[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Proposed Rules]
[Page 58323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23202]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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  Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / 
Proposed Rules  

[[Page 58323]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 107

[Docket No. APHIS-2011-0048]
RIN 0579-AD66


Viruses, Serums, Toxins, and Analogous Products; Exemptions From 
Preparation Pursuant to an Unsuspended and Unrevoked License

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: We are reopening the comment period for our proposed rule that 
clarified our interpretation of the veterinary practitioner exemption 
provided by the Virus-Serum-Toxin Act. This action will allow 
interested persons additional time to prepare and submit comments.

DATES: We will consider all comments that we receive on or before 
November 16, 2012.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2011-0048-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2011-0048, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2011-
0048 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Operational Support 
Section, Center for Veterinary Biologics, Policy, Evaluation, and 
Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-
1231; phone (301) 851-3426, fax (301) 734-4314.

SUPPLEMENTARY INFORMATION: The Virus-Serum-Toxin Act, as amended (21 
U.S.C. 151-159) includes an exemption that allows veterinary biologics 
to be prepared by a veterinary practitioner solely for administration 
to animals in the course of a State-licensed professional practice of 
veterinary medicine under a veterinarian-client-patient relationship. 
On July 18, 2012, we published in the Federal Register (77 FR 42195-
42197, Docket No. APHIS-2011-0048) a proposal that clarified our 
interpretation of this exemption.
    Comments on the proposed rule were required to be received on or 
before September 17, 2012. We are reopening the comment period on 
Docket No. APHIS-2011-0048 for an additional 60 days. This action will 
allow interested persons additional time to prepare and submit 
comments. We will also consider all comments received between September 
18, 2012, (the day after the close of the original comment period) and 
the date of this notice.

    Authority:  21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 14th day of September 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-23202 Filed 9-19-12; 8:45 am]
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