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

Privacy Notice: This collection of information is authorized by Executive Order 13505, Removing Barriers to Responsible Scientific Research Involving Human Stem Cells (3/9/09) and 42 CFR 52.4, pertaining to documentation and assurances that must accompany requests for NIH funding. Information submitted through this web site about human embryonic stem cell (hESC) lines is wholly voluntary, and will be reviewed by NIH to determine eligibility of lines for use in NIH funded research in accord with the NIH Guidelines for Human Stem Cell Research (74 FR 32170). All information submitted with regard to a request for approval of a human embryonic stem cell line must be submitted in a form so that it may be made available by NIH to the public. Do not submit any financial, commercial, confidential or proprietary information. Do not submit consent documents with the personally identifying information/names of donor(s) of the embryos (the individual(s) who sought reproductive treatment). Proprietary and/or personal information may be redacted by the submitters. PLEASE NOTE: NIH Intends to treat all information which is submitted, unless there is written agreement to the contrary, as information which may be made available to the public.

If hESC lines are approved for use in NIH funded research, the stem cell lines, and provider information if the lines are available for distribution, will be posted on the NIH Human Embryonic Stem Cell Registry. NIH also posts the organization name and the name of the stem cell line for institutions intending to submit hESC lines for review (those submissions begun and saved but not submitted), lines pending review , and lines not approved for NIH funding eligibility . Final, but incomplete submissions of information may obviate NIH's ability to conduct a review to determine eligibility for use in NIH funded research.

Burden Disclosure Statement: The NIH estimates that the average time to complete this form is 17 hours, including time to collect and prepare supporting information, physically complete the form, and upload all supporting information. An agency may not conduct or sponsor the collection of information unless it displays a currently valid OMB control number. Nor is a person required to respond to requests for the collection of information without this control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Office, 6705 Rockledge Drive MSC 7974, Bethesda, MD 20892-7974, ATT: PRA (0925-0001).

Introduction

NIH Guidelines for Human Stem Cell Research , effective July 7, 2009, established an NIH Human Embryonic Stem Cell Registry listing human embryonic stem cells (hESCs) eligible for use in NIH funded research. Only hESCs that have been reviewed and deemed eligible by the NIH in accordance with the Guidelines may be used in NIH supported research.

NIH Form 2890 is provided for the purposes of submitting information about hESC lines to the NIH, along with assurances and supporting documentation of compliance with the NIH Guidelines. NIH will conduct either an Administrative Review, or review by a Working Group of the Advisory Committee to the [NIH] Director (ACD). The Working Group of the ACD will make recommendations to the ACD, which will advise the NIH Director, who will make the final determination of whether a hESC line is approved for use in NIH funded research. All approved lines are listed on the NIH Registry. The Registry also contains basic information about organizations intending to submit lines to the Registry, lines pending NIH review and lines not approved for NIH funding eligibility .

Submission of hESC line through the NIH Form 2890 Web Site

eRA Commons Registration: An organization wishing to submit a hESC line for review must be registered in the eRA Commons. This is a one-time registration and is necessary for NIH validation purposes. To register an Organization in the eRA Commons follow these instructions: Register in eRA Commons | eRA (nih.gov). Note that a UEI number must be included in the Institutional Profile. If your organization does not have a UEI number you may obtain one from: https://sam.gov/content/home.

app_loging Official Authority: Requests may be submitted by the individual with a app_loging Official (SO) role for the organization. Requests may also be submitted by another appropriate individual within an organization who has an eRA Commons UserID and password, provided that the SO approves the submission and provides the necessary certification and assurance via a signed letter on institutional letterhead, and attached as an uploaded document with the request. A sample letter (MS Word - 44 KB) is provided for this purpose. To log into the system and complete NIH 2890, the individual must provide his/her eRA Commons UserID and password. Once a Commons user enters a draft request, only that individual has the rights to edit and submit the request. However, the system provides a way to email copies of draft requests to the individuals of their choosing for review.

eRA Commons Support: For questions or problems concerning obtaining an eRA Commons account, please contact Commons Support at 1-866-504-9552, or submit a request for support at https://www.era.nih.gov/need-help and a specialist will contact you.

NIH Form 2890 hESC Request Support: Questions about this system may be emailed to the hESC Registry Help Desk. In addition, instructions for Completing NIH Form 2890 are available for review.

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