PART 530 - EXTRALABEL DRUG USE IN ANIMALS

Description:

This final rule provides that FDA may require the development of an acceptable analytical method for the quantification of residues above an established safe level. FDA estimates that it will likely establish safe levels for one to two drugs per year if the rule is finalized, and that an analytical methodology for drug residue detection will be required for each of these drugs. If no method is provided, the Secretary may prohibit the extralabel use. This requirement may be fulfilled by any interested person. FDA believes that the sponsor may be willing to provide the methodology in some cases, while in others, FDA, the Sponsor, and perhaps a third party may negotiate a cooperative arrangement for method development

None of the 110 comments received had an impact on the Paperwork Reduction Act requirements. As a result, OMB has waived its option to review the paperwork at the final rule stage. Therefore, the information collection provisions in the final rule are approved under OMB Control No. 0910-0325 and are effective upon publication of this document. OMB approval expires on July 31, 1999. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.


IX. Congressional Review

This rule is not a major rule for purposes of 5 U.S.C. 801 et seq., Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121). Agency reports on this final rule have been submitted to Congress and the Comptroller General as required by 5 U.S.C. 801 et seq.


List of Subjects in 21 CFR Part 530

Administrative practice and procedures, Advertising, Animal drugs, Animal feeds, Drugs, Labeling, Prescription drugs, Reporting and recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, Title 21 of the Code of Federal Regulations is amended to add a new part 530 to read as follows:
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