[Federal Register: October 6, 2003 (Volume 68, Number 193)]
[Notices]
[Page 57697-57698]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc03-66]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 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
time.
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.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
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
program.
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
application.
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
.fda.gov/cber/guidelines.htm.
Dated: September 29, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25306 Filed 10-1-03; 4:09 pm]
BILLING CODE 4160-01-S