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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2008-N-0312]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
 DATES: Fax written comments on the collection of information by February 9, 2018.
 ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, 
                        ( print page 1263)
                        OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to 
                        *oira_submission@omb.eop.gov.*
                         All comments should be identified with the OMB control number 0910-0325. Also include the FDA docket number found in brackets in the heading of this document.
 FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
                        *PRAStaff@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION: In compliance with 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 Number 0910-0325—Extension The Animal Medicinal Drug Use Clarification Act of 1994 (Pub. L. 103-396) allows a veterinarian to prescribe the extralabel use of approved new animal drugs. Also, it permits FDA, if it finds that there is a reasonable probability that the extralabel use of an animal drug may present a risk to the public health, to establish a safe level for a residue from the extralabel use of the drug, and to require the development of an analytical method for the detection of residues above that established safe level (21 CFR 530.22(b)). Although, to date, we have not established a safe level for a residue from the extralabel use of any new animal drug and, therefore, have not required the development of analytical methodology, we believe that there may be instances when analytical methodology will be required. We are, therefore, estimating the reporting burden based on two methods being required annually. The requirement to establish an analytical method may be fulfilled by any interested person. We believe that the sponsor of the drug will be willing to develop the method in most cases. Alternatively, FDA, the sponsor, and perhaps a third party may cooperatively arrange for method development. The respondents may be sponsors of new animal drugs, State, or Federal and/or State Agencies, academia, or individuals. In the 
                    **Federal Register**
                     of June 26, 2017 (82 FR 28858), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1—Estimated Annual Reporting Burden 1
21 CFR section
Number of
                             respondents
Number of
                             responses per 
                             respondent
Total annual
                             responses
Average
                             burden per 
                             response
Total
                             hours530.22(b), Submission(s) of Analytical Method
2
1
2
4,160
8,3201
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 The burden estimate has not changed, and remains the same. Dated: January 4, 2018. Leslie Kux, Associate Commissioner for Policy.


[FR Doc. 2018-00237 Filed 1-9-18; 8:45 am] BILLING CODE 4164-01-P