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

Forms and Documents

Document Name	Status
Form 7 Interinstitutional Assurance for Domestic Performance Site or Interinstitutional Assurance Triad for Domestic Performance Site Form and Instruction	Modified
Form 5 Interinstitutional Assurance for Foreign Performance Site or Interinstitutional Assurance Triad for Foreign Performance Site Form and Instruction	Modified
Form 4 Foreign Annual Report Form and Instruction	Modified
Form 3 Foreign Assurance Renewal and New Form and Instruction	Modified
Form 2 Domestic Annual Report Form and Instruction	Modified
Form 1 Domestic Assurance Form and Instruction	Modified
OD 30 day notice.pdf Supplementary Document	2023-12-04
OD Support_Statement_A revised 10.30.2023.docx Supporting Statement A	2023-12-04

IC Document Collections

IC ID	Document Title	Status
237707	Interinstitutional Assurance for Domestic Performance Site or Interinstitutional Assurance Triad for Domestic Performance Site Form and Instruction	Modified
237706	Interinstitutional Assurance for Foreign Performance Site or Interinstitutional Assurance Triad for Foreign Performance Site Form and Instruction	Modified
237704	Foreign Annual Report Form and Instruction	Modified
237703	Foreign Assurance Renewal and New Form and Instruction	Modified
237702	Domestic Annual Report Form and Instruction	Modified
237701	Domestic Assurance Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0765	ICR Reference No: 202310-0925-002
Status: Received in OIRA	Previous ICR Reference No: 202002-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Assurance (Interinstitutional, Foreign, and Domestic) and Annual Report (Office of Director)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/06/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	2,323	0
Time Burden (Hours)	9,219	0
Cost Burden (Dollars)	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 for a reinstatement with change for the information collection requirements of the Paperwork Reduction Act of 1995. The purpose of the Assurance (Interinstitutional, Foreign, and Domestic) and Annual Report is to provide OLAW with documentation to satisfy the requirements of the Health Research Extension Act (HREA) of 1985 (Public Law 99-158 section 495 as codified in 42 U.S.C. 289d), illustrate institutional adherence to Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (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. Delay of the submission for OMB approval was multifactorial and due to human error and unforeseen circumstances including personal illness. Office of Management and Budget (OMB) approval is requested for 3 years.

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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:
	87 FR 76631	12/15/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 83952	12/01/2023
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
Domestic Annual Report	2	Domestic Annual Report
Domestic Assurance	1	Domestic Assurance
Foreign Annual Report	4	Foreign Annual Report
Foreign Assurance Renewal and New	3	Foreign Assurance
Interinstitutional Assurance for Domestic Performance Site or Interinstitutional Assurance Triad for Domestic Performance Site	7, 8	Interinstitutional Assurance for Domestic Performance Site ,   Interinstitutional Assurance Triad for Domestic Performance Site
Interinstitutional Assurance for Foreign Performance Site or Interinstitutional Assurance Triad for Foreign Performance Site	5, 6	Interinstitutional Assurance for Foreign Performance Site ,   Interinstitutional Assurance Triad for Foreign Performance Site

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ICR Summary of Burden

	Total Request	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	2,323	0	0	2,323	0	0
Annual Time Burden (Hours)	9,219	0	0	9,219	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: Throughout, italicized instructional text is in black font to improve readability and accessibility. Previously approved forms may have included italicized instructional text in green font which has now been changed to black font. Documents refer to all funding entities that the NIH OLAW provides animal care and use program oversight for. In addition to providing oversight for Public Health Service funded animal work, the NIH OLAW has memoranda of understandings with the National Science Foundation (NSF) and National Aeronautics and Space Administration (NASA) for live, vertebrate animal activities. Some documents only referenced NSF and not also NASA. The MOU outlining oversight responsibility between the NIH OLAW and NASA was announced in NIH Guide Notice NOT-OD-20-095 Notice of Memorandum of Understanding Between NIH and NASA Concerning Laboratory Animal Welfare which was released on April 16, 2020. As a result of this change, there is no additional information requested and no increase of burden on the respondent.

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Annual Cost to Federal Government: $472,364

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? No

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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: 12/06/2023

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