[Federal Register: October 6, 2003 (Volume 68, Number 193)]
[Page 57697-57698]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003D-0228]

Guidance for Industry on Continuous Marketing Applications: Pilot 
1--Reviewable Units for Fast Track Products Under the Prescription Drug 
User Fee Act of 1992

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a 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 early feedback to applicants.

DATES: Submit written or electronic comments on agency guidances at any 

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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

    John Jenkins, CDER (HFD-020), Food

[[Page 57698]]

and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 301-
594-3937, or
    Robert A. Yetter, CBER (HFM-25), Food and Drug Administration, 8800 
Rockville Pike, Bethesda, MD 20892, 301-827-0373.


I. Description of the Guidance

    FDA is announcing the availability of a 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.
    In the Federal Register of June 17, 2003 (68 FR 35903), FDA 
announced the availability of a draft version of this guidance. FDA 
received a number of comments on the draft guidance. We have considered 
the comments carefully and have made some changes to address those 
comments. Among other things, we have revised the guidance to further 
describe the selection of marketing applications for inclusion in Pilot 
1, clarify the content and submission process for reviewable units, and 
provide for public availability of additional information during the 
    Under the CMA pilot program, Pilot 1, applicants submitting new 
drug applications or biological licensing applications 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 those presubmissions in the form of 
discipline review letters.
    This guidance provides information on how the agency will implement 
Pilot 1. As described in the guidance, Pilot 1 is 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 
    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 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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www

    Dated: September 29, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25306 Filed 10-1-03; 4:09 pm]