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

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule; withdrawal.

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 § 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).