81_FR_47144 81 FR 47005 - Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products

81 FR 47005 - Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 81, Issue 139 (July 20, 2016)

Page Range47005-47005
FR Document2016-17073

In a final rule published in the Federal Register on July 10, 2015, and effective on September 8, 2015, we amended the Virus-Serum- Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. Among other things, we provided the address of a Web site for accessing transmittal forms to be used with each submission of sketches and labels. However, the Web site address provided is incorrect. Therefore, we are amending the regulations to provide the correct address.

Federal Register, Volume 81 Issue 139 (Wednesday, July 20, 2016) 
[Federal Register Volume 81, Number 139 (Wednesday, July 20, 2016)]
[Rules and Regulations]
[Page 47005]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17073]



[[Page 47005]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 112

[Docket No. APHIS-2011-0049]
RIN 0579-AD64


Viruses, Serums, Toxins, and Analogous Products; Single Label 
Claim for Veterinary Biological Products

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule; technical amendment.

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

SUMMARY: In a final rule published in the Federal Register on July 10, 
2015, and effective on September 8, 2015, we amended the Virus-Serum-
Toxin Act regulations to provide for the use of a simpler labeling 
format that would better communicate product performance to the user. 
Among other things, we provided the address of a Web site for accessing 
transmittal forms to be used with each submission of sketches and 
labels. However, the Web site address provided is incorrect. Therefore, 
we are amending the regulations to provide the correct address.

DATES: Effective July 20, 2016.

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; 
(301) 851-2352.

SUPPLEMENTARY INFORMATION: In a final rule \1\ that was published in 
the Federal Register on July 10, 2015 (80 FR 39669-39675, Docket No. 
APHIS-2011-0049), and effective on September 8, 2015, we amended the 
Virus-Serum-Toxin Act regulations to provide for the use of a simpler 
labeling format that would better communicate product performance to 
the user. Among other things, we provided the address of a Web site in 
Sec.  112.5(a) for accessing transmittal forms to be used with each 
submission of sketches (including proofs) and labels. However, the Web 
site address provided is for accessing product licensing data and not 
transmittal forms. Therefore, we are amending Sec.  112.5(a) to correct 
the address.
---------------------------------------------------------------------------

    \1\ To view the final rule and supporting documents, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0049.
---------------------------------------------------------------------------

Lists of Subjects in 9 CFR Part 112

    Animal biologics, Exports, Imports, Labeling, packaging and 
containers, Reporting and recordkeeping requirements.

    Accordingly, we are amending 9 CFR part 112 as follows:

PART 112--PACKAGING AND LABELING

0
1. The authority citation for part 112 continues to read as follows:

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


Sec.  112.5  [Amended]

0
2. In Sec.  112.5, paragraph (a) is amended by removing the words 
``(productdata.aphis.usda.gov)'' and adding the words ``(http://www.aphis.usda.gov/animalhealth/cvb/forms)'' in their place.

    Done in Washington, DC, this 14th day of July 2016.
Jere L. Dick,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-17073 Filed 7-19-16; 8:45 am]
 BILLING CODE 3410-34-P

Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Rules and Regulations 47005 DEPARTMENT OF AGRICULTURE Lists of Subjects in 9 CFR Part 112 obtain publicly-available information Animal biologics, Exports, Imports, related to this action by any of the Animal and Plant Health Inspection following methods: Labeling, packaging and containers, Service Reporting and recordkeeping • Federal Rulemaking Web site: Go to requirements. http://www.regulations.gov and search 9 CFR Part 112 for Docket ID NRC–2016–0117. Address Accordingly, we are amending 9 CFR questions about NRC dockets to Carol part 112 as follows: Gallagher; telephone: 301–415–3463; [Docket No. APHIS–2011–0049] PART 112—PACKAGING AND email: Carol.Gallagher@nrc.gov. For RIN 0579–AD64 LABELING other questions, contact the individual listed in the FOR FURTHER INFORMATION Viruses, Serums, Toxins, and ■ 1. The authority citation for part 112 CONTACT section of this document. Analogous Products; Single Label continues to read as follows: • NRC’s Public Document Room Claim for Veterinary Biological (PDR): You may examine and purchase Authority: 21 U.S.C. 151–159; 7 CFR 2.22, Products 2.80, and 371.4. copies of public documents at the NRC’s PDR, Room O1–F21, One White Flint AGENCY: Animal and Plant Health § 112.5 [Amended] North, 11555 Rockville Pike, Rockville, Inspection Service, USDA. Maryland 20852. ■ 2. In § 112.5, paragraph (a) is amended ACTION: Final rule; technical by removing the words FOR FURTHER INFORMATION CONTACT: amendment. ‘‘(productdata.aphis.usda.gov)’’ and Tison Campbell, Office of the General adding the words ‘‘(http:// Counsel, telephone: 301–287–9290, SUMMARY: In a final rule published in email: Tison.Campbell@nrc.gov, U.S. the Federal Register on July 10, 2015, www.aphis.usda.gov/animalhealth/cvb/ forms)’’ in their place. Nuclear Regulatory Commission, and effective on September 8, 2015, we Washington DC 20555–0001. amended the Virus-Serum-Toxin Act Done in Washington, DC, this 14th day of regulations to provide for the use of a July 2016. SUPPLEMENTARY INFORMATION: simpler labeling format that would Jere L. Dick, I. Summary of Changes better communicate product Acting Administrator, Animal and Plant Health Inspection Service. In 1962, the Atomic Energy performance to the user. Among other Commission (the NRC’s predecessor things, we provided the address of a [FR Doc. 2016–17073 Filed 7–19–16; 8:45 am] agency) adopted revised rules of Web site for accessing transmittal forms BILLING CODE 3410–34–P practice and procedure to govern the to be used with each submission of conduct of adjudicatory proceedings sketches and labels. However, the Web before the agency (27 FR 377; January site address provided is incorrect. NUCLEAR REGULATORY 13, 1962). As part of those regulations, Therefore, we are amending the COMMISSION the Commission adopted a paragraph regulations to provide the correct governing the correction of hearing address. 10 CFR Part 2 transcripts. That provision, originally at DATES: Effective July 20, 2016. [NRC–2016–0117] § 2.750(b) of title 10 of the Code of FOR FURTHER INFORMATION CONTACT: Dr. RIN 3150–AJ76 Federal Regulations (10 CFR), provided Donna Malloy, Operational Support specific, prescriptive direction to the Section, Center for Veterinary Biologics, Update to Transcript Correction Commission’s staff regarding the Policy, Evaluation, and Licensing, VS, Procedures method for recording and showing APHIS, 4700 River Road, Unit 148, corrections to transcripts. For example, Riverdale, MD 20737; (301) 851–2352. AGENCY: Nuclear Regulatory the Secretary was directed to make any Commission. physical corrections to the official SUPPLEMENTARY INFORMATION: In a final rule 1 that was published in the Federal ACTION: Final rule. transcript, not by replacing pages, but Register on July 10, 2015 (80 FR 39669– by drawing a line through the text to be SUMMARY: The U.S. Nuclear Regulatory changed in the original transcript and 39675, Docket No. APHIS–2011–0049), Commission (NRC) is amending its and effective on September 8, 2015, we writing the correct text immediately regulation that governs the correction of above. amended the Virus-Serum-Toxin Act official transcripts for agency regulations to provide for the use of a The current agency practice varies. In adjudicatory proceedings. The current Commission proceedings, an appendix simpler labeling format that would regulation has not been substantively better communicate product listing the transcript corrections and a updated since it was adopted in 1962 clean version of the transcript are performance to the user. Among other and the NRC’s internal procedures have things, we provided the address of a attached to the order adopting the evolved since that time to incorporate parties’ proposed transcript corrections. Web site in § 112.5(a) for accessing technological development. The NRC is transmittal forms to be used with each In Atomic Safety and Licensing Board not soliciting public comment on this Panel proceedings, the boards generally submission of sketches (including change because the change is limited to proofs) and labels. However, the Web issue an order adopting the parties’ joint an agency rule of procedure and proposed transcript corrections, with or site address provided is for accessing practice that does not affect the rights product licensing data and not without an appendix listing the and responsibilities of outside parties. corrections. The Secretary does not rmajette on DSK2TPTVN1PROD with RULES transmittal forms. Therefore, we are DATES: This final rule is effective on July prepare transcripts of board amending § 112.5(a) to correct the 20, 2016. proceedings. address. ADDRESSES: Please refer to Docket ID The NRC is, therefore, updating the 1 To view the final rule and supporting NRC–2016–0117 when contacting the regulation that governs the correction of documents, go to http://www.regulations.gov/ NRC about the availability of official transcripts for agency #!docketDetail;D=APHIS-2011-0049. information for this action. You may adjudicatory proceedings, currently at VerDate Sep<11>2014 14:53 Jul 19, 2016 Jkt 238001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\20JYR1.SGM 20JYR1


Document Created: 2018-02-08 07:57:24
Document Modified: 2018-02-08 07:57:24
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; technical amendment.
DatesEffective July 20, 2016.
ContactDr. Donna Malloy, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737; (301) 851-2352.
FR Citation81 FR 47005 
RIN Number0579-AD64
CFR AssociatedAnimal Biologics; Exports; Imports; Labeling; Packaging and Containers and Reporting and Recordkeeping Requirements
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR