Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 2008)

Forms and Documents

Document Name	Status
Form 3744 Recordkeeping: Requirement for All Applicants to Include Separate Information for Each Month in Their Records Form and Instruction	New
Form 3744 Reporting: Submission of Annual Reports For Sponsors With Inactive Applications Form and Instruction	New
Form 3744 Reporting: Submission of Annual Reports for Sponsors with Active Applications Form and Instruction	New
FDA-2009-N-0512-0002[1].1 - APUA.doc Supplementary Document	2010-03-12
FDA-2009-N-0512-0003[1].1 - KAW.pdf Supplementary Document	2010-03-12
SS- Section 105 ADUFA#3.doc Supporting Statement A	2010-03-16

IC Document Collections

IC ID	Document Title	Status
192142	Recordkeeping: Requirement for All Applicants to Include Separate Information for Each Month in Their Records Form and Instruction	New
192141	Reporting: Submission of Annual Reports For Sponsors With Inactive Applications Form and Instruction	New
192140	Reporting: Submission of Annual Reports for Sponsors with Active Applications Form and Instruction	New

ICR Details

OMB Control No: 0910-0659	ICR Reference No: 201002-0910-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 2008)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/31/2010
	Date Received in OIRA: 02/26/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2013	36 Months From Approved
Responses	320	0	0
Time Burden (Hours)	15,680	0	0
Cost Burden (Dollars)	107,880	0	0

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Abstract: Section 105 0f the Animal Drug User Fee Amendments of 2008 (ADUFA) amended section 512 of the Federal Food Drug and Cosmetic Act(the act) (21 U..C.360b,)to require that the sponsors of each new animal drug that contains an antimicrobial agent, submit an annual report to FDA on the amount of each antimicrobial ingredient in the drug that is sold or distributed for use in food producing animals, including information on any distributor-labeled poduct.

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Authorizing Statute(s): US Code: 21 USC 360b Name of Law: null
  

Citations for New Statutory Requirements: US Code: 21 USC 360b Name of Law: null

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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 55046	10/26/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 7272	02/18/2010
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Reporting: Submission of Annual Reports for Sponsors with Active Applications	3744	Antimicrobial Drug Distribution Report
Reporting: Submission of Annual Reports For Sponsors With Inactive Applications	3744	Antimicrobial Animal Drug Distribution Report
Recordkeeping: Requirement for All Applicants to Include Separate Information for Each Month in Their Records	3744	Antimicrobial Animal Drug Distribution Report

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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	320	0	320	0	0	0
Annual Time Burden (Hours)	15,680	0	15,680	0	0	0
Annual Cost Burden (Dollars)	107,880	0	107,880	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: This is a new collection of infomation.

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Annual Cost to Federal Government: $112,678

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]? Uncollected

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: 02/26/2010

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