Document ID: FDA-2010-N-0541-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Special Protocol Assessment
Posted Date: 2010-10-26T04:00Z

[Federal Register: October 26, 2010 (Volume 75, Number 206)]
[Notices]               
[Page 65636-65638]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc10-63]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0541]

 
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.

-----------------------------------------------------------------------

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 
November 26, 2010.

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 e-mailed 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: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.berbakos@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

[[Page 65637]]

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 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 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 requests for special protocol 
assessment.
    Notification 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 years (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.
    In the Federal Register of July 13, 2010 (75 FR 39949), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
collection.
    FDA estimates the burden of this collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                         Annual
                                         No. of       frequency per   Total annual      Hours per    Total hours
                                       respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
Notification for Carcinogenicity                 29            2.10              61               8          488
 Protocols.........................

[[Page 65638]]

Requests for Special Protocol                   226            1.69             382              15        5,730
 Assessment........................
                                    ----------------------------------------------------------------------------
    Total..........................  ..............  ..............  ..............  ..............        6,218
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.

    Dated: October 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26985 Filed 10-25-10; 8:45 am]
BILLING CODE 4160-01-P