Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### National Institutes of Health

# SUMMARY:

The National Institutes of Health (NIH) is requesting public comment on a revision to the definition of human embryonic stem cells (hESCs) in the “National Institutes of Health Guidelines for Human Stem Cell Research” (Guidelines).

                        On July 7, 2009, NIH issued Guidelines (                        *http://edocket.access.gpo.gov/​2009/​pdf/​E9-15954.pdf*) to implement Executive Order 13505, as it pertains to NIH-funded stem cell research, to establish policy and procedures under which the NIH will fund such research, and help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.                    

In Section II of the final Guidelines, hESCs are defined as: “For the purpose of these Guidelines, `human embryonic stem cells (hESCs)' are cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.”

This definition had the unintended consequence of excluding certain hESCs which may otherwise be appropriate for Federal funding. For example, the current definition excludes hESCs from an embryo which fails to develop to the blastocyst stage.

                        Therefore, the NIH proposes replacing the current definition of hESCs in Section II with the following: “For the purpose of these Guidelines, `human embryonic stem cells (hESCs)' are pluripotent cells that are derived from                               ( print page 8086)                            early stage human embryos, up to and including the blastocyst stage, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.”                    

This proposed change in no way alters the rigorous ethical standards set forth in the Guidelines.

# DATES:

Written comments on this proposed change must be received by NIH on or before March 25, 2010 in order to be considered.

# ADDRESSES:

                        Public comments may be may be entered at:                         *http://hescregapp.od.nih.gov/​comments/​add.htm.*

Comments may also be mailed to: NIH Stem Cell Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, Maryland 20892-7997. Comments will be made publicly available. Personally identifiable information (except for organizational affiliations) will be removed prior to making comments publicly available.

Dated: February 16, 2010.

Francis S. Collins,

Director, National Institutes of Health.

[FR Doc. 2010-3527 Filed 2-19-10; 4:15 pm]

BILLING CODE 4140-01-P