Current Good Manufacturing Practice Regulations For Type A Medicated Articles and Medicated Feeds

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Comment from Pharmgate Inc.pdf	Public Comments	Uploaded 2026-06-25	Available
0152_0154 Supporting Statement 06_18_2026.docx	Supporting Statement A	Uploaded 2026-06-23	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5764	Recordkeeping requirements for registered/licensed and non-registered/non-licensed commercial feed mills and mixer/feeders		Modified
281170	Recordkeeping requirements for cGMP Regulations for Type A Medicated Feeds		New

ICR Details

OMB Control No: 0910-0152	ICR Reference No: 202601-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202212-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Current Good Manufacturing Practice Regulations For Type A Medicated Articles and Medicated Feeds
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/26/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2026
Responses	2,791,120	16,493,487
Time Burden (Hours)	1,410,846	2,162,819
Cost Burden (Dollars)	2,793,499	0

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Abstract: This ICR concerns the recordkeeping requirements of FDA’s current good manufacturing practice (cGMP) regulations for medicated feeds and for Type A medicated articles. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease, or growth promotion and feed efficiency. A manufacturer is required to establish, maintain, and retain records for a medicated feed, including records to document procedures required during the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (i.e. batch and stability testing), labels, and product distribution. A Type A medicated article is a feed product containing a concentrated drug diluted with a feed carrier substance. A Type A medicated article is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease or for growth promotion and feed efficiency. Under part 226, a manufacturer is required to establish, maintain, and retain records for Type A medicated articles, including records to document procedures required under the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (i.e. batch and stability testing), and product distribution. These records are subject to FDA review during an inspection. Medicated feeds that are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

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Authorizing Statute(s): US Code: 21 USC 351 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:
	91 FR 9285	02/25/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 36863	06/18/2026
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Recordkeeping requirements for cGMP Regulations for Type A Medicated Feeds
Recordkeeping requirements for registered/licensed and non-registered/non-licensed commercial feed mills and mixer/feeders

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ICR Summary of Burden

table that charts list 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	2,791,120	16,493,487	0	89,050	-13,791,417	0
Annual Time Burden (Hours)	1,410,846	2,162,819	0	89,050	-841,023	0
Annual Cost Burden (Dollars)	2,793,499	0	0	2,793,499	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: After review of the information collection, we have reduced the number of CGMP for medicated feeds recordkeepers by 2,722. The reduction accurately reflects the current number of firms that hold a medicated feed mill license and the number of firms that are listed in the FDA database as manufacturing with medicated feeds and meet the definition of a commercial feed manufacturing facility. With this update, we note a corresponding decrease of 13,731,017 records and a decrease of 913,153 hours.

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Annual Cost to Federal Government: $64,296

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.     Yes

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: 06/26/2026

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