Antimicrobial Animal Drug Distribution Reports and Recordkeeping

Forms and Documents

Document Name	Status
Form FDA 3744 New animal drug sponsors w/inactive applications; electronic submissions Form and Instruction	Modified
Form FDA 3744 New animal drug sponsors w/inactive applications; paper submissions Form and Instruction	Modified
Form FDA 3744 New animal drug sponsors w/active applications; electronic submissions Form and Instruction	Modified
Form FDA 3744 New animal drug sponsors w/active applications; paper submissions Form and Instruction	Modified
0910-0659 Supporting Statement 4-10-2019.doc Supporting Statement A	2019-04-10

IC Document Collections

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

ICR Details

OMB Control No: 0910-0659	ICR Reference No: 201904-0910-009
Status: Active	Previous ICR Reference No: 201605-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Antimicrobial Animal Drug Distribution Reports and Recordkeeping
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 without change	Conclusion Date: 06/11/2019
	Date Received in OIRA: 05/09/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2022	36 Months From Approved	06/30/2019
Responses	388	0	565
Time Burden (Hours)	9,026	0	9,813
Cost Burden (Dollars)	541,018	0	419,709

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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): US Code: 21 USC 360b Name of Law: FFDCA
  

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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 49395	10/01/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 20142	05/08/2019
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
New animal drug sponsors w/active applications; paper submissions	FDA 3744	Antimicrobial Animal Drug Distribution Report
New animal drug sponsors w/active applications; electronic submissions	FDA 3744	Antimicrobial Animal Drug Distribution Report
New animal drug sponsors w/inactive applications; paper submissions	FDA 3744	Antimicrobial Animal Drug Distribution Report
New animal drug sponsors w/inactive applications; electronic submissions	FDA 3744	Antimicrobial Animal Drug 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	388	565	0	0	-177	0
Annual Time Burden (Hours)	9,026	9,813	0	0	-787	0
Annual Cost Burden (Dollars)	541,018	419,709	0	0	121,309	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: FDA removed the one-time burden of 787 hours which represented the time needed to review the provisions of the final rule and develop a compliance plan in the first year of compliance. Otherwise, FDA has not made adjustments to burden estimates as reported in tables 1 and 2.

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Annual Cost to Federal Government: $341,614

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 05/09/2019

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