[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