81 FR 78499 - Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 81, Issue 216 (November 8, 2016)

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.

[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Rules and Regulations]
[Pages 78499-78500]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26936]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 112

[Docket No. APHIS-2008-0008]
RIN 0579-AD19


Viruses, Serums, Toxins, and Analogous Products; Packaging and 
Labeling

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule; technical amendment.

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SUMMARY: 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.

DATES: Effective November 8, 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 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 Sec.  
112.2(a)(5) to clarify that ``full instructions for the

[[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 Sec.  112.2(a) to 
re-establish the requirement for an indications statement.
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    \1\ To view the final rule and supporting documents, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0008.
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List 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.


0
2. Section 112.2 is amended by adding paragraph (a)(12) to read as 
follows:


Sec.  112.2   Final container label, carton label, and enclosure.

    (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.
[FR Doc. 2016-26936 Filed 11-7-16; 8:45 am]
 BILLING CODE 3410-34-P