Substantial Evidence of Effectiveness of New Animal Drugs

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
SS-0910-0356.doc	Supporting Statement A	Uploaded 0000-00-00	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5973	Substantial Evidence of Effectiveness of New Animal Drugs		Modified

ICR Details

OMB Control No: 0910-0356	ICR Reference No: 200703-0910-013
Status: Historical Active	Previous ICR Reference No: 200401-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Substantial Evidence of Effectiveness of New Animal Drugs
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: 06/06/2007
	Date Received in OIRA: 03/23/2007
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2010	36 Months From Approved	06/30/2007
Responses	4	0	860
Time Burden (Hours)	544,036	0	544,036
Cost Burden (Dollars)	0	0	0

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Abstract: The Animal Drug Availability Act (ADAA), enacted on October 9, 1996, amended section 512(d)(3) of the Federal Food, Drug, and Cosmetic Act to redefine "substantial evidence" in a manner to encourage the submission of new animal drug applications and encourage dose range labeling. Submissions of substantial evidence are made in support of New Animal Drug Applications (NADA). Respondents are sponsors of NADAs.

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Authorizing Statute(s): Statute at Large: 21 Stat. 360 Name of Statute: 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:
	71 FR 64535	11/02/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 7047	02/14/2007
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Substantial Evidence of Effectiveness of New Animal Drugs

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ICR Summary of Burden

table that charts list 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	4	860	0	-856	0	0
Annual Time Burden (Hours)	544,036	544,036	0	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There was no change in the burden.

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Annual Cost to Federal Government: $3,172,400

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 03/23/2007

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