Antiparasitic Resistance and Combination New Animal Drugs Survey

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Supporting Statement B - Antiparasitic.doc	Supporting Statement B	Uploaded 2011-06-02	Available
Supporting Statement A - Antiparasitic.doc	Supporting Statement A	Uploaded 2011-06-02	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
198003	Survey	Other-Antiparastic Drug Survey	New
198002	Pre-Test	Other-Antiparasitic Drug Survey	New

ICR Details

OMB Control No:	ICR Reference No: 201106-0910-003
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Antiparasitic Resistance and Combination New Animal Drugs Survey
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Disapproved	Conclusion Date: 10/12/2011
	Date Received in OIRA: 06/07/2011
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB disapproves this FDA request to collect information. The statistical methods proposed by FDA, a convenience sample facilitated by "Survey Monkey," are inappropriate and insufficient for the purposes described in the Supporting Statement. OMB notes that FDA intends this survey to influence future policy on antiparasitic resistance and that FDA intends to release the results of this survey to the public. FDA should consult OMB's Information Quality Guidelines before resubmitting this collection for consideration.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this survey is to gather information from experts involved with research, development, and use of antiparasitic drugs (primarily industry, academicians, and veterinarians) on emerging issues involving antiparasitic drug use, antiparasitic resistance, and new animal drug combinations. The survey is one part of a strategy to set future direction for FDA regulation of veterinary antiparasitic drugs. FDA will share the results of the survey with the public as part of its educational efforts and in order to seek further input from a wider audience.

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Authorizing Statute(s): None

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 39948	07/13/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 29762	05/23/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Pre-Test
Survey

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

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection.

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Annual Cost to Federal Government: $12,131

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 06/07/2011

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