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 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 § 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 § 112.5(a) to correct the address.

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

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.

2. In § 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.