The Inclusion Enrollment Report Form

Forms and Documents

Document Name	Status
Form 1 Inclusion Enrollment Form Form	Modified
Attachment 1_eRA PIA 1-12-24.pdf Supplementary Document	2024-09-27
0770 30day frn.pdf Supplementary Document	2024-09-27
Supporting Statement A_0925-0770 IER_FORMS-I.docx Supporting Statement A	2024-09-27

IC Document Collections

IC ID	Document Title	Status
248482	Inclusion Enrollment Form Form	Modified

ICR Details

OMB Control No: 0925-0770	ICR Reference No: 202409-0925-006
Status: Received in OIRA	Previous ICR Reference No: 202103-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The Inclusion Enrollment Report Form
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  Yes
Type of Review Request: Regular	Date Submitted to OIRA: 09/27/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2024
Responses	69,888	67,888
Time Burden (Hours)	69,888	67,888
Cost Burden (Dollars)	0	0

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Abstract: NIH is requesting an extension of a currently approved collection. NIH converted the Inclusion Enrollment Report form (IER) to a common from during the last approval cycle which included the Department of Defense (DoD). Previously, the form was housed in NIH’s Pre/Post grant application and forms clearances approved under OMB#s 0925-0002 and 0925-0002 (expiration date 1/31/2026).

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Authorizing Statute(s): US Code: 42 USC CFR Part 52 Name of Law: Grants and Research Projects
  

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:
	89 FR 59746	07/23/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 79300	09/27/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Inclusion Enrollment Form	1	Form

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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	69,888	67,888	0	2,000	0	0
Annual Time Burden (Hours)	69,888	67,888	0	2,000	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: The previous burden estimate was inadvertently keys in incorrectly which shows a difference of 2,000. There are no changes of burden from the last approval cycle.

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Annual Cost to Federal Government: $39,594

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:  Yes

Description/Changes for Common Form Usage:  NIH converted the Inclusion Enrollment Report form (IER) to a common from during the last approval cycle which included the Department of Defense (DoD). Previously, the form was housed in NIH’s Pre/Post grant application and forms clearances approved under OMB#s 0925-0002 and 0925-0002 (expiration date 1/31/2026).

Approved RCFs using this ICR

Agency/Sub Agency	RCF ID	RCF Title	RCF Status	IC Title

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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: 09/27/2024

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