Notice of Meeting of the Advisory Committee on Organ Transplantation, 18407-18408 [05-7160]
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Federal Register / Vol. 70, No. 68 / Monday, April 11, 2005 / Notices
Dated: April 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–7130 Filed 4–8–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Advisory Committee for
Pharmaceutical Science; Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Advisory
Committee for Pharmaceutical Science.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 3 and 4, 2005, from 8:30
a.m. to 5 p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Hilda Scharen, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093) Rockville,
MD 20857, 301–827–7001, e-mail:
scharenh@cder.fda.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572) in the
Washington, DC area), code
3014512539. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On May 3, 2005, the
committee will: (1) Receive an update
from the Clinical Pharmacology
Subcommittee and (2) discuss and
provide comments on the general topic
of establishing drug release or
dissolution specifications. On May 4,
2005, the committee will: (1) Receive an
update on current activities of the
Parametric Tolerance Interval Test
Workgroup, (2) discuss and provide
comments on the general topic of
considerations for assessment of
pharmaceutical equivalence and
product design, and (3) discuss criteria
for establishing a working group for
review and assessment of Office of
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Pharmaceutical Science research
programs.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person by April 25, 2005. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. each day. Time allotted
for each presentation may be limited.
Those desiring to make formal oral
presentations should notify the contact
person before April 25, 2005, and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Hilda
Scharen at least 7 days in advance of the
meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–7129 Filed 4–8–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Meeting of the Advisory
Committee on Organ Transplantation
Health Resources and Services
Administration, HHS.
SUMMARY: Pursuant to Pub. L. 92–463,
the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the eighth meeting of
the Advisory Committee on Organ
Transplantation (ACOT), Department of
Health and Human Services (HHS). The
meeting will be held from
approximately 9 a.m. to 5:30 p.m. on
May 9, 2005, and from 9 a.m. to 3 p.m.
on May 10, 2005, at the Rockville
DoubleTree Hotel, 1750 Rockville Pike,
Rockville, Maryland 20852. The meeting
AGENCY:
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18407
will be open to the public; however,
seating is limited and pre-registration is
encouraged (see below).
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. Section 217a,
Section 222 of the Public Health Service
Act, as amended, and 42 CFR 121.12
(2000), ACOT was established to assist
the Secretary in enhancing organ
donation, ensuring that the system of
organ transplantation is grounded in the
best available medical science, and
assuring the public that the system is as
effective and equitable as possible, and,
thereby, increasing public confidence in
the integrity and effectiveness of the
transplantation system. ACOT is
composed of up to 25 members,
including the Chair. Members are
serving as Special Government
Employees and have diverse
backgrounds in fields such as organ
donation, health care public policy,
transplantation medicine and surgery,
critical care medicine and other medical
specialties involved in the identification
and referral of donors, non-physician
transplant professions, nursing,
epidemiology, immunology, law and
bioethics, behavioral sciences,
economics and statistics, as well as
representatives of transplant candidates,
transplant recipients, organ donors, and
family members.
ACOT will hear presentations from
staff of the Centers for Medicare and
Medicaid Services (CMS) on the CMS
Organ Procurement Organization Notice
of Proposed Rulemaking and the
Transplant Center Notice of Proposed
Rulemaking. The presentations may
include a discussion and summary of
the comments received during the 60day public comment period which
began February 4.
The draft meeting agenda will be
available on April 15 on the
Department’s donation Web site at http:/
/www.organdonor.gov/acot.html.
A registration form will be available
on March 15 on the Department’s
donation Web site at https://
www.organdonor.gov/acot.html. The
completed registration form should be
submitted by facsimile to Professional
and Scientific Associates (PSA), the
logistical support contractor for the
meeting, at fax number (703) 234–1701.
Individuals without access to the
Internet who wish to register may call
Bryan Slattery with PSA at (703) 234–
1734. Individuals who plan to attend
the meeting and need special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify the ACOT Executive
Director, Thomas E. Balbier, Jr., in
advance of the meeting. Mr. Balbier may
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18408
Federal Register / Vol. 70, No. 68 / Monday, April 11, 2005 / Notices
be reached by telephone at 301–443–
1896, e-mail:
Thom.Balbier@hrsa.hhs.gov, or in
writing at the address of the Division of
Transplantation provided below.
Management and support services for
ACOT functions are provided by the
Division of Transplantation, Healthcare
Systems Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Parklawn Building, Room 12C–06,
Rockville, Maryland 20857; telephone
number 301–443–7577.
After the presentations from CMS and
ACOT discussions, members of the
public will have an opportunity to
provide comments. Because of the
Committee’s full agenda and the
timeframe in which to cover the agenda
topics, public comment will be limited.
All public comments will be included
in the record of the ACOT meeting.
Dated: April 5, 2005.
Elizabeth M. Duke,
Administrator.
[FR Doc. 05–7160 Filed 4–8–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Galveston National Laboratory Record
of Decision
ACTION:
Notice.
SUMMARY: The Department of Health and
Human Services, the National Institutes
of Health (NIH), has decided, after
completion of a Final Environmental
Impact Statement (EIS) and a thorough
consideration of the public comments
on the Draft EIS to implement the
Proposed Action, which is identified as
the Preferred Alternative in the Final
EIS. This action is to partially fund the
construction of a state-of-the-art
National Biocontainment Laboratory
(NBL), which will be known as the
Galveston National Laboratory (GNL),
on the University of Texas Medical
Branch (UTMB) Campus in Galveston,
Texas.
FOR FURTHER INFORMATION CONTACT:
Valerie Nottingham, Chief of the
Environmental Quality Branch, Division
of Environmental Protection, Office of
Research Facilities Development and
Operations, NIH, Building 13, Room
2W64, 9000 Rockville Pike, Bethesda,
MD 20892, telephone 301–496–7775,
Fax 301–480–8056, e-mail
nihnepa@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
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Decision
After careful review of the
environmental consequences in the
Final Environmental Impact Statement
for the Galveston National Laboratory
for Biodefense and Emerging Infectious
Diseases Research Facility in Galveston,
TX (Final GNL EIS), and consideration
of public comment throughout the
NEPA process, the NIH has decided to
implement the Proposed Action
described below as the Selected
Alternative.
Selected Alternative
The NIH plans to partially fund the
construction of a state-of the-art
National Biocontainment Laboratory,
which will be known as the Galveston
National Laboratory (GNL), on the
UTMB Campus in Galveston, Texas. The
total cost of the proposed GNL project
is estimated at approximately $147
million. NIH will fund approximately
$110 million with UTMB providing the
remaining approximately $37 million.
The proposed GNL will enhance
national security through the
development and evaluation of
improved diagnostics, therapeutics, and
vaccines for protection against diseases,
including those that have the potential
for bioterrorism. The proposed GNL will
not conduct research to develop
biological weapons.
The proposed GNL facility will be a
new reinforced concrete seven-story
building that will be constructed within
the footprint of a recently demolished
building on the UTMB campus. The
proposed GNL, with a total net area of
approximately 82,411 square feet, will
house Biosafety Level (BSL)–4, BSL–3,
and BSL–2 facilities, BSL–4 and BSL–3
animal facilities, Arthropod
Containment Level (ACL)–3 insectary,
offices, conference rooms, and support
facilities including an effluent treatment
room, secure loading dock, and
dedicated mechanical floors to enhance
containment and minimize the risk of
exposure.
The proposed GNL facility will be
designed to safely support all of the
superimposed loads applied to the
building and to resist 140 mile-per-hour
hurricane force winds. Also, as required
by the National Earthquake Hazards
Reduction Program, it will be designed
and constructed to the highest building
protection classification category of IV.
Furthermore, the proposed GNL will be
designed with regard to its location
within a 100-year flood plain. For
example, the BSL–4 laboratories will be
located above the extreme 25-foot storm
surge that might occur during a category
4 or 5 hurricane. In addition to standby
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generators to provide power in the event
of a power outage, the proposed GNL
facility will have a distributed on-line
uninterruptible power supply module or
a fuel cell power supply to power the
BSL–4 biosafety cabinets, BSL–3
enhanced biosafety cabinets, critical
building control panels and alarms.
In addition to designing for severe
weather conditions, operating
procedures will call for a lockdown of
all infectious materials and
decontamination of high-level
biocontainment laboratories in the event
of an approaching hurricane. Storm
preparedness will be based on
approximately 24-hour notice of
probable landfall, taking into account
the predicted strength of a storm. This
allows sufficient time to close down
high containment operations, should
this be deemed necessary, including the
management of animals.
The building also will be provided
with an environmental monitoring
system to assess room pressure
differentials (to ensure negative pressure
in the biocontainment areas), smoke
detection, automatic watering system
pressure and flow, and the condition of
high efficiency particulate air (HEPA)
filters. Visual indications (such as
pressure gauges) and audible or strobic
alarms will alert GNL personnel to an
emergency or a situation that requires
corrective action. The proposed GNL
will have fire protection systems that
meet or exceed requirements specified
by the National Fire Protection
Association and all applicable local,
State, Federal, and UTMB requirements.
The design of the proposed GNL
facility’s BSL–4, –3, and –2 laboratories
will comply with the recommendations
and requirements of the Centers for
Disease Control (CDC) and the NIH joint
publication addressing biosafety in
laboratories, the 4th Edition Biosafety in
Microbiological and Biomedical
Laboratories, as well as NIH’s Design
Policies and Guidelines for Biomedical
Research Laboratories. The BSL–4, –3,
–2 animal laboratories will further
comply with the recommendations and
requirements of the latest edition of
Guide for Care and Use of Laboratory
Animals published by the National
Research Council. The four biosafety
levels have increasingly stringent
design, security, and containment
requirements. The safety levels are
determined based on the biological
materials used in research and the ways
they affect the human population. BSL–
1 facilities have no requirements for
safety equipment, while BSL–4 facilities
have extensive and multiple
requirements for safety equipment and
facility design such as isolation, buffer
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[Federal Register Volume 70, Number 68 (Monday, April 11, 2005)]
[Notices]
[Pages 18407-18408]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7160]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Meeting of the Advisory Committee on Organ
Transplantation
AGENCY: Health Resources and Services Administration, HHS.
SUMMARY: Pursuant to Pub. L. 92-463, the Federal Advisory Committee
Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the
eighth meeting of the Advisory Committee on Organ Transplantation
(ACOT), Department of Health and Human Services (HHS). The meeting will
be held from approximately 9 a.m. to 5:30 p.m. on May 9, 2005, and from
9 a.m. to 3 p.m. on May 10, 2005, at the Rockville DoubleTree Hotel,
1750 Rockville Pike, Rockville, Maryland 20852. The meeting will be
open to the public; however, seating is limited and pre-registration is
encouraged (see below).
SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. Section
217a, Section 222 of the Public Health Service Act, as amended, and 42
CFR 121.12 (2000), ACOT was established to assist the Secretary in
enhancing organ donation, ensuring that the system of organ
transplantation is grounded in the best available medical science, and
assuring the public that the system is as effective and equitable as
possible, and, thereby, increasing public confidence in the integrity
and effectiveness of the transplantation system. ACOT is composed of up
to 25 members, including the Chair. Members are serving as Special
Government Employees and have diverse backgrounds in fields such as
organ donation, health care public policy, transplantation medicine and
surgery, critical care medicine and other medical specialties involved
in the identification and referral of donors, non-physician transplant
professions, nursing, epidemiology, immunology, law and bioethics,
behavioral sciences, economics and statistics, as well as
representatives of transplant candidates, transplant recipients, organ
donors, and family members.
ACOT will hear presentations from staff of the Centers for Medicare
and Medicaid Services (CMS) on the CMS Organ Procurement Organization
Notice of Proposed Rulemaking and the Transplant Center Notice of
Proposed Rulemaking. The presentations may include a discussion and
summary of the comments received during the 60-day public comment
period which began February 4.
The draft meeting agenda will be available on April 15 on the
Department's donation Web site at https://www.organdonor.gov/acot.html.
A registration form will be available on March 15 on the
Department's donation Web site at https://www.organdonor.gov/acot.html.
The completed registration form should be submitted by facsimile to
Professional and Scientific Associates (PSA), the logistical support
contractor for the meeting, at fax number (703) 234-1701. Individuals
without access to the Internet who wish to register may call Bryan
Slattery with PSA at (703) 234-1734. Individuals who plan to attend the
meeting and need special assistance, such as sign language
interpretation or other reasonable accommodations, should notify the
ACOT Executive Director, Thomas E. Balbier, Jr., in advance of the
meeting. Mr. Balbier may
[[Page 18408]]
be reached by telephone at 301-443-1896, e-mail:
Thom.Balbier@hrsa.hhs.gov, or in writing at the address of the Division
of Transplantation provided below. Management and support services for
ACOT functions are provided by the Division of Transplantation,
Healthcare Systems Bureau, Health Resources and Services
Administration, 5600 Fishers Lane, Parklawn Building, Room 12C-06,
Rockville, Maryland 20857; telephone number 301-443-7577.
After the presentations from CMS and ACOT discussions, members of
the public will have an opportunity to provide comments. Because of the
Committee's full agenda and the timeframe in which to cover the agenda
topics, public comment will be limited. All public comments will be
included in the record of the ACOT meeting.
Dated: April 5, 2005.
Elizabeth M. Duke,
Administrator.
[FR Doc. 05-7160 Filed 4-8-05; 8:45 am]
BILLING CODE 4165-15-P
