[Federal Register Volume 66, Number 103 (Tuesday, May 29, 2001)]
[Notices]
[Pages 29147-29148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13304]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-0084]
Agency Information Collection Activities; Submission for OMB
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 the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (PRA).
DATES: Submit written comments on the collection of information by June
28, 2001.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Wendy Taylor, Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION:
I. Background
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
FDA is issuing a guidance on agency procedures to evaluate issues
related to the adequacy 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
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.
II. 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
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. The agency is currently
drafting a separate guidance describing the type of information that
would be appropriate to submit before requesting carcinogenicity
protocol assessment.
III. 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 September 30, 2002, under the OMB control number
0910-0014. In the Federal Register of May 6, 1999 (64 FR 24402), FDA
published a notice requesting comments on the burden estimates for the
information collection requirements in part 312. The notice also
requested an extension of OMB approval for this information collection.
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 stability protocol, product characterization and relevant
manufacturing data.
A. 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 who requests
special protocol assessment.
[[Page 29148]]
B. 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 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, as follows:
1. Notification for a Carcinogenicity Protocol
Based on data collected from the review divisions and offices
within CDER and CBER, including the number of carcinogenicity protocols
submitted for review in the first half of fiscal year (FY) 1999 and the
number of INDs for new molecular entities that were received by the
agency per year over the last 5 years, CDER and CBER anticipate that
approximately 30 respondents will notify the agency of an intent to
request special protocol assessment of a carcinogenicity protocol. The
agency further estimates that the total annual responses, i.e., the
total number of notifications that will be sent to CDER and CBER, will
be 60, based on data collected from the offices within CDER and CBER.
Therefore, the agency estimates that there will be approximately two
responses per respondent. The hours per response, which is the
estimated number of hours that a respondent would spend preparing the
notification and background information to be submitted in accordance
with the guidance, is estimated to be approximately 8 hours. While FDA
has not finalized the separate guidance describing background
information that should be submitted with notification of a
carcinogenicity protocol for assessment, the agency anticipates that it
will take respondents approximately 8 hours to gather and copy articles
and study reports that are relevant to the carcinogenicity protocol.
Therefore, the agency estimates that respondents will spend 480 hours
per year notifying the agency of an intent to request special protocol
assessment of a carcinogenicity protocol.
2. 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 in the first half of FY 1999, the number of INDs
for new molecular entities that were received by the agency per year
over the past 5 years, the number of sponsors who have submitted
protocols for agency review in the past and in the first half of FY
1999, and the number of end-of-phase 2/prephase 3 meetings that occur
between respondents and the agency per year, FDA anticipates that 70
respondents will request special protocol assessment per year. The
total annual responses are the total number of requests for special
protocol assessment that are submitted to CDER and CBER in 1 year.
Based on data collected from the review divisions and offices within
CDER and CBER, FDA estimates that it will receive approximately 180
requests for special protocol assessment per year. Therefore, the
agency estimates that there will be approximately 2.57 responses per
respondent. 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 estimates provided by the
regulated industry and on the agency's experience in requesting similar
information, FDA estimates approximately 15 hours on average would be
needed per response.
Therefore, FDA estimates that 2,700 hours will be spent per year by
respondents requesting special protocol assessment. Overall, FDA
anticipates that respondents will spend 3,180 hours per year to
participate in the programs described in the guidance.
In the Federal Register of February 9, 2000 (65 FR 6377), the
agency requested comments on the proposed collections of information.
Eight comments were received, however they were related to the Protocol
Assessment and not to the collection of information.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Number of
Notification and Number of Responses per Total Annual Hours per Total Hours
Requests Respondents Respondent Responses Response
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Notification for 30 2.0 60 8 480
Carcinogencity
Protocols
Requests for Special 70 2.57 180 15 2,700
Protocol Assessment
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Total 3,180
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-13304 Filed 5-25-01; 8:45 am]
BILLING CODE 4160-01-S