[Federal Register Volume 69, Number 131 (Friday, July 9, 2004)]
[Notices]
[Pages 41502-41504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15659]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0103]


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 August 
9, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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: 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

    In the Federal Register of March 22, 2004 (69 FR 13304), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    The ``Guidance for Industry on Special Protocol Assessment'' (69 FR 
13304) 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

[[Page 41503]]

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 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 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 (Sec.  
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 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: (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 (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. 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 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:

[[Page 41504]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                    No. of Responses        Total Annual
                                             No. of Respondents      per Respondent           Responses        Hours per Response        Total Hours
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Notification for carcinogenicity protocols          21                     1.78                 41                     8                   328
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Requests for special protocol assessment           114                     2.57                293                    15                 4,395
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Total                                       ....................  ....................  ....................  ....................       4,723
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.


    Dated: July 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15659 Filed 7-8-04; 8:45 am]
BILLING CODE 4160-01-S