[Federal Register Volume 70, Number 201 (Wednesday, October 19, 2005)]
[Notices]
[Pages 60842-60843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20921]


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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://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: 
[email protected], 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://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/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