[Federal Register: March 22, 2004 (Volume 69, Number 55)]
[Notices]
[Page 13304-13306]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr04-69]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
[[Page 13305]]
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