[Federal Register Volume 69, Number 55 (Monday, March 22, 2004)]
[Notices]
[Pages 13304-13306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0103]


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 written or electronic comments on the collection of 
information by May 21, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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: Karen L. Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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 
1320.39(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 will interpret and apply 
provisions of the Food and Drug Administration Modernization Act of 
1987 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.

A. 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

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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.

B. Request for Special Protocol Assessment

    In the guidance, CDER and CBER ask 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 
agency 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 until January 31, 2006, 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 assessment. The agency recommends that a 
request for special protocol assessment be submitted as an amendment to 
an IND for the following 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.
    CDER and CBER have determined and 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 the following: 
(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 PHS Act 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. The procedures for requesting special protocol assessment 
that are set forth in the guidance document have not been previously 
described by the agency, although the PDUFA goals and the requirements 
of section 505(b)(4)(B) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)(4)(B)), have been in effect since October and November 
1998, respectively.
    Notification for a Carcinogenicity Protocol. Based on data 
collected from the review divisions and offices within CDER and CBER, 
including the number of notifications for carcinogenicity protocols and 
the number of carcinogenicity protocols submitted in fiscal year (FY) 
2003, CDER estimates that it will receive approximately 40 
notifications of an intent to request special protocol assessment of a 
carcinogenicity protocol per year from approximately 20 sponsors. CBER 
anticipates one notification. 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 
from the review divisions and offices within CDER and CBER, including 
the number of requests for special protocol assessment submitted in FY 
2003, CDER estimates that it will receive approximately 273 requests 
for special protocol assessment per year from approximately 102 
sponsors. CBER estimates that it will receive approximately 20 requests 
from approximately 12 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. 
Overall, FDA estimates that respondents will spend 4,523 hours per year 
to participate in the programs described in the guidance document.
    FDA estimates the burden of this collection as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                               Number of Responses   Total Annual     Hours per
                         No. of Respondents      per Respondent        Responses      Response      Total Hours
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Notification for                21                     1.78              41              8            328
 Carcinogenicity
 Protocols
Requests for Special           114                     2.57             293             15          4,395
 Protocol Assessment
Total                   ....................  ....................  ..............  ............    4,723
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 13306]]

    Dated: March 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-6252 Filed 3-19-04; 8:45 am]
BILLING CODE 4160-01-S