[Federal Register: September 25, 2001 (Volume 66, Number 186)]
[Notices]
[Page 49029-49030]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25se01-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0361]
International Conference on Harmonisation; Draft Guidance on ICH
Q1D Bracketing and Matrixing Designs for Stability Testing of Drug
Substances and Drug Products; 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availability of a draft guidance entitled ``Q1D Bracketing and
Matrixing Designs for Stability Testing of Drug Substances and Drug
Products.'' The draft guidance was prepared under the auspices of the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). This draft
guidance is an annex to an ICH draft guidance entitled ``Q1A(R)
Stability Testing of New Drug Substances and Products,'' that published
in the Federal Register of April 21, 2000 (65 FR 21446). ICH Q1D is
intended to provide guidance on the application of reduced designs
(i.e., bracketing and matrixing) for stability studies conducted in
accordance with the principles outlined in ICH Q1A(R).
DATES: Submit written or electronic comments on the draft guidance by
November 26, 2001.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Drug Information Branch (HFD-210), Center for Drug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), 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comments on the draft guidance to the Dockets Management Branch (HFA-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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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electronic access to the draft guidance document.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 guidance: Chi-wan Chen, Center for Drug Evaluation
and Research (HFD-830), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-2001, or Andrew Shrake, Center for
Biologics Evaluation and Research (HFM-345), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-402-4635.
Regarding the ICH: Janet J. Showalter, Office of Health Affairs
(HFY-20), 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
[[Page 49030]]
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 (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, FDA no longer includes the text of ICH
guidances in the Federal Register. Instead, the agency publishes 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 will be left in the original ICH format. The final
guidance will be reformatted to conform to the GGP style before
publication.
In November 2000, the ICH Steering Committee agreed that an ICH
draft guidance entitled ``Q1D Bracketing and Matrixing Designs for
Stability Testing of New Drug Substances and Drug Products'' should be
made available for public comment. The draft guidance is the product of
the Quality Expert Working Group of the ICH. Comments about this draft
will be considered by FDA and the Quality Expert Working Group.
ICH Q1A(R) notes that, if justified, the use of two types of
reduced stability study designs (i.e., bracketing and matrixing) can be
applied to the testing of new drug substances and products, but ICH
Q1A(R) provides no further guidance on the subject. This draft guidance
(ICH Q1D) describes the principles for applying bracketing or matrixing
in situations where further justification is or is not important.
Design factors and other considerations are presented, and potential
risks of using reduced designs are discussed. Sample designs are
provided as illustrations.
This draft guidance represents the agency's current thinking on
reduced stability testing of new drug substances and products. 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
(address above) written comments on the draft guidance by November 26,
2001. 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 are available for public
examination 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/publications.htm.
Dated: September 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-23981 Filed 9-24-01; 8:45 am]
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