International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Uniformity of Dosage Units General Chapter; Availability, 7449-7450 [E9-3166]

Download as PDF Federal Register / Vol. 74, No. 30 / Tuesday, February 17, 2009 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0011] International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Uniformity of Dosage Units General Chapter; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. sroberts on PROD1PC70 with NOTICES SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 6: Uniformity of Dosage Units General Chapter.’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance provides the results of the ICH Q4B evaluation of the Uniformity of Dosage Units General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing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. This draft guidance is the sixth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by April 20, 2009. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire VerDate Nov<24>2008 19:45 Feb 13, 2009 Jkt 217001 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 draft guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. Send two selfaddressed adhesive labels to assist the office in processing your requests. 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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the draft 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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 7449 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 November 2008, the ICH Steering Committee agreed that a draft guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 6: Uniformity of Dosage Units General Chapter’’ should be made available for public comment. The draft guidance is the product of the Q4B Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Q4B Expert Working Group. The draft guidance provides the specific evaluation results from the ICH Q4B process for the Uniformity of Dosage Units General Chapter harmonization proposal originating 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 E:\FR\FM\17FEN1.SGM 17FEN1 7450 Federal Register / Vol. 74, No. 30 / Tuesday, February 17, 2009 / Notices 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. 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.regulations.gov, https:// www.fda.gov/cder/guidance/index.htm, or https://www.fda.gov/cber/ guidelines.htm. Dated: February 6, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–3166 Filed 2–13–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–S–0002] Phonetic Orthographic Computer Analysis Software Program for Review of Proprietary Drug and Biologic Names; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the source code and supporting technical documentation for the Phonetic Orthographic Computer Analysis (POCA) software program. POCA is an analytic tool designed to help identify drug and biologic names and medical terminology that are phonetically and orthographically similar to one another. POCA is one analytic tool that FDA uses to review proposed proprietary drug and biologic names. ADDRESSES: Requests for single copies of the POCA software should be submitted to the following e-mail address: pocasourcecoderequest@fda.hhs.gov. Communications other than requests for POCA software should be directed to the Division of Medication Error Prevention and Analysis, Center for Drug Evaluation and Research, 10903 New Hampshire Ave. Bldg. 22, Mail Stop 4447, Silver Spring, MD 20993– 0002, 301–796–2360. sroberts on PROD1PC70 with NOTICES SUMMARY: VerDate Nov<24>2008 19:45 Feb 13, 2009 Jkt 217001 FOR FURTHER INFORMATION CONTACT: Carol Holquist, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4416, Silver Spring, MD 20993–0002, 301– 796–2360. Dated: February 6, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–3170 Filed 2–13–09; 8:45 am] FDA is announcing the availability of the source code and supporting technical documentation for the POCA software program, an analytic tool designed to help identify drug and biologic names and medical terminology that are phonetically and orthographically1 similar to one another. POCA is one analytic tool that FDA uses in its review of proposed proprietary drug and biologic names to help FDA identify proprietary names that look alike or sound alike. FDA is not providing technical support for the software program. In title I of the Food and Drug Administration Amendments Act of 2007 (Public Law 110–85), Congress reauthorized and expanded the Prescription Drug User Fee Act (PDUFA IV). As part of the PDUFA IV performance goals, FDA agreed to provide the full source code and supporting technical documentation for the POCA tool and make it available on disk for use by industry and others from the general public (see section IX.C.2. at https://www.fda.gov/oc/pdufa4/ pdufa4goals.html). The POCA software was produced under a U.S. Government contract, and the United States has unlimited rights in the software. The United States has determined that it is in its best interest to provide it royalty-free to the public to use or modify the software for any purpose. Thus, the software is hereby provided free of any restriction on use or distribution. The software is furthermore provided ‘‘as is’’ without warranty of any kind or any guarantee that the software will work for any purpose. Project Performance Corp. developed the software under a U.S. Government contract. Single copies of the POCA software are available from FDA upon request (see ADDRESSES). DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: 1 Merriam-Webster Online defines the term ‘‘orthography’’ in part as: (1) The representation of the sounds of a language by written or printed symbols or (2) a part of language study that deals with letters and spelling. Complete definitions of ‘‘orthography’’ and ‘‘orthographic’’ are available at https://www.merriam-webster.com/dictionary.htm. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 BILLING CODE 4160–01–S National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, March 11, 2009, 8 a.m. to March 12, 2009, 6 p.m., National Cancer Institute/NIH, 6116 Executive Blvd., Room 8053, Rockville, MD 20852 which was published in the Federal Register on January 29, 2009, 74FR5170. The meeting notice is changed to reflect the date change from March 11– 12, 2009 to March 18–19, 2009. The meeting is closed to the public. Dated: February 11, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–3309 Filed 2–13–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Limited Competition for Data Sharing for Demographic Research Infrastructure. E:\FR\FM\17FEN1.SGM 17FEN1

Agencies

[Federal Register Volume 74, Number 30 (Tuesday, February 17, 2009)]
[Notices]
[Pages 7449-7450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3166]



[[Page 7449]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0011]


International Conference on Harmonisation; Draft Guidance on Q4B 
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 
International Conference on Harmonisation Regions; Uniformity of Dosage 
Units General Chapter; 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 Evaluation and 
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; 
Annex 6: Uniformity of Dosage Units General Chapter.'' 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 provides the 
results of the ICH Q4B evaluation of the Uniformity of Dosage Units 
General Chapter harmonized text from each of the three pharmacopoeias 
(United States, European, and Japanese) represented by the 
Pharmacopoeial Discussion Group (PDG). The draft guidance conveys 
recognition of the three pharmacopoeial methods by the three ICH 
regulatory regions and provides specific information regarding the 
recognition. The draft 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. This draft guidance is the sixth annex to the 
core Q4B guidance, which was made available in the Federal Register of 
February 21, 2008 (73 FR 9575).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115 (g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by April 20, 2009.

ADDRESSES: 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, 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 draft 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 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.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the draft 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 November 2008, the ICH Steering Committee agreed that a draft 
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial 
Texts for Use in the ICH Regions; Annex 6: Uniformity of Dosage Units 
General Chapter'' should be made available for public comment. The 
draft guidance is the product of the Q4B Expert Working Group of the 
ICH. Comments about this draft will be considered by FDA and the Q4B 
Expert Working Group.
    The draft guidance provides the specific evaluation results from 
the ICH Q4B process for the Uniformity of Dosage Units General Chapter 
harmonization proposal originating 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

[[Page 7450]]

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. 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.regulations.gov, https://www.fda.gov/cder/guidance/index.htm, 
or https://www.fda.gov/cber/guidelines.htm.

    Dated: February 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3166 Filed 2-13-09; 8:45 am]
BILLING CODE 4160-01-S

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