International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Guidances for the Validation of Analytical Methods Used in Residue Depletion Studies (VICH GL49); Availability, 18505-18507 [2010-8230]

Download as PDF Federal Register / Vol. 75, No. 69 / Monday, April 12, 2010 / Notices sroberts on DSKD5P82C1PROD with NOTICES products in the EU, Japan, and the United States, and includes input from both regulatory and industry representatives. The VICH Steering Committee is composed of member representatives from the European Commission, European Medicines Evaluation Agency, European Federation of Animal Health, Committee on Veterinary Medicinal Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal Health Institute, the Japanese Veterinary Pharmaceutical Association, the Japanese Association of Veterinary Biologics, and the Japanese Ministry of Agriculture, Forestry, and Fisheries. Four observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH Steering Committee meetings. II. Draft Guidance on Study to Marker Residue Depletion Studies to Establish Product Withdrawal Periods The VICH Steering Committee held a meeting on November 5, 2009, and agreed that the draft guidance document entitled ‘‘Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods,’’ VICH GL48 should be made available for public comment. This draft VICH guidance document is one of a series developed to facilitate the mutual acceptance of residue chemistry data for veterinary drugs used in food-producing animals. This guidance was prepared after consideration of the current requirements for evaluating veterinary drug residues in the EU, Japan, United States, Australia, New Zealand, and Canada. As part of the approval process for veterinary medicinal products in foodproducing animals, regulatory authorities recommend data from marker residue depletion studies in order to establish appropriate withdrawal periods in edible products including meat, milk, eggs, and honey. The objective of this guidance is to provide study design recommendations which will facilitate the universal VerDate Nov<24>2008 17:58 Apr 09, 2010 Jkt 220001 18505 acceptance of the generated residue depletion data to fulfill this recommendation. FDA and the VICH Expert Working Group will consider comments about the draft guidance document. Dated: April 6, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. III. Significance of Guidance DEPARTMENT OF HEALTH AND HUMAN SERVICES This draft guidance, developed under the VICH process, has been revised to conform to FDA’s good guidance practices regulation (21 CFR 10.115). For example, the document has been designated ‘‘guidance’’ rather than ‘‘guideline.’’ In addition, guidance documents must not include mandatory language such as ‘‘shall,’’ ‘‘must,’’ ‘‘require,’’ or ‘‘requirement,’’ unless FDA is using these words to describe a statutory or regulatory requirement. 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 applicable statutes and regulations. IV. Paperwork Reduction Act of 1995 This draft guidance 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 sections 1–2 of the guidance have been approved under OMB control no. 0910–0032. V. 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. VI. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ default.htm or https:// www.regulations.gov. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 [FR Doc. 2010–8231 Filed 4–9–10; 8:45 am] BILLING CODE 4160–01–S Food and Drug Administration [Docket No. FDA–2010–D–0165] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Guidances for the Validation of Analytical Methods Used in Residue Depletion Studies (VICH GL49); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (#208) entitled ‘‘Draft Guidance for Industry on Guidances for the Validation of Analytical Methods Used in Residue Depletion Studies,’’ (VICH GL49). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide a general description of the criteria that has been found to be acceptable to the European Union (EU), Japan, the United States, Australia, New Zealand, and Canada for the validation of analytical methods used in veterinary drug residue studies. 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 May 12, 2010. ADDRESSES: Submit written requests for single copies of the draft guidance 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. 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 E:\FR\FM\12APN1.SGM 12APN1 18506 Federal Register / Vol. 75, No. 69 / Monday, April 12, 2010 / Notices sroberts on DSKD5P82C1PROD with NOTICES electronic comments to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary Medicine, (HFV–151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8204, email: julia.oriani@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry (#208) entitled ‘‘Draft Guidance for Industry on Guidances for the Validation of Analytical Methods Used in Residue Depletion Studies,’’ VICH GL49. In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the EU, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the EU, Japan, and the United States, and includes input from both regulatory and industry representatives. The VICH Steering Committee is composed of member representatives from the European Commission, European Medicines Evaluation Agency, European Federation of Animal Health, Committee on Veterinary Medicinal Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal Health Institute, the Japanese Veterinary Pharmaceutical Association, the Japanese Association of Veterinary Biologics, and the Japanese Ministry of Agriculture, Forestry, and Fisheries. VerDate Nov<24>2008 17:58 Apr 09, 2010 Jkt 220001 Four observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH Steering Committee meetings. II. Draft Guidance on the Validation of Analytical Methods Used in Residue Depletion Studies The VICH Steering Committee held a meeting on November 5, 2009, and agreed that the draft guidance document entitled ‘‘Draft Guidances for the Validation of Analytical Methods Used in Residue Depletion Studies,’’ (VICH GL49) should be made available for public comment. This draft VICH guidance document is one of a series developed to facilitate the mutual acceptance of residue chemistry data for veterinary drugs used in food-producing animals. This guidance was prepared after consideration of the current requirements for evaluating veterinary drug residues in the EU, Japan, the United States, Australia, New Zealand, and Canada. During the veterinary drug development process, residue depletion studies are conducted to determine the concentration of the residue or residues present in the edible products (tissues, milk, eggs, or honey) of animals treated with veterinary drugs. This information is used in regulatory submissions around the world. Submission of regulatory methods (postapproval control methods) and the validation requirements of the regulatory methods are usually well defined by various regulatory agencies worldwide and may even be defined by law. Consequently, it has been difficult to harmonize the procedures used for validation of these methods. However, the residue studies are generally conducted before the regulatory methods have been completed. Often the in-house validated residue methods provide the framework for the methods submitted for regulatory monitoring. Harmonization of the validation requirements for methodology used during residue studies and submitted to the regulatory agencies in support of the maximum residue limits and withdrawal periods should be achievable. It is the intent of this document to describe a validation PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 procedure that is acceptable to the regulatory bodies of the EU, Japan, the United States, Australia, New Zealand, and Canada for use in the residue depletion studies. This validated method may continue on to become the ‘‘regulatory method’’ but that phase of the process will not be addressed in any detail in these guidances. FDA and the VICH Expert Working Group will consider comments about the draft guidance document. III. Significance of Guidance This draft guidance, developed under the VICH process, has been revised to conform to FDA’s good guidance practices regulation (21 CFR 10.115). For example, the document has been designated ‘‘guidance’’ rather than ‘‘guideline.’’ In addition, guidance documents must not include mandatory language such as ‘‘shall,’’ ‘‘must,’’ ‘‘require,’’ or ‘‘requirement,’’ unless FDA is using these words to describe a statutory or regulatory requirement. 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 applicable statutes and regulations. IV. Paperwork Reduction Act of 1995 This draft guidance 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 sections 1–3 of this guidance have been approved under OMB control no. 0910–0032. V. 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. VI. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ E:\FR\FM\12APN1.SGM 12APN1 Federal Register / Vol. 75, No. 69 / Monday, April 12, 2010 / Notices default.htm or https:// www.regulations.gov. Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your request. 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. Dated: April 6, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–8230 Filed 4–9–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0164] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals (VICH GL47); Availability AGENCY: Food and Drug Administration, HHS. sroberts on DSKD5P82C1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (#206) entitled ‘‘Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals,’’ VICH GL47. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide recommendations for internationally harmonized procedures to identify the metabolites of veterinary food animal drugs in laboratory animals used for toxicological testing for the purpose of comparison to the residues of the drugs in food animals. 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 May 12, 2010. ADDRESSES: Submit written requests for single copies of the draft guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., VerDate Nov<24>2008 17:58 Apr 09, 2010 Jkt 220001 FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary Medicine (HFV–151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8204, email: julia.oriani@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry (#206) entitled ‘‘Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals,’’ VICH GL47. In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union (EU), Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the EU, Japan, and the United States, and includes input from both regulatory and industry representatives. The VICH Steering Committee is composed of member representatives from the European Commission, PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 18507 European Medicines Evaluation Agency, European Federation of Animal Health, Committee on Veterinary Medicinal Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal Health Institute, the Japanese Veterinary Pharmaceutical Association, the Japanese Association of Veterinary Biologics, and the Japanese Ministry of Agriculture, Forestry, and Fisheries. Four observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH Steering Committee meetings. II. Draft Guidance on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in FoodProducing Animals The VICH Steering Committee held a meeting on November 5, 2009, and agreed that the draft guidance document entitled ‘‘Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals,’’ VICH GL47 should be made available for public comment. This draft VICH guidance document is one of a series developed to facilitate the mutual acceptance of residue chemistry data for veterinary drugs used in food-producing animals. This guidance was prepared after consideration of the current requirements for evaluating veterinary drug residues in the EU, Japan, United States, Australia, New Zealand and Canada. The objective of this guidance is to provide recommendations for internationally harmonized procedures to identify the metabolites of veterinary food animal drugs in laboratory animals used for toxicological testing for the purpose of comparison to the residues of the drugs in food animals. The purpose of comparative metabolism studies is to determine if laboratory animals used for toxicological testing have been exposed to the metabolites that humans will be exposed to as residues in products of food animal origin. The human food safety evaluation of veterinary drug residues assures that food derived from treated animals is E:\FR\FM\12APN1.SGM 12APN1

Agencies

[Federal Register Volume 75, Number 69 (Monday, April 12, 2010)]
[Notices]
[Pages 18505-18507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8230]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0165]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Draft 
Guidance for Industry on Guidances for the Validation of Analytical 
Methods Used in Residue Depletion Studies (VICH GL49); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (208) entitled 
``Draft Guidance for Industry on Guidances for the Validation of 
Analytical Methods Used in Residue Depletion Studies,'' (VICH GL49). 
This draft guidance has been developed for veterinary use by the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This draft 
VICH guidance document is intended to provide a general description of 
the criteria that has been found to be acceptable to the European Union 
(EU), Japan, the United States, Australia, New Zealand, and Canada for 
the validation of analytical methods used in veterinary drug residue 
studies.

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 May 12, 2010.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that 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

[[Page 18506]]

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

FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary 
Medicine, (HFV-151), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8204, e-mail: julia.oriani@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
(208) entitled ``Draft Guidance for Industry on Guidances for 
the Validation of Analytical Methods Used in Residue Depletion 
Studies,'' VICH GL49. In recent years, many important initiatives have 
been undertaken by regulatory authorities and industry associations to 
promote the international harmonization of regulatory requirements. FDA 
has participated in efforts to enhance harmonization and has expressed 
its commitment to seek scientifically based harmonized technical 
procedures for the development of pharmaceutical products. One of the 
goals of harmonization is to identify and then reduce differences in 
technical requirements for drug development among regulatory agencies 
in different countries.
    FDA has actively participated in the International Conference on 
Harmonisation of Technical Requirements for Approval of Pharmaceuticals 
for Human Use for several years to develop harmonized technical 
requirements for the approval of human pharmaceutical and biological 
products among the EU, Japan, and the United States. The VICH is a 
parallel initiative for veterinary medicinal products. The VICH is 
concerned with developing harmonized technical requirements for the 
approval of veterinary medicinal products in the EU, Japan, and the 
United States, and includes input from both regulatory and industry 
representatives.
    The VICH Steering Committee is composed of member representatives 
from the European Commission, European Medicines Evaluation Agency, 
European Federation of Animal Health, Committee on Veterinary Medicinal 
Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal 
Health Institute, the Japanese Veterinary Pharmaceutical Association, 
the Japanese Association of Veterinary Biologics, and the Japanese 
Ministry of Agriculture, Forestry, and Fisheries.
    Four observers are eligible to participate in the VICH Steering 
Committee: One representative from the government of Australia/New 
Zealand, one representative from the industry in Australia/New Zealand, 
one representative from the government of Canada, and one 
representative from the industry of Canada. The VICH Secretariat, which 
coordinates the preparation of documentation, is provided by the 
International Federation for Animal Health (IFAH). An IFAH 
representative also participates in the VICH Steering Committee 
meetings.

II. Draft Guidance on the Validation of Analytical Methods Used in 
Residue Depletion Studies

    The VICH Steering Committee held a meeting on November 5, 2009, and 
agreed that the draft guidance document entitled ``Draft Guidances for 
the Validation of Analytical Methods Used in Residue Depletion 
Studies,'' (VICH GL49) should be made available for public comment. 
This draft VICH guidance document is one of a series developed to 
facilitate the mutual acceptance of residue chemistry data for 
veterinary drugs used in food-producing animals. This guidance was 
prepared after consideration of the current requirements for evaluating 
veterinary drug residues in the EU, Japan, the United States, 
Australia, New Zealand, and Canada.
    During the veterinary drug development process, residue depletion 
studies are conducted to determine the concentration of the residue or 
residues present in the edible products (tissues, milk, eggs, or honey) 
of animals treated with veterinary drugs. This information is used in 
regulatory submissions around the world. Submission of regulatory 
methods (postapproval control methods) and the validation requirements 
of the regulatory methods are usually well defined by various 
regulatory agencies worldwide and may even be defined by law. 
Consequently, it has been difficult to harmonize the procedures used 
for validation of these methods. However, the residue studies are 
generally conducted before the regulatory methods have been completed. 
Often the in-house validated residue methods provide the framework for 
the methods submitted for regulatory monitoring. Harmonization of the 
validation requirements for methodology used during residue studies and 
submitted to the regulatory agencies in support of the maximum residue 
limits and withdrawal periods should be achievable. It is the intent of 
this document to describe a validation procedure that is acceptable to 
the regulatory bodies of the EU, Japan, the United States, Australia, 
New Zealand, and Canada for use in the residue depletion studies. This 
validated method may continue on to become the ``regulatory method'' 
but that phase of the process will not be addressed in any detail in 
these guidances.
    FDA and the VICH Expert Working Group will consider comments about 
the draft guidance document.

III. Significance of Guidance

    This draft guidance, developed under the VICH process, has been 
revised to conform to FDA's good guidance practices regulation (21 CFR 
10.115). For example, the document has been designated ``guidance'' 
rather than ``guideline.'' In addition, guidance documents must not 
include mandatory language such as ``shall,'' ``must,'' ``require,'' or 
``requirement,'' unless FDA is using these words to describe a 
statutory or regulatory requirement.
    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 applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This draft guidance 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 sections 1-3 of this guidance have been 
approved under OMB control no. 0910-0032.

V. 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.

VI. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either https://www.fda.gov/AnimalVeterinary/

[[Page 18507]]

default.htm or https://www.regulations.gov.

    Dated: April 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8230 Filed 4-9-10; 8:45 am]
BILLING CODE 4160-01-S

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