[Federal Register Volume 67, Number 115 (Friday, June 14, 2002)]
[Notices]
[Pages 40951-40952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14999]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0231]


International Conference on Harmonisation; Stability Data Package 
for Registration in Climatic Zones III and IV; 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availability of a draft guidance entitled ``Q1F Stability Data Package 
for Registration in Climatic Zones III and IV.'' The draft guidance was 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 This draft guidance, an annex to 
an ICH guidance entitled ``Q1A(R) Stability Testing of New Drug 
Substances and Products,'' defines an approach for broader use of 
Q1A(R) for territories in climatic zones III and IV.

DATES: Submit written or electronic comments on the draft guidance by 
August 20, 2002.

ADDRESSES: Submit written comments on the 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. 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single copies of the draft guidance to the Division of Drug Information 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 the office in processing your requests. Requests and comments 
should be identified with the docket number found in brackets in the 
heading of this document. See the SUPPLEMENTARY

[[Page 40952]]

INFORMATION section for electronic access to the draft guidance 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, Rockville, MD 20852-1148, 301-402-
4635.
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 (EU), 
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 (WHO), 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. Beginning 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 February 2002, the ICH Steering Committee agreed that a draft 
guidance entitled ``Q1F Stability Data Package for Registration in 
Climatic Zones III and IV'' 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.
    This draft guidance, an annex to an ICH guidance entitled ``Q1A(R) 
Stability Testing of New Drug Substances and Products'' (66 FR 56332, 
November 7, 2001), defines an approach for broader use of Q1A(R) for 
territories in climatic zones III and IV.
    There are four climatic zones in the world that are distinguished 
by their characteristic prevalent annual climatic conditions, based on 
the concept described by P. Schumacher (Pharmazeutische Zeitung, 
119:321-324, 1974). The Q1A(R) guidance defines the stability data 
package for the ICH tripartite regions (the EU, Japan, and the United 
States), which are in climatic zones I or II. The WHO has published a 
guideline entitled ``Stability testing of pharmaceutical products 
containing well established drug substances in conventional dosage 
forms'' (WHO technical report series, no. 863, annex 5), updated in the 
``Report of the thirty-seventh meeting of the WHO Expert Committee on 
Specifications for Pharmaceutical Preparations,'' Geneva, October 22-
26, 2001. The WHO guideline defines stability testing recommendations, 
including storage conditions for all four climatic zones.
    Harmonized global stability testing recommendations have been 
established in this draft guidance based on Q1A(R) and the WHO 
guideline. For territories in climatic zones III and IV, the data 
package as described in Q1A(R) can be considered applicable except for 
the defined long-term storage condition. The draft guidance recommends 
the long-term storage condition for a stability data package for 
registration of drug substances and products intended to be marketed in 
climatic zones III and IV.
    When this draft guidance is finalized, Q1A(R) will be revised to 
harmonize the intermediate storage condition for zones I and II with 
the long-term storage condition for zones III and IV.
    This draft guidance, when finalized, will represent the agency's 
current thinking on a stability data package for registration in 
climatic zones III and IV. 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 statues 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 20, 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 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 
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.

    Dated: June 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-14999 Filed 6-13-02; 8:45 am]
BILLING CODE 4160-01-S