[Federal Register Volume 68, Number 193 (Monday, October 6, 2003)]
[Notices]
[Pages 57696-57697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25305]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0229]


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 of 1992

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Continuous Marketing 
Applications: Pilot 2--Scientific Feedback and Interactions During 
Development of Fast Track Products Under PDUFA.'' This is one in a 
series of guidance documents that FDA agreed to draft and implement in 
conjunction with the June 2002 reauthorization of the Prescription Drug 
User Fee Act of 1992 (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 development for certain Fast Track drug and biological 
products. Applicants are being asked to apply to participate in the 
Pilot 2 program.

DATES: Submit written or electronic comments on agency guidances at any 
time. FDA will begin accepting applications for participation in Pilot 
2 on October 6, 2003.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information (HFD-240), Center for Drug Evaluation 
and Research (CDER), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857; or to the Office of Communications, Training, and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research (CBER), 1401 Rockville Pike, Rockville, MD 20852-1448. Send 
one self addressed adhesive label to assist either office in processing 
your requests. Submit written comments on the guidance to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

[[Page 57697]]

    John Jenkins, CDER (HFD-020), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-3937, or
     Robert A. Yetter, CBER (HFM-25), Food and Drug Administration, 
8800 Rockville Pike, Bethesda, MD 20892, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Description of the Guidance

    FDA is announcing the availability of a guidance for industry 
entitled ``Continuous Marketing Applications: Pilot 2--Scientific 
Feedback and Interactions During Development of Fast Track Products 
Under PDUFA.'' In conjunction with the June 2002 reauthorization of 
PDUFA, FDA agreed to meet specific performance goals (PDUFA Goals). The 
PDUFA Goals include two pilot programs to explore the continuous 
marketing application (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.
    In the Federal Register of June 17, 2003 (68 FR 35901), FDA 
announced the availability of a draft version of this guidance. FDA 
received a number of comments when it issued the draft version of this 
guidance. We have considered the comments on the draft guidance 
carefully and have made some changes to address those comments. Among 
other things, we have revised the guidance to clarify the eligibility 
requirements and selection process for Pilot 2 and provide for public 
availability of additional information during the program.
    Under the CMA Pilot 2 program, 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 be considered for participation in 
Pilot 2. Pilot 2 is an exploratory program and FDA will evaluate its 
impact on the investigational phase of drug development. Under the 
pilot program, a maximum of one Fast Track product per review division 
in CDER and CBER will be selected to participate. This guidance 
provides information regarding the selection of applications for Pilot 
2, the formation of agreements between FDA and applicants on the 
investigational new drug application communication process, and other 
procedural aspects of Pilot 2. See DATES for when FDA will begin 
accepting applications for participation in Pilot 2.
    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). 
The collection(s) of information in this guidance was approved under 
OMB control number 0910-0518, and will expire on March, 31, 2004. In 
the notice announcing the availability of the draft version of this 
guidance (68 FR 35901), FDA published a notice of the proposed 
collection of information related to the draft guidance. The Federal 
Register notice also requested comments on the burden estimated for the 
guidance. In the Federal Register of September 9, 2003 (68 FR 53174), 
the agency announced that it was submitting the collection of 
information to OMB for review and clearance under the PRA. An agency 
may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number. The time required to complete this information 
collection is estimated to average 80 hours per response, including the 
time to review instructions, search existing data resources, gather the 
data needed, and complete and review the information collection.
    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking on this topic. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance at any 
time. Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance and received comments are available for public examination in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet can obtain the guidance at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm.

    Dated: September 29, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25305 Filed 10-1-03; 4:09 pm]
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