Office of the Director, National Institutes of Health; Request for Public Comment on Draft Reports on Xenotransplantation, 11680 [05-4568]
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Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Notices
2005, 8 a.m. to March 15, 2005, 4 p.m.,
Hubert H. Humphrey Building, Room
800, 200 Independence Avenue,
Washington, DC 20201, which was
published in the Federal Register on
February 4, 2005, 70 FR 6025.
The meeting location has changed to
the National Library of Medicine,
Building 38, 2nd Floor Mezzanine,
Board Room, 8600 Rockville Pike,
Bethesda, Maryland 20894. The meeting
is open to the public.
Dated: March 2, 2005.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–4569 Filed 3–8–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Request for Public
Comment on Draft Reports on
Xenotransplantation
The Secretary’s Advisory Committee
on Xenotransplantation (SACX) is
requesting public comment on two draft
reports on xenotransplantation. One is
on the state of the science of
xenotransplantation and the other is on
informed consent issues in clinical trials
involving xenotransplantation.
Before the reports are finalized and
transmitted to the Secretary, the SACX
is requesting comments on the draft
reports from members of the public. All
public comments received will be
considered in finalizing the reports.
Comments should be submitted by
March 31, 2005. Received comments
will be available for public inspection at
the NIH Office of Biotechnology
Activities, Monday through Friday
between the hours of 8:30 a.m. and 5
p.m., at the contact address noted
below.
Information: The Secretary’s Advisory
Committee on Xenotransplantation,
Department of Health and Human
Services, considers the scientific,
medical, social, and ethical issues and
the public health concerns raised by
xenotransplantation and makes
recommendations to the Secretary on
policy and procedures. The Committee’s
charges include advising on the current
state of knowledge regarding
xenotransplantation and on the
potential for transmission of infectious
diseases as a consequence of
xenotransplantation; and deliberating
on medical, public health, ethical, legal
and socioeconomic issues, including
VerDate jul<14>2003
18:06 Mar 08, 2005
Jkt 205001
international policies and developments
that are relevant to xenotransplantation.
Overview of Drafts: The state of the
science report addresses the scientific
challenges in xenotransplantation, the
infectious disease risks associated with
xenotransplantation, public health
concerns associated with xenotourism,
knowledge gaps and resource
limitations, and alternative strategies to
xenotransplantation. The report also
proposes a series of recommendations
regarding these issues.
The report on informed consent issues
in clinical research involving
xenotransplantation addresses the
ethical foundations and functions of
informed consent, components of
informed consent, the informed consent
process, informed consent forms, and
special issues raised by
xenotransplantation. The report
proposes a series of recommendations
regarding informed consent in
xenotransplantation research.
The full draft reports are available
electronically at https://
www4.od.nih.gov/oba/Sacx.htm. A
paper or electronic copy can also be
requested by calling the NIH Office of
Biotechnology Activities at (301) 496–
9838 or by e-mailing Mary Groesch at
groeschm@od.nih.gov.
Contact Person: Mary Groesch, Ph.D.,
Executive Director, Secretary’s Advisory
Committee on Xenotransplantation,
Office of Biotechnology Activities,
Rockledge I, Room 750, Bethesda, MD
20892. (301) 496–9838.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds; 93.22, Clinical
Research Loan Repayment Program for
Individuals from Disadvantaged
Backgrounds; 93.232, Loan Repayment
Program for Research Generally; 93.39,
Academic Research Enhancement Award;
93.936, NIH Acquired Immunodeficiency
Syndrome Research Loan Repayment
Program, National Institutes of Health, HHS.)
Dated: March 1, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–4568 Filed 3–8–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
Center for the Evaluation of Risks to
Human Reproduction (CERHR);
Announcement of the Styrene Expert
Panel Meeting and Availability of the
Draft Expert Panel Report on Styrene;
Request for Public Comment on the
Draft Report
National Institute for
Environmental Health Sciences
(NIEHS); National Institutes of Health
(NIH).
ACTION: Announcement of a meeting and
request for comment.
AGENCY:
SUMMARY: The CERHR announces the
availability of the draft expert panel
report for styrene on March 18, 2005,
from the CERHR Web site (https://
cerhr.niehs.nih.gov) or in printed text
from the CERHR (see FOR FURTHER
INFORMATION CONTACT below). The
CERHR invites the submission of public
comments on sections 1–4 of the draft
expert panel report (see SUPPLEMENTARY
INFORMATION below). The expert panel
will meet on June 1–3, 2005, at the
Holiday Inn Old Town Select in
Alexandria, Virginia to review and
revise the draft expert panel report and
reach conclusions regarding whether
exposure to styrene is a hazard to
human development or reproduction.
The expert panel will also identify data
gaps and research needs. CERHR expert
panel meetings are open to the public
with time scheduled for oral public
comment. Attendance is limited only by
the available meeting room space.
Following the expert panel meeting and
completion of the expert panel report,
the CERHR will post the report on its
Web site and solicit public comment on
it through a Federal Register notice.
DATES: The expert panel meeting for
styrene will be held on June 1–3, 2005.
Sections 1–4 of the draft expert panel
report will be available for public
comment on March 18, 2005. Written
public comments on the draft report
must be received by May 2, 2005. Time
is set-aside at the expert panel meeting
on June 1, 2005 for oral public
comments. Individuals wishing to make
oral public comments are asked to
contact Dr. Michael D. Shelby, CERHR
Director, by May 25, 2005, and if
possible, also send a copy of the
statement or talking points at that time.
Persons needing special assistance in
order to attend are asked to contact Dr.
Shelby at least 7 business days prior to
the meeting.
ADDRESSES: The expert panel meeting
for styrene will be held at the Holiday
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]]>Agencies
[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Notices]
[Page 11680]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4568]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director, National Institutes of Health; Request
for Public Comment on Draft Reports on Xenotransplantation
The Secretary's Advisory Committee on Xenotransplantation (SACX) is
requesting public comment on two draft reports on xenotransplantation.
One is on the state of the science of xenotransplantation and the other
is on informed consent issues in clinical trials involving
xenotransplantation.
Before the reports are finalized and transmitted to the Secretary,
the SACX is requesting comments on the draft reports from members of
the public. All public comments received will be considered in
finalizing the reports. Comments should be submitted by March 31, 2005.
Received comments will be available for public inspection at the NIH
Office of Biotechnology Activities, Monday through Friday between the
hours of 8:30 a.m. and 5 p.m., at the contact address noted below.
Information: The Secretary's Advisory Committee on
Xenotransplantation, Department of Health and Human Services, considers
the scientific, medical, social, and ethical issues and the public
health concerns raised by xenotransplantation and makes recommendations
to the Secretary on policy and procedures. The Committee's charges
include advising on the current state of knowledge regarding
xenotransplantation and on the potential for transmission of infectious
diseases as a consequence of xenotransplantation; and deliberating on
medical, public health, ethical, legal and socioeconomic issues,
including international policies and developments that are relevant to
xenotransplantation.
Overview of Drafts: The state of the science report addresses the
scientific challenges in xenotransplantation, the infectious disease
risks associated with xenotransplantation, public health concerns
associated with xenotourism, knowledge gaps and resource limitations,
and alternative strategies to xenotransplantation. The report also
proposes a series of recommendations regarding these issues.
The report on informed consent issues in clinical research
involving xenotransplantation addresses the ethical foundations and
functions of informed consent, components of informed consent, the
informed consent process, informed consent forms, and special issues
raised by xenotransplantation. The report proposes a series of
recommendations regarding informed consent in xenotransplantation
research.
The full draft reports are available electronically at https://
www4.od.nih.gov/oba/Sacx.htm. A paper or electronic copy can also be
requested by calling the NIH Office of Biotechnology Activities at
(301) 496-9838 or by e-mailing Mary Groesch at groeschm@od.nih.gov.
Contact Person: Mary Groesch, Ph.D., Executive Director,
Secretary's Advisory Committee on Xenotransplantation, Office of
Biotechnology Activities, Rockledge I, Room 750, Bethesda, MD 20892.
(301) 496-9838.
(Catalogue of Federal Domestic Assistance Program Nos. 93.14,
Intramural Research Training Award; 93.187, Undergraduate
Scholarship Program for Individuals from Disadvantaged Backgrounds;
93.22, Clinical Research Loan Repayment Program for Individuals from
Disadvantaged Backgrounds; 93.232, Loan Repayment Program for
Research Generally; 93.39, Academic Research Enhancement Award;
93.936, NIH Acquired Immunodeficiency Syndrome Research Loan
Repayment Program, National Institutes of Health, HHS.)
Dated: March 1, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 05-4568 Filed 3-8-05; 8:45 am]
BILLING CODE 4140-01-M
