[Federal Register Volume 71, Number 141 (Monday, July 24, 2006)]
[Notices]
[Pages 41819-41821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11643]


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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