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157688061
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Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [2]
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157688061
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Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [2]
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Records of the Domestic Policy Council (George W. Bush Administration)
W. Karl Zinsmeister's Files
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2017-0029-F
[
]
Thursday, May 30, 2019
FOIA Marker
This is not a textual record. This FOIA Marker indicates that material has been removed
during FOIA processing by George W. Bush Presidential Library staff.
Domestic Policy Council
Zinsmeister, W. Karl - Subject Files
Location or
NARA Number:
FRC ID:
OA Number:
Stack: Row: Sect.: Shelf: Pos.:
Hollinger ID:
W
31
24
6
7
14303
88293
14062
14165
Folder Title:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [2]
Withdrawn/Redacted Material
The George W. Bush Library
DOCUMENT
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
NO.
001
Email
[Email] - To: Karl Rove - From: Karl Zinsmeister
2
06/13/2007
P5; P6/b6;
002
Draft
[Draft]
2
N.D.
P5;
003
Email
RE: Stem Cell Event - To: Karl Zinsmeister
1
06/14/2007
P5;
004
Email
Tuesday Meetings? - To: Karl Zinsmeister - From:
1
06/18/2007
P5;
Christopher Papagianis
005
Handwritten Note
S.C. Principals' Mtg Notes
2
06/2007
P5;
006
Draft
Frame
1
N.D.
P5;
007
Email
S.5 Veto Statement - To: John Marburger - From: Karl
1
06/12/2007
P5;
Zinsmeister
COLLECTION TITLE:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [2]
FRC ID:
14303
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to EOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
Page 1 of 4
This document was prepared on Thursday, May 30, 2019
2014-0503-F
2017-0029-F
Withdrawn/Redacted Material
The George W. Bush Library
DOCUMENT FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
NO.
008
Email
RE: OSTP Comments to Veto Statement - To:
1
06/12/2007
P5;
Christopher Papagianis - From: Karl Zinsmeister
009
Email
RE: - To: Karl Zinsmeister - From: Kevin Sullivan
1
06/18/2007
P5;
010
Email
RE: Stem Cell Qs - To: Karl Zinsmeister, et al. - From:
1
06/18/2007
P5;
Christopher Papagianis
011
Email
RE: Stem Cell Guidance - To: Karl Zinsmeister, et al. -
1
06/18/2007
P5;
From: John Marburger
012
Email
RE: Stem Cell Guidance - To: John Marburger, et al. -
3
06/18/2007
P5;
From: Karl Zinsmeister
013
Draft
[Draft]
2
N.D.
P5;
COLLECTION TITLE:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [2]
FRC ID:
14303
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
Page 2 of 4
2014-0503-F
This document was prepared on Thursday, May 30, 2019
2017-0029-F
Withdrawn/Redacted Material
The George W. Bush Library
DOCUMENT FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
NO.
014
Handwritten Note [Notes]
1
N.D.
P5;
015
Draft
Draft Statement by the President
2
06/07/2007
P5;
016
Email
FOR REVIEW - Draft Statement on Passage of Stem Cell
2
06/06/2007 P5;
Bill - To: VP Staff Sec, et al. - From: Thomas Bowman
017
Email
Re: Patients and Statement - To: Christopher
3
06/06/2007
P5;
Papagianis - From: Karl Zinsmeister
018
Email
Re: EO - To: Christopher Papagianis - From: Karl
1
06/06/2007 P5;
Zinsmeister
019
Handwritten Note
[Notes]
1
N.D.
P5;
COLLECTION TITLE:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [2]
FRC ID:
14303
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
2014-0503-F
Page 3 of 4
This document was prepared on Thursday, May 30, 2019
2017-0029-F
Withdrawn/Redacted Material
The George W. Bush Library
DOCUMENT FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
NO.
020
Email
[Email] - To: Karl Zinsmeister - From: Christopher
1
06/06/2007
P5;
Papagianis
021
Email
Statement by the President - To: Christopher Papagianis
2
04/11/2007
P5;
022
Email
Today's Stem Cell Papers - To: Christopher Papagianis -
1
06/06/2007
P5;
From: Yuval Levin
023
Email
RE: - To: Christopher Papagianis - From: Tevi Troy
1
06/06/2007
P5;
COLLECTION TITLE:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [2]
FRC ID:
14303
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information |(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRAJ
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
Page 4 of 4
2014-0503-F
This document was prepared on Thursday, May 30, 2019
2017-0029-F
Withdrawal Marker
The George W. Bush Library
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
Email
[Email] - To: Karl Rove - From: Karl Zinsmeister
2
06/13/2007
P5; P6/b6;
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
Withdrawal/Redaction Sheet at the front of the folder.
COLLECTION:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [2]
FRC ID:
FOIA IDs and Segments:
14303
2017-0029-F
OA Num.:
14165
2014-0503-F
NARA Num.:
14062
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 5/30/2019 by erg
110TH CONGRESS
1ST SESSION
S.5
AN ACT
To amend the Public Health Service Act to provide for
human embryonic stem cell research.
1
Be it enacted by the Senate and House of Representa-
2 tives of the United States of America in Congress assembled,
3 SECTION 1. SHORT TITLE.
4
This Act may be cited as the "Stem Cell Research
5 Enhancement Act of 2007".
2
1 SEC. 2. HUMAN EMBRYONIC STEM CELL RESEARCH.
2
Part H of title IV of the Public Health Service Act
3 (42 U.S.C. 289 et seq.) is amended by inserting after sec-
4 tion 498C the following:
5 "SEC. 498D. HUMAN EMBRYONIC STEM CELL RESEARCH.
6
"(a) IN GENERAL-Notithstanding any other pro-
7 vision of law (including any regulation or guidance), the
8 Secretary shall conduct and support research that utilizes
9 human embryonic stem cells in accordance with this sec-
10 tion (regardless of the date on which the stem cells were
11 derived from a human embryo)
12
"(b) ETHICAL REQUIREMENTS.-Human embryonic
13 stem cells shall be eligible for use in any research con-
14 ducted or supported by the Secretary if the cells meet each
15 of the following:
16
"(1) The stem cells were derived from human
17
embryos that have been donated from in vitro fer-
18
tilization clinics, were created for the purposes of
19
fertility treatment, and were in excess of the clinical
20
need of the individuals seeking such treatment.
21
"(2) Prior to the consideration of embryo dona-
22
tion and through consultation with the individuals
23
seeking fertility treatment, it was determined that
24
the embryos would never be implanted in a woman
25
and would otherwise be discarded.
t S 5 ES
3
1
"(3) The individuals seeking fertility treatment
2
donated the embryos with written informed consent
3
and without receiving any financial or other induce-
4
ments to make the donation.
5
"(c) GUIDELINES.-Not later than 60 days after the
6 date of the enactment of this section, the Secretary, in
7 consultation with the Director of NIH, shall issue final
8 guidelines to carry out this section.
9
"(d) REPORTING REQUIREMENTS.-The Secretary
10 shall annually prepare and submit to the appropriate com-
11 mittees of the Congress a report describing the activities
12 carried out under this section during the preceding fiscal
13 year, and including a description of whether and to what
14 extent research under subsection (a) has been conducted
15 in accordance with this section."
16 SEC. 3. ALTERNATIVE HUMAN PLURIPOTENT STEM CELL
17
RESEARCH.
18
Part H of title IV of the Public Health Service Act
19 (42 U.S.C. 284 et seq.), as amended by section 2, is fur-
20 ther amended by inserting after section 498D the fol-
21 lowing:
22 "SEC. 498E. ALTERNATIVE HUMAN PLURIPOTENT STEM
23
CELL RESEARCH.
24
"(a) IN GENERAL.-In accordance with section 492,
25 the Secretary shall conduct and support basic and applied
tS 5 ES
4
1 research to develop techniques for the isolation, derivation,
2 production, or testing of stem cells that, like embryonic
3 stem cells, are capable of producing all or almost all of
4 the cell types of the developing body and may result in
5 improved understanding of or treatments for diseases and
6 other adverse health conditions, but are not derived from
7 a human embryo.
8
"(b) GUIDELINES.-Not later than 90 days after the
9 date of the enactment of this section, the Secretary, after
10 consultation with the Director, shall issue final guidelines
11 to implement subsection (a), that-
12
"(1) provide guidance concerning the next steps
13
required for additional research, which shall include
14
a determination of the extent to which specific tech-
15
niques may require additional basic or animal re-
16
search to ensure that any research involving human
17
cells using these techniques would clearly be con-
18
sistent with the standards established under this sec-
19
tion;
20
"(2) prioritize research with the greatest poten-
21
tial for near-term clinical benefit; and
22
"(3) consistent with subsection (a), take into
23
account techniques outlined by the President's Coun-
24
cil on Bioethics and any other appropriate tech-
25
niques and research.
tS 5 ES
5
1
"(c) REPORTING REQUIREMENTS.-Not later than
2 January 1 of each year, the Secretary shall prepare and
3 submit to the appropriate committees of the Congress a
4 report describing the activities carried out under this sec-
5 tion during the fiscal year, including a description of the
6 research conducted under this section.
7
"(d) RULE OF CONSTRUCTION.-Nothing in this sec-
8 tion shall be construed to affect any policy, guideline, or
9 regulation regarding embryonic stem cell research, human
10 cloning by somatic cell nuclear transfer, or any other re-
11 search not specifically authorized by this section.
12
"(e) DEFINITION.-
13
"(1) IN GENERAL.-In this section, the term
14
'human embryo' shall have the meaning given such
15
term in the applicable appropriations Act.
16
"(2) APPLICABLE ACT.-For purposes of para-
17
graph (1), the term 'applicable appropriations Act'
18
means, with respect to the fiscal year in which re-
19
search is to be conducted or supported under this
20
section, the Act making appropriations for the De-
21
partment of Health and Human Services for such
22
fiscal year, except that if the Act for such fiscal year
23
does not contain the term referred to in paragraph
24
(1), the Act for the previous fiscal year shall be
25
deemed to be the applicable appropriations Act.
t S 5 ES
6
1
"(f) AUTHORIZATION OF APPROPRIATIONS.-There
2 is authorized to be appropriated such sums as may be nec-
3 essary for each of fiscal years 2008 through 2010, to carry
4 out this section."
Passed the Senate April 11, 2007.
Attest:
Secretary.
tS 5 ES
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF MANAGEMENT AND BUDGET
WASHINGTON, D.C. 20503
April 10, 2007
(Senate)
STATEMENT OF ADMINISTRATION POLICY
S.5 - Stem Cell Research Enhancement Act of 2007
(Sen. Reid (D) NV and 39 cosponsors)
The Administration strongly opposes Senate passage of S. 5, which would use Federal taxpayer
dollars to support and encourage the destruction of human life for research. The bill would
compel all American taxpayers to pay for research that relies on the intentional destruction of
human embryos for the derivation of stem cells, overturning the President's policy that funds
research without promoting such ongoing destruction. If S. 5 were presented to the President, he
would veto the bill.
The President strongly supports medical research and has worked with Congress to increase
resources for the National Institutes of Health. This Administration is the first to provide Federal
funds for human embryonic stem cell research and has done so without encouraging the
destruction of human embryos. The President's policy permits the Federal funding of research
using embryonic cell lines created prior to August 9, 2001, the date his policy was announced,
along with stem cell research using other kinds of cell lines. Scientists can therefore explore the
potential applications of such cells, but the Federal government does not offer incentives or
encouragement for the destruction of human life.
Over the past six years, more than $130 million in taxpayer dollars has been devoted to human
embryonic stem cell research consistent with the President's policy. Overall, more than $3
billion has gone to innovative research on all forms of stem cells, contributing to proven medical
treatments that use human stem cells from adult and other non-embryonic sources. S.5 seeks to
replace the Administration's policy by providing Federal funding for the first time for a line of
research that involves the intentional destruction of living human embryos for the derivation of
their cells. Destroying nascent human life for research raises serious ethical problems, and
millions of Americans consider the practice immoral. The Administration believes that
government has a duty to use the people's money responsibly, both supporting important public
purposes and respecting moral boundaries.
Alternative types of human stem cells - drawn from adults, children, umbilical-cord blood, and
other non-embryonic sources, without doing harm to the donors - have already achieved
therapeutic results in thousands of patients with many different diseases. Moreover, a recent
series of encouraging research reports offer hope that stem cells drawn from non-embryonic
sources may possess characteristics like those of embryonic stem cells. In addition, researchers
are now working to develop promising new techniques to produce stem cells similar in nature to
those derived from human embryos, but without harming or destroying embryos.
S.5 clearly acknowledges the potential of these new advances and the importance of supporting
them. The provisions in the bill to promote research leading to new techniques for deriving the
functional equivalent of embryonic stem cells, without harming or destroying human embryos,
encourage science that is not in conflict with ethics.
Unfortunately, the bill then crosses that same ethical line, by proposing to use taxpayer dollars to
encourage destruction of nascent human life for research. The Administration believes that
research on alternative sources of stem cells is extremely promising and provides robust
opportunities to advance science without compelling American taxpayers to participate in
ongoing destruction of human embryos.
Moreover, private sector support and public funding by several States for this line of research,
which will add up to several billion dollars in the coming few years, argue against the notion of
any urgent shortfall of research funding. Whatever one's view of the ethical issues or the state of
the research, the future of this field does not require a policy of Federal subsidies that is
offensive to the moral principles of millions of Americans.
The President believes that by enacting appropriate policy safeguards while encouraging the
development of novel scientific techniques, it is possible to advance scientific and medical
frontiers without violating moral principles. S.5 fails to find that balance and is therefore deeply
troubling to millions of Americans. The President urges Congress to pass an alternative bill that
would advance stem cell research without encouraging destruction of human life.
*****
2
110TH CONGRESS
1ST SESSION
S.30
AN ACT
To intensify research to derive human pluripotent stem cell
lines.
1
Be it enacted by the Senate and House of Representa-
2 tives of the United States of America in Congress assembled,
3 SECTION 1. SHORT TITLE.
4
This Act may be cited as the "Hope Offered through
5 Principled and Ethical Stem Cell Research Act" or the
6 "HOPE Act".
2
1 SEC. 2. PURPOSES.
2
It is the purpose of this Act to-
3
(1) intensify research that may result in im-
4
proved understanding of or treatments for diseases
5
and other adverse health conditions; and
6
(2) promote the derivation of pluripotent stem
7
cell lines without the creation of human embryos for
8
research purposes and without the destruction or
9
discarding of, or risk of injury to, a human embryo
10
or embryos other than those that are naturally dead.
11 SEC. 3. HUMAN PLURIPOTENT STEM CELL RESEARCH.
12
Part H of title IV of the Public Health Service Act
13 (42 U.S.C. 289 et seq.) is amended by inserting after see-
14 tion 498C the following:
15 "SEC. 498D. HUMAN PLURIPOTENT STEM CELL RESEARCH.
16
"(a) IN GENERAL.-The Secretary shall conduct and
17 support basic and applied research to develop techniques
18 for the isolation, derivation, production, or testing of stem
19 cells, including pluripotent stem cells that have the flexi-
20 bility of embryonic stem cells (whether or not they have
21 an embryonic source), that may result in improved under-
22 standing of or treatments for diseases and other adverse
23 health conditions, provided that the isolation, derivation,
24 production, or testing of such cells will not involve-
25
"(1) the creation of a human embryo or em-
26
bryos for research purposes; or
tS 30 ES
3
1
"(2) the destruction or discarding of, or risk of
2
injury to, a human embryo or embryos other than
3
those that are naturally dead.
4
"(b) GUIDELINES.-Not later than 90 days after the
5 date of the enactment of this section, the Secretary, after
6 consultation with the Director of NIH, shall issue final
7 guidelines that-
8
"(1) provide guidance concerning the next steps
9
required for additional research, which shall include
10
a determination of the extent to which specific tech-
11
niques may require additional animal research to en-
12
sure that any research involving human cells using
13
these techniques would clearly be consistent with the
14
standards established under subsection (a);
15
"(2) prioritize research with the greatest poten-
16
tial for near-term clinical benefit;
17
"(3) consistent with standards established
18
under subsection (a), take into account techniques
19
outlined by the President's Council on Bioethics and
20
any other appropriate techniques and research; and
21
"(4) in the case of research involving stem cells
22
from a naturally dead embryo, require assurances
23
from grant applicants that no alteration of the tim-
24
ing, methods, or procedures used to create, main-
25
tain, or intervene in the development of a human
t S 30 ES
4
1
embryo was made solely for the purpose of deriving
2
the stem cells.
3
"(c) REPORTING REQUIREMENTS.-Not later than
4 January 1 of each year, the Secretary shall prepare and
5 submit to the appropriate committees of the Congress a
6 report describing the activities carried out under this sec-
7 tion during the fiscal year, including a description of the
8 research conducted under this section.
9
"(d) RULE OF CONSTRUCTION.-Nothing in this sec-
10 tion shall be construed as altering the policy in effect on
11 the date of enactment of this section regarding the eligi-
12 bility of stem cell lines for funding by the National Insti-
13 tutes of Health.
14
"(e) AUTHORIZATION OF APPROPRIATIONS.-There
15 is authorized to be appropriated such sums as may be nec-
16 essary to carry out this section.
17
"(f) DEFINITIONS.-In this section:
18
"(1) NATURALLY DEAD.-The term 'naturally
19
dead' means having naturally and irreversibly lost
20
the capacity for integrated cellular division, growth,
21
and differentiation that is characteristic of an orga-
22
nism, even if some cells of the former organism may
23
be alive in a disorganized state.
24
"(2) HUMAN EMBRYO OR EMBRYOS.-The term
25
'human embryo or embryos' includes any organism,
t S 30 ES
5
1
not protected as a human subject under part 46 of
2
title 45, Code of Federal Regulations, as of the date
3
of enactment of this section, that is derived by fer-
4
tilization, parthenogenesis, cloning, or any other
5
means from one or more human gametes or human
6
diploid cells.
7
"(3) RISK OF INJURY.-The term 'risk of in-
8
jury' means subjecting a. human embryo or embryos
9
to risk of injury or death greater than that allowed
10
for research on fetuses in utero under section
11
46.204(b) of title 45, Code of Federal Regulations,
12
and section 498(b) of this Act."
13 SEC. 4. NATIONAL AMNIOTIC AND PLACENTAL STEM CELL
14
BANK.
15
(a) IN GENERAL.-The Secretary of Health and
16 Human Services shall enter into a contract with the Insti-
17 tute of Medicine for the conduct of a study to recommend
18 an optimal structure for an amniotic and placental stem
19 cell bank program and to address pertinent issues to maxi-
20 mize the potential of such technology, including collection,
21 storage, standards setting, information sharing, distribu-
22 tion, reimbursement, research, and outcome measures. In
23 conducting such study, the Institute should receive input
24 from relevant experts including the existing operators of
tS 30 ES
6
1 federal tissue bank programs and the biomedical research
2 programs within the Department of Defense.
3
(b) REPORT.-Not later than 180 days after the date
4 of enactment of this Act, the Institute of Medicine shall
5 complete the study under subsection (a) and submit to the
6 Secretary of Health and Human Services and the appro-
7 priate committees of Congress a report on the results of
8 such study.
Passed the Senate April 11, 2007.
Attest:
Secretary.
$ S 30 ES
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF MANAGEMENT AND BUDGET
WASHINGTON, D.C. 20503
April 10, 2007
(Senate)
STATEMENT OF ADMINISTRATION POLICY
S. 30 - Hope Offered through Principled and Ethical Stem Cell Research Act
(Sens. Coleman (R) MN and Isakson (R) GA)
The Administration strongly supports Senate passage of S. 30, a bill to support and intensify
research into techniques of deriving pluripotent stem cells without harming or destroying human
embryos.
Pluripotent stem cells are cells that can be differentiated into nearly all the cell types in the
human body. At present, the means of obtaining such cells involve the destruction or
endangerment of living human embryos, raising serious moral concerns. Ongoing research is
investigating whether stem cells derived from the tissues of donors, umbilical cord blood,
amniotic fluid, placentas, and other non-embryonic sources may be pluripotent. Numerous
techniques are being explored by researchers, and significant scientific advances have been
reported in the past few years.
This bill authorizes the Department of Health and Human Services to support the use and further
development of techniques for producing pluripotent cells like those derived from human
embryos, but without harming or destroying the embryos. Research using pluripotent stem cells
is still at a very early stage, and it will be years before researchers know how much promise lies
in therapeutic applications. This early stage is precisely when it is most important to develop
ethically responsible techniques, so that the potential of pluripotent stem cells can be explored
without violating human dignity and life:
This bill also directs the Department, under contract with the Institute of Medicine, to study and
recommend the optimal structure for an amniotic and placental stem cell bank. While research
in this area is still developing, recent publications suggest that a new and readily available source
of pluripotent stem cells may exist in the amniotic fluid that cushions babies in the womb. The
Administration supports further investigation in this area.
The Administration does not believe science and ethics need be at odds. Scientists have shown
they have the ingenuity and skill to pursue the potential benefits of stem cell research without
endangering nascent human life in the process. By seeking intensified support for non-
destructive alternatives, we believe we can advance medical research in valuable ways while
respecting ethical boundaries that are vital to millions of American taxpayers.
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THE WHITE HOUSE
Office of the Press Secretary
(Heiligendamm, Germany)
For Immediate Release
June 7, 2007
STATEMENT BY THE PRESIDENT
Today, the United States House of Representatives, with its vote
on the embryonic stem cell bill, chose to discard existing
protections on human life. This bill puts scientific research
and ethical principle into conflict, rather than supporting a
balanced approach that advances scientific and medical frontiers
without violating moral principles.
My Administration has sought to understand the dilemmas of stem
cell research not as a choice between science and ethics, but as
a challenge to advance medicine while meeting our solemn
obligation to defend human life. That is why in 2001 I
authorized the first federal funding for research on embryonic
stem cells, under careful safeguards. This policy encouraged
ethical research, while requiring taxpayer funds not be used to
support the creation, destruction, or harming of living human
embryos.
Recent scientific developments have reinforced my conviction
that stem cell science can progress in ethical ways. Researchers
have been investigating innovative techniques that could allow
doctors and scientists to produce stem cells just as versatile
as those derived from human embryos, but without harming life,
and the House vote on this bill took place just after
significant advances in stem cell research were reported in
leading scientific journals. These reports give us added hope
that we may one day enjoy the potential benefits of embryonic
stem cells without destroying human life.
I am disappointed the leadership of Congress recycled an old
bill that would simply overturn our country's carefully balanced
policy on embryonic stem cell research. If this bill were to
become law, American taxpayers would for the first time in our
history be compelled to support the deliberate destruction of
human embryos. Crossing that line would be a grave mistake. For
that reason, I will veto the bill passed today.
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Page 1 of 2
Zinsmeister, Karl
From:
Papagianis, Christopher C.
Sent:
Thursday, June 07, 2007 3:42 PM
To:
Zinsmeister, Karl; Troy, Tevi D.
Subject: GOP Proposal to Boost Federal Support for Pluripotent Stem Cell Research
Here is how the MTR was described in the House.
From: GOP Leader Alert [mailto:[email protected]]
Sent: Thursday, June 07, 2007 1:16 PM
Subject: GOP Proposal to Boost Federal Support for Pluripotent Stem Cell Research
GOP PROPOSAL TO BOOST FEDERAL SUPPORT FOR PLURIPOTENT STEM
CELL RESEARCH
SUPPORT FOR RESEARCH THAT DOESN'T REQUIRE DESTROYING HUMAN LIFE
June 7, 2007
Today House Republicans will offer a proposal to direct the National Institute of Health (NIH) to conduct and
support research involving stem cells that have "pluripotent" or embryonic-like qualities without harming or
destroying an embryo. The proposal will be offered as a motion-to-recommit (MTR) on the Stem Cell Research
Enhancement Act (S.5), a bill that would force taxpayers to foot the bill for the destruction of human life for
research.
The U.S. Conference of Catholic Bishops delivered a letter to Congress stating that those who support S.5 would
"explore ways to achieve the benefits of stem cell research within moral limits, but only if they can also violate those
limits," which "only underscores the underlying bill's cavalier attitude towards moral limits."
The Republican proposal, based on legislation authored by Reps. Roscoe Bartlett (R-MD) and Phil Gingrey (R-GA),
removes the provisions of S.5 that would force taxpayers to pay for the destruction of human life, leaving only the
ethical alternative stem cell research. This approach is bolstered by new research showing the full potential of stem
cell research can be realized without destroying living human embryos that are capable of growing into healthy
human adults. According to the Washington Post:
"Three teams of scientists said yesterday they had coaxed ordinary mouse skin cells
to become what are effectively embryonic stem cells without creating or
destroying embryos in the process
"If the process also works with human cells, as scientists suspect it will with some
6/8/2007
Page 2 of 2
modifications, it would mean that a person's own skin cells could be converted directly
into stem cells without having to collect healthy human eggs or destroy human
embryos -- steps that until now have been required to obtain embryonic stem cells.
"Those stem cells could then be used to make a wide variety of personalized
replacement tissues."
At a press conference today, House Republican Leader John Boehner (R-OH) reiterated his support for stem cell
research that does not involve the destruction of human life:
"The question here is not whether you support stem cell research -- the question is
whether taxpayers should be forced to fund ethically-questionable research
that crosses the line. We should be focusing on research that shows promise, like
adult stem cell research."
Republicans are urged to support the MTR.
REPUBLICAN LEADER PRESS OFFICE
REP. JOHN BOEHNER (R-OH)
H-204, THE CAPITOL
(202) 225-4000
HTTP://REPUBLICANLEADER.HOUSE.GOV/
6/8/2007
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-
Tell
Zor hours
(100 keyl
Registry
Name Change
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Simple switch turns cells embryonic
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Nature
Published online: 6 June 2007; I :10.1038/447618a
nature
Simple switch turns cells embryonic
Technique removes need for eggs or embryos.
7
Thought world take
David Cyranoski
10 yrs.
Research reported this week by three different groups shows that normal skin cells can be
reprogrammed to an embryonic state in mice 1, 2, The race is now on to apply the
surprisingly straightforward procedure to human cells.
If researchers succeed, it will make it relatively easy to produce cells that seem
indistinguishable from embryonic stem cells, and that are genetically matched to individual
patients. There are limits to how useful and safe these would be for therapeutic use in the near
term, but they should quickly prove a boon in the lab.
The birth of this chimaeric mouse suggests that the cells used to generate it
behave like embryonic stem cells.
S. OGDEN
"It would change the way we see things quite dramatically," says Alan Trounson of Monash
University in Victoria, Australia. Trounson wasn't involved in the new work but says he plans to
start using the technique "tomorrow". "I can think of a dozen experiments right now - and
they're all good ones," he says.
In theory, embryonic stem cells can propagate themselves indefinitely and are able to become
any type of cell in the body. But so far, the only way to obtain embryonic stem cells involves
destroying an embryo, and to get a genetic match for a patient would mean, in effect, cloning
that person - all of which raise difficult ethical questions.
http://www.nature.com/news/2007/070604/pf/447618a_pf.html
6/6/2007
Simple switch turns cells embryonic
Page 2 of 3
As well as having potential ethical difficulties, the 'cloning' procedure is technically difficult. It
involves obtaining unfertilized eggs, replacing their genetic material with that from an adult
cell and then forcing the cell to divide to create an early-stage embryo, from which the stem
cells can be harvested. Those barriers may have now been broken down.
"Neither eggs nor embryos are necessary. I've never worked with either," says Shinya
Yamanaka of Kyoto University, who has pioneered the new technique.
Last year, Yamanaka introduced a system that uses mouse fibroblasts, a common cell type
that can easily be harvested from skin, instead of eggs⁴. Four genes, which code for four
specific proteins known as transcription factors, are transferred into the cells using
retroviruses. The proteins trigger the expression of other genes that lead the cells to become
pluripotent, meaning that they could potentially become any of the body's cells. Yamanaka
calls them induced pluripotent stem cells (iPS cells). "It's easy. There's no trick, no magic,"
says Yamanaka.
It's unbelievable, just
The results were met with amazement, along with a good dose of
amazing. It's like Dolly.
scepticism. Four factors seemed too simple. And although the cells
It's that type of
had some characteristics of embryonic cells - they formed
accomplishment.
colonies, could propagate continuously and could form cancerous
growths called teratomas - they lacked others. Introduction of iPS
cells into a developing embryo, for example, did not produce a 'chimaera' - a mouse carrying
a mix of DNA from both the original embryo and the iPS cells throughout its body. "I was not
comfortable with the term 'pluripotent' last year," says Hans Schöler, a stem-cell specialist at
the Max Planck Institute for Molecular Biomedicine in Münster who is not involved with any of
the three articles.
This week, Yamanaka presents a second generation of iPS cells¹, which pass all these tests. In
addition, a group led by Rudolf Jaenisch² at the Whitehead Institute for Biomedical Research in
Cambridge, Massachusetts, and a collaborative effort³ between Konrad Hochedlinger of the
Harvard Stem Cell Institute and Kathrin Plath of the University of California, Los Angeles, used
the same four factors and got strikingly similar results.
"It's a relief as some people questioned our results, especially after the Hwang scandal," says
Yamanaka, referring to the irreproducible cloning work of Woo Suk Hwang, which turned out to
be fraudulent. Schöler agrees: "Now we can be confident that this is something worth building
on."
The improvement over last year's results was simple. The four transcription factors used by
Yamanaka reprogramme cells inconsistently and inefficiently, so that less than 0.1% of the
million cells in a simple skin biopsy will be fully reprogrammed. The difficulty is isolating those
in which reprogramming has been successful. Researchers do this by inserting a gene for
antibiotic resistance that is activated only when proteins characteristic of stem cells are
expressed. The cells can then be doused with antibiotics, killing off the failures.
The protein Yamanaka used as a marker for stem cells last year was not terribly good at
identifying reprogrammed cells. This time, all three groups used two other protein markers -
Nanog and Oct4 - to great effect. All three groups were able to produce chimaeric mice using
iPS cells isolated in this way; and the mice passed iPS DNA on to their offspring.
Jaenisch also used a special embryo to produce fetuses whose cells were derived entirely from
iPS cells. "Only the best embryonic stem cells can do this," he says.
http://www.nature.com/news/2007/070604/pf/447618a_pf.html
6/6/2007
Simple switch turns cells embryonic
Page 3 of 3
"It's unbelievable, just amazing," says Schöler, who heard Jaenisch present his results at a
meeting on 31 May in Bavaria. "For me it's like Dolly [the first cloned mammal]. It's that type
of accomplishment."
The method is inviting. Whereas cloning with humans was limited by the number of available
eggs and by a tricky technique that takes some six months to master, Yamanaka's method can
use the most basic cells and can be accomplished with simple lab techniques.
But applying the method to human cells has yet to be successful. "We are working very hard
- day and night," says Yamanaka. It will probably require more transcription factors, he adds.
If it works, researchers could produce iPS cells from patients with conditions such as
Parkinson's disease or diabetes and observe the molecular changes in the cells as they
develop. This 'disease in a dish' would offer the chance to see how different environmental
factors contribute to the condition, and to test the ability of drugs to check disease
progression.
But the iPS cells aren't perfect, and could not be used safely to make genetically matched cells
for transplant in, for example, spinal-cord injuries. Yamanaka found that one of the factors
seems to contribute to cancer in 20% of his chimaeric mice. He thinks this can be fixed, but
the retroviruses used may themselves also cause mutations and cancer. "This is really
dangerous. We would never transplant these into a patient," says Jaenisch. In his view,
research into embryonic stem cells made by cloning remains "absolutely essential".
If the past year is anything to judge by, change will come quickly. "I'm not sure if it will be us,
or Jaenisch, or someone else, but I expect some big success with humans in the next year,"
says Yamanaka.
Additional reporting by Heidi Ledford
For more on alternative stem-cell work, see 'Stem cells: Recycling the abnormal';
and see http://www.nature.com/stemcells
Article brought to you by: Nature
Top
References
1. Okita, K., Ichisaka, T. & Yamanaka, S. Nature doi: 10.1038/nature05934 (2007).
2. Wernig, M. et al. Nature doi: 10.1038/nature05944 (2007).
3. Maherali, N. et al. Cell Stem Cell doi: 10.1016/j.stem.2007.05.014 (2007).
4. Takahashi, K. & Yamanaka, S. Cell 126, 663-676
(2006). I Article I PubMed I ChemPort I
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