[Federal Register Volume 75, Number 133 (Tuesday, July 13, 2010)]
[Notices]
[Pages 39949-39950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16972]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0337]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection in 
the guidance for industry on special protocol assessment.

DATES:  Submit either electronic or written comments on the collection 
of information by September 13, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 extension 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.

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 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 of 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 facsimile 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 facsimile to the appropriate 
division in CDER or CBER to enable agency staff to prepare for the 
arrival of the protocol for

[[Page 39950]]

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 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 requests for special protocol 
assessment.
Notifications for a Carcinogenicity Protocol
    Based on data collected within CDER and CBER, including the number 
of notifications for carcinogenicity protocols and the number of 
carcinogenicity protocols submitted in fiscal year (FY) 2007, 2008, and 
2009, CDER estimates that it will receive approximately 60 
notifications of an intent to request special protocol assessment of a 
carcinogenicity protocol per year from approximately 28 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 data collected within CDER and CBER, including the number 
of requests for special protocol assessment submitted in FY 2007, 2008, 
and 2009, CDER estimates that it will receive approximately 372 
requests for special protocol assessment per year from approximately 
216 sponsors. CBER estimates that it will receive approximately 10 
requests from approximately 10 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                          No. of        Annual Frequency per     Total Annual          Hours per
                                                        Respondents            Response            Responses           Response           Total Hours
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Notification for Carcinogenicity Protocols                          29                  2.10                  61                   8                 488
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Requests for Special Protocol Assessment                           226                  1.69                 382                  15               5,730
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Total                                                                                                                                              6,218
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: July 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16972 Filed 7-12-10; 8:45 am]
BILLING CODE 4160-01-S