Human Embryonic Stem Cell Line (OD)

Forms and Documents

Document Name	Status
Form 1 Form 2890-Stem Cell Form	Modified
FRN 30-day Notice 23 July 2019.pdf Supplementary Document	2019-07-23
Support_StatementA_7-18-2019 FINAL.2 with clarifications for OMB 7 Oct 2019.docx Supporting Statement A	2019-10-10
Attachment 2 NIH Form 2890 Privacy Impact Assessment.pdf Supplementary Document	2019-07-19

IC Document Collections

IC ID	Document Title	Status
190155	Form 2890-Stem Cell Form	Modified

ICR Details

OMB Control No: 0925-0601	ICR Reference No: 201907-0925-003
Status: Active	Previous ICR Reference No: 201605-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No: 19378
Title: Human Embryonic Stem Cell Line (OD)
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 with change	Conclusion Date: 10/10/2019
	Date Received in OIRA: 07/24/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2022	36 Months From Approved	10/31/2019
Responses	15	0	150
Time Burden (Hours)	255	0	2,550
Cost Burden (Dollars)	0	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:
	84 FR 22153	05/16/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 35401	07/23/2019
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
Form 2890-Stem Cell	1	Form 2890

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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	15	150	0	-135	0	0
Annual Time Burden (Hours)	255	2,550	0	-2,295	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This an extension even though the number of responses have been reduced substantially. Program indicates that through Form 2890, NIH receives information from institutions about human embryonic stem cell lines that they have derived. NIH then determines whether the embryo donation consent process meets the strict requirements in NIH policy for use of the cell lines by NIH-funded investigators. NIH does not fund the derivation of the cell lines and has no involvement in the decisions that institutions make regarding derivation of new cell lines. In recent years, there have been fewer submissions to NIH about newly derived cell lines.

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Annual Cost to Federal Government: $26,117

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: 07/24/2019

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