Animal Drug User Fee Cover Sheet

Forms and Documents

Document Name	Status
Form 3546 Animal Drug User Fee Cover Sheet Form and Instruction	Modified
0539 SS Part A 2014.doc Supporting Statement A	2014-04-24

IC Document Collections

IC ID	Document Title	Status
6258	Animal Drug User Fee Cover Sheet Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0539	ICR Reference No: 201404-0910-016
Status: Historical Inactive	Previous ICR Reference No: 201102-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Animal Drug User Fee Cover Sheet
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 07/03/2014
	Date Received in OIRA: 04/28/2014
Terms of Clearance: In accordance with 5 CFR 1320, this ICR is improperly submitted. It lists a change due to agency discretion, precluding this from being an extension. Please correct this and resubmit.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2014	36 Months From Approved	08/31/2014
Responses	76	0	76
Time Burden (Hours)	76	0	76
Cost Burden (Dollars)	0	0	0

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Abstract: This request collects information regarding animal drug applications or supplemental animal drug applications to the Food and Drug Administration. Respondents are sponsors of animal drugs who are asked to provide information required by the Federal Food, Drug, and Cosmetic Act in support of their application. The information is used to initiate application review and to determine applicable user fees.

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Authorizing Statute(s): US Code: 21 USC 379h Name of Law: Authority to assess and use drug fees
  

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:
	79 FR 6199	02/03/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 22689	04/23/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Animal Drug User Fee Cover Sheet	3546	Animal Drug User Fee Cover Sheet

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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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There is a decrease in the number of respondents since our last approval. This is due to a smaller number of applications in the past three years. Our previous estimate of an average of 76 submissions annually appears to have been incorrect, while we believe our current estimate more accurately reflects the current burden and may be attributed to the streamlining of agency tracking resources and improved database management.

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Annual Cost to Federal Government: $47,485

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: 04/28/2014

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