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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2018-N-3353]
 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 June 6, 2022.
 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 0910-0659. 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, 
                        *PRAStaff@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA 
                    ( print page 26765)
                    has submitted the following proposed collection of information to OMB for review and clearance. Antimicrobial Animal Drug Distribution Reports and Recordkeeping—21 CFR 514.87 OMB Control Number 0910-0659—Extension Sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient are required by section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b) to submit to FDA an annual report on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals. Sponsors are also required to maintain distribution records for their animal drug products, including separate information for each month of the calendar year, under section 512(l)(3) of the FD&C Act. These provisions were enacted to assist FDA in our continuing analysis of the interactions (including drug resistance), efficacy, and safety of antimicrobials approved for use in both humans and food-producing animals for the purpose of mitigating the public health risk associated with antimicrobial resistance. Section 514.87 of our regulations (21 CFR 514.87) codifies the reporting requirements established in the FD&C Act. Sponsors submit antimicrobial animal drug sales and distribution reports to us on Form FDA 3744. Each report must specify: (1) The amount of each antimicrobial active ingredient by container size, strength, and dosage form; (2) quantities distributed domestically and quantities exported; and (3) a listing of the target animals, indications, and production classes that are specified on the approved label of the product. The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year. Each report must also provide a species-specific estimate of the percentage of each product that was sold or distributed domestically in the reporting year for use in cattle, swine, chickens, or turkeys for such species that appear on the approved label. In the 
                    **Federal Register**
                     of November 9, 2021 (86 FR 62178), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: Table 1—Estimated Annual Reporting Burden 1
21 CFR section
FDA form
Number of
                             respondents
Number of
                             responses per 
                             respondent
Total annual
                             responses
Average
                             burden per 
                             response
Total hours514.87(a)-(e)—Annual Reports for Sponsors With Active Applications—Paper Submission
3,744
4
1.5
6
62
372514.87(a)-(e)—Annual Reports for Sponsors With Active Applications—Electronic Submission
3,744
16
9.1
146
52
7,592514.87(a)-(e)—Annual Reports for Sponsors With Inactive Applications—Paper Submission
3,744
5
3
15
2
30514.87(a)-(e)—Annual Reports for Sponsors With Inactive Applications—Electronic Submission
3,744
16
12.6
201
2
402Total





8,3961
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 We base our estimate of the average burden per response on our recent experience with the existing antimicrobial animal drug distribution reports program. We base our estimate of the number of affected respondents reported in tables 1 and 2 and the average number of responses per respondent in table 1 on a review of our records of sponsors with active and inactive applications. We estimate that 20 sponsors will have active applications, and we assume that 75 percent of the respondents will report electronically, while the other 25 percent will report on paper. We estimate that 4 sponsors with active applications will spend 62 hours annually to assemble the necessary information, prepare, and submit an annual antimicrobial animal drug sales and distribution report on paper and 16 sponsors with active applications will spend 52 hours annually to assemble the necessary information, prepare, and electronically submit an annual antimicrobial animal drug sales and distribution report. We estimate that 21 sponsors will have inactive applications, and we assume that 93 percent of these respondents will report electronically, while the other 7 percent will report on paper. We estimate that sponsors with inactive applications will spend 2 hours to prepare their annual antimicrobial animal drug sales and distribution reports, whether electronically or on paper. Table 2—Estimated Annual Recordkeeping Burden 1
Activity
Number of
                             respondents
Number of
                             records per 
                             respondent
Total annual
                             records
Average
                             burden per 
                             recordkeeping
Total hoursRecordkeeping required by section 512(l)(3) of the FD&C Act
21
1
21
2
421
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 
 
 Animal drug manufacturers are already required to maintain distribution records for their animal drug products to comply with FDA's current good manufacturing regulations for periodic drug reports under § 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)), approved under OMB control number 0910-0284. Section 512(l)(3) of the FD&C Act differs from § 514.80(b)(4)(i) in that it requires that records include separate information for each month of the calendar year. In addition, under 21 CFR 211.196 (approved under OMB control number 0910-0139), manufacturers currently are required to maintain distribution records that include dosage form, and date drug is distributed. Based on these requirements, FDA believes that manufacturers already keep detailed records of the dates when antimicrobial drugs are distributed for marketing and recall purposes from which monthly reports can be prepared as part of usual and customary business practices. However, FDA estimates an additional recordkeeping burden of 42 hours for further compliance with section 512(l)(3) of the FD&C Act, as detailed in table 2. We have adjusted our burden estimate, which has resulted in a decrease to the currently approved burden. We attribute this to respondents who reported by paper in previous years and are now reporting electronically. We also note a decrease in recordkeeping respondents. We attribute this to the mergers of sponsors over the years. Dated: April 29, 2022. Lauren K. Roth, Associate Commissioner for Policy.


[FR Doc. 2022-09632 Filed 5-4-22; 8:45 am] BILLING CODE 4164-01-P