International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability, 45059-45060 [E6-12807]

Download as PDF Federal Register / Vol. 71, No. 152 / Tuesday, August 8, 2006 / Notices jlentini on PROD1PC65 with NOTICES 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 In June 2006, the ICH Steering Committee agreed that a draft guidance entitled ‘‘Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex 1: Residue on Ignition/Sulfated Ash General Chapter’’ should be made available for public comment. The draft guidance is the product of the Q4B Quality Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Q4B Quality Expert Working Group. The draft guidance provides the specific evaluation outcome from the ICH Q4B process for the Residue on Ignition/Sulphated Ash General Chapter harmonization proposal originating VerDate Aug<31>2005 20:06 Aug 07, 2006 Jkt 208001 from the three-party PDG. This draft guidance is in the form of an annex to the core ICH Q4B guidance. Once finalized, the annex will provide guidance to assist industry and regulators in the implementation of the specific topic evaluated by the ICH Q4B process. 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 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 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 https:// www.fda.gov/ohrms/dockets/ default.htm, https://www.fda.gov/cder/ guidance/index.htm, or https:// www.fda.gov/cber/publications.htm. Dated: July 31, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–12806 Filed 8–7–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0297] International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00066 Fmt 4703 Sfmt 4703 45059 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria.’’ 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 a procedure to facilitate acceptance by regulatory authorities of pharmacopoeial test methods (referred to in the draft guidance as analytical procedures and/or acceptance criteria (APAC)) for use in the three ICH regions. The draft guidance is intended to facilitate regulatory acceptance of these proposed test methods and their interchangeability with test methods contained in the local regional pharmacopoeias, thus avoiding redundant testing and different acceptance criteria in favor of a common testing strategy in each ICH regulatory region. Elsewhere in this issue of theFederal Register, FDA is announcing the availability of a draft guidance entitled ‘‘Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex 1: Residue on Ignition/Sulphated Ash General.’’ DATES: Submit written or electronic comments on the draft guidance by October 10, 2006. 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 https:// 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 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Robert H. King, Sr., Center for Drug E:\FR\FM\08AUN1.SGM 08AUN1 45060 Federal Register / Vol. 71, No. 152 / Tuesday, August 8, 2006 / Notices Evaluation and Research (HFD– 003), Food and Drug Administration, 10993 New Hampshire Ave., Bldg. 21, rm. 3542, Silver Spring, MD 20993–0002, 301–796–1242; or Christopher Joneckis, Center for Biologics Evaluation and Research (HFM–20), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301– 435–5681. 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: jlentini on PROD1PC65 with NOTICES 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 VerDate Aug<31>2005 20:06 Aug 07, 2006 Jkt 208001 Organization, Health Canada, and the European Free Trade Area. In June 2006, the ICH Steering Committee agreed that a draft guidance entitled ‘‘Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria’’ should be made available for public comment. The draft guidance is the product of the Q4B Quality Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Q4B Quality Expert Working Group. The draft guidance provides information on a Q4B process for evaluating harmonization proposals for specific APAC topics originating principally from the three-party Pharmacopoeial Discussion Group (PDG). The PDG consists of representatives from the European Directorate for the Quality of Medicines in the Council of Europe; the Japanese Ministry of Health, Labour and Welfare, and the United States Pharmacopeial Convention, Inc. Once finalized, the Q4B guidance will describe the process for formally conveying the evaluation outcomes as topic-specific annexes to the core Q4B guidance. Each annex will be issued separately following the ICH step process, providing guidance to assist industry and regulators in the implementation of the specific topic evaluated by the ICH Q4B process. 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 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 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 https:// www.fda.gov/ohrms/dockets/ PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 default.htm, https://www.fda.gov/cder/ guidance/index.htm, or https:// www.fda.gov/cber/publications.htm. Dated: July 31, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–12807 Filed 8–7–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2006–25528] Chemical Transportation Advisory Committee Coast Guard, DHS. Notice of meeting. AGENCY: ACTION: SUMMARY: The Chemical Transportation Advisory Committee (CTAC), its Subcommittee on Hazardous Cargo Transportation Security (HCTS), as well as its Working Groups on MARPOL Annex II, Barge Hazard Communication and Vapor Control Systems (VCS) will meet to discuss various issues relating to the marine transportation of hazardous materials in bulk. These meetings will be open to the public. DATES: The Working Group on MARPOL Annex II will meet on Tuesday, August 22, 2006, from 8:30 a.m. to 12 p.m. and the HCTS Subcommittee will meet on Tuesday, August 22, 2006 from 12:30 p.m. to 5 p.m. The Working Group on VCS will meet on Wednesday, August 23, 2006 from 8:30 a.m. to 12 p.m. and the Working Group on Barge Hazard Communication will meet on Wednesday, August 23, 2006, from 12:30 p.m. to 5 p.m. CTAC will meet on Thursday, August 24, 2006, from 9 a.m. to 3:30 p.m. These meetings may close early if all business is finished. Written material and requests to make oral presentations should reach the Coast Guard on or before August 18, 2006. Requests to have a copy of your material distributed to each member of the Committee should reach the Coast Guard on or before August 18, 2006. ADDRESSES: The HCTS Subcommittee and the Working Groups on MARPOL Annex II, VCS, and Barge Hazard Communication will be held at American Commercial Barge Lines LLC, 1701 East Market Street, Jeffersonville, IN 47130. The CTAC meeting will be held at The Ramada Inn Jeffersonville, 700 W. Riverside Drive, Jeffersonville, IN 47130. Send written material and requests to make oral presentations to Commander Richard Raksnis, Executive Director of CTAC, Commandant (G- E:\FR\FM\08AUN1.SGM 08AUN1

Agencies

[Federal Register Volume 71, Number 152 (Tuesday, August 8, 2006)]
[Notices]
[Pages 45059-45060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12807]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0297]


International Conference on Harmonisation; Draft Guidance on Q4B 
Regulatory Acceptance of Analytical Procedures and/or Acceptance 
Criteria; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Q4B Regulatory Acceptance 
of Analytical Procedures and/or Acceptance Criteria.'' 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 a 
procedure to facilitate acceptance by regulatory authorities of 
pharmacopoeial test methods (referred to in the draft guidance as 
analytical procedures and/or acceptance criteria (APAC)) for use in the 
three ICH regions. The draft guidance is intended to facilitate 
regulatory acceptance of these proposed test methods and their 
interchangeability with test methods contained in the local regional 
pharmacopoeias, thus avoiding redundant testing and different 
acceptance criteria in favor of a common testing strategy in each ICH 
regulatory region. Elsewhere in this issue of theFederal Register, FDA 
is announcing the availability of a draft guidance entitled ``Q4B 
Regulatory Acceptance of Analytical Procedures and/or Acceptance 
Criteria; Annex 1: Residue on Ignition/Sulphated Ash General.''

DATES: Submit written or electronic comments on the draft guidance by 
October 10, 2006.

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 https://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 
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. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Robert H. King, Sr., Center for Drug

[[Page 45060]]

Evaluation and Research (HFD-003), Food and Drug Administration, 10993 
New Hampshire Ave., Bldg. 21, rm. 3542, Silver Spring, MD 20993-0002, 
301-796-1242; or
    Christopher Joneckis, Center for Biologics Evaluation and Research 
(HFM-20), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852, 301-435-5681.
    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 June 2006, the ICH Steering Committee agreed that a draft 
guidance entitled ``Q4B Regulatory Acceptance of Analytical Procedures 
and/or Acceptance Criteria'' should be made available for public 
comment. The draft guidance is the product of the Q4B Quality Expert 
Working Group of the ICH. Comments about this draft will be considered 
by FDA and the Q4B Quality Expert Working Group.
    The draft guidance provides information on a Q4B process for 
evaluating harmonization proposals for specific APAC topics originating 
principally from the three-party Pharmacopoeial Discussion Group (PDG). 
The PDG consists of representatives from the European Directorate for 
the Quality of Medicines in the Council of Europe; the Japanese 
Ministry of Health, Labour and Welfare, and the United States 
Pharmacopeial Convention, Inc. Once finalized, the Q4B guidance will 
describe the process for formally conveying the evaluation outcomes as 
topic-specific annexes to the core Q4B guidance. Each annex will be 
issued separately following the ICH step process, providing guidance to 
assist industry and regulators in the implementation of the specific 
topic evaluated by the ICH Q4B process.
    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 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 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 
https://www.fda.gov/ohrms/dockets/default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://www.fda.gov/cber/publications.htm.

    Dated: July 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12807 Filed 8-7-06; 8:45 am]
BILLING CODE 4160-01-S

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