Document ID: FDA-2010-D-0432-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry; Availability, etc.: Small Entities Compliance GuideDesignation of New Animal Drugs for Minor Uses or MinorSpecies
Posted Date: 2010-09-02T04:00Z

[Federal Register: September 2, 2010 (Volume 75, Number 170)]
[Notices]               
[Page 53973]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se10-67]                         

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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.

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SUMMARY: 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 
self-addressed 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 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: 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:

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 
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.
    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 
http://www.fda.gov/cvm or http://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]
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