Medicated Fee Mill License Application

Forms and Documents

Document Name	Status
Form 3448 Medicated Feed Mill License Application Using Form FDA 3448 Form	Modified
Form 3448 Maintenance of Records for Appoved Labeling fo Each "Type B" and "Type C" Labeling Form	Modified
Form FDA 3448 Supplemental Medicated Feed Mill License Application; Form FDA 3448 Form and Instruction	Removed
0337 FINAL SUPPORTING STATEMENT 6-22-2016.doc Supporting Statement A	2016-06-22

IC Document Collections

IC ID	Document Title	Status
5931	Medicated Feed Mill License Application Using Form FDA 3448 Form	Modified
191908	Maintenance of Records for Appoved Labeling fo Each "Type B" and "Type C" Labeling Form	Modified
191907	Filing a Request fo a Hearing on a Medicated Feed Mill License Application	Removed
191906	Voluntary Revocation of Medicated Feed Mill License Application	Removed
191905	Supplemental Medicated Feed Mill License Application; Form FDA 3448 Form and Instruction	Removed

ICR Details

OMB Control No: 0910-0337	ICR Reference No: 201606-0910-002
Status: Historical Active	Previous ICR Reference No: 201305-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Medicated Fee Mill License Application
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/21/2016
	Date Received in OIRA: 06/23/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	36 Months From Approved	09/30/2016
Responses	991	0	1,051
Time Burden (Hours)	56	0	58
Cost Burden (Dollars)	0	0	0

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Abstract: Feed manufacturers that seek to manufacture feed using Category II, Type A medicated articles or manufacture certain liquid and free-choice feed, using Category I, Type A medicated articles that must follow proprietary formulas or specifications are required to obtain a facility license under section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b). Our regulations in part 515 (21 CFR part 515) establish the procedures associated with applying for a facility license. We require that a manufacturer seeking a facility license submit a completed medicated feed mill license application using Form FDA 3448 (21 CFR 515.10(b)).

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Authorizing Statute(s): None

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 12509	03/09/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 37602	06/10/2016
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Medicated Feed Mill License Application Using Form FDA 3448	3448	Medicated Feed Mill License Applications
Voluntary Revocation of Medicated Feed Mill License Application
Filing a Request fo a Hearing on a Medicated Feed Mill License Application
Maintenance of Records for Appoved Labeling fo Each "Type B" and "Type C" Labeling	3448	Medicated Feed Mill License Application
Supplemental Medicated Feed Mill License Application; Form FDA 3448	FDA 3448	Medicated Feed Mill License Application

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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	991	1,051	0	0	-60	0
Annual Time Burden (Hours)	56	58	0	0	-2	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: Over the past three years, the estimated annual number of responses decreased from 1,051 to 991 due to the natural fluctuation in the number of licenses from 950 to 890. The decrease in these responses resulted in a decrease in burden (an adjustment) from 58 hours to 56 (a difference of 2 hours). The previously approved ICR submitted to OMB included five ICs entered in ROCIS. Upon this submission we are consolidating the ICs, thereby, reducing the number of ICs in ROCIS to two. The information collection activities, however, remain broken down in this supporting statement document.

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Annual Cost to Federal Government: $3,134

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

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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: 06/23/2016

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