18578 Federal Register / Vol. 74, No. 77 / Thursday, April 23, 2009 / Notices 

Matthew Jennings, BSC Coordinator, 

CDC, Coordinating Office for Terrorism 

Preparedness and Emergency Response, 

1600 Clifton Road, NE., Mailstop D–44, 

Atlanta, Georgia 30333, Telephone (404) 

639–7357. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry. 

Dated: April 17, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Service 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–9331 Filed 4–22–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Draft National Institutes of Health 

Guidelines for Human Stem Cell 

Research Notice 

SUMMARY: The National Institutes of 

Health (NIH) is requesting public 

comment on draft guidelines entitled 

‘‘National Institutes of Health 

Guidelines for Human Stem Cell 

Research’’ (Guidelines). 

The purpose of these draft Guidelines 

is to implement Executive Order 13505, 

issued on March 9, 2009, as it pertains 

to extramural NIH-funded research, to 

establish policy and procedures under 

which NIH will fund research in this 

area, and to help ensure that NIHfunded research in this area is ethically 

responsible, scientifically worthy, and 

conducted in accordance with 

applicable law. Internal NIH 

procedures, consistent with Executive 

Order 13505 and these Guidelines, will 

govern the conduct of intramural NIH 

research involving human stem cells. 

These draft Guidelines would allow 

funding for research using human 

embryonic stem cells that were derived 

from embryos created by in vitro 

fertilization (IVF) for reproductive 

purposes and were no longer needed for 

that purpose. Funding will continue to 

be allowed for human stem cell research 

using adult stem cells and induced 

pluripotent stem cells. Specifically, 

these Guidelines describe the conditions 

and informed consent procedures that 

would have been required during the 

derivation of human embryonic stem 

cells for research using these cells to be 

funded by the NIH. NIH funding for 

research using human embryonic stem 

cells derived from other sources, 

including somatic cell nuclear transfer, 

parthenogenesis, and/or IVF embryos 

created for research purposes, is not 

allowed under these Guidelines. 

NIH funding of the derivation of stem 

cells from human embryos is prohibited 

by the annual appropriations ban on 

funding of human embryo research 

(Consolidated Appropriations Act, 2009, 

Pub. L. 110–161, 3/11/09), otherwise 

known as the Dickey-Wicker 

Amendment. 

According to these Guidelines, there 

are some uses of human embryonic stem 

cells and human induced pluripotent 

stem cells that, although those cells may 

come from allowable sources, are 

nevertheless ineligible for NIH funding. 

For questions regarding ongoing NIHfunded research involving human 

embryonic stem cells, as well as 

pending applications and those 

submitted prior to the issuance of Final 

Guidelines, see the NIH Guide http:// 

grants.nih.gov/grants/guide/notice-files/ 

NOT-OD-09-085.html. 

DATES: Written comments must be 

received by NIH on or before May 26, 

2009. 

ADDRESSES: The NIH welcomes public 

comment on the draft Guidelines set 

forth below. Comments may be entered 

at: http://nihoerextra.nih.gov/ 

stem_cells/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, including any personally 

identifiable or confidential business 

information they contain. 

SUPPLEMENTARY INFORMATION: On March 

9, 2009, President Barack H. Obama 

issued Executive Order 13505: 

Removing Barriers to Responsible 

Scientific Research Involving Human 

Stem Cells. The Executive Order 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 research, to the extent 

permitted by law. 

The purpose of these draft Guidelines 

is to implement Executive Order 13505, 

issued on March 9, 2009, as it pertains 

to extramural NIH-funded research, to 

establish policy and procedures under 

which NIH will fund research in this 

area, and to help ensure that NIHfunded research in this area is ethically 

responsible, scientifically worthy, and 

conducted in accordance with 

applicable law. Internal NIH 

procedures, consistent with Executive 

Order 13505 and these Guidelines, will 

govern the conduct of intramural NIH 

research involving human stem cells. 

Long-standing Department of Health 

and Human Services regulations for 

Protection of Human Subjects, 45 CFR 

part 46, establish safeguards for 

individuals who are the sources of many 

human tissues used in research, 

including non-embryonic human adult 

stem cells and human induced 

pluripotent stem cells. When research 

involving human adult stem cells or 

induced pluripotent stem cells 

constitutes human subject research, 

Institutional Review Board review may 

be required and informed consent may 

need to be obtained per the 

requirements detailed in 45 CFR part 46. 

Applicants should consult http:// 

www.hhs.gov/ohrp/humansubjects/ 

guidance/45cfr46.htm. 

As described in these draft 

Guidelines, human embryonic stem 

cells are cells that are derived from 

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. Although 

human embryonic stem cells are derived 

from embryos, such stem cells are not 

themselves human embryos. 

Studies of human embryonic stem 

cells may yield information about the 

complex events that occur during 

human development. Some of the most 

serious medical conditions, such as 

cancer and birth defects, are due to 

abnormal cell division and 

differentiation. A better understanding 

of the genetic and molecular controls of 

these processes could provide 

information about how such diseases 

arise and suggest new strategies for 

therapy. Human embryonic stem cells 

may also be used to test new drugs. For 

example, new medications could be 

tested for safety on differentiated 

somatic cells generated from human 

embryonic stem cells. 

Perhaps the most important potential 

use of human embryonic stem cells is 

the generation of cells and tissues that 

could be used for cell-based therapies. 

Today, donated tissues and organs are 

often used to replace ailing or destroyed 

tissue, but the need for transplantable 

tissues and organs far outweighs the 

available supply. Stem cells, directed to 

differentiate into specific cell types, 

offer the possibility of a renewable 

source of replacement cells and tissues 

to treat diseases and conditions, 

including Parkinson’s disease, 

amyotrophic lateral sclerosis, spinal 

cord injury, burns, heart disease, 

diabetes, and arthritis. 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 74, No. 77 / Thursday, April 23, 2009 / Notices 18579 

NIH currently funds ongoing research 

involving human embryonic stem cells 

as detailed under prior Presidential 

policy. Under that policy, Federal funds 

have been used for research on human 

embryonic stem cells where the 

derivation process was initiated prior to 

9 p.m. EDT August 9, 2001, the embryo 

was created for reproductive purposes, 

the embryo was no longer needed for 

these purposes, informed consent was 

obtained for the donation of the embryo, 

and no financial inducements were 

provided for donation of the embryo. 

These draft Guidelines would allow 

funding for research using only those 

human embryonic stem cells that were 

derived from embryos created by in 

vitro fertilization (IVF) for reproductive 

purposes and were no longer needed for 

that purpose. Funding will continue to 

be allowed for human stem cell research 

using adult stem cells and induced 

pluripotent stem cells. Specifically, 

these Guidelines describe the conditions 

and informed consent procedures that 

would have been required during the 

derivation of human embryonic stem 

cells for research using these cells to be 

funded by the NIH. NIH funding for 

research using human embryonic stem 

cells derived from other sources, 

including somatic cell nuclear transfer, 

parthenogenesis, and/or IVF embryos 

created for research purposes, is not 

allowed under these Guidelines. 

Please note that, for NIH funded 

research using the permitted human 

embryonic stem cells, the requirements 

of the Department’s protection of human 

subjects regulations, 45 CFR part 46, 

may or may not apply, depending on the 

nature of the research. For further 

information, see Human Embryonic 

Stem Cells, Germ Cells and Cell Derived 

Test Articles: OHRP Guidance for 

Investigators and Institutional Review 

Boards. 

NIH funding of the derivation of stem 

cells from human embryos is prohibited 

by the annual appropriations ban on 

funding of human embryo research 

(Consolidated Appropriations Act, 2009, 

Pub. L. 110–161, 3/11/09), otherwise 

known as the Dickey-Wicker 

Amendment. 

According to these Guidelines, there 

are some uses of human embryonic stem 

cells that, although those cells may 

come from allowable sources, are 

nevertheless ineligible for NIH funding. 

In developing these draft Guidelines, 

the NIH consulted its Guidelines issued 

in 2000, as well as the thoughtful 

guidelines developed by other national 

and international committees of 

scientists, bioethicists, patient 

advocates, physicians and other 

stakeholders, including the U.S. 

National Academies, the International 

Society for Stem Cell Research, and 

others. 

As directed by Executive Order 

13505, the NIH shall review and update 

these Guidelines periodically, as 

appropriate. 

The Draft Guidelines Follow: 

National Institutes of Health Guidelines 

for Human Stem Cell Research 

I. Scope of Guidelines 

These Guidelines describe the 

circumstances under which human 

embryonic stem cells are eligible for use 

in extramural NIH-funded research, and 

they also include a section on uses of 

human embryonic stem cells or human 

induced pluripotent stem cells that are 

ineligible for NIH funding. 

For the purpose of these Guidelines, 

‘‘human embryonic stem cells’’ are cells 

that are derived from 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. Although human 

embryonic stem cells are derived from 

embryos, such stem cells are not 

themselves human embryos. 

II. Guidelines for Eligibility of Human 

Embryonic Stem Cells for Use in 

Research 

A. The Executive Order: Executive 

Order 13505, Removing Barriers to 

Responsible Scientific Research 

Involving Human Stem Cells, states that 

the Secretary of the Department of 

Health and Human Services (DHHS), 

through the Director of the NIH, may 

support and conduct responsible, 

scientifically worthy human stem cell 

research, including human embryonic 

stem cell research, to the extent 

permitted by law. 

B. Eligibility of Human Embryonic 

Stem Cells Derived from Human 

Embryos: Human embryonic stem cells 

may be used in research using NIH 

funds, if the cells were derived from 

human embryos that were created for 

reproductive purposes, were no longer 

needed for this purpose, were donated 

for research purposes, and for which 

documentation for all of the following 

can be assured: 

1. All options pertaining to use of 

embryos no longer needed for 

reproductive purposes were explained 

to the potential donor(s). 

2. No inducements were offered for 

the donation. 

3. A policy was in place at the health 

care facility where the embryos were 

donated that neither consenting nor 

refusing to donate embryos for research 

would affect the quality of care 

provided to potential donor(s). 

4. There was a clear separation 

between the prospective donor(s)’s 

decision to create human embryos for 

reproductive purposes and the 

prospective donor(s)’s decision to 

donate human embryos for research 

purposes. 

5. At the time of donation, consent for 

that donation was obtained from the 

individual(s) who had sought 

reproductive services. That is, even if 

potential donor(s) had given prior 

indication of their intent to donate to 

research any embryos that remained 

after reproductive treatment, consent for 

the donation should have been given at 

the time of the donation. Donor(s) were 

informed that they retained the right to 

withdraw consent until the embryos 

were actually used for research. 

6. Decisions related to the creation of 

human embryos for reproductive 

purposes were made free from the 

influence of researchers proposing to 

derive or utilize human embryonic stem 

cells in research. Whenever it was 

practicable, the attending physician 

responsible for reproductive clinical 

care and the researcher deriving and/or 

proposing to utilize human embryonic 

stem cells should not have been the 

same person. 

7. Written informed consent was 

obtained from individual(s) who sought 

reproductive services and who elected 

to donate human embryos for research 

purposes. The following information, 

which is pertinent to making the 

decision of whether or not to donate 

human embryos for research purposes, 

was in the written consent form for 

donation and discussed with potential 

donor(s) in the informed consent 

process: 

a. A statement that donation of the 

embryos for research was voluntary; 

b. A statement that donor(s) 

understood alternative options 

pertaining to use of the embryos; 

c. A statement that the embryos 

would be used to derive human 

embryonic stem cells for research; 

d. Information about what would 

happen to the embryos in the derivation 

of human embryonic stem cells for 

research; 

e. A statement that human embryonic 

stem cells derived from the embryos 

might be maintained for many years; 

f. A statement that the donation was 

made without any restriction or 

direction regarding the individual(s) 

who may receive medical benefit from 

the use of the stem cells; 

g. A statement that the research was 

not intended to provide direct medical 

benefit to the donor(s); 


sroberts on PROD1PC70 with NOTICES
18580 Federal Register / Vol. 74, No. 77 / Thursday, April 23, 2009 / Notices 

h. A statement as to whether or not 

information that could identify the 

donor(s) would be retained prior to the 

derivation or the use of the human 

embryonic stem cells (relevant guidance 

from the DHHS Office for Human 

Research Protections (OHRP) should be 

followed, as applicable; see OHRP’s 

Guidance for Investigators and 

Institutional Review Boards Regarding 

Research Involving Human Embryonic 

Stem Cells, Germ Cells, and Stem CellDerived Test Articles and Guidance on 

Research Involving Coded Private 

Information or Biological Specimens, or 

successor guidances); and 

i. A statement that the results of 

research using the human embryonic 

stem cells may have commercial 

potential, and a statement that the 

donor(s) would not receive financial or 

any other benefits from any such 

commercial development. 

C. Prior to the use of NIH funds: 

Funding recipients must ensure that: (1) 

The human embryonic stem cells were 

derived consistent with sections II.A 

and B of these Guidelines; and (2) the 

grantee institution maintains 

appropriate documentation 

demonstrating such consistency in 

accordance with 45 CFR 74.53, which 

also details rights of access by NIH. The 

responsible grantee institutional official 

must provide assurances with respect to 

(1) and (2) when endorsing applications 

and progress reports submitted to NIH 

for projects that utilize these cells. 

III. Research Using Human Embryonic 

Stem Cells and/or Human Induced 

Pluripotent Stem Cells That, Although 

the Cells May Come From Allowable 

Sources, Is Nevertheless Ineligible for 

NIH Funding 

This section governs research using 

human embryonic stem cells and 

human induced pluripotent stem cells, 

i.e., human cells that 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. There 

are some uses of these cells that, 

although they may come from allowable 

sources, are nevertheless ineligible for 

NIH funding, as follows: 

A. Research in which human 

embryonic stem cells (even if derived 

according to these Guidelines) or human 

induced pluripotent stem cells are 

introduced into non-human primate 

blastocysts. 

B. Research involving the breeding of 

animals where the introduction of 

human embryonic stem cells (even if 

derived according to these Guidelines) 

or human induced pluripotent stem 

cells may have contributed to the germ 

line. 

IV. Other Non-Allowable Research 

A. NIH funding of the derivation of 

stem cells from human embryos is 

prohibited by the annual appropriations 

ban on funding of human embryo 

research (Consolidated Appropriations 

Act, 2009, Pub. L. 110–161, 3/11/09), 

otherwise known as the Dickey-Wicker 

Amendment. 

B. NIH funding for research using 

human embryonic stem cells derived 

from other sources, including somatic 

cell nuclear transfer, parthenogenesis, 

and/or IVF embryos created for research 

purposes, is not allowed under these 

Guidelines. 

Dated: April 17, 2009. 

Raynard S. Kington, 

Acting Director, NIH. 

[FR Doc. E9–9313 Filed 4–22–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

Federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

On-Demand In Vitro Assembly of 

Protein Microarrays 

Description of Technology: Protein 

microarrays are becoming an 

indispensable biomedical tool to 

facilitate rapid high-throughput 

detection of protein-protein, proteindrug and protein-DNA interactions for 

large groups of proteins. The novel 

Protein Microarray of this invention is 

essentially a DNA microarray that 

becomes a protein microarray on 

demand and provides an efficient 

systematic approach to the study of 

protein interactions and drug target 

identification and validation, thereby 

speeding up the discovery process. The 

technology allows a large number of 

proteins to be synthesized and 

immobilized at their individual site of 

expression on an ordered array without 

the need for protein purification. As a 

result, proteins are ready for subsequent 

use in binding studies and other 

analysis. 

The Protein Microarray is based on 

high affinity and high specificity of the 

protein-nucleic acid interaction of the 

Tus protein and the Ter site of E. coli. 

The DNA templates are arrayed on the 

microarray to perform dual function: (1) 

Synthesizing the protein in situ (cellfree protein synthesis) in the array and 

(2) at the same time capturing the 

protein it synthesizes by DNA-protein 

interaction. This method utilizes an 

expression vector containing a DNA 

sequence which serves a dual purpose: 

(a) Encoding proteins of interest fused to 

the Tus protein for in vitro synthesis of 

the protein and (b) encoding the Ter 

sequence, which captures the fusion 

protein through the high affinity 

interaction with the Tus protein. 

Applications: 

• Simultaneous analysis of 

interactions of many proteins with other 

proteins, antibodies, nucleic acids, 

lipids, drugs, etc, in a single 

experiment. 

• Efficient discovery of novel drugs 

and drug targets. 

Development Status: The technology 

is in early stages of development. 

Inventors: Deb K. Chatterjee, 

Kalavathy Sitaraman, James L. Hartley, 

David J. Munroe, Cassio Baptista (NCI). 

Patent Status: 

U.S. Patent Application No. 11/ 

252,735 filed 19 Oct 2005 (HHS 

Reference No. E–244–2005/0–US–01). 

U.S. Patent Application No. 12/ 

105,636 filed 18 Apr 2008 (HHS 

Reference No. E–244–2005/1–US–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jeffrey A. James, 

Ph.D.; 301–435–5474; 

jeffreyja@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute Protein 

Expression Laboratory is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 


sroberts on PROD1PC70 with NOTICES