[Federal Register: November 19, 2004 (Volume 69, Number 223)]
[Notices]
[Page 67745-67746]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no04-61]
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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;
Extension of Application Deadline
AGENCY: Food and Drug Administration, HHS.
[[Page 67746]]
ACTION: Notice of extension of application deadline.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
extension for acceptance of applications to its continuous marketing
applications (CMA) Pilot 2 program implemented under the guidance for
industry entitled ``Continuous Marketing Applications: Pilot 2-
Scientific Feedback and Interactions During Development of Fast Track
Products Under PDUFA.'' The extension applies only to the Center for
Drug Evaluation and Research (CDER) and the Center for Biologics
Evaluation and Research (CBER) review divisions that have not received
acceptable applications for participation in the Pilot 2 program.
DATES: Submit written or electronic comments on agency guidances at any
time. FDA will accept applications through December 31, 2004, for
participation in the CMA Pilot 2 program per the restrictions described
in the SUMMARY section of this document.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information (HFD-240), Center for Drug Evaluation
and Research, 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, 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 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.
FOR FURTHER INFORMATION CONTACT:
John Jenkins, Center for Drug Evaluation and Research (HFD-020),
Food and Drug Administration, 5515 Security Lane, Rockville, MD 20852,
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. Background
In the Federal Register of October 6, 2003 (68 FR 57696), FDA
announced the availability of a guidance entitled ``Continuous
Marketing Applications: Pilot 2-Scientific Feedback and Interactions
During Development of Fast Track Products Under PDUFA.'' This guidance
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). The guidance discusses
how the agency will implement a CMA Pilot 2 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.
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
the CMA Pilot 2 program. The CMA Pilot 2 program 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. The guidance provides information regarding the selection
of applications for the CMA Pilot 2 program, the formation of
agreements between FDA and applicants on the investigational new drug
(IND) communication process, and other procedural aspects of the CMA
Pilot 2 program.
Per section III.A.4 of the guidance, applicants were originally
asked to apply for participation in the CMA Pilot 2 program from
October 6, 2003, through December 8, 2003. For review divisions that
had not received any acceptable CMA Pilot 2 program applications by
December 8, 2003, applications were also accepted between February 9,
2004, and September 30, 2004. This notice further extends that deadline
to December 31, 2004, to ensure inclusive and relevant results from the
CMA Pilot 2 program. A description of the application submission
process, evaluation criteria, and selection process is in the guidance.
Applications will be accepted only in CDER and CBER divisions that have
not previously selected a Pilot 2 application. Information regarding
the CDER and CBER divisions that are available to select the CMA Pilot
2 program application can be found on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/pdufa/CMA.htm.
For each of these divisions, the first
application received that adequately meets the evaluation criteria will
be accepted into the CMA Pilot 2 program and applicants will be
informed within 6 weeks of application submission.
II. Electronic Access
Persons with access to the Internet can obtain the guidance at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm.
Dated: November 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-25799 Filed 11-17-04; 1:52 pm]
BILLING CODE 4160-01-S