International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 12 on Analytical Sieving General Chapter; Availability, 53973-53974 [2010-21979]

Download as PDF Federal Register / Vol. 75, No. 170 / Thursday, September 2, 2010 / Notices V. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/AnimalVeterinary/ default.htm or https:// www.regulations.gov. Dated: August 30, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–21981 Filed 9–1–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0432] Guidance for Industry; Small Entities Compliance Guide—Designation of New Animal Drugs for Minor Uses or Minor Species; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #200 entitled ‘‘Small Entities Compliance Guide—Designation of New Animal Drugs for Minor Uses or Minor Species.’’ This small entities compliance guide (SECG) aids industry in complying with the requirements of the final rule that published in the Federal Register of July 26, 2007. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) establishes new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. DATES: Submit either electronic or written comments on the SECG at any time. ADDRESSES: Submit written requests for single copies of the SECG to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. Submit electronic comments on the SECG to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 SUMMARY: VerDate Mar<15>2010 15:22 Sep 01, 2010 Meg Oeller, Center for Veterinary Medicine (HFV–50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–9090, Margaret.oeller@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Jkt 220001 I. Background FDA is announcing the availability of an SECG #200 entitled ‘‘Small Entities Compliance Guide—Designation of New Animal Drugs for Minor Uses or Minor Species.’’ This SECG aids industry in complying with the requirements of the final rule published in the Federal Register of July 26, 2007 (72 FR 41010). FDA has prepared this SECG in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104–121). This document is intended to provide guidance to small businesses on the requirements of section 573 of the MUMS act. In enacting MUMS, Congress sought to encourage the development of animal drugs that are currently unavailable to minor species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats) in the United States or to major species afflicted with uncommon diseases or conditions (minor uses). These regulations describe the procedures for designating a new animal drug as a minor use or minor species drug. Such designation establishes eligibility for the incentives provided by the MUMS act. II. Significance of Guidance FDA is issuing this SECG as a level 2 guidance 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. III. Paperwork Reduction Act of 1995 This SECG refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in section 573 of the MUMS act have been approved under OMB control no. 0910– 0605. IV. Comments Submit written requests for single copies of the guidance to the PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 53973 Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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. V. Electronic Access Persons with access to the Internet may obtain the SECG at either https:// www.fda.gov/cvm or https:// www.regulations.gov. Dated: August 30, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–21980 Filed 9–1–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0574] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 12 on Analytical Sieving General Chapter; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 12: Analytical Sieving 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 Analytical Sieving General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by SUMMARY: E:\FR\FM\02SEN1.SGM 02SEN1 wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 53974 Federal Register / Vol. 75, No. 170 / Thursday, September 2, 2010 / Notices 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. This guidance is in the form of an annex to the core guidance on the Q4B process entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions’’ (the core ICH Q4B guidance). DATES: Submit either electronic or written 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, 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. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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 VerDate Mar<15>2010 15:22 Sep 01, 2010 Jkt 220001 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 December 17, 2009 (74 FR 66982), 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 12: Analytical Sieving General Chapter.’’ The notice gave interested persons an opportunity to submit comments by February 16, 2010. After consideration of the comments received and revisions to the guidance, PO 00000 Frm 00028 Fmt 4703 Sfmt 9990 a final draft guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 12: Analytical Sieving General Chapter’’ was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies in June 2010. The guidance provides the specific evaluation outcome from the ICH Q4B process for the Analytical Sieving General Chapter harmonization proposal originating from the threeparty PDG. This guidance is in the form of an annex to the core ICH Q4B guidance made available in the Federal Register of February 21, 2008 (73 FR 9575). 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) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Dated: August 30, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–21979 Filed 9–1–10; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\02SEN1.SGM 02SEN1

Agencies

[Federal Register Volume 75, Number 170 (Thursday, September 2, 2010)]
[Notices]
[Pages 53973-53974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21979]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0574]


International Conference on Harmonisation; Guidance on Q4B 
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 
International Conference on Harmonisation Regions; Annex 12 on 
Analytical Sieving 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 12: 
Analytical Sieving 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 Analytical Sieving General Chapter harmonized text from each of 
the three pharmacopoeias (United States, European, and Japanese) 
represented by

[[Page 53974]]

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. This guidance is in the form of an annex to the 
core guidance on the Q4B process entitled ``Q4B Evaluation and 
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' 
(the core ICH Q4B guidance).

DATES:  Submit either electronic or written 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, 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. Send one self-addressed adhesive label to assist the office in 
processing your requests. The guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

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 December 17, 2009 (74 FR 66982), 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 12: Analytical Sieving General 
Chapter.'' The notice gave interested persons an opportunity to submit 
comments by February 16, 2010.
    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 12: Analytical Sieving General Chapter'' was submitted to the ICH 
Steering Committee and endorsed by the three participating regulatory 
agencies in June 2010.
    The guidance provides the specific evaluation outcome from the ICH 
Q4B process for the Analytical Sieving 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 made available in the 
Federal Register of February 21, 2008 (73 FR 9575). 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: August 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21979 Filed 9-1-10; 8:45 am]
BILLING CODE 4160-01-S
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