Guidance for Industry; Small Entities Compliance Guide-The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Availability, 53972-53973 [2010-21981]

Download as PDF 53972 Federal Register / Vol. 75, No. 170 / Thursday, September 2, 2010 / Notices requirements of the applicable statute and regulations. DEPARTMENT OF HEALTH AND HUMAN SERVICES III. Electronic Access Food and Drug Administration Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘Impact-Resistant Lenses: Questions and Answers,’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number (23) to identify the guidance you are requesting. A search capability for all CDRH guidance documents is available at https://www.fda.gov/ MedicalDevices/DeviceRegulation andGuidance/GuidanceDocuments/ default.htm. Guidance documents are also available at https:// www.regulations.gov. [Docket No. FDA–2010–D–0435] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. Dated: August 27, 2010. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. The Food and Drug Administration (FDA) is announcing the availability of a Level 2 guidance for industry #201 entitled ‘‘Small Entities Compliance Guide—The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.’’ This small entities compliance guide aids industry in complying with the requirements of the final rule that published in the Federal Register of December 6, 2007. This regulation establishes administrative procedures and criteria for index listing a new animal drug for use in a minor species as provided by the Minor Use and Minor Species Animal Health Act of 2004 (MUMS). 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 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 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: Joan Gotthardt, Center for Veterinary Medicine (HFV–50), Food and Drug Administration, 7500 Standish Pl., MPN2, rm. N371, Rockville, MD 20855, 240–276–9090, email: Joan.gotthardt@fda.hhs.gov. [FR Doc. 2010–21908 Filed 9–1–10; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4160–01–S I. Background IV. Paperwork Reduction Act of 1995 This 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 21 CFR 801.109 have been approved under OMB Control No. 0910–0485; the collections of information in 21 CFR 807.87 have been approved under OMB Control No. 0910–0120; and the collections of information in 21 CFR Part 820 have been approved under OMB Control No. 0910–0073. V. 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. wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 Guidance for Industry; Small Entities Compliance Guide—The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Availability SUMMARY: FDA is announcing the availability of a Level 2 guidance for industry #201 entitled ‘‘Small Entities Compliance VerDate Mar<15>2010 15:22 Sep 01, 2010 Jkt 220001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 Guide—The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.’’ This guidance aids industry in complying with the requirements of the final rule published in the Federal Register of December 6, 2007 (72 FR 69108) (the indexing regulation). FDA has prepared this guidance 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 572 of the MUMS act. Congress, in enacting MUMS, 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). The indexing regulation establishes procedures and criteria for index listing a new animal drug for use in a minor species. II. Significance of Guidance This level 2 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. III. Paperwork Reduction Act of 1995 This 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 section 572 of the MUMS act have been approved under OMB Control No. 0910– 0620. IV. 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. E:\FR\FM\02SEN1.SGM 02SEN1 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

Agencies

[Federal Register Volume 75, Number 170 (Thursday, September 2, 2010)]
[Notices]
[Pages 53972-53973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21981]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0435]

Guidance for Industry; Small Entities Compliance Guide--The Index
of Legally Marketed Unapproved New Animal Drugs for Minor Species;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a Level 2 guidance for industry 201 entitled
``Small Entities Compliance Guide--The Index of Legally Marketed
Unapproved New Animal Drugs for Minor Species.'' This small entities
compliance guide aids industry in complying with the requirements of
the final rule that published in the Federal Register of December 6,
2007. This regulation establishes administrative procedures and
criteria for index listing a new animal drug for use in a minor species
as provided by the Minor Use and Minor Species Animal Health Act of
2004 (MUMS).

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 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. 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: Joan Gotthardt, Center for Veterinary
Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl.,
MPN2, rm. N371, Rockville, MD 20855, 240-276-9090, email:
Joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a Level 2 guidance for
industry 201 entitled ``Small Entities Compliance Guide--The
Index of Legally Marketed Unapproved New Animal Drugs for Minor
Species.'' This guidance aids industry in complying with the
requirements of the final rule published in the Federal Register of
December 6, 2007 (72 FR 69108) (the indexing regulation).
FDA has prepared this guidance 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 572 of the MUMS act. Congress, in
enacting MUMS, 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). The indexing regulation establishes procedures and
criteria for index listing a new animal drug for use in a minor
species.

II. Significance of Guidance

This level 2 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.

III. Paperwork Reduction Act of 1995

This 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 section 572 of the MUMS act have been
approved under OMB Control No. 0910-0620.

IV. 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.

[[Page 53973]]

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

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