[Federal Register: September 6, 2005 (Volume 70, Number 171)]
[Notices]
[Page 53021-53022]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se05-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0324]
International Conference on Harmonisation; Draft Guidance on M5
Data Elements and Standards for Drug Dictionaries; 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availability of a draft guidance entitled ``M5 Data Elements and
Standards for Drug Dictionaries.'' The draft guidance was prepared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 The draft guidance describes the data elements and standards
that ICH recommends be made available to interested parties to assist
in the development and maintenance of drug dictionaries. The draft
guidance is intended to facilitate the exchange and practical use of
medicinal product information at the international level, such as with
postmarketing safety reporting.
DATES: Submit written or electronic comments on the draft guidance by
October 21, 2005. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written comments on the draft guidance to the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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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requests for single copies of the draft guidance to the Division of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. The
draft guidance may also be obtained by mail by calling the CBER Voice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 your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Randy Levin, Center for Drug Evaluation and
Research (HFD-001), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7784; or Ann Schwartz, Center for
Biologics Evaluation and Research (HFM-475), Food and Drug
Administration, 1401 Rockville Pike, rm. 300N, Rockville, MD 20832,
301-827-3070.
Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4480.
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
ICH's sponsors and IFPMA, as well as observers from the World Health
Organization, Health Canada, and the European Free Trade Area.
In May 2005, the ICH Steering Committee agreed that a draft
guidance entitled ``M5 Data Elements and Standards for Drug
Dictionaries'' should be made available for public comment. The draft
guidance is the product of the M5 Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the M5 expert
working group.
The draft guidance describes the data elements that ICH recommends
be made available to interested parties to assist in the development
and maintenance of drug dictionaries. The draft guidance outlines each
data element and provides recommended standards for the data elements.
The draft guidance addresses medicinal products (drugs and biologics)
and is intended to accomplish the following goals:
Improve the exchange of medicinal product information,
Improve consistency in evaluating and comparing medicinal
products for postmarketing surveillance activities,
Provide consistent terminology for the health care
community, and
Reduce administrative burdens for the pharmaceutical
industry when complying with different regional regulatory
requirements.
The draft guidance refers to approved medicinal products. The draft
guidance does not apply to homeopathic medicinal products or
investigational medicinal products. The draft guidance does not cover
the establishment and maintenance of a drug dictionary.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on M5 data
elements and standards for drug dictionaries. 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.
[[Page 53022]]
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft 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 draft 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/reading.htm.
v/cber/reading.htm.
Dated: August 29, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17597 Filed 9-2-05; 8:45 am]
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