[Federal Register: June 30, 1999 (Volume 64, Number 125)] [Notices] [Page 35173-35174] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr30jn99-97] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 99N-0240] Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extralabel Drug Use in Animals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 ( the PRA). DATES: Submit written comments on the collection of information by July 30, 1999. ADDRESSES: Submit written comments on the collection of information to Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm 10235, Washington, DC 20503, Attention: Desk Officer for FDA. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA (44 U.S.C. 3507), FDA has submitted the following proposed collection of information to OMB for review and clearance. Extralabel Drug Use in Animals--21 CFR Part 530 (OMB Control No. 0910-0325--Extension) Description: The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) (Pub. L. 103-396), amended the Federal Food, Drug, and Cosmetic Act (the act), to permit licensed veterinarians to prescribe extralabel use in animals of approved human and new animal drugs. Regulations implementing provisions of AMDUCA were codified in 1996 at part 530 (21 CFR part 530). A provision of these regulations, Sec. 530.22(b), permits FDA to establish a safe level for the extralabel use in animals of an approved human or animal drug when the agency determines there is reasonable probability that this extralabel use may present a risk to the public health. The extralabel use in animals of an approved human or animal drug that results in residues exceeding the safe level is considered an unsafe use of the drug. In conjunction with the establishment of a safe level, FDA may request development of an acceptable residue detection method for an analysis of residues above any safe level established under this part. In some cases, the sponsor may be willing to provide this methodology, while in others, FDA, the sponsor, the U.S. Department of Agriculture (USDA), States, or a consortium of interested parties may negotiate a cooperative arrangement to develop such a methodology. If no acceptable analytical method is developed, the agency would be permitted to prohibit extralabel use of the drug. In the Federal Register of March 1, 1999 (64 FR 10002), the agency requested comments on the proposed collection of information. In response, FDA received one comment, which included several parts with questions. The comments and questions are listed in the following paragraphs with the agency's responses. The comment asked: ``How will FDA determine a safe level?'' As stated in the preamble to the final rule, the agency may establish a finite safe level based on all relevant scientific information (61 FR 57732 at 57741, November 7, 1996). The comment asked: ``What will they use?'' As stated in the rule, the agency may establish a safe level based on the lowest level that can be measured by a practical analytical method; or establish a safe level based on other appropriate scientific technical or regulatory criteria. The comment asked: ``If data [is] not in the approved information or in [the] general domain, then how will they collect it and who will pay for it?'' As stated in the preamble to the final rule (61 FR 57732), the sponsor may be willing to provide the methodology for residue detection in some cases, while in others, FDA, the sponsor, USDA, States, or a consortium of interested parties may negotiate a cooperative arrangement to develop methodology. Conceivably, a third party who might submit such data could include a distributor or group of distributors who wish to make the drug available for extralabel use. The comment asked: ``Will they force [a] company to collect the data to establish a safe level?'' FDA has no authority under AMDUCA or its implementing regulations to require a sponsor or any other person to collect data to establish a safe level for extralabel use if the sponsor or other person is not willing to do so. If the agency determines that an extralabel use in animals of a particular human drug or animal drug presents a risk to the public health, or if no required acceptable analytical method has been developed, the agency would be permitted to prohibit extralabel use of the drug. The comment asked: ``How much data will they demand to be collected ?'' The nature and extent of data necessary to establish a safe level or to develop an [[Page 35174]] analytical method will be determined on a case-by-case basis. The comment asked: ``Will this rule apply to old approved drugs or just new approvals ?'' This rule applies to the extralabel use in animals of currently approved new animal and human drugs and new approvals of human and new animal drugs. The comment asked: ``Who pays to have the analytical method developed ?'' As stated previously, the sponsor may be willing to provide the methodology for assay of residue in some cases, while in others, FDA, the sponsor, USDA, States, or a consortium of interested parties may negotiate a cooperative arrangement to development the methodology. Conceivably, a third party who might submit such data could include a distributor or group of distributors who wish to make a drug available for extralabel use. The comment asked: ``To what extent will it have to be validated and how many tissues will it have to be validated for?'' As stated in the preamble to the final rule, methods validation is anticipated to be necessary. The number of tissues for which method validation might be required would be determined on a case-by-case basis. The comment asked: ``If [there are] multiple approvals of [the] same active [ingredient], will they force all manufacturers to do the same work because of a different salt? If not, how will they decide who does the work?'' As was stated in the preamble to the final rule, the sponsor may be willing to provide the methodology for residue detection in some case, while in others, FDA, the sponsor, States, USDA, or a consortium of interested parties could negotiate a cooperative arrangement to develop the methodology. The third party could conceivably include a group of drug sponsors who might cooperatively submit data on behalf of all drugs with a particular active drug ingredient. The comment asked: ``What will they do to generic approvals? Force the originator to pay?'' FDA does not comtemplate requiring a sponsor or any other person to collect data to establish a safe level for extralabel use if the sponsor or other person is not willing to do so. If the agency determines that an extralabel use in animals of a particular human drug or animal drug presents a risk to the public health, or if no required acceptable analytical method has been developed, the agency would be permitted to prohibit extralabel use of the drug. The comment asked: ``If it is FDA's plan to demand this data for all existing drug[s] that might be used in food animals, please announce your intentions.'' FDA has no plan to require the submission of data for extralabel use for all existing drugs that might be used in food-producing animals. The respondents may be sponsors of new animal drugs, State(s) or Federal Government or individuals. FDA estimates the burden for this collection of information as follows: Table 1.--Estimated Annual Reporting Burden\1\ ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Respondents Response Responses Response ---------------------------------------------------------------------------------------------------------------- 530.22(b) 2 1 2 4,160 8,320 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Based on agency records and experience, the agency estimates that two methods of intermediate difficulty will be developed per year and each method may take up to two person years to develop. Dated: June 18, 1999. William K. Hubbard, Senior Associate Commissioner for Policy, Planning and Legislation. [FR Doc. 99-16593 Filed 6-29-99; 8:45 am] BILLING CODE 4160-01-F