[Federal Register Volume 60, Number 8 (Thursday, January 12, 1995)]
[Rules and Regulations]
[Pages 2876-2877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-806]



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DEPARTMENT OF AGRICULTURE
9 CFR Part 112

[Docket No. 92-098-3]


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule; postponement of effective date.

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SUMMARY: This document postpones the effective date, upon which the 
final rule on the packaging and labeling of veterinary biological 
products takes effect, from February 21, 1995, to August 19, 1995. Upon 
the effective date, the final rule prohibits the repackaging and 
relabeling, for further sale or distribution, of final containers of 
product that are imported or that are packaged at licensed 
establishments in cartons or other containers. The extension of the 
effective date is necessary in order to allow a sufficient transition 
period and to ensure the continued availability of single-dose 
veterinary biologics.

EFFECTIVE DATE: The effective date of the final rule is postponed from 
February 21, 1995, to August 19, 1995.

FOR FURTHER INFORMATION CONTACT:
Dr. David A. Espeseth, Deputy Director, Veterinary Biologics, BBEP, 
APHIS, USDA, PO Drawer 810, Riverdale, MD 20738. The telephone number 
for the agency contact will change when agency offices in Hyattsville, 
MD, move to Riverdale, MD, during January 1995. Telephone: (301) 436-
8245 (Hyattsville); (301) 734-8245 (Riverdale).

SUPPLEMENTARY INFORMATION: Under authority of the Virus-Serum-Toxin Act 
(21 U.S.C. 151-159), as amended by the Food Security Act of 1985, the 
Animal and Plant Health Inspection Service (APHIS), U.S. Department of 
Agriculture, published a proposed rule on April 28, 1993 (58 FR 25786-
25788, Docket No. 92-098-1) on the packaging and labeling of veterinary 
biologics. During the 60-day comment period, thirty-nine comments were 
received. Thirty-six comments were in support of the rule; three were 
not. The final rule was published on August 24, 1994 (59 FR 43441-
43445, Docket No. 92-098-2). Unless otherwise exempted, the final rule 
prohibits the repackaging and relabeling, for further sale or 
distribution, of final containers of veterinary biologics that are 
imported or that are prepared in licensed establishments. The effective 
date of the final rule that was published on August 24, 1994, was to 
have been 180 days after the date of publication or February 21, 1995.
    Since the publication of the final rule, APHIS has received a large 
number of (in excess of 400) letters and numerous inquiries from 
congresspersons, a State governor, distributors, consumers, and 
representatives of kennel clubs and humane societies expressing concern 
that implementation of the final rule would result in a shortage of 
single-dose animal vaccines which could be sold without restriction. 
This shortage, it was claimed, would result in the failure to vaccinate 
a large number of animals that are currently vaccinated by owners. 
Based on these letters and inquiries and its own monitoring efforts, 
APHIS has determined that additional time is necessary to allow for 
coordination between producers and distributors of veterinary biologics 
in order to provide distributors and consumers with fully packaged and 
labeled single-dose biological products.
    Therefore, the effective date of the final rule that was published 
at 59 FR 43441-43445, August 24, 1994, Docket No. 92-098-2, is 
postponed until August 19, 1995.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).

    [[Page 2877]] Done in Washington, DC, this 6th day of January 
1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-806 Filed 1-11-95; 8:45 am]
BILLING CODE 3410-34-M