[Federal Register Volume 69, Number 111 (Wednesday, June 9, 2004)]
[Notices]
[Pages 32358-32359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13064]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0509]


International Conference on Harmonisation; Guidance on the M4 
Common Technical Document--Quality: Questions and Answers/Location 
Issues; 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 ``M4: The CTD--Quality: Questions 
and Answers/Location Issues.'' The guidance was prepared under the 
auspices of the International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
This guidance provides further clarification for preparing the quality 
components of an application file in the common technical document 
(CTD) format. The guidance addresses the relationship between linked 
sections for certain parameters (such as polymorphism and particle 
size), and it addresses location issues (by indicating the section in 
which to place requested information). The guidance is intended to ease 
the preparation of paper and electronic submissions, facilitate 
regulatory reviews, and simplify the exchange of regulatory information 
among regulatory authorities.

DATES: Submit written or electronic comments on the guidance at any 
time.

ADDRESSES: 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. 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. The 
guidance may also be obtained by mail by calling the CBER Voice 
Information System at 1-800-835-4709 or 301-827-1800. Send two self-
addressed adhesive labels to assist the office in processing

[[Page 32359]]

your requests. Requests and comments should be identified with the 
docket number found in brackets in the heading of the document. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: 
    Regarding the guidance: Justina A. Molzon, Center for Drug 
Evaluation and Research (HFD-1), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5400; or Christopher C. 
Joneckis, Center for Biologics Evaluation and Research (HFM-20), Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-
827-0833.
    Regarding the ICH: C. Michelle Limoli, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0908.

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, and the European Free Trade Area.
    In the Federal Register of October 16, 2001 (66 FR 52634), FDA made 
available the ICH guidance entitled ``M4 Organization of the Common 
Technical Document for the Registration of Pharmaceuticals for Human 
Use'' (M4 CTD), which describes a harmonized format for new product 
applications (including applications for biotechnology-derived 
products) for submission to the regulatory authorities in the three ICH 
regions. The M4 CTD guidance was made available in four parts: (1) A 
description of the organization of the M4 CTD; (2) the quality section; 
(3) the safety, or nonclinical, section; and (4) the efficacy, or 
clinical, section.
    In the Federal Register of December 30, 2002 (67 FR 79639), FDA 
published a notice announcing the availability of a draft tripartite 
guidance entitled ``Common Technical Document--Quality: Questions and 
Answers/Location Issues.'' The notice gave interested persons an 
opportunity to submit comments by February 28, 2003. 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 July 
2003.
    This guidance provides further clarification for preparing the 
quality components of an application in the CTD-Q format. The guidance 
addresses the relationship between linked sections for certain 
parameters, such as polymorphism and particle size. The guidance also 
addresses location issues by indicating the section in which to place 
requested information. The guidance is intended to ease the preparation 
of paper and electronic submissions, facilitate regulatory reviews, and 
simplify the exchange of regulatory information among regulatory 
authorities.
    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 Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance. 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 may be 
seen in the Division of Dockets Management 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/cder/guidance/index.htm, http://www.fda.gov/cber/publications.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: June 3, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-13064 Filed 6-8-04; 8:45 am]
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