[Federal Register Volume 69, Number 223 (Friday, November 19, 2004)]
[Notices]
[Pages 67745-67746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25799]


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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://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://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://www.fda.gov/cder/guidance/index.htm or at 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