[Federal Register Volume 68, Number 116 (Tuesday, June 17, 2003)]
[Notices]
[Page 35903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15167]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0228]


Draft Guidance for Industry on Continuous Marketing Applications: 
Pilot 1--Reviewable Units for 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 the 
availability of a draft guidance for industry entitled ``Continuous 
Marketing Applications: Pilot 1--Reviewable Units for 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). Pilot 1 will enable certain applicants to receive early 
feedback on portions of their applications. Pilot 1 will also evaluate 
the benefits and costs of providing applicants early feedback.

DATES: Submit written or electronic comments on the draft guidance by 
August 1, 2003. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 request. Submit written comments on the draft 
guidance to the Division of Dockets Management (HFA-305), Food and Drug 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 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: John Jenkins, Center for Drug 
Evaluation and Research (HFD-020), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-3937, or
    Robert A. Yetter, Center for Biologics Evaluation and Research 
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Description of the Guidance

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Continuous Marketing Applications: Pilot 1--Reviewable Units 
for 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.
    Under this CMA pilot program, Pilot 1, applicants submitting new 
drug applications (NDAs) or biological licensing applications (BLAs) 
for products that have been designated as Fast Track drug or biological 
products (i.e., products intended to treat a serious and/or life-
threatening disease for which there is an unmet medical need) may be 
eligible to submit portions of their marketing applications (reviewable 
units) in advance of the complete marketing application. FDA has agreed 
to complete reviews of reviewable units within a specified time and to 
provide early feedback for the presubmissions in the form of discipline 
review letters.
    This draft guidance provides information on how the agency will 
implement Pilot 1. The draft guidance describes Pilot 1 as an 
exploratory program that will allow FDA to evaluate the added value, 
costs, and impact of early review and feedback on parts of applications 
(reviewable units) in advance of submission of the complete 
application.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the 
implementation of the Pilot 1 program for reviewable units of certain 
Fast Track drug and biological products. 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 draft guidance. 
Submit a single copy of electronic comments or two copies of mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. The draft 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. The Paperwork Reduction Act of 1995

    This notice contains no new collections of information. The 
information requested for a reviewable unit (a predefined portion of an 
NDA or BLA that may be submitted prior to submission of a complete NDA/
BLA) is already covered by the collection of information for NDAs and 
BLAs (21 CFR 314.50 and 601.2). This notice merely provides applicants 
an opportunity to submit already required information in advance of the 
complete NDA or BLA.
    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520), OMB approved the information collection for an application 
to market a new drug and assigned it OMB control number 0910-0001 
(expires March 31, 2005). OMB also approved the information collection 
for an application to market a biologic product and assigned it OMB 
control number 0910-0338 (expires March 31, 2005).

IV. 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: June 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15167 Filed 6-16-03; 11:36 am]
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