[Federal Register: July 24, 2006 (Volume 71, Number 141)]
[Notices]
[Page 41819-41821]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jy06-93]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0278]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Continuous Marketing
Applications: Pilot 2--Scientific Feedback and Interactions During
Development of Fast Track Products Under the Prescription Drug User Fee
Act
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
contained in the guidance for industry on Continuous Marketing
Applications: Pilot 2--Scientific Feedback and Interactions During
Development of Fast Track Products Under the Prescription Drug User Fee
Act.
DATES: Submit written or electronic comments on the collection of
information by September 22, 2006.
ADDRESSES: Submit electronic comments on the collection of information
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: Elizabeth Berbakos, 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
1320.3(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 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 Continuous Marketing Applications: Pilot 2--
Scientific Feedback and Interactions During Development of Fast Track
Products Under the Prescription Drug User Fee Act--(OMB Control Number
0910-0518)-- Extension
FDA is requesting OMB approval under the PRA (44 U.S.C. 3507) for
the reporting and recordkeeping requirements contained in the guidance
for industry entitled ``Continuous Marketing Applications (CMA): Pilot
2--Scientific Feedback and Interactions During Development of Fast
Track Products Under PDUFA.'' This guidance discusses how the agency
will implement a pilot program for frequent scientific feedback and
interactions between FDA and applicants during the investigational
phase of the development of certain Fast Track drug and biological
products. Applicants are asked to apply to participate in the Pilot 2
program.
In conjunction with the June 2002 reauthorization of the
Prescription Drug User Fee Act of 1992 (PDUFA), FDA agreed to meet
specific performance goals (PDUFA Goals). The PDUFA Goals include two
pilot programs to explore the CMA concept. The CMA concept builds on
the current practice of interaction between FDA and applicants during
drug development and application review and proposes opportunities for
improvement. Under
[[Page 41820]]
the CMA pilot program, Pilot 2, certain drug and biologic products that
have been designated as Fast Track (i.e., products intended to treat a
serious and/or life-threatening disease for which there is an unmet
medical need) are eligible to participate in the program. Pilot 2 is an
exploratory program that allows FDA to evaluate the impact of frequent
scientific feedback and interactions with applicants during the
investigational new drug application (IND) phase. Under the pilot
program, a maximum of 1 Fast Track product per review division in FDA's
Center for Drug Evaluation and Research (CDER) and Center for Biologics
Evaluation and Research (CBER) is selected to participate. This
guidance provides information regarding the selection of participant
applications for Pilot 2, the formation of agreements between FDA and
applicants on the IND communication process, and other procedural
aspects of Pilot 2. FDA began accepting applications for participation
in Pilot 2 on October 1, 2003.
The guidance describes 1 collection of information: Applicants who
would like to participate in Pilot 2 must submit an application (Pilot
2 application) containing certain information outlined in the guidance.
The purpose of the Pilot 2 application is for the applicants to
describe how their designated Fast Track product would benefit from
enhanced communications between FDA and the applicant during the
product development process.
FDA's regulation at Sec. 312.23 (21 CFR 312.23) states that
information provided to the agency as part of an IND must be submitted
in triplicate and with an appropriate cover form. Form FDA 1571 must
accompany submissions under INDs. 21 CFR part 312 and FDA Form 1571
have a valid OMB control number: OMB control number 0910-0014, which
expires May 31, 2009.
In the guidance document, CDER and CBER ask that a Pilot 2
application be submitted as an amendment to the application for the
underlying product under the requirements of Sec. 312.23; therefore,
Pilot 2 applications should be submitted to the agency in triplicate
with Form FDA 1571. The agency recommends that a Pilot 2 application be
submitted in this manner for two reasons: (1) To ensure that each Pilot
2 application is kept in the administrative file with the entire
underlying application, and (2) to ensure that pertinent information
about the Pilot 2 application is entered into the appropriate tracking
databases. Use of the information in the agency's tracking databases
enables the agency to monitor progress on activities.
Under the guidance, the agency asks applicants to include the
following information in the Pilot 2 application:
Cover letter prominently labeled ``Pilot 2 application;''
IND number;
Date of Fast Track designation;
Date of the end-of-phase 1 meeting, or equivalent meeting,
and summary of the outcome;
A timeline of milestones from the drug or biological
product development program, including projected date of new drug
application (NDA)/biologics license application (BLA) submissions;
Overview of the proposed product development program for a
specified disease and indication(s), providing information about each
of the review disciplines (e.g., chemistry/manufacturing/controls,
pharmacology/toxicology, clinical, clinical pharmacology and
biopharmaceutics);
Rationale for interest in participating in Pilot 2,
specifying the ways in which development of the subject drug or
biological product would be improved by frequent scientific feedback
and interactions with FDA and the potential for such communication to
benefit public health by improving the efficiency of the product
development program; and
Draft agreement for proposed feedback and interactions
with FDA.
This information is used by the agency to determine which Fast
Track products are eligible for participation in Pilot 2. Participation
in this pilot program is voluntary.
Based on the number of Pilot 2 applications submitted to CDER and
CBER during fiscal year 2004 and 2005, we estimate that the number of
applications received annually for Pilot 2 is 7 for products regulated
by CDER and 1 for products regulated by CBER. FDA anticipates that
approximately 7 applicants (respondents) will submit these Pilot 2
applications annually to CDER and approximately 1 applicant
(respondent) will submit these Pilot 2 applications annually to CBER.
The hours per response, which is the estimated number of hours that a
respondent would spend preparing the information to be submitted in a
Pilot 2 application in accordance with the guidance, is estimated to be
approximately 80 hours. Based on FDA's experience, we expect it will
take respondents this amount of time to obtain and draft the
information to be submitted with a Pilot 2 application. Therefore, the
agency estimates that applicants use approximately 640 hours annually
to submit the Pilot 2 applications.
Table 1.--Estimated Annual Reporting Burden\1\
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No. of No. of Responses Hours per
Pilot 2 Application Respondents per Response Total Responses Response Total Hours
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CDER 7 1 7 80 560
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CBER 1 1 1 80 80
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Total 640
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 41821]]
Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11643 Filed 7-21-06; 8:45 am]
BILLING CODE 4160-01-S