[Federal Register: June 14, 2002 (Volume 67, Number 115)]
[Notices]               
[Page 40948-40949]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jn02-89]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0435]

 
International Conference on Harmonisation; Draft Guidance on 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availability of a second draft guidance entitled ``Electronic Common 
Technical Document Specification'' (eCTD). The draft guidance was 
prepared under the auspices of the International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH). The draft guidance defines the 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 The draft guidance is intended 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DATES: Submit written or electronic comments on the draft guidance by 
August 1, 2002. 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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), 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 that 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 Submit written comments on the draft guidance to the Dockets 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section for electronic access to the draft guidance document.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:
    Regarding the draft guidance: Robert Yetter, Center for Biologics 
Evaluation and Research (HFM-25), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-0373, or Gregory V. 
Brolund, Center for Drug Evaluation and Research (HFD-70), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
3517.
    Regarding the ICH: Janet J. Showalter, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0864.

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 will 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 June 2001, the ICH Steering Committee agreed that a draft 
guidance entitled ``Electronic Common Technical Document 
Specification'' would be made available for public comment and testing. 
The draft guidance, a product of the Multidisciplinary Group 2 (M2) 
Expert Working Group (EWG) of the ICH, was made available for comment 
in the Federal Register of November 28, 2001 (66 FR 59431). Comments 
about the draft guidance were considered by FDA and the M2 EWG, and in 
February 2002, the ICH Steering Committee agreed that a second draft 
guidance should be made available for public comment (step 2).
    The draft guidance on the eCTD provides guidance on industry-to-
agency electronic transfer of marketing applications for human drug and

[[Page 40949]]

biological products. The draft 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 draft guidance is intended to assist 
industry in transferring their marketing applications for human drug 
and biological products to a regulatory authority. The second draft 
guidance includes the following changes:
     The language in the guidance has been edited to improve 
clarity.
     The maximum length of a file name has been increased from 
32 characters to 64 characters.
     Throughout the guidance, references to Common Technical 
Document (CTD) sections have been updated to reflect the current CTD.
     Appendix 4 has been reorganized.
     The examples in Appendix 6 have been updated.
     The Glossary of Terms has been completed.
    This draft guidance, when finalized, will represent the agency's 
current thinking on ``Electronic Common Technical Document 
Specification.'' 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 draft guidance by 
August 1, 2002. 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 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 
either http://www.fda.gov/cder/guidance/index.htm or http://
www.fda.gov/ohrms/dockets/default.htm.

    Dated: June 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15003 Filed 6-13-02; 8:45 am]
BILLING CODE 4160-01-S