protocol assessment at least 30 days prior to 
submitting the request. With such notification, the sponsor should 
submit relevant background information so that the Agency may review 
reference material related to carcinogenicity protocol design prior to 
receiving the carcinogenicity protocol.

Request for Special Protocol Assessment

    The guidance asks that a request for special protocol assessment be 
submitted as an amendment to the investigational new drug application 
(IND) for the underlying product and that it be submitted to the Agency 
in triplicate with Form FDA 1571 attached. The guidance also suggests 
that the sponsor submit the cover letter to a request for special 
protocol assessment via fax to the appropriate division in CDER or 
CBER. Agency regulations (21 CFR 312.23(d)) state that information 
provided to the Agency as part of an IND is to be submitted in 
triplicate and with the appropriate cover form, Form FDA 1571. An IND 
is submitted to FDA under existing regulations in part 312 (21 CFR part 
312), which specifies the information that manufacturers must submit so 
that FDA may properly evaluate the safety and effectiveness of 
investigational drugs and biological products. The information 
collection requirements resulting from the preparation and submission 
of an IND under part 312 have been estimated by FDA and the reporting 
and recordkeeping burden has been approved by OMB under OMB control 
number 0910-0014.
    FDA suggests that the cover letter to the request for special 
protocol assessment be submitted via fax to the appropriate division in 
CDER or CBER to enable Agency staff to prepare for the arrival of the 
protocol for assessment. The Agency recommends that a request for 
special protocol assessment be submitted as an amendment to an IND for 
two reasons: (1) To ensure that each request is kept in the 
administrative file with the entire IND and (2) to ensure that 
pertinent information about the request is entered into the appropriate 
tracking databases. Use of the information in the Agency's tracking 
databases enables the appropriate Agency official to monitor progress 
on the evaluation of the protocol and to ensure that appropriate steps 
will be taken in a timely manner.
    The guidance recommends that the following information should be 
submitted to the appropriate Center with each request for special 
protocol assessment so that the Center may quickly and efficiently 
respond to the request:
     Questions to the Agency concerning specific issues 
regarding the protocol; and
     All data, assumptions, and information needed to permit an 
adequate evaluation of the protocol, including: (1) The role of the 
study in the overall development of the drug; (2) information 
supporting the proposed trial, including power calculations, the choice 
of study endpoints, and other critical design features; (3) regulatory 
outcomes that could be supported by the results of the study; (4) final 
labeling that could be supported by the results of the study; and (5) 
for a stability protocol, product characterization and relevant 
manufacturing data.
    Description of Respondents: A sponsor, applicant, or manufacturer 
of a drug or biologic product regulated by the Agency under the Federal 
Food, Drug, and Cosmetic Act or section 351 of the Public Health 
Service Act (42 U.S.C. 262) who requests special protocol assessment.
    Burden Estimate: Table 1 of this document provides an estimate of 
the annual reporting burden for notifications for a carcinogenicity 
protocol and requests for a special protocol assessment.
    Notification for a Carcinogenicity Protocol. Based on the number of 
notifications for carcinogenicity protocols and the number of 
carcinogenicity protocols currently submitted to CDER and CBER, CDER

[[Page 7677]]

estimates that it will receive approximately 50 notifications of an 
intent to request special protocol assessment of a carcinogenicity 
protocol per year from approximately 23 sponsors. CBER estimates that 
it will receive approximately one notification of an intent to request 
special protocol assessment of a carcinogenicity protocol per year from 
approximately one sponsor. The hours per response, which is the 
estimated number of hours that a sponsor would spend preparing the 
notification and background information to be submitted in accordance 
with the guidance, is estimated to be approximately 8 hours.
    Requests for Special Protocol Assessment. Based on the number of 
requests for special protocol assessment currently submitted to CDER 
and CBER, CDER estimates that it will receive approximately 300 
requests for special protocol assessment per year from approximately 
145 sponsors. CBER estimates that it will receive approximately 14 
requests from approximately 11 sponsors. The hours per response is the 
estimated number of hours that a respondent would spend preparing the 
information to be submitted with a request for special protocol 
assessment, including the time it takes to gather and copy questions to 
be posed to the Agency regarding the protocol and data, assumptions, 
and information needed to permit an adequate evaluation of the 
protocol. Based on the Agency's experience with these submissions, FDA 
estimates approximately 15 hours on average would be needed per 
response.
    In the Federal Register of November 18, 2013 (78 FR 69093), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Notification for carcinogenicity              24             2.1              51               8             408
 protocols......................
Requests for special protocol                156               2             314              15           4,710
 assessment.....................
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    Total.......................  ..............  ..............  ..............  ..............           5,118
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: February 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02754 Filed 2-7-14; 8:45 am]
BILLING CODE 4160-01-P


