90 FR 83 pgs. 18679-18680 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application
Type: NOTICEVolume: 90Number: 83Pages: 18679 - 18680
Pages: 18679, 18680Docket number: [Docket No. FDA-2024-N-4687]
FR document: [FR Doc. 2025-07584 Filed 4-30-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4687]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application
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 2, 2025.
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 0910-0337. 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 has submitted the following proposed collection of information to OMB for review and clearance.
Medicated Feed Mill License Application
OMB Control Number 0910-0337-Extension
[top] This information collection helps support implementation of statutory and regulatory provisions related to medicated animal feed mill licensing. Feed manufacturers that seek to manufacture a Type B or Type C medicated feed using Category II, Type A medicated articles or manufacture certain liquid and free-choice feed using Category I, Type A medicated articles that must follow proprietary formulas or specifications, are required to obtain a facility license under section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b). Our regulations in 21 CFR part 515 establish the procedures associated with applying for a facility license. We require that a manufacturer seeking a facility license submit a completed medicated feed mill license application using Form FDA 3448 (§?515.10(b) (21 CFR 515.10(b))). This form may be submitted via U.S. mail or electronically to a dedicated email address, MedicatedFeedsTeamMail@fda.hhs.gov. We use the information submitted to establish that the applicant has made the certifications required by section 512 of the FD&C Act, to register the mill, and to schedule a preapproval inspection. Form FDA 3448 may be accessed on our website at: https://
We require the submission of a supplemental medicated feed mill license application for a change in facility ownership or a change in facility address (§?515.11(b) (21 CFR 515.11(b))). If a licensed facility is no longer manufacturing medicated animal feed under §?515.23 (21 CFR 515.23), a manufacturer may request voluntary revocation of a medicated feed mill license. An applicant also has the right to file a request for hearing under §?515.30(c) (21 CFR 515.30(c)) to give reasons why a medicated feed mill license should not be refused or revoked.
Under §?510.305 (21 CFR 510.305), we require each applicant to maintain in a single accessible location: (a) A copy of the approved medicated feed mill license (Form FDA 3448) on the premises of the manufacturing establishment; and (b) approved or index listed labeling for each Type B and/or Type C feed being manufactured on the premises of the manufacturing establishment or the facility where the feed labels are generated.
In the Federal Register of November 29, 2024 (89 FR 94740), 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:
| 21 CFR section; activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| 515.10(b), 515.11(b); Medicated Feed Mill License Application and Supplemental Applications using Form FDA 3448 | 34 | 1 | 34 | 0.25 (15 minutes) | 8.5 |
| 515.23; Voluntary Revocation of Medicated Feed Mill License | 14 | 1 | 14 | 0.25 (15 minutes) | 3.5 |
| 515.30; Filing a Request for a Hearing on Medicated Feed Mill License | 1 | 1 | 1 | 4 | 4 |
| Total | 49 | 16 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
We estimate that respondents will spend 15 minutes to assemble the necessary information, prepare, and submit an application for a feed mill license or revocation of a feed mill license. We estimate that respondents will spend 4 hours to prepare their request for a hearing.
| 21 CFR section; activity | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| 510.305; Maintenance of Records for Approved Labeling for Each "Type B" and "Type C" Feed | 779 | 1 | 779 | 0.03 (2 minutes) | 23 |
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
We base our estimates on our recent experience with the existing medicated feed mill license application process. Our estimated burden for the information collection reflects an overall increase of 2.5 hours. We attribute this adjustment to a slight increase in the overall number of submissions we received over the last few years.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07584 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P