[Federal Register: July 9, 2004 (Volume 69, Number 131)]
[Notices]
[Page 41502-41504]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy04-94]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Responses Total Annual
No. of Respondents per Respondent Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification for carcinogenicity protocols 21 1.78 41 8 328
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for special protocol assessment 114 2.57 293 15 4,395
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total .................... .................... .................... .................... 4,723
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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