[Federal Register Volume 68, Number 72 (Tuesday, April 15, 2003)]
[Notices]
[Page 18248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9224]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0368]


Draft Guidance for Industry on Submitting Marketing Applications 
According to the ICH/CTD Format; General Considerations; Availability; 
Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until June 
16, 2003, the comment period for the draft guidance for industry 
entitled ``Submitting Marketing Applications According to the ICH/CTD 
Format; General Considerations'' that appeared in the Federal Register 
of September 5, 2001 (66 FR 46464). The agency is taking this action in 
response to several informal requests for an extension of the comment 
period.

DATES: Submit written or electronic comments on the draft guidance by 
June 16, 2003. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 Communication, Training and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research (CBER), 1401 Rockville Pike, Rockville, MD 20852-1448, 301-
827-3844, FAX 888-CBERFAX. Send two self-addressed adhesive labels to 
assist the office in processing your request. Submit written comments 
on the draft guidance to the Dockets Management Branch (HFA-305), Food 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access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Randy Levin, Center for Drug 
Evaluation and Research (HFD-001), Food and Drug Administration, 1451 
Rockville Pike, Rockville, MD 20857, 301-594-5400; or Robert 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 September 5, 2001 (66 FR 46464), FDA 
published a notice announcing the availability of a draft guidance for 
industry entitled ``Submitting Marketing Applications According to the 
ICH/CTD Format; General Considerations.'' This guidance provides 
information on how to organize new drug applications, abbreviated new 
drug applications, and biologics license applications based on the 
International Conference on Harmonization M4 guidance on organizing the 
Common Technical Document for the registration of pharmaceuticals for 
human use. Interested persons were given until November 5, 2001, to 
submit written or electronic comments on the draft guidance. In 
response to several informal requests from drug and biologic 
manufacturers, FDA has decided to reopen the comment period on the 
draft guidance until June 16, 2003, to allow interested persons 
additional time to submit comments.

II. Comments

    Interested persons may, on or before June 16, 2003, submit to the 
Dockets Management Branch (see ADDRESSES) written or electronic 
comments on the draft guidance. Submit a single copy of electronic 
comments to http://www.fda.gov/dockets/ecomments or two hard copies of 
any written comments, 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 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 at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 8, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9224 Filed 4-14-03; 8:45 am]
BILLING CODE 4160-01-S