Human Embryonic Stem Cell Line

Forms and Documents

Document Name	Status
Form 2890 Form 2890-Stem Cell Form	Modified
Attachment 3 - hESC Review Decision Tree (part of Instructions).pdf Supplementary Document	2010-03-15
Mar 2010 Supporting Statement NIH Form 2890 hESC Registry - Reinstatement.doc Supporting Statement A	2010-03-15

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: 201003-0925-003
Status: Historical Active	Previous ICR Reference No: 200907-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Human Embryonic Stem Cell Line
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/02/2010
	Date Received in OIRA: 03/18/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2013	36 Months From Approved
Responses	300	0	0
Time Burden (Hours)	900	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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. The NIH Guidelines for Human Stem Cell Research (Guidelines) implementing the EO and establishing policy and procedures under which the NIH will fund such research became effective on July 7, 2009, and are available at http://stemcells.nih.gov/index.asp. The Guidelines provide scientists who apply for NIH funding with a specific set of standards reflecting currently recognized ethical principles and practices specific to embryo donation, and prescribe the assurances and supporting documentation necessary for NIH funding of research using hESCs, and describe research that is not eligible for NIH funding. The Guidelines establish a new NIH Registry of eligible hESC lines that comply with the set of standards described in the Guidelines. NIH will also post lines that are not approved for use in NIH funding.

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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:
	74 FR 48973	09/25/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 9418	03/02/2010
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	2890	Application

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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	300	0	0	200	0	100
Annual Time Burden (Hours)	900	0	0	600	0	300
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: There are no substantive changes to the data collection. This is a reinstatement of a previously approved submission. The minor adjustments to Form 2890 and related instructions are: (1) requests may be submitted by either the Signing Official for the organization, or another appropriate individual within the organization who has an eRA Commons UserID and Password, provided that the Signing Official approved the submission and provides the necessary certification and assurance via a signed letter on institutional letterhead, and, (2) NIH now encourages users to select NIH Administrative Review if they believe that the cell line meets the Section II(A) requirements of the Guidelines, and if NIH determines that the line is not approvable under Section II(A) then NIH will refer the submission for review by the Advisory Committee to the Director under Section II(B) of the Guidelines.

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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: 03/18/2010

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