[Federal Register: October 6, 2003 (Volume 68, Number 193)]
[Notices]
[Page 57696-57697]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc03-65]
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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://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:
[[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://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. 03-25305 Filed 10-1-03; 4:09 pm]
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