[Federal Register: September 5, 2001 (Volume 66, Number 172)]
[Notices]
[Page 46464-46465]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se01-88]
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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Draft Guidance for Industry on Submitting Marketing Applications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availability of a draft guidance for industry entitled ``Submitting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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Dockets Management Branch (HFA-305), Food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access to the draft guidance document.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