Effectiveness Indications Statements in Veterinary Biologics Labeling

Docket ID: APHIS-2011-0049
Agency: Animal and Plant Health Inspection Service (APHIS)
Parent Agency: Department of Agriculture (USDA)

This rulemaking amends 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. Under this rulemaking, the previous label format, which reflected any of four different levels of effectiveness, is replaced with a single, uniform label format. We are also requiring biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A simpler label format, along with publicly available safety and efficacy data, will help biologics producers to more clearly communicate product performance to their customers.


RIN: 0579-AD64
Impacts and Effects: None
CFR Citation: 9 CFR 112
Priority: Substantive, Nonsignificant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Fall 2015
Agenda Stage of Rulemaking: Completed Action
Major Rule: No
Legal Authorities: 21 U.S.C. 151 to 159
Legal Deadlines: None
Government Levels Affected: No
Federalism Implications: No
Unfunded Mandates: No
Requires Regulatory Flexibility Analysis: Business
Small Entities Affected: No
International Impacts: No
Included in Regulatory Plan: No
ActionDateFR Citation
Notice05/24/201176 FR 30093
Comment Period End07/25/2011
NPRM04/21/201479 FR 22048
NPRM Comment Period End06/20/2014
Final Rule07/10/201580 FR 39669
Final Rule Effective09/08/2015
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Category: Domestic Animal Health Programs
Keyword(s): USDA, agriculture
Type: Rulemaking
Program: Veterinary Services

Primary Documents

View All  (4)
Comment Period Closed
Jun 20, 2014 11:59 PM ET
Proposed Rule
Posted: 04/21/2014
ID: APHIS-2011-0049-0010
Comment Period Closed
Jul 25, 2011 11:59 PM ET
Posted: 05/24/2011
ID: APHIS-2011-0049-0001
Comment Period Closed
Posted: 07/20/2016
ID: APHIS-2011-0049-0021
Comment Period Closed
Posted: 07/10/2015
ID: APHIS-2011-0049-0019

Supporting Documents

View All  (4)
Comments Not Accepted
Supporting & Related Material
Posted: 07/10/2015
ID: APHIS-2011-0049-0020
Comments Not Accepted
Supporting & Related Material
Posted: 04/22/2014
ID: APHIS-2011-0049-0011
Comments Not Accepted
Supporting & Related Material
Posted: 05/24/2011
ID: APHIS-2011-0049-0002


View All  (13)

Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Current Stage
Agency Contact
Donna L Malloy
Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS
301 851-3426
4700 River Road, Unit 148
Riverdale, MD 20737-1231
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.