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Statement of Need: The intent of this proposal is to address a request made by our stakeholders and to more clearly communicate product performance information to the user by requiring a uniform label format and a summary of efficacy and safety data (with confidential business information removed).

Summary of the Legal Basis: APHIS administers and enforces the Virus-Serum-Toxin Act, as amended (21 U.S.C. 151 to 159). The regulations issued pursuant to the Act are intended to ensure that veterinary biological products are pure, safe, potent, and efficacious when used according to label instructions.

Alternatives: We could retain the current APHIS labeling guidance, but maintaining the status quo would not address the concern reported by stakeholders concerning the interpretation of product performance.

Anticipated Costs and Benefits: APHIS anticipates that the only costs associated with the proposed labeling format would be one-time costs incurred by licensees and permittees in having labels for existing licensed products updated in accordance with the proposed new format. A simpler, uniform label format would allow biologics licensees and permittees to more clearly communicate product performance information to the end user. In addition, the rule would simplify the evaluation of efficacy studies and reduce the amount of time required by APHIS to evaluate study data, thus allowing manufacturers to market their products sooner.

Risks: APHIS has not identified any risks associated with this proposed action.