[Federal Register Volume 65, Number 45 (Tuesday, March 7, 2000)]
[Notices]
[Pages 12020-12021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5464]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-0296]


Guidance for Industry on Formal Meetings With Sponsors and 
Applicants for PDUFA Products; Availability

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 ``Formal Meetings with 
Sponsors and Applicants for PDUFA Products.'' This guidance is intended 
to provide guidance to industry on procedures that will be adopted by 
the Center for Drug Evaluation and Research (CDER) and the Center for 
Biologics Evaluation and Research (CBER) for formal meetings between 
the agency and sponsors or applicants concerning certain drug products.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Copies of the guidance for industry are available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm. Submit written requests for single 
copies of this guidance to the Drug Information Branch (HFD-210), 
Center for Drug Evaluation and Research, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, or to the Office of 
Communication, Training, and Manufacturers Assistance (HFM-40), Center 
for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, 
MD 20852-1448, 301-827-3844, FAX 888-CBERFAX. Send two self-addressed 
adhesive labels to assist that office in processing your requests. 
Submit written comments on this guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Murray M. Lumpkin, Center for Drug Evaluation and Research (HFD-2), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-594-5400, or
    Robert A. Yetter, Center for Biologics Evaluation and Research 
(HFM-10), 1401 Rockville Pike, Rockville, MD 20852-448, 301-827-0373.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``Formal Meetings with Sponsors and 
Applicants for PDUFA Products.''This guidance is intended to provide 
guidance to industry on procedures that will be adopted by CDER and 
CBER for formal meetings between the agency and sponsors or applicants 
concerning certain drug products.
    In the Federal Register of March 19, 1999 (64 FR 13591), FDA 
announced the availability of a draft version of this guidance. The 
agency has finalized that draft guidance after considering comments 
received on the draft version. Few comments were received, and only 
minor changes were made to the draft version in response to the 
comments in an effort to make the document clearer.
    CDER and CBER participate in many meetings each year with sponsors 
of investigations and applicants for marketing who seek guidance 
relating to the development and review (including the initial launch) 
of products in human drug applications as defined in section 735(1) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379g(1)) 
(PDUFA products). These meetings often represent critical points in the 
regulatory process. It is essential that FDA maintain procedures for 
the

[[Page 12021]]

timely and effective conduct of such meetings.
    Section 119(a) of the Food and Drug Administration Modernization 
Act of 1997 (the Modernization Act) (Public Law 105-115) amends section 
505(b) of the act (21 U.S.C. 355(b)) and directs FDA to meet with 
sponsors and applicants, provided certain conditions are met, for the 
purpose of reaching agreement on the design and size of clinical trials 
intended to form the primary basis of an effectiveness claim in a new 
drug application submitted under section 505(b) of the act or in a 
biologics license application submitted under section 351 of the Public 
Health Service Act (21 U.S.C. 355(b)(4)(B)). Moreover, in conjunction 
with the reauthorization of the Prescription Drug User Fee Act of 1992 
(PDUFA) in November 1997, FDA agreed to specific performance goals for 
the management of meetings with sponsors and applicants for PDUFA 
products. The performance goals are summarized in an enclosure to a 
letter dated November 12, 1997, from the Secretary of Health and Human 
Services, Donna E. Shalala, to Senator James M. Jeffords.
    The procedures and policies described in this guidance are designed 
to promote efficient, well-managed meetings between sponsors, 
applicants, and CDER or CBER. These procedures will implement section 
119(a) of the Modernization Act and are consistent with the timeframes 
described in the performance goals.
    In the notice announcing the availability of the draft version of 
this guidance (64 FR 13591), FDA published notice of the proposed 
collection of information related to the draft guidance. The Federal 
Register notice also requested comments on the burden estimates for the 
guidance. In the Federal Register of August 26, 1999 (64 FR 46684), the 
agency announced that it was submitting the collection of information 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995. The information collection 
provisions related to this guidance have been approved under OMB 
control number 0910-0429. This approval expires December 31, 2002. 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.
    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). The guidance 
represents the agency's current thinking on formal meetings with 
sponsors and applicants for PDUFA 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 statute, regulations, or 
both.
    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). Two copies 
of any 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 Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 20, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-5464 Filed 3-6-00; 8:45 am]
BILLING CODE 4160-01-F