New Animal Drugs for Investigational Use

Forms and Documents

Document Name	Status
0117_Supporting Statement_2018.doc Supporting Statement A	2018-06-20

IC Document Collections

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

ICR Details

OMB Control No: 0910-0117	ICR Reference No: 201806-0910-009
Status: Active	Previous ICR Reference No: 201507-0910-004
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: 08/17/2018
	Date Received in OIRA: 07/18/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved	08/31/2018
Responses	6,723	0	6,226
Time Burden (Hours)	15,060	0	13,805
Cost Burden (Dollars)	0	0	607,376

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Abstract: This information collection request supports FDA's regulations regarding new animal drugs for investigational uses. Respondents to this collection of information are persons who use new animal drugs for investigational purposes, such as drug industry firms, academic institutions, and the government. Investigators may include individuals from these entities, as well as research firms and members of the medical professions. Our regulations require that certain information be submitted to us in a “Notice of Claimed Investigational Exemption for a New Animal Drug” (NCIE) to qualify for the exemption and to control shipment of the new animal drug and prevent potential abuse. Our regulations also require recordkeeping. We use the reported information to determine that investigational animal drugs are distributed only to qualified investigators, adequate drug accountability records are maintained, and edible food products from treated food-producing animals are safe for human consumption. We also use the information collected to monitor the validity of the studies submitted to us to support new animal drug approval.

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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:
	83 FR 7735	02/22/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 32877	07/16/2018
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
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(b)(3) - Recordkeeping for clinical investigations
511.1(b)(7)(ii) - Recordkeeping sponsor
511.1(b)(8)(i) - Recordkeeping of investigator reports
Reporting: NAD for Investigational Use
Recordkeeping: NAD for Investigational Use

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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	6,723	6,226	0	0	497	0
Annual Time Burden (Hours)	15,060	13,805	0	0	1,255	0
Annual Cost Burden (Dollars)	0	607,376	0	0	-607,376	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: $640,782

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 07/18/2018

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