[Federal Register Volume 72, Number 97 (Monday, May 21, 2007)]
[Notices]
[Pages 28495-28496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9709]



[[Page 28495]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0278]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.

-----------------------------------------------------------------------

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 June 
20, 2007.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-6974. All comments should be identified with the OMB 
control number 0910-0518. Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Liz Berbakos, Office of the Chief 
Information Officer (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 Continuous Marketing Applications: Pilot--
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 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 one 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 one 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 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

[[Page 28496]]

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.
    In the Federal Register of July 24, 2006 (71 FR 41819), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         No. of  Responses                          Hours per
                  Pilot 2 Application                      Respondents         per Response       Total Responses        Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER                                                                    7                     1                  7                 80                560
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER                                                                    1                     1                  1                 80                 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                640
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: May 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9709 Filed 5-18-07; 8:45 am]
BILLING CODE 4160-01-S