[Federal Register: October 19, 2005 (Volume 70, Number 201)]
[Notices]
[Page 60842-60843]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc05-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0367]
Guidance for Industry on Providing Regulatory Submissions in
Electronic Format--Human Pharmaceutical Product Applications and
Related Submissions Using the Electronic Common Technical Document
Specifications; 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 guidance for industry entitled ``Providing Regulatory
Submissions in Electronic Format--Human Pharmaceutical Product
Applications and Related Submissions Using the eCTD Specifications.''
This is one in a series of guidance documents on providing regulatory
submissions to FDA in electronic format. This guidance discusses issues
related to the electronic submission of new drug applications (NDAs),
abbreviated new drug applications (ANDAs), biologics license
applications (BLAs), investigational new drug applications (INDs),
master files, advertising material, and promotional labeling using the
electronic common technical document (eCTD) specifications. The
submission of these documents in electronic format should improve the
agency's efficiency in processing, archiving, and reviewing them.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the 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 to the Office of Communication, Training, and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448. Send one self-addressed adhesive label to assist that
office in processing your requests. Submit telephone requests to 800-
835-4709 or 301-827-1800. Submit written comments on the guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: Randy Levin, Center for Drug
Evaluation and Research (HFD-001), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5411, e-mail:
levinr@cder.fda.gov, 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 guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications.'' This document provides guidance to industry
regarding submission of marketing applications (NDAs, ANDAs, BLAs),
INDs, and related submissions (master files, advertising, and
promotional labeling) in electronic format based on the International
Conference on Harmonisation eCTD specifications.
In the Federal Register of August 29, 2003 (68 FR 52044), FDA made
available a draft guidance for industry entitled ``Providing Regulatory
Submissions in Electronic Format--Human Pharmaceutical Product
Applications and Related Submissions'' and gave interested persons an
opportunity to submit comments by October 28, 2003. The agency
considered received comments as it finalized this guidance.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on providing applications and related
submissions in electronic 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
[[Page 60843]]
requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance at any
time. Submit a single copy of electronic comments or two paper copies
of any mailed comments, except that individuals may submit one paper
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The guidance and received
comments are available for public examination in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance have been approved under
OMB control number 0910-0014 (until January 31, 2006), OMB control
number 0910-0001 (until May 31, 2008), and OMB control number 0910-0338
(until September 30, 2008).
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
ets/default.htm.
Dated: October 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20921 Filed 10-18-05; 8:45 am]
BILLING CODE 4160-01-S