Assurance (Interinstitutional, Foreign, and Domestic) and Annual Report (Office of Director)

Forms and Documents

Document Name	Status
Form 4 Annual Report Form and Instruction	New
Form 3 Domestic Assurance (New) Form and Instruction	New
Form 3 Domestic Assurance (Renewal) Form and Instruction	New
Form 2 Foreign Assurance Renewal and New Form and Instruction	New
Form 1 Interinstitutional Assurance (Domestic) Form and Instruction	New
Form 1 Interinstitutional Assurance (Foreign) Form and Instruction	New
OLAW Assurance Published 30-day.pdf Supplementary Document	2019-09-11
Support_Statement_A (1).docx Supporting Statement A	2019-09-09

IC Document Collections

IC ID	Document Title	Status
237707	Annual Report Form and Instruction	New
237706	Domestic Assurance (New) Form and Instruction	New
237704	Domestic Assurance (Renewal) Form and Instruction	New
237703	Foreign Assurance Renewal and New Form and Instruction	New
237702	Interinstitutional Assurance (Domestic) Form and Instruction	New
237701	Interinstitutional Assurance (Foreign) Form and Instruction	New

ICR Details

OMB Control No: 0925-0765	ICR Reference No: 201909-0925-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Assurance (Interinstitutional, Foreign, and Domestic) and Annual Report (Office of Director)
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: Approved without change	Conclusion Date: 11/15/2019
	Date Received in OIRA: 09/12/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved
Responses	1,940	0	0
Time Burden (Hours)	8,140	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Office of Laboratory Animal Welfare (OLAW), Office of Extramural Research, Office of the Director, National Institutes of Health (NIH) is requesting approval of an information collection request. OLAW is responsible for the implementation, general administration, and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) as codified in 42 CFR 52.8. An institution’s animal care and use program is described in the Animal Welfare Assurance (Assurance) document and sets forth institutional compliance with PHS Policy. The purpose of the Assurance (Interinstitutional, Foreign, and Domestic) and Annual Report is to provide OLAW with documentation to satisfy the requirements of the HREA, illustrate institutional adherence to PHS Policy, and enable OLAW to carry out its mission to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported activities.

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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:
	84 FR 28065	06/17/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 47966	09/11/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Interinstitutional Assurance (Foreign)	1	Interinstitutional Assurance (IA) for Foriegn
Foreign Assurance Renewal and New	2	Foreign Assurance
Interinstitutional Assurance (Domestic)	1	Interinstitutional Assurance (IA) for Domestic
Domestic Assurance (Renewal)	3	Domestic Assurance
Annual Report	4	Annual Report
Domestic Assurance (New)	3	Domestic Assurance (New)

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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	1,940	0	0	1,940	0	0
Annual Time Burden (Hours)	8,140	0	0	8,140	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: No

Burden Reduction Due to:

Short Statement: New collection

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Annual Cost to Federal Government: $336,946

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.     Yes

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.     Yes

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: 09/12/2019

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