Document ID: FDA-2010-D-0435-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry; Availability, etc.: Small Entities Compliance GuideIndex of Legally Marketed Unapproved New Animal Drugs forMinor Species
Posted Date: 2010-09-02T04:00Z

[Federal Register: September 2, 2010 (Volume 75, Number 170)]
[Notices]               
[Page 53972-53973]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se10-66]                         

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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.

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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 http://
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 http://www.fda.gov/AnimalVeterinary/default.htm or http://
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