[Federal Register: January 9, 2009 (Volume 74, Number 6)]
[Notices]
[Page 908-909]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja09-43]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0081] (formerly Docket No. 2006D-0297)
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex on Test for
Extractable Volume of Parenteral Preparations General Chapter;
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 guidance entitled ``Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 2: Test for
Extractable Volume of Parenteral Preparations 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 Test for Extractable Volume of
Parenteral Preparations 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.
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, Training, and Manufacturers Assistance (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. 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-1), 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
[[Page 909]]
Organization, Health Canada, and the European Free Trade Area.
In the Federal Register of December 17, 2007 (72 FR 71417), 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 2: Test for Extractable Volume
of Parenteral Preparations General Chapter.'' The notice gave
interested persons an opportunity to submit comments by February 15,
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 2: Test for Extractable Volume of Parenteral Preparations General
Chapter'' was submitted to the ICH Steering Committee and endorsed by
the three participating regulatory agencies in June 2008.
The guidance provides the specific evaluation outcome from the ICH
Q4B process for the Test for Extractable Volume of Parenteral
Preparations 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 this document.
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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
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: December 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-155 Filed 1-8-09; 8:45 am]
BILLING CODE 4160-01-S