[Federal Register Volume 65, Number 105 (Wednesday, May 31, 2000)]
[Proposed Rules]
[Page 34599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13549]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 112

[Docket No. 96-034-2]


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule; withdrawal.

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SUMMARY: We are withdrawing a proposed rule to amend the regulations 
regarding the packaging and labeling of veterinary biological products. 
The proposed rule would have required the Animal and Plant Health 
Inspection Service product code number as well as an appropriate 
consumer contact telephone number to appear on labeling. In addition, 
the proposed rule would have clarified label requirements with respect 
to overshadowing the true name of the product and requirements for 
products shipped to a foreign country. The proposed rule also contained 
label requirements concerning the minimum age for product 
administration and the potential for maternal antibody interference. We 
are withdrawing the proposed rule due to the comments we received 
following its publication.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff 
Officer, Operational Support Section, Center for Veterinary Biologics, 
Licensing and Policy Development, APHIS, 4700 River Road Unit 148, 
Riverdale, MD 20737-1231; (301) 734-8245.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 112 set forth packaging and labeling 
requirements for veterinary biological products. On March 18, 1999, we 
published in the Federal Register (64 FR 13365-13368, Docket No. 96-
034-1) a proposed rule to amend the regulations. First, we proposed to 
require labels for veterinary biological products to include the Animal 
and Plant Health Inspection Service (APHIS) product code number and a 
consumer contact telephone number. Second, we proposed to require 
labels for veterinary biological products to bear the true name of the 
product in a prominent fashion and more prominently than the trade 
name. Third, we proposed to amend the requirements for labels for 
exported products to state that labels that do not conform to the 
regulations may be used with an exported product if the labels do not 
contain false or misleading information and are acceptable to the 
appropriate regulatory officials of the foreign country to which the 
products are exported. We proposed that verification of foreign 
regulatory acceptance of the labels could be supplied to APHIS through 
the submission of a label mounting prepared as described in 
Sec. 112.5(d)(2) that bears a stamp or other mark of approval of the 
appropriate foreign regulatory agency. Finally, we proposed to require 
labels for veterinary biological products, as described in the proposed 
rule, to consider the potential for maternal antibody interference with 
product efficacy and to specify a minimum age for product 
administration that is consistent with the efficacy and safety data 
developed for the product.
    We solicited comments concerning our proposal for 60 days ending 
May 17, 1999. We received 11 comments by that date. The comments were 
from licensed veterinary biologics manufacturers, a national trade 
association representing U.S. manufacturers of animal health products, 
an organization representing veterinarians, and a university. Most of 
the commenters expressed concerns and opposition regarding certain 
provisions of the proposed rule, including concerns regarding the 
economic effects of the proposed provisions on veterinary biologics 
manufacturers and the estimated burden for information collection that 
was provided in the Paperwork Reduction Act section of the proposed 
rule.
    After considering all of the comments we received, we have 
concluded that we must reevaluate the provisions of the proposed rule. 
Therefore, we are withdrawing the March 18, 1999, proposed rule 
referenced above. The concerns and recommendations of all of the 
commenters will be considered if any new proposed regulations regarding 
the packaging and labeling of veterinary biological products are 
developed.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).

    Done in Washington, DC, this 24th day of May 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-13549 Filed 5-30-00; 8:45am]
BILLING CODE 3410-34-U