
[Federal Register: April 8, 2009 (Volume 74, Number 66)]
[Notices]               
[Page 15992-15993]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap09-76]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0400]

 
International Conference on Harmonisation; Guidance on Q4B 
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 
International Conference on Harmonisation Regions; Annex 4C on 
Microbiological Examination of Nonsterile Products: Acceptance Criteria 
for Pharmaceutical Preparations and Substances for Pharmaceutical Use 
General Chapter; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Q4B Evaluation and Recommendation 
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4C: 
Microbiological Examination of Nonsterile Products: Acceptance Criteria 
for Pharmaceutical Preparations and Substances for Pharmaceutical Use 
General Chapter.'' The guidance was prepared under the auspices of the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). The guidance 
provides the results of the ICH Q4B evaluation of the Microbiological 
Examination of Nonsterile Products: Acceptance Criteria for 
Pharmaceutical Preparations and Substances for Pharmaceutical Use 
General Chapter harmonized text from each of the three pharmacopoeias 
(United States, European, and Japanese) represented by the 
Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition 
of the three pharmacopoeial methods by the three ICH regulatory regions 
and provides specific information regarding the recognition. The 
guidance is intended to recognize the interchangeability between the 
local regional pharmacopoeias, thus avoiding redundant testing in favor 
of a common testing strategy in each regulatory region. In the Federal 
Register of February 21, 2008 (73 FR 9575), FDA made available a 
guidance on the Q4B process entitled ``Q4B Evaluation and 
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''

DATES:  Submit written or electronic comments on agency guidances at 
any time.

[[Page 15993]]


ADDRESSES:  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, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. The guidance may also be obtained by mail by calling CBER at 1-
800-835-4709 or 301-827-1800. 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. 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.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Robert H. King, Sr., Center for Drug 
Evaluation and Research (HFD-003), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002, 
301-796-1242; or Christopher Joneckis, Center for Biologics Evaluation 
and Research (HFM-25), Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-0373.
    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 
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 August 5, 2008 (73 FR 45467), FDA 
published a notice announcing the availability of a draft tripartite 
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial 
Texts for Use in the ICH Regions; Annex 4C: Microbiological Examination 
of Non-Sterile Products: Acceptance Criteria for Pharmaceutical 
Preparations and Substances for Pharmaceutical Use General Chapter.'' 
The notice gave interested persons an opportunity to submit comments by 
October 6, 2008.
    After consideration of the comments received and revisions to the 
guidance, a final draft guidance entitled ``Q4B Evaluation and 
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; 
Annex 4C: Microbiological Examination of Nonsterile Products: 
Acceptance Criteria for Pharmaceutical Preparations and Substances for 
Pharmaceutical Use General Chapter'' was submitted to the ICH Steering 
Committee and endorsed by the three participating regulatory agencies 
in November 2008.
    The guidance provides the specific evaluation outcome from the ICH 
Q4B process for the Microbiological Examination of Nonsterile Products: 
Acceptance Criteria for Pharmaceutical Preparations and Substances for 
Pharmaceutical Use General Chapter harmonization proposal originating 
from the three-party PDG. This guidance is in the form of an annex to 
the core ICH Q4B guidance. When implemented, the annex will provide 
guidance for industry and regulators on the use of the specific 
pharmacopoeial texts evaluated by the ICH Q4B process. Following 
receipt of comments on the draft, no substantive changes were made to 
the annex.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The 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 regarding 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. 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.regulations.gov, http://www.fda.gov/cder/guidance/index.htm, 
or http://www.fda.gov/cber/guidelines.htm.

    Dated: March 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7905 Filed 4-7-09; 8:45 am]

BILLING CODE 4160-01-S
