Human Embryonic Stem Cell Line

Forms and Documents

Document Name	Status
Form 2890 Form 2890- Stem Cell Form	New
Attachment 3 - hESC Review Decision Tree (part of Instructions).pdf Supplementary Document	2009-07-31
Supporting Statement NIH Form 2890 hESC Registry.doc Supporting Statement A	2009-07-31

IC Document Collections

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

ICR Details

OMB Control No: 0925-0601	ICR Reference No: 200907-0925-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Human Embryonic Stem Cell Line
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 08/04/2009
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/03/2009
	Date Received in OIRA: 07/31/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2010	6 Months From Approved
Responses	100	0	0
Time Burden (Hours)	300	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research (hereafter referred to as Form 2890) will be used by respondents who have hESC lines and wish for the lines to be approved for use in NIH funded research. NIH will review the requests in accord with the NIH Guidelines, by either Administrative Review, or review by the Working Group of the Advisory Committee to the [NIH] Director. Those hESC lines that NIH determines meet the criteria of the Guidelines will be posted on the NIH Registry and NIH funded researchers will be required to cite lines from the Registry when applying to the NIH for hESC funding. The information also will be used for program management, as well as for reporting to Congress and to the public on hESC lines that are eligible for NIH funding. Applicants will cite the lines on applicable grant applications, the PHS 398 and 398 components, and the PHS 416, approved by OMB under 0925-0001 and 0925-0002, respectively.

Emergency Justfication: President Barack H. Obama issued Executive Order(EO)13505 Removing Barriers to Responsible Scientific Research Involving Human Stem Cells on March 9, 2009. The EO states that the Secretary of Health and Human Services, through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law. The EO also directs the Secretary, through the Director of NIH, to review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and issue new NIH Guidelines on such research.This is an emergency request for data collection is for the purpose of reviewing requests for inclusion of hESC lines in the NIH Human Embryonic Stem Cell Registry in order to establish eligibility for NIH funding.

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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

Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Form 2890- Stem Cell	2890	Stem Cell

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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	100	0	0	100	0	0
Annual Time Burden (Hours)	300	0	0	300	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 is a new emergency ICR.

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Annual Cost to Federal Government: $300,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 07/31/2009

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