Antimicrobial Animal Drug Distribution Reports and Recordkeeping

Forms and Documents

Document Name	Status
0659 FRIA for Final Rule 2016.pdf Supplementary Document	2016-05-11
0659 SS Part A Final Rule 2016.pdf Supporting Statement A	2016-05-11

IC Document Collections

IC ID	Document Title	Status
221449	ONE TIME Burden; administrative review of rulemaking and species-specific information	New
206692	Recordkeeping under 21 USC 360b(l)(3)(C)	Modified
206691	New animal drug sponsors w/inactive applications; electronic submissions Instruction	Modified
192142	New animal drug sponsors w/inactive applications; paper submissions Instruction	Modified
192141	New animal drug sponsors w/active applications; electronic submissions Instruction	Modified
192140	New animal drug sponsors w/active applications; paper submissions Instruction	Modified

ICR Details

OMB Control No: 0910-0659	ICR Reference No: 201605-0910-004
Status: Historical Active	Previous ICR Reference No: 201304-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Antimicrobial Animal Drug Distribution Reports and Recordkeeping
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: 06/13/2016
	Date Received in OIRA: 05/12/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	11/30/2016
Responses	565	0	350
Time Burden (Hours)	9,813	0	9,354
Cost Burden (Dollars)	419,709	0	6,975

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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.

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Authorizing Statute(s): PL: Pub.L. 110 - 316 105 Name of Law: Animal Drug User Fee Amendments
  

Citations for New Statutory Requirements: PL: Pub.L. 110 - 316 105 Name of Law: Animal Drug User Fee Amendments

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG45	Final or interim final rulemaking	81 FR 29129	05/11/2016

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 28863	05/20/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 29129	05/11/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
New animal drug sponsors w/active applications; paper submissions	FDA 3744	Antimicrobial Animal Drug Sales and Distribution Report
New animal drug sponsors w/active applications; electronic submissions	FDA 3744	Antimicrobial Animal Drug Sales and Distribution Report
New animal drug sponsors w/inactive applications; paper submissions	FDA 3744	Antimicrobial Animal Drug Sales and Distribution Report
New animal drug sponsors w/inactive applications; electronic submissions	FDA 3744	Antimicrobial Animal Drug Sales and Distribution Report
Recordkeeping under 21 USC 360b(l)(3)(C)
ONE TIME Burden; administrative review of rulemaking and species-specific information

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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	565	350	177	37	1	0
Annual Time Burden (Hours)	9,813	9,354	787	-330	2	0
Annual Cost Burden (Dollars)	419,709	6,975	0	410,223	2,511	0

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Information collection is being revised to reflect current rulemaking.

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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: 05/12/2016

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