Medicated Feed Mill License Application

Forms and Documents

Document Name	Status
Form FDA 3448 Medicated Feed Mill License - 21 CFR 515 Form and Instruction	Modified
0337 Medicated Feed 83-C forms and addresses JUNE 2024.docx Justification for No Material/Nonsubstantive Change	2024-06-27
0337 SupportingStatement 02_06_2025.docx Supporting Statement A	2025-02-06

IC Document Collections

IC ID	Document Title	Status
5931	Medicated Feed Mill License - 21 CFR 515 Form and Instruction	Modified
191908	Maintenance of Records for Appoved Labeling fo Each "Type B" and "Type C" Labeling	Modified

ICR Details

OMB Control No: 0910-0337	ICR Reference No: 202409-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202405-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Medicated Feed Mill License Application
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/12/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2025
Responses	828	830
Time Burden (Hours)	39	36
Cost Burden (Dollars)	0	0

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Abstract: This collection of information supports implementation of requirements found in 21 CFR part 515. Manufacturers seeking a facility license submit a completed medicated feed mill license application using Form FDA 3448. We require the submission of a supplemental medicated feed mill license application for a change in facility ownership or a change in facility address. Respondents to the collection of information are those seeking a medicated feed mill license in accordance with FDA regulations.

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Authorizing Statute(s): US Code: 21 USC 360b Name of Law: Federal Food, Drug and Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 94740	11/29/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 18679	05/01/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Medicated Feed Mill License - 21 CFR 515	FDA 3448	Medicated Feed Mill License Application
Maintenance of Records for Appoved Labeling fo Each "Type B" and "Type C" Labeling

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	828	830	0	0	-2	0
Annual Time Burden (Hours)	39	36	0	0	3	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $1,711

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/12/2025

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