[Federal Register Volume 66, Number 172 (Wednesday, September 5, 2001)]
[Notices]
[Pages 46464-46465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22199]


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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Draft Guidance for Industry on Submitting Marketing Applications 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 46465]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Submitting 
Marketing Applications According to the ICH/CTD Format; General 
Considerations.'' This guidance provides general guidance on how to 
organize new drug applications (NDAs), abbreviated new drug 
applications (ANDAs) and biologics license applications (BLAs) based on 
the International Conference on Harmonisation (ICH) M4 guidance on 
organizing the Common Technical Document (CTD) for the registration of 
pharmaceuticals for human use.

DATES: Submit written or electronic comments on the draft guidance by 
November 5, 2001. 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 requests. 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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access to the draft guidance document.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

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Submitting Marketing Applications According to the ICH/CTD 
Format; General Considerations.'' This guidance is intended to 
supplement the ICH M4 guidances on quality, safety, and efficacy, which 
were signed off at step 4 of the ICH process in October 2000. Final 
versions of the M4 guidances on organizing the CTD will be available 
soon. This general considerations guidance applies to NDAs, ANDAs, and 
BLAs for both new molecular entities and nonnew molecular entities and 
all related presubmissions, supplements, and amendments.
    This guidance provides some general information on the organization 
and format of the CTD as well as recommendations for completing module 
1, which contains administrative and prescribing information specific 
to each regulatory authority. The content of documents in the CTD is 
provided in other FDA guidance documents. When finalized, this guidance 
will supersede the ``Guidelines on Formatting, Assembling, and 
Submitting of New Drug and Antibiotic Applications,'' issued in 
February 1987.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the agency's current thinking on general considerations for 
submitting marketing applications according to the ICH/CTD format. 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 statutes 
and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. 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 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 document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: August 28, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-22199 Filed 9-4-01; 8:45 am]
BILLING CODE 4160-01-S