Request Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research (OD)

Forms and Documents

Document	Type	Status	Availability
Form 1 NIH Form 2890-Request for Human Embryonic Stem Cell	Form	Modified	Repair queued
PIA approved Human Embryonic Stem Cell Registry Application 412022.pdf	Supplementary Document	Uploaded 2022-09-15	Repair queued
pub 30-day FRN2022-19775.pdf	Supplementary Document	Uploaded 2022-09-15	Repair queued
Support Statement Form 2890 8-22-2022.docx	Supporting Statement A	Uploaded 2022-09-15	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
190155	NIH Form 2890-Request for Human Embryonic Stem Cell	Form	Modified

ICR Details

OMB Control No: 0925-0601	ICR Reference No: 202209-0925-001
Status: Received in OIRA	Previous ICR Reference No: 201907-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No: 19378
Title: Request Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research (OD)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/15/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2022
Responses	15	15
Time Burden (Hours)	255	255
Cost Burden (Dollars)	0	0

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Abstract: This is an extension of 0925-0601, Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research. Executive Order (EO) 13505 states that NIH may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research. The NIH Guidelines for Human Stem Cell Research (Guidelines), implementing the EO, established an NIH Registry of eligible hESC lines that comply with the set of standards described in the Guidelines. The Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research will continue to be used by respondents who have hESC lines and wish for the lines to be approved for use in NIH funded research.

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Authorizing Statute(s): EO: EO 13505 Name/Subject of EO: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells
  

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 34892	06/08/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 56078	09/13/2022
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
NIH Form 2890-Request for Human Embryonic Stem Cell	1	Form 2890

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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	15	15	0	0	0	0
Annual Time Burden (Hours)	255	255	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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: $30,805

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: 09/15/2022

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