Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226

Forms and Documents

Document Name	Status
0154 ss 7-27-2017.pdf Supporting Statement A	2017-07-27

IC Document Collections

IC ID	Document Title	Status
5767	Requirement that Records be Prepared and Maintained for Two Years with Respect to Components (Drug and Non-Drug) Used in the Manufacture of the Medicated Premixes	Modified
197524	Requirement for Maintenance of Complaint Files for Type A Medicated Articles for Two Years	Modified
197523	Requirement for Maintenance of Distribution Records for Each Shipment for Type A Medicated Articles for Two Years	Modified
197522	Requirement for Maintenance of Master-Formula and Batch Production Records for Type A Medicated Articles	Modified
197521	Requires Maintenance of Records for Packaging and Labeling of Type A Medicated Articles	Modified
197520	Specifies Recordkeeping Requirements for Establishment of Laboratory Controls to Ensure that Adequate Specifications and Test Procedures Conform to Appropriate Standards	Modified

ICR Details

OMB Control No: 0910-0154	ICR Reference No: 201707-0910-002
Status: Historical Active	Previous ICR Reference No: 201406-0910-017
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/28/2017
	Date Received in OIRA: 07/27/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2020	36 Months From Approved	08/31/2017
Responses	85,150	0	85,150
Time Burden (Hours)	89,050	0	89,050
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR concerns the recordkeeping requirements of FDA’s current good manufacturing practice (cGMP) regulations for Type A medicated articles in part 226 (21 CFR part 226). 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. Type A medicated articles which 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 301 et seq. 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:
	81 FR 71513	10/17/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 32834	07/18/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Requirement that Records be Prepared and Maintained for Two Years with Respect to Components (Drug and Non-Drug) Used in the Manufacture of the Medicated Premixes
Specifies Recordkeeping Requirements for Establishment of Laboratory Controls to Ensure that Adequate Specifications and Test Procedures Conform to Appropriate Standards
Requires Maintenance of Records for Packaging and Labeling of Type A Medicated Articles
Requirement for Maintenance of Master-Formula and Batch Production Records for Type A Medicated Articles
Requirement for Maintenance of Distribution Records for Each Shipment for Type A Medicated Articles for Two Years
Requirement for Maintenance of Complaint Files for Type A Medicated Articles for Two Years

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ICR Summary of Burden

	Total Approved	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	85,150	85,150	0	0	0	0
Annual Time Burden (Hours)	89,050	89,050	0	0	0	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:

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Annual Cost to Federal Government: $41,353

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.     No

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? Uncollected

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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: 07/27/2017

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