[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 This draft guidance is intended to 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ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: Information Request and 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to the draft guidance document.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