[Federal Register Volume 64, Number 158 (Tuesday, August 17, 1999)]
[Notices]
[Pages 44741-44742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21254]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-2405]
Draft ``Guidance for Industry: Information Request and Discipline
Review Letters Under the Prescription Drug User Fee Act;'' 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 draft document entitled ``Guidance for Industry:
Information Request and Discipline Review Letters Under the
Prescription Drug User Fee Act.'' This draft guidance is intended to
provide guidance to industry on the use of certain types of letters by
the Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER) as part of the review of
marketing applications for certain drug and biological products.
DATES: Written comments may be submitted at any time, however, comments
should be submitted by November 15, 1999, to ensure their adequate
consideration in preparation of the final document.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry: Information Request and
Discipline Review Letters Under the Prescription Drug User Fee Act'' to
the Drug Information Branch (HFD-210), Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, or the Office of Communication, 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 the office in processing
your request. The document may also be obtained by mail by calling the
CBER Voice Information System at 1-800-835-4709 or 301--827-1800, or by
fax by calling the FAX Information System at 1-888-CBER-FAX or 301-827-
3844. See the SUPPLEMENTARY INFORMATION section for electronic access
to the draft guidance document. Submit written comments on the document
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 20852-1448, 301-827-0373.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Information Request and Discipline Review
Letters Under the Prescription Drug User Fee Act.'' In a November 1997
letter to Congress regarding the reauthorization of the Prescription
Drug User Fee Act (PDUFA) as part of the Food and Drug Administration
Modernization Act of 1997 (Public Law 105-115), the Secretary of Health
and Human Services (the Secretary) committed FDA to certain user fee
performance goals and additional procedures related to the review of
products in human drug applications as defined in section 735(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) (PDUFA
products). As one of the additional procedures intended to help
expedite the development of drugs and biologics, the Secretary
specified that FDA intends to provide early agency thoughts on possible
deficiencies to applicants in a letter as each discipline finishes its
initial review of its portion of the pending application. The
procedures and policies described in this draft guidance are intended
to explain how the agency will issue and use information request
letters and discipline review letters during the review of PDUFA
products.
This draft guidance document represents the agency's current
thinking on information request letters and discipline review letters
under PDUFA. 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. As with other guidance
documents, FDA does not intend this document to be all-inclusive and
cautions that not all information may be applicable to all situations.
The document is intended to provide
[[Page 44742]]
information and does not set forth requirements.
II. Comments
This draft document is being distributed for comment purposes
only, and is not intended for implementation at this time. Interested
persons may submit to the Dockets Management Branch (address above)
written comments regarding this guidance document. Written comments may
be submitted at any time, however, comments should be submitted by
November 15, 1999, to ensure adequate consideration in preparation of
the final document. Two copies of any comments are to be submitted,
except individuals may submit one copy. Comments are to be identified
with the docket number found in the brackets in the heading of this
document. The draft 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.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
document using the World Wide Web (WWW). For WWW access, connect to
CDER at ``http://www.fda.gov/cder/guidance/index.htm'', or CBER at
``http://www.fda.gov/cber/guidelines.htm''.
Dated: August 9, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-21254 Filed 8-16-99; 8:45 am]
BILLING CODE 4160-01-F
