[Federal Register: June 17, 2003 (Volume 68, Number 116)]
[Notices]
[Page 35903]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jn03-69]
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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Draft Guidance for Industry on Continuous Marketing Applications: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availability of a draft guidance for industry entitled ``Continuous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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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 Submit written comments on the draft
guidance to the Division of Dockets Management (HFA-305), Food and Drug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://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
draft guidance document.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://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: June 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15167 Filed 6-16-03; 11:36 am]
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