[Federal Register Volume 66, Number 229 (Wednesday, November 28, 2001)]
[Notices]
[Pages 59431-59432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29511]


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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International Conference on Harmonisation; Draft Guidance on 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availability of a draft guidance entitled ``Electronic Common Technical 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 The draft guidance was prepared under 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 The draft guidance defines the means for industry-to-agency 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

[[Page 59432]]

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 The draft 
guidance is intended to assist industry in transferring electronically 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DATES: Submit written or electronic comments on the draft guidance by 
February 26, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 Submit written comments on the draft guidance to the Dockets 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. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the 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-070), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
3516.
    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, the Canadian Health 
Protection Branch, and the European Free Trade Area.
    In accordance with FDA's good guidance practices regulation (GGP) 
(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 the ADDRESSES section). 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'' should be made available for public comment and 
testing. The draft guidance is the product of the Multidisciplinary 
Group 2 (M2) Expert Working Group (EWG) of the ICH. Comments about this 
draft guidance will be considered by FDA and the M2 EWG and another 
draft will be published for comment (Step 2).
    The draft guidance provides guidance on industry-to-agency 
electronic transfer of marketing applications for human drug and 
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.
    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 
(addresses above) written or electronic comments on the draft guidance 
by February 26, 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 office above 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/m2/ or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: October 30, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-29511 Filed 11-27-01; 8:45 am]
BILLING CODE 4160-01-S