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 FDA 3744 Requirement for All Applicants to Include Separate Information for Each Month in Their Records Form and Instruction	New
Form FDA 3744 Annual Reports for Sponsors with Inactive Applications (e-form FDA 3744a) Form and Instruction	New
Form FDA 3744 Annual Reports for Sponsors with Inactive Applications (paper submission form FDA 3744) Form and Instruction	Modified
Form FDA 3744 Annual Reports for Sponsors with Active Applications (e-form FDA 3744a) Form and Instruction	Modified
Form FDA 3744 Submission of Annual Reports for Sponsors with Active Applications (paper submission form FDA 3744) Form and Instruction	Modified
0659 ss 23 OCT 2013.docx Supporting Statement A	2013-10-23

IC Document Collections

IC ID	Document Title	Status
206692	Requirement for All Applicants to Include Separate Information for Each Month in Their Records Form and Instruction	New
206691	Annual Reports for Sponsors with Inactive Applications (e-form FDA 3744a) Form and Instruction	New
192142	Annual Reports for Sponsors with Inactive Applications (paper submission form FDA 3744) Form and Instruction	Modified
192141	Annual Reports for Sponsors with Active Applications (e-form FDA 3744a) Form and Instruction	Modified
192140	Submission of Annual Reports for Sponsors with Active Applications (paper submission form FDA 3744) Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0659	ICR Reference No: 201304-0910-007
Status: Historical Active	Previous ICR Reference No: 201002-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: 19321
Title: Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 2008)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/08/2013
	Date Received in OIRA: 04/25/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2016	36 Months From Approved	11/30/2013
Responses	350	0	320
Time Burden (Hours)	9,354	0	15,680
Cost Burden (Dollars)	6,975	0	107,880

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Abstract: This information collection requires that sponsors of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. Its purpose is to ensure that the FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals. With this revision of the information collection, FDA is adding a voluntary e-form FDA 3744a that will enable sponsors to submit electronically and capture all information as mandated by Section 105 of the Animal Drug User Fee Amendments of 2008.

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

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:
	77 FR 2302	01/17/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 5463	01/25/2013
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Submission of Annual Reports for Sponsors with Active Applications (paper submission form FDA 3744)	FDA 3744	ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORT
Annual Reports for Sponsors with Active Applications (e-form FDA 3744a)	FDA 3744	Electronic Form FDA 3744 Antimicrobial Animal Drug Distribution Report for ADUFA Section 105
Annual Reports for Sponsors with Inactive Applications (paper submission form FDA 3744)	FDA 3744	ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORT
Annual Reports for Sponsors with Inactive Applications (e-form FDA 3744a)	FDA 3744	Electronic Form FDA 3744 Antimicrobial Animal Drug Distribution Report for ADUFA Section 105
Requirement for All Applicants to Include Separate Information for Each Month in Their Records	FDA 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	350	320	0	0	30	0
Annual Time Burden (Hours)	9,354	15,680	0	2	-6,328	0
Annual Cost Burden (Dollars)	6,975	107,880	0	0	-100,905	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: FDA is adding e-form FDA 3744a, an electronic format of the already approved paper form FDA 3744.

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Annual Cost to Federal Government: $355,469

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: 04/25/2013

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