This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
Animal and Plant Health Inspection Service, USDA.
Final rule; technical amendment.
In a final rule published in the Federal Register on August 30, 2016, and effective on October 31, 2016, we amended the Virus-Serum-Toxin Act regulations to make veterinary biologics labeling requirements more consistent with current science and veterinary practice. However, we inadvertently removed a requirement for an indications statement that should appear on final container labels, carton labels, and enclosures. This document corrects that error.
Effective November 8, 2016.
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.
In a final rule [1] that was published in the Federal Register on August 30, 2016 (81 FR 59427, Docket No. APHIS-2008-0008), and effective on October 31, 2016, we amended the Virus-Serum-Toxin Act regulations to make veterinary biologics labeling requirements more consistent with current science and veterinary practice. Among other things, in 9 CFR part 112, we amended § 112.2(a)(5) to clarify that “full instructions for the ( printed page 78500) proper use of the product” refers to vaccination schedules, revaccination schedules (if necessary), indications for use, target species, recommended age for vaccination, vaccination route(s), and product license restrictions prescribed by the Animal and Plant Health Inspection Service that have a bearing on product use. However, when we made that change, we inadvertently removed a requirement for an indications statement to appear on final container labels, carton labels, and enclosures. Therefore, we are amending § 112.2(a) to re-establish the requirement for an indications statement.
Accordingly, we are amending 9 CFR part 112 as follows:
1. The authority citation for part 112 continues to read as follows:
2. Section 112.2 is amended by adding paragraph (a)(12) to read as follows:
(a) * * *
(12) An indications statement to read, “This product has been shown to be effective for the vaccination of healthy (insert name of species) __ weeks of age or older against __.” Provided, That in the case of very small final container labels or carton, a statement as to where such information is to be found, such as “See enclosure for complete directions,” “Full directions on carton,” or comparable statement.
Done in Washington, DC, this 2nd day of November 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
1. To view the final rule and supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0008.
Back to Citation[FR Doc. 2016-26936 Filed 11-7-16; 8:45 am]
BILLING CODE 3410-34-P