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

Forms and Documents

Document Name	Status
0154 SS Part A 2014.doc Supporting Statement A	2014-06-29

IC Document Collections

IC ID	Document Title	Status
5767	226.42 - Recordkeeping	Modified
197524	226.115 - Recordkeeping	Modified
197523	226.110 - Recordkeeping	Modified
197522	226.102 - Recordkeeping	Modified
197521	226.80 - Recordkeeping	Modified
197520	226.58 - Recordkeeping	Modified

ICR Details

OMB Control No: 0910-0154	ICR Reference No: 201406-0910-017
Status: Historical Active	Previous ICR Reference No: 201104-0910-012
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: 08/27/2014
	Date Received in OIRA: 06/30/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved	08/31/2014
Responses	85,150	0	150,650
Time Burden (Hours)	89,050	0	157,550
Cost Burden (Dollars)	0	0	0

---

Abstract: A "Type A" medicated article is a feed product containing a concentrated drug, diluted with a feed carrier substance. Medicated feeds are administered to animals for prevention, mitigation, or treatment of disease or for growth promotion and feed efficiency. This collection requests information regarding adherence to regultoary controls to ensure the quality control of these products. Respondents are manufacturers of human and veterinary drugs that produce Type A articles as well as commercial feed mills.

---

Authorizing Statute(s): US Code: 21 USC 350 Name of Law: null
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 19093	04/07/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 35360	06/20/2014
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
226.42 - Recordkeeping
226.58 - Recordkeeping
226.80 - Recordkeeping
226.102 - Recordkeeping
226.110 - Recordkeeping
226.115 - Recordkeeping

---

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	150,650	0	-65,500	0	0
Annual Time Burden (Hours)	89,050	157,550	0	-68,500	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is an extension of a currently approved collection and reflects a decrease in the number of respondents. This adjustment is explained in the agency's supporting statement, Part A, at question 15.

---

Annual Cost to Federal Government: $30,739

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

---

Common Form ICR:  No

---

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: 06/30/2014

---