[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Notices]
[Pages 16060-16061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0435]


International Conference on Harmonisation; Guidance on Electronic 
Common Technical Document Specification; 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 entitled ``M2 eCTD: Electronic Common 
Technical Document Specification.'' The guidance was prepared under the 
auspices of the International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
The guidance defines the means for industry-to-agency transfer of 
regulatory information that will facilitate the creation, review, life 
cycle management, and archiving of the electronic submission. The 
guidance is intended to assist industry in transferring electronically 
their marketing applications for human drug and biological products to 
a regulatory authority.

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 the Office of Communication, Training and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research (CBER), Food and Drug Administration, 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 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. Requests and comments should be 
identified with the docket number found in brackets in the heading of 
this document. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert Yetter, Center for Biologics Evaluation 
and

[[Page 16061]]

Research (HFM-25), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852, 301-827-0373, or Timothy M. Mahoney, Center for 
Drug Evaluation and Research (HFD-73), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-3540.
Regarding the ICH: Janet Showalter, Office of International Programs 
(HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-0865.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of regulatory requirements. FDA has 
participated in many meetings designed to enhance harmonization and is 
committed to seeking scientifically based harmonized technical 
procedures for pharmaceutical development. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. FDA also seeks input from 
consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and the United States. The six ICH sponsors are the European 
Commission, the European Federation of Pharmaceutical Industries 
Associations, the Japanese Ministry of Health, Labour, and Welfare, the 
Japanese Pharmaceutical Manufacturers Association, the Centers for Drug 
Evaluation and Research and Biologics Evaluation and Research, FDA, and 
the Pharmaceutical Research and Manufacturers of America. The ICH 
Secretariat, which coordinates the preparation of documentation, is 
provided by the International Federation of Pharmaceutical 
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization, Health Canada's Health Products and Food Branch, 
and the European Free Trade Area.
    In accordance with FDA's good guidance practices (GGPs) regulation 
(21 CFR 10.115), this document is being called a guidance, rather than 
a guideline.
    To facilitate the process of making ICH guidances available to the 
public, the agency has changed its procedure for publishing ICH 
guidances. As of April 2000, we no longer include the text of ICH 
guidances in the Federal Register. Instead, we publish a notice in the 
Federal Register announcing the availability of an ICH guidance. The 
ICH guidance is be placed in the docket and can be obtained through 
regular agency sources (see ADDRESSES). Draft guidances are left in the 
original ICH format. The final guidance is reformatted to conform to 
the GGP style before publication.
    In the Federal Register of June 14, 2002 (67 FR 40948), FDA 
announced the availability of a second draft guidance entitled 
``Electronic Common Technical Document Specification.'' The notice gave 
interested persons an opportunity to submit comments by August 1, 2002.
    After consideration of the comments received and revisions to the 
guidance, a final draft of the guidance was submitted to the ICH 
Steering Committee and endorsed by the three participating regulatory 
agencies in September 2002.
    The eCTD guidance describes the recommended method for industry-to-
agency electronic transfer of marketing applications for human drug and 
biological products. The guidance defines the means for industry-to-
agency transfer of regulatory information that will facilitate the 
creation, review, life cycle management, and archiving of the 
electronic submission. The guidance is intended to assist industry in 
transferring their marketing applications for human drug and biological 
products to a regulatory authority. The guidance includes the following 
changes:
    [sbull] The Document Type Definition (DTD) and specificaton version 
numbers were harmonized to 3.0.
    [sbull] Throughout the guidance, references to Common Technical 
Document (CTD) sections were updated to reflect the current CTD 
specifications.
    [sbull] Path names in Appendix 4 were abbreviated to avoid 
exceeding maximum path character limits.
    [sbull] The Glossary of Terms was updated.
    [sbull] Technical errors discovered during testing were corrected.
    This guidance represents the agency's current thinking on this 
topic. 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 (see 
ADDRESSES) written or electronic comments on the guidance at any time. 
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 guidance 
and received comments may be seen 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 
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.

    Dated: March 25, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-7818 Filed 4-1-03; 8:45 am]
BILLING CODE 4160-01-S