Viruses, Serums, Toxins, and Analogous Products; Exemptions From Preparation Pursuant to an Unsuspended and Unrevoked License, 58323 [2012-23202]

Download as PDF 58323 Proposed Rules Federal Register Vol. 77, No. 183 Thursday, September 20, 2012 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. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2011–0048] RIN 0579–AD66 Viruses, Serums, Toxins, and Analogous Products; Exemptions From Preparation Pursuant to an Unsuspended and Unrevoked License Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule; reopening of comment period. AGENCY: 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 https://www.regulations.gov/ #!documentDetail;D=APHIS-2011-00480001. • 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 https:// 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 wreier-aviles on DSK5TPTVN1PROD with PROPOSALS VerDate Mar<15>2010 14:44 Sep 19, 2012 Jkt 226001 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. The VirusSerum-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-clientpatient 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. SUPPLEMENTARY INFORMATION: 9 CFR Part 107 SUMMARY: help you, please call (202) 799–7039 before coming. 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] BILLING CODE 3410–34–P PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA–2012–0986; Directorate Identifier 2012–NM–077–AD] RIN 2120–AA64 Airworthiness Directives; Gulfstream Aerospace LP (Type Certificate Previously Held by Israel Aircraft Industries, Ltd.) Airplanes Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). AGENCY: We propose to adopt a new airworthiness directive (AD) for all Gulfstream Aerospace LP (Type Certificate Previously Held by Israel Aircraft Industries, Ltd.) Model Gulfstream G150 airplanes. This proposed AD was prompted by a review that determined that the runway slope and anti-ice corrections to V1 and takeoff distances in the Gulfstream G150 Airplane Flight Manual (AFM) were presented in a non-conservative manner. This proposed AD would require revising the performance section of the AFM to include procedures to advise the flightcrew of certain runway slope and anti-ice corrections and takeoff distance values. We are proposing this AD to prevent the use of published non-conservative data, which could result in the inability to meet the required take-off performance, with consequent hazard to safe operation during performance-limited take-off operations. DATES: We must receive comments on this proposed AD by November 5, 2012. ADDRESSES: You may send comments by any of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments. • Fax: (202) 493–2251. • Mail: U.S. Department of Transportation, Docket Operations, M– 30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. • Hand Delivery: U.S. Department of Transportation, Docket Operations, M– 30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 SUMMARY: E:\FR\FM\20SEP1.SGM 20SEP1

Agencies

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


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

========================================================================


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.

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

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 https://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 https://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]
BILLING CODE 3410-34-P

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