Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

Forms and Documents

Document Name	Status
0910-0620 - Supporting Statement A.doc Supporting Statement A	2011-04-26

IC Document Collections

IC ID	Document Title	Status
197486	516.165 - Recordkeeping	New
197485	516.141 - Recordkeeping	New
197484	516.165	New
197483	516.163	New
197482	516.161	New
197481	516.145	New
197480	516.143	New
197479	516.141	New
197478	516.129	New
197477	516.125	New
197476	516.123	New
197475	516.121	New
183179	516.119	Modified

ICR Details

OMB Control No: 0910-0620	ICR Reference No: 201104-0910-009
Status: Historical Active	Previous ICR Reference No: 200712-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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: 06/27/2011
	Date Received in OIRA: 04/27/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2014	36 Months From Approved	06/30/2011
Responses	293	0	358
Time Burden (Hours)	4,922	0	4,923
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection approval request is for a Food and Drug Administration (FDA) regulation that implements section 572 of the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The MUMS Act is made up of three sections (571, 572, and 573) and it establishes new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species as well as uncommon diseases in major animal species. Section 572 of the legislation provides for a public index listing of legally-marketed unapproved new animal drugs for minor species of animals. The drugs in this index are only indicated for use in non-food minor species or for use in early non-food life stages of food-producing minor species. This regulation, among other things, specifies the procedures for requesting eligibility and addition to the index as well as the annual reporting requirements for index holders.

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Authorizing Statute(s): US Code: 21 USC 360ccc Name of Law: null
   US Code: 21 USC 369ccc-1 Name of Law: null
   US Code: 21 USC 360ccc-2 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:
	75 FR 75481	12/03/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 10605	02/25/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
516.121
516.123
516.125
516.141
516.143
516.145
516.161
516.129
516.119
516.163
516.165
516.141 - Recordkeeping
516.165 - Recordkeeping

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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	293	358	0	0	-65	0
Annual Time Burden (Hours)	4,922	4,923	0	0	-1	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: $128,654

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: 04/27/2011

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