Human Embryonic Stem Cell Line

Forms and Documents

Document Name	Status
8 Attachment 2 60-day FRN 20130220.pdf Supplementary Document	2013-04-30
Supporting Statement A Stem Cell.doc Supporting Statement A	2013-04-29

IC Document Collections

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

ICR Details

OMB Control No: 0925-0601	ICR Reference No: 201304-0925-005
Status: Historical Active	Previous ICR Reference No: 201003-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No: 19378
Title: Human Embryonic Stem Cell Line
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 without change	Conclusion Date: 05/29/2013
	Date Received in OIRA: 04/30/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2016	36 Months From Approved	05/31/2013
Responses	150	0	300
Time Burden (Hours)	2,550	0	900
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): 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:
	73 FR 13688	02/28/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 25091	04/29/2013
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	NIH 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	150	300	0	0	-150	0
Annual Time Burden (Hours)	2,550	900	0	0	1,650	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: There are no substantive changes to the data collection. The minor adjustments to Form 2890 and related instructions are: (1) clarification of the date format for responding to question 10, (2) a description of the potential types of supporting information pertaining to question 11, and (3) a slightly different process for making changes to a submission, described in the instructions under "Final Submission and Email Confirmation."

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Annual Cost to Federal Government: $187,000

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]? 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: 04/30/2013

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