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

Forms and Documents

Document Name	Status
Type A Medicated Articles - Supporting Statement A.doc Supporting Statement A	2011-02-09

IC Document Collections

IC ID	Document Title	Status
5767	Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.42	Modified
196326	Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.115	New
196325	Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.110	New
196324	Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.102	New
196323	Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.80	New
196322	Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.58	New

ICR Details

OMB Control No: 0910-0154	ICR Reference No: 201102-0910-005
Status: Historical Inactive	Previous ICR Reference No: 200712-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No:
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: Improperly submitted and continue	Conclusion Date: 04/25/2011
	Date Received in OIRA: 02/22/2011
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB considers this information collection request to be improperly submitted. OMB notes that this collection lists a decrease in responses of 931,500 due to error in agency estimate. The decrease is not explained in the agency's supporting statement and, thus, there is insufficient information to evaluate this request. Please resumbit with a description of how such a large error in estimate occured.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved	06/30/2011
Responses	1,082,150	0	1,082,150
Time Burden (Hours)	157,550	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.

---

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:
	75 FR 72827	11/26/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 6142	02/03/2011
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
Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.42
Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.58
Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.80
Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.102
Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.110
Good Manufacturing Practice Regulations for Type A Medicated Articles - 21 CFR 226.115

---

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:

---

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: 02/22/2011

---