# Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals
**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:**
Submit written comments (including recommendations) on the collection of information by February 12, 2021.
**ADDRESSES:**
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to *https://www.reginfo.gov/public/do/PRAMain.* Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0325. Also include the FDA docket number found in brackets in the heading of this document.
**FOR FURTHER INFORMATION CONTACT:**
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, *[email protected]* .
**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 for Animals—21 CFR 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 prevent the 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, Federal, and/or State Agencies; academia; or individuals.
In the *Federal Register* of August 6, 2020 (85 FR 47794), we published a 60-day notice requesting public comment on the proposed collection of information. One comment was received but was not responsive to topics solicited regarding the information collection.
We estimate the burden of this collection of information as follows:
| 21 CFR part | Number of | Number of | Total annual responses | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| 530.22(b); Submission(s) of Analytical Method | 2 | 1 | 2 | 4,160 | 8,320 |
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
Dated: January 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.