New Animal Drugs for Investigational Use

Forms and Documents

Document Name	Status
0117 SS Part A 2015.pdf Supporting Statement A	2015-07-09

IC Document Collections

IC ID	Document Title	Status
5728	511.1(b)(4) NCIE for clinical investigations Instruction	Modified
203024	511.1(b)(8)(i) - Recordkeeping of investigator reports	Modified
203023	511.1(b)(7)(ii) - Recordkeeping sponsor	Modified
203022	511.1(b)(3) - Recordkeeping for clinical investigations	Modified
203021	511.1(a)(3) - Recordkeeping for laboratory research	Modified
203020	511.1(b)(9) Import for clinical investigation	Modified
203019	511.1(b)(8) (ii) Report of significant hazards	Modified
203018	511.1(b)(6) Information required in order to determine if there are grounds for terminating exemption	Modified
203017	511.1(b)(5) Data submission for use of edible food products	Modified

ICR Details

OMB Control No: 0910-0117	ICR Reference No: 201507-0910-004
Status: Historical Active	Previous ICR Reference No: 201207-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: New Animal Drugs for Investigational Use
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: 08/14/2015
	Date Received in OIRA: 07/14/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2018	36 Months From Approved	10/31/2015
Responses	6,226	0	5,528
Time Burden (Hours)	13,805	0	12,328
Cost Burden (Dollars)	607,376	0	0

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Abstract: This information collection request supports FDA's regulations regarding new animal drugs for investigational uses. Respondents to the collection are new animal drug sponsors.

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Authorizing Statute(s): US Code: 21 USC 512j 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:
	80 FR 17758	04/02/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 35956	06/23/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
511.1(b)(4) NCIE for clinical investigations
511.1(b)(5) Data submission for use of edible food products
511.1(b)(6) Information required in order to determine if there are grounds for terminating exemption
511.1(b)(8) (ii) Report of significant hazards
511.1(b)(9) Import for clinical investigation
511.1(a)(3) - Recordkeeping for laboratory research
511.1(b)(3) - Recordkeeping for clinical investigations
511.1(b)(7)(ii) - Recordkeeping sponsor
511.1(b)(8)(i) - Recordkeeping of investigator reports

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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	6,226	5,528	0	698	0	0
Annual Time Burden (Hours)	13,805	12,328	0	1,477	0	0
Annual Cost Burden (Dollars)	607,376	0	0	607,376	0	0

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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This collection reflects an overall increase attributed to an increase in respondents. This is explained more fully in the agency's supporting statement at Q15. The agency also notes that the cost to industry for the information collection was not previously included in our last submission; however we have included that information in this request at Question 12b.

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Annual Cost to Federal Government: $640,782

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: 07/14/2015

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