Federal Register: November 15, 2004 (Volume 69, Number 219)
DOCID: FR Doc 04-25280
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: Meetings:
SUBJECT CATEGORY:
National Toxicology Program (NTP) Board of Scientific Counselors Technical Reports Review Subcommittee Meeting; Review of Draft NTP Technical Reports
DOCUMENT SUMMARY:
Pursuant to Pub. L. 92463, notice is hereby given of the next
meeting of the NTP Board of Scientific Counselors Technical Reports
Review Subcommittee (``TRR Subcommittee'') on December 910, 2004, in the Rodbell Auditorium, Rall Building at the
[[Page 65614]]
National Institute of Environmental Health Sciences, 111 T.W. Alexander
Drive, Research Triangle Park, NC 27709. The meeting will begin each
day at 8:30 a.m. The meeting is open to the public with attendance
limited only by the space available (see ``Attendance, Registration, and Remote Access'' below).
Agenda
The primary agenda topic is the peer review by the TRR Subcommittee
of the findings and conclusions of seven draft NTP Technical Reports
(TR) of rodent toxicology and carcinogenesis studies conducted by the
NTP (see Preliminary Agenda below). There will also be a presentation
on how the NTP handles contaminants in study materials and their impact
on the interpretation of 2year bioassays. In addition, at the request
of the NTP Board of Scientific Counselors, the TRR Subcommittee will
readdress the title of the Draft NTP Technical Report on Anthraquinone
(see minutes from the NTP Board of Scientific Counselors meeting held
June 29, 2004, available at http://ntpserver.niehs.nih.gov/ntpweb/index.cfm?objectid=720164E3BDB7CEBAF338FA2626639D56 ). As an
introduction to the reports on the studies of polychlorinated biphenyl
(PCB), a short presentation will be given on the use of Toxic
Equivalency Factors (TEFs). The TEF methodology was developed as a
mathematical tool that ranks the dioxinlike activity of a compound
relative to 2,3,7,8tetrachlorodibenzopdioxin (TCDD), the most potent
dioxin. This methodology has been applied to the NTP studies reported
in TR 531: Mixture of 3,3',4,4',5Pentachlorobiphenyl (PCB 126) and
2,3',4,4',5Pentachlorobiphenyl (PCB 118), TR 529: 2,2',4,4',5,5'
Hexachlorobiphenyl (PCB 153), and TR 530: Mixture of PCB 126 and PCB 153.
A copy of the agenda, TRR Subcommittee roster, and the draft NTP
Technical Reports, as available, will be posted on the NTP Web site
(http://ntpserver.niehs.nih.gov/ under Latest News) and will be
available upon request to the NTP Executive Secretary, Dr. Barbara S.
Shane (PO Box 12233, 111 T.W. Alexander Dr., MD A301, Research
Triangle Park, NC 27709, T: 9195414253; F: 9195410295; email:
shane@niehs.nih.gov). Following the meeting, summary minutes will be
available on the TRR Subcommittee Web site (see http://ntpserver.niehs.nih.gov/ntpweb/index.cfm?objectid=227FC084=EB0C7E939DCD6F03104F0D22 ) and in hard copy upon request to the NTP Executive
Secretary.
Draft Reports Available for Public Review and Comment
Approximately four weeks prior to the meeting, the draft reports
will be available for public review, through the NTP Web page (http://ntpserver.niehs.nih.gov/ under Latest News). Printed copies of the
Draft NTP Technical Reports can be obtained, as available, from Central
Data Management (NIEHS, PO Box 12233, MD EC03, Research Triangle Park,
NC 27709, T: 9195413419, F: 9195413687, email: CDM@niehs.nih.gov). Attendance, Registration and Remote Access
The meeting is open to the public with attendance limited only by
the space available. Individuals who plan to attend are strongly
encouraged to register with the NTP Executive Secretary by December 2,
2004 to ensure easy access to the NIEHS campus (contact information
above) or online on the NTP Web site (http://ntp.niehs.nih.gov under
Latest News). Please note that a photo ID is required to access the
NIEHS campus. Persons needing special assistance, such as sign language
interpretation or other reasonable accommodation in order to attend are
asked to notify the NTP Executive Secretary at least seven business
days in advance of the meeting. The NTP is also making plans to
videocast the TRR Subcommittee meeting through the Internet at http://www.niehs.nih.gov/external/video.htm. The NTP cannot guarantee the
technical quality of the video casting and people wishing to use this
option are encouraged to test their ability to access the video cast at
the above Internet address under Check your live video setup. Public Comment
Comments on any of the Draft NTP Technical Reports are welcome. Time will be provided at the meeting for oral public comment on the reports. Persons requesting time for an oral presentation on a particular report are asked to notify the NTP Executive Secretary (contact information given above) by December 2, 2004, and to provide their contact information (name, affiliation, mailing address, phone, fax, email), and supporting organization (if any). Persons registering to make comments are asked to provide a written copy of their statement to the NTP Executive Secretary on or before December 2, 2004, to enable review by the TRR Subcommittee and NTP staff prior to the meeting. These statements can supplement or expand an oral presentation. Each speaker will be allotted at least 7 minutes and, if time permits, up 10 minutes for presentation of oral comments. Each organization is allowed one time slot per report being reviewed. Registration for making public comments will also be available onsite. If registering onsite to speak and reading comments from printed text, the speaker is asked to provide 25 copies of the statement for distribution to the Subcommittee and NTP staff, and to supplement the record.
Written comments without an oral presentation at the meeting are also welcome. Comments should include contact information for the submitter (name, affiliation, mailing address, phone, fax, and email) and supporting organization (if any). Written comments should be received by the NTP Executive Secretary on or before December 2, 2004, to enable distribution to the Subcommittee and NTP staff for their review and consideration prior to the meeting. Written comments received in response to this notice will be posted on the NTP Web site (http://ntp.niehs.nih.gov under Latest News). Request for Additional Information
The NTP would welcome receiving toxicology and carcinogenesis information from completed, ongoing or planned studies as well as current production data, human exposure information, and use patterns for any of the chemicals listed in this announcement. Please send this information to Central Data Management at the address given above and it will be forwarded to the appropriate NTP staff.
NTP Technical and Toxicity Report Series
The NTP conducts toxicology and carcinogenesis studies of agents of
public health concern. Any scientist, organization, or member of the
public may nominate a chemical for NTP testing. Details about the
nomination process are available on the NTP Web site (http://ntp.niehs.nih.gov under Nominations to the Testing Program). The
results of shortterm rodent toxicology studies are published in the
NTP Toxicity Report series. Longerterm studies, generally, rodent
carcinogenicity studies, are published in the NTP Technical Report
series. The NTP has a new technical report series for studies conducted
in genetically modified models. PDF files of completed reports are
available freeofcharge at the NTP Web site (http://ntpserver.niehs.nih.gov/index.cfm?objectid=084801F0F43F7B740BE549908B5E5C1C ).
[[Page 65615]]
NTP Board of Scientific Counselors
The NTP Board of Scientific Counselors (``the Board'') is a technical advisory body composed of scientists from the public and private sectors who provide primary scientific oversight and peer review to the NTP. Specifically, the Board advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purpose of determining and advising on the scientific merit of its activities and overall scientific quality. The TRR Subcommittee of the Board provides scientific peer review of the findings and conclusions of NTP Technical Reports. The Report on Carcinogens Subcommittee of the Board provides scientific peer review of nominations to the Report on Carcinogens, a Congressionally mandated listing of agents known or reasonably anticipated to be human carcinogens.
The Board's members are selected from recognized authorities
knowledgeable in fields, such as toxicology, pharmacology, pathology,
biochemistry, epidemiology, risk assessment, carcinogenesis,
mutagenesis, molecular biology, behavioral toxicology, neurotoxicology,
immunotoxicology, reproductive toxicology or teratology, and
biostatistics. The NTP strives for equitable geographic distribution and for minority and female representation on the Board.
Dated: November 5, 2004.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences. Preliminary Agenda
National Toxicology Program (NTP) Technical Reports (TR) Scheduled for
Review by the NTP Board of Scientific Counselors Technical Reports Review Subcommittee
December 910, 2004
Rodbell Auditorium, National Institute of Environmental Health
Sciences, 111 TW Alexander Drive, Research Triangle Park, NC. 1. Overview of Dioxin Toxic Equivalency Factors (TEFs).
2. TR 531: Mixture of 3,3',4,4',5Pentachlorobiphenyl (PCB 126) and
2,3',4,4',5Pentachlorobiphenyl (PCB 118) (CAS Nos. 57465288 and 31508006, respectively).
3. TR 529: 2,2',4,4',5,5'Hexachlorobiphenyl (PCB 153) (CAS No. 35065 271).
4. TR 530: Mixture of PCB 126 and PCB 153 (CAS No: 57465288 and 835065271, respectively).
5. Discussion on Contaminants in NTP Study Materials: Impact on Interpretation of 2year Bioassays.
6. TR 517: Sodium Chlorate (CAS No. 7775099).
8. TR 522: 3'Azido3'thymidine (AZT) (CAS No. 30516871).
9. TR 533: Benzophenone (CAS No. 119619).
BILLING CODE 414001P
SUMMARY:
National Toxicology Program—; Scientific Counselors Board,
DOCUMENT BODY 2:
Pursuant to Pub. L. 92463, notice is hereby given of the next
meeting of the NTP Board of Scientific Counselors Technical Reports
Review Subcommittee (``TRR Subcommittee'') on December 910, 2004, in the Rodbell Auditorium, Rall Building at the
[[Page 65614]]
National Institute of Environmental Health Sciences, 111 T.W. Alexander
Drive, Research Triangle Park, NC 27709. The meeting will begin each
day at 8:30 a.m. The meeting is open to the public with attendance
limited only by the space available (see ``Attendance, Registration, and Remote Access'' below).
Agenda
The primary agenda topic is the peer review by the TRR Subcommittee
of the findings and conclusions of seven draft NTP Technical Reports
(TR) of rodent toxicology and carcinogenesis studies conducted by the
NTP (see Preliminary Agenda below). There will also be a presentation
on how the NTP handles contaminants in study materials and their impact
on the interpretation of 2year bioassays. In addition, at the request
of the NTP Board of Scientific Counselors, the TRR Subcommittee will
readdress the title of the Draft NTP Technical Report on Anthraquinone
(see minutes from the NTP Board of Scientific Counselors meeting held
June 29, 2004, available at http://ntpserver.niehs.nih.gov/ntpweb/index.cfm?objectid=720164E3BDB7CEBAF338FA2626639D56 ). As an
introduction to the reports on the studies of polychlorinated biphenyl
(PCB), a short presentation will be given on the use of Toxic
Equivalency Factors (TEFs). The TEF methodology was developed as a
mathematical tool that ranks the dioxinlike activity of a compound
relative to 2,3,7,8tetrachlorodibenzopdioxin (TCDD), the most potent
dioxin. This methodology has been applied to the NTP studies reported
in TR 531: Mixture of 3,3',4,4',5Pentachlorobiphenyl (PCB 126) and
2,3',4,4',5Pentachlorobiphenyl (PCB 118), TR 529: 2,2',4,4',5,5'
Hexachlorobiphenyl (PCB 153), and TR 530: Mixture of PCB 126 and PCB 153.
A copy of the agenda, TRR Subcommittee roster, and the draft NTP
Technical Reports, as available, will be posted on the NTP Web site
(http://ntpserver.niehs.nih.gov/ under Latest News) and will be
available upon request to the NTP Executive Secretary, Dr. Barbara S.
Shane (PO Box 12233, 111 T.W. Alexander Dr., MD A301, Research
Triangle Park, NC 27709, T: 9195414253; F: 9195410295; email:
shane@niehs.nih.gov). Following the meeting, summary minutes will be
available on the TRR Subcommittee Web site (see http://ntpserver.niehs.nih.gov/ntpweb/index.cfm?objectid=227FC084=EB0C7E939DCD6F03104F0D22 ) and in hard copy upon request to the NTP Executive
Secretary.
Draft Reports Available for Public Review and Comment
Approximately four weeks prior to the meeting, the draft reports
will be available for public review, through the NTP Web page (http://ntpserver.niehs.nih.gov/ under Latest News). Printed copies of the
Draft NTP Technical Reports can be obtained, as available, from Central
Data Management (NIEHS, PO Box 12233, MD EC03, Research Triangle Park,
NC 27709, T: 9195413419, F: 9195413687, email: CDM@niehs.nih.gov). Attendance, Registration and Remote Access
The meeting is open to the public with attendance limited only by
the space available. Individuals who plan to attend are strongly
encouraged to register with the NTP Executive Secretary by December 2,
2004 to ensure easy access to the NIEHS campus (contact information
above) or online on the NTP Web site (http://ntp.niehs.nih.gov under
Latest News). Please note that a photo ID is required to access the
NIEHS campus. Persons needing special assistance, such as sign language
interpretation or other reasonable accommodation in order to attend are
asked to notify the NTP Executive Secretary at least seven business
days in advance of the meeting. The NTP is also making plans to
videocast the TRR Subcommittee meeting through the Internet at http://www.niehs.nih.gov/external/video.htm. The NTP cannot guarantee the
technical quality of the video casting and people wishing to use this
option are encouraged to test their ability to access the video cast at
the above Internet address under Check your live video setup. Public Comment
Comments on any of the Draft NTP Technical Reports are welcome. Time will be provided at the meeting for oral public comment on the reports. Persons requesting time for an oral presentation on a particular report are asked to notify the NTP Executive Secretary (contact information given above) by December 2, 2004, and to provide their contact information (name, affiliation, mailing address, phone, fax, email), and supporting organization (if any). Persons registering to make comments are asked to provide a written copy of their statement to the NTP Executive Secretary on or before December 2, 2004, to enable review by the TRR Subcommittee and NTP staff prior to the meeting. These statements can supplement or expand an oral presentation. Each speaker will be allotted at least 7 minutes and, if time permits, up 10 minutes for presentation of oral comments. Each organization is allowed one time slot per report being reviewed. Registration for making public comments will also be available onsite. If registering onsite to speak and reading comments from printed text, the speaker is asked to provide 25 copies of the statement for distribution to the Subcommittee and NTP staff, and to supplement the record.
Written comments without an oral presentation at the meeting are also welcome. Comments should include contact information for the submitter (name, affiliation, mailing address, phone, fax, and email) and supporting organization (if any). Written comments should be received by the NTP Executive Secretary on or before December 2, 2004, to enable distribution to the Subcommittee and NTP staff for their review and consideration prior to the meeting. Written comments received in response to this notice will be posted on the NTP Web site (http://ntp.niehs.nih.gov under Latest News). Request for Additional Information
The NTP would welcome receiving toxicology and carcinogenesis information from completed, ongoing or planned studies as well as current production data, human exposure information, and use patterns for any of the chemicals listed in this announcement. Please send this information to Central Data Management at the address given above and it will be forwarded to the appropriate NTP staff.
NTP Technical and Toxicity Report Series
The NTP conducts toxicology and carcinogenesis studies of agents of
public health concern. Any scientist, organization, or member of the
public may nominate a chemical for NTP testing. Details about the
nomination process are available on the NTP Web site (http://ntp.niehs.nih.gov under Nominations to the Testing Program). The
results of shortterm rodent toxicology studies are published in the
NTP Toxicity Report series. Longerterm studies, generally, rodent
carcinogenicity studies, are published in the NTP Technical Report
series. The NTP has a new technical report series for studies conducted
in genetically modified models. PDF files of completed reports are
available freeofcharge at the NTP Web site (http://ntpserver.niehs.nih.gov/index.cfm?objectid=084801F0F43F7B740BE549908B5E5C1C ).
[[Page 65615]]
NTP Board of Scientific Counselors
The NTP Board of Scientific Counselors (``the Board'') is a technical advisory body composed of scientists from the public and private sectors who provide primary scientific oversight and peer review to the NTP. Specifically, the Board advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purpose of determining and advising on the scientific merit of its activities and overall scientific quality. The TRR Subcommittee of the Board provides scientific peer review of the findings and conclusions of NTP Technical Reports. The Report on Carcinogens Subcommittee of the Board provides scientific peer review of nominations to the Report on Carcinogens, a Congressionally mandated listing of agents known or reasonably anticipated to be human carcinogens.
The Board's members are selected from recognized authorities
knowledgeable in fields, such as toxicology, pharmacology, pathology,
biochemistry, epidemiology, risk assessment, carcinogenesis,
mutagenesis, molecular biology, behavioral toxicology, neurotoxicology,
immunotoxicology, reproductive toxicology or teratology, and
biostatistics. The NTP strives for equitable geographic distribution and for minority and female representation on the Board.
Dated: November 5, 2004.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences. Preliminary Agenda
National Toxicology Program (NTP) Technical Reports (TR) Scheduled for
Review by the NTP Board of Scientific Counselors Technical Reports Review Subcommittee
December 910, 2004
Rodbell Auditorium, National Institute of Environmental Health
Sciences, 111 TW Alexander Drive, Research Triangle Park, NC. 1. Overview of Dioxin Toxic Equivalency Factors (TEFs).
2. TR 531: Mixture of 3,3',4,4',5Pentachlorobiphenyl (PCB 126) and
2,3',4,4',5Pentachlorobiphenyl (PCB 118) (CAS Nos. 57465288 and 31508006, respectively).
3. TR 529: 2,2',4,4',5,5'Hexachlorobiphenyl (PCB 153) (CAS No. 35065 271).
4. TR 530: Mixture of PCB 126 and PCB 153 (CAS No: 57465288 and 835065271, respectively).
5. Discussion on Contaminants in NTP Study Materials: Impact on Interpretation of 2year Bioassays.
6. TR 517: Sodium Chlorate (CAS No. 7775099).
8. TR 522: 3'Azido3'thymidine (AZT) (CAS No. 30516871).
9. TR 533: Benzophenone (CAS No. 119619).
BILLING CODE 414001P