Medicated Fee Mill License Application

Forms and Documents

Document	Type	Status	Availability
Form 3448 Medicated Feed Mill License Application Using Form FDA 3448	Form and Instruction	Modified	Repair queued
Form 3448 Supplemental Medicated Feed Mill License Application ; Form FDA 3448	Form and Instruction	New	Available
SS-0910-0337 #1 rev 03-29-10.doc	Supporting Statement A	Uploaded 2010-03-30	Available

IC Document Collections

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

ICR Details

OMB Control No: 0910-0337	ICR Reference No: 201001-0910-017
Status: Historical Active	Previous ICR Reference No: 200611-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medicated Fee Mill License Application
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 with change	Conclusion Date: 06/27/2010
	Date Received in OIRA: 01/31/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2013	36 Months From Approved	06/30/2010
Responses	1,206	0	1,202
Time Burden (Hours)	70	0	72
Cost Burden (Dollars)	0	0	0

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Abstract: The Animal Drug Availability Act (ADAA) of October 9, 1996 amended Section 512 of the FD&C Act to replace the system for the approval of specific medicated feed with a general licensing system for feed mills. Before passage of the ADAA, medicated feed manufacturers were required to obtain approved Medicated Feed Applications (MFAs), in order to manufacture certain types of medicated feeds. An individual approved MFA was required for each and every applicable medicated feed. The ADAA streamlined the paperwork process for gaining approval to manufacture medicated feeds by replacing the MFA system with a facility license system for each medicated feed manufacturing facility. The implementing regulations are 21 CFR Part 515.

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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:
	74 FR 55556	10/28/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 3735	01/22/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Medicated Feed Mill License Application Using Form FDA 3448	3448	Form FDA 3448
Supplemental Medicated Feed Mill License Application ; Form FDA 3448	3448	Medicated Feed Mill License Application
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

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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	1,206	1,202	0	0	4	0
Annual Time Burden (Hours)	70	72	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:

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Annual Cost to Federal Government: $4,560

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]? Uncollected

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: 01/31/2010

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