National Toxicology Program (NTP); Report on Carcinogens (RoC); Availability of the Draft Background Documents for Aristolochic Acid Related Exposures (Two Candidate Substances: Botanical Products Containing Aristolochic Acid and Aristolochic Acid) and Riddelliine and Request for Public Comment on the Draft Background Documents; Announcement of the Aristolochic Acid Related Exposures and Riddelliine Expert Panel Meeting, 63900-63901 [E7-22178]
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rfrederick on PROD1PC67 with NOTICES
63900
Federal Register / Vol. 72, No. 218 / Tuesday, November 13, 2007 / Notices
Chronic Fatigue Syndrome Advisory
Committee (CFSAC) will hold a
meeting. The meeting will be open to
the public.
DATES: The meeting will be held on
Wednesday, November 28, 2007 and
Thursday, November 29, 2007. The
meeting will be held from 9 a.m. to
approximately 5 p.m. on both days.
ADDRESSES: Department of Health and
Human Services; Room 800 Hubert H.
Humphrey Building; 200 Independence
Avenue, SW; Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Dr.
Anand K. Parekh, Executive Secretary,
Chronic Fatigue Syndrome Advisory
Committee; Department of Health and
Human Services; 200 Independence
Avenue, SW., Room 727H; Washington,
DC 20201; (202) 260–2873.
SUPPLEMENTARY INFORMATION: CFSAC
was established on September 5, 2002.
The Committee was established to
advise, consult with, and make
recommendations to the Secretary,
through the Assistant Secretary for
Health, on a broad range of topics
including (1) The current state of
knowledge and research about the
epidemiology and risk factors relating to
chronic fatigue syndrome, and
identifying potential opportunities in
these areas; (2) current and proposed
diagnosis and treatment methods for
chronic fatigue syndrome; and (3)
development and implementation of
programs to inform the public, health
care professionals, and the biomedical,
academic, and research communities
about chronic fatigue syndrome
advances.
The agenda for this meeting is being
developed. The agenda will be posted
on the CFSAC Web site, https://
www.hhs.gov/advcomcfs, when it is
finalized.
Public attendance at the meeting is
limited to space available. Individuals
must provide a photo ID for entry into
the building where the meeting is
scheduled to be held. Individuals who
plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
designated contact person. Members of
the public will have the opportunity to
provide comments at the meeting.
Individuals who wish to address the
Committee during the public comment
session must pre-register by November
26, 2007. Any individual who wishes to
participate in the public comment
session should call the telephone
number listed in the contact information
to register. Public comment will be
limited to five minutes per speaker.
Members of the public who wish to
VerDate Aug<31>2005
15:30 Nov 09, 2007
Jkt 214001
have printed material distributed to
CFSAC members for discuss should
submit, at a minimum, one copy of the
material to the Executive Secretary,
CFSAC prior to close of business on
November 26, 2007. Contact information
for the Executive Secretary, CFSAC is
listed above.
Dated: November 6, 2007.
Anand K. Parekh,
Executive Secretary, Chronic Fatigue
Syndrome Advisory Committee.
[FR Doc. E7–22100 Filed 11–9–07; 8:45 am]
BILLING CODE 4150–42–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
Report on Carcinogens (RoC);
Availability of the Draft Background
Documents for Aristolochic Acid
Related Exposures (Two Candidate
Substances: Botanical Products
Containing Aristolochic Acid and
Aristolochic Acid) and Riddelliine and
Request for Public Comment on the
Draft Background Documents;
Announcement of the Aristolochic
Acid Related Exposures and
Riddelliine Expert Panel Meeting
National Institute of
Environmental Health Sciences
(NIEHS); National Institutes of Health
(NIH), Department of Health and Human
Services (HHS).
ACTION: Request for public comments
and meeting announcement.
AGENCY:
SUMMARY: The NTP announces the
availability of the draft background
documents for (1) aristolochic acid
related exposures (the background
document describes information on two
candidate substances: Botanical
products containing aristolochic acid
and aristolochic acid) and (2) riddelliine
on November 13, 2007, on the RoC Web
site (https://ntp.niehs.nih.gov/go/10091
see aristolochic acid related exposures
or riddelliine) or in printed text from
the RoC (see FOR FURTHER INFORMATION
CONTACT below). The NTP invites the
submission of public comments on the
two draft background documents (see
SUPPLEMENTARY INFORMATION below).
The expert panel will meet on January
24–25, 2008, at the Chapel Hill Sheraton
Hotel, One Europa Drive, Chapel Hill,
North Carolina 27514, to peer review
the draft background documents for
aristolochic acid related exposures and
riddelliine and, once completed, make a
recommendation regarding the listing
status (i.e., known to be a human
carcinogen, reasonably anticipated to be
a human carcinogen, or not to list) for
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
botanical products containing
aristolochic acid, for aristolochic acid,
and for riddelliine in the 12th Edition
of the RoC (12th RoC). The RoC expert
panel meeting is open to the public with
time scheduled for oral public
comments. Attendance is limited only
by the available meeting room space.
Following the expert panel meeting and
completion of the expert panel report,
the NTP will post the final version of
the background documents and the
expert panel peer review reports on the
RoC Web site.
DATES: The expert panel meeting for
aristolochic acid related exposures and
riddelliine will be held on January 24–
25, 2008. The draft background
documents for these substances will be
available for public comment on
November 13, 2007. The deadline to
submit written comments is January 11,
2008, and the deadline for preregistration to attend the meeting and
provide oral comments at the meeting is
January 18, 2008. Persons needing
special assistance, such as sign language
interpretation or other reasonable
accommodations in order to attend,
should contact 919–541–2475 (voice),
919–541–4644 TTY (text telephone),
through the Federal TTY Relay System
at 800–877–8339, or by e-mail to
niehsoeeo@niehs.nih.gov. Requests
should be made at least seven business
days in advance of the event.
ADDRESSES: The RoC expert panel
meeting on aristolochic acid related
exposures and riddelliine will be held at
the Chapel Hill Sheraton Hotel, One
Europa Drive, Chapel Hill, North
Carolina 27514. Access to on-line
registration and materials for the
meeting is available on the RoC Web site
(https://ntp.niehs.nih.gov/go/29679).
Comments on the draft background
documents should be sent to Dr. C. W.
Jameson, RoC Director, NIEHS, P.O. Box
12233, MD EC–14, Research Triangle
Park, NC 27709, Fax: (919) 541–0144, or
jameson@niehs.nih.gov. Courier
address: Report on Carcinogens, 79 T.W.
Alexander Drive, Building 4401, Room
3118, Research Triangle Park, NC 27709.
FOR FURTHER INFORMATION CONTACT: Dr.
C. W. Jameson, RoC Director, 919–541–
4096, jameson@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
On April 16, 2007 (72 FR 18999
available at https://ntp.niehs.nih.gov/go/
9732), the NTP announced the RoC
review process for the 12th RoC. An
expert panel meeting is being convened
on January 24–25, 2008, to review three
candidate substances (botanical
products containing aristolochic acid,
E:\FR\FM\13NON1.SGM
13NON1
Federal Register / Vol. 72, No. 218 / Tuesday, November 13, 2007 / Notices
rfrederick on PROD1PC67 with NOTICES
aristolochic acid, and riddelliine) under
consideration for possible listing in the
12th RoC. The available scientific and
exposure information on botanical
products containing aristolochic acid
and aristolochic acid overlap is
described in one background document
(aristolochic acid related exposures);
however, the expert panel will be asked
to make separate recommendations for
listing status for each candidate
substance. The draft background
documents for aristolochic acid related
exposures and riddelliine will be
available on the RoC Web site on
November 13, 2007, or in printed text
from the RoC Director (see ADDRESSES
above). Persons can register free-ofcharge with the NTP listserv to receive
notification when draft RoC background
documents for other candidate
substances for the 12th RoC are made
available on the RoC Web site (https://
ntp.niehs.nih.gov/go/231).
Botanical products containing
aristolochic acid are used in traditional
folk medicines, particularly in Chinese
herbal medicine and have been used
inadvertently as part of a weight-loss
regimen. Aristolochic acid is a generic
name for a family of nitrophenanthrene
carboxylic acids that occurs naturally in
plants in the Aristolochiaceae family,
primarily of the genera Aristolochia and
Asarum. Riddelliine is a pyrrolizidine
alkaloid that occurs in plants of the
genus Senecio that are found in sandy
desert areas of the western United States
and other parts of the world. Humans
may be exposed to riddelliine via direct
contamination of foodstuffs by parts of
Senecio plants or from indirect
introduction of the alkaloid through
products derived from animals that have
fed on the plants. Pyrrolizidine alkaloid
residues have been detected in honey.
Request for Comments
The NTP invites written public
comments on the draft background
documents on aristolochic acid related
exposures and riddelliine. All
comments received will be posted on
the RoC Web site prior to the meeting
and distributed to the expert panel and
RoC staff for their consideration in the
peer review of the draft background
documents and/or preparing for the
expert panel meeting. Persons
submitting written comments are asked
to include their name and contact
information (affiliation, mailing address,
telephone and facsimile numbers, email, and sponsoring organization, if
any) and send them to Dr. Jameson (see
ADDRESSES above) for receipt by January
11, 2008. Time is set-aside on January
24–25, 2008, for the presentation of oral
public comments at the expert panel
VerDate Aug<31>2005
16:59 Nov 09, 2007
Jkt 214001
meeting. Seven minutes will be
available for each speaker (one speaker
per organization). Persons can register
on-line to present oral comments or
contact Dr. Jameson (see ADDRESSES
above). When registering to comment
orally, please provide your name,
affiliation, mailing address, telephone
and facsimile numbers, e-mail and
sponsoring organization (if any). If
possible, send a copy of the statement
or talking points to Dr. Jameson by
January 18, 2008. This statement will be
provided to the expert panel to assist
them in identifying issues for discussion
and will be noted in the meeting record.
Registration for presentation of oral
comments will also be available at the
meeting on January 24–25, 2008, from
7:30–8:30 a.m. Persons registering at the
meeting are asked to bring 25 copies of
their statement or talking points for
distribution to the expert panel and for
the record.
Preliminary Agenda, Availability of
Meeting Topics and Registration
Preliminary agenda topics include:
• Oral public comments on
aristolochic acid related exposures.
• Peer review of the background
document on aristolochic acid related
exposures.
• Recommendation for listing status
in the 12th RoC for botanical products
containing aristolochic acid and for
aristolochic acid.
• Oral public comments on
riddelliine.
• Peer review of the background
document on riddelliine.
• Recommendation for listing status
in the 12th RoC for riddelliine.
The meeting is scheduled for January
24–25, 2008, from 8:30 a.m. to
adjournment each day. The review of
riddelliine will immediately follow the
review of aristolochic acid related
exposures. A copy of the preliminary
agenda, expert panel roster, and any
additional information, when available,
will be posted on the RoC Web site or
may be requested from the RoC Director
(see ADDRESSES above). Individuals who
plan to attend the meeting are
encouraged to register on-line by
January 18, 2008, to facilitate planning
for the meeting.
Background Information on the RoC
The RoC is a congressionally
mandated document that identifies and
discusses agents, substances, mixtures,
or exposure circumstances (collectively
referred to as ‘‘substances’’) that may
pose a hazard to human health by virtue
of their carcinogenicity. Substances are
listed in the report as either known or
reasonably anticipated human
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
63901
carcinogens. The NTP prepares the RoC
on behalf of the Secretary of Health and
Human Services. Information about the
RoC and the nomination process can be
obtained from its homepage (https://
ntp.niehs.nih.gov/go/roc) or by
contacting Dr. Jameson (see FOR FURTHER
INFORMATION CONTACT above). The NTP
follows a formal, multi-step process for
review and evaluation of selected
chemicals. The formal evaluation
process is available on the RoC Web site
(https://ntp.niehs.nih.gov/go/15208) or in
printed copy from the RoC Director.
Dated: October 30, 2007.
Samuel H. Wilson,
Acting Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E7–22178 Filed 11–9–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Meetings of the Advisory Committee
for Injury Prevention and Control, and
Its Subcommittee, the Science and
Program Review Subcommittee
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following subcommittee
and committee meetings.
Name: Science and Program Review
Subcommittee (SPRS).
Time and Date: 8:30 a.m.–12 p.m.,
December 11, 2007.
Place: CDC, Global Communications
Center, 1600 Clifton Road, NE., Bldg. 19,
Room 117, Atlanta, GA 30333.
Purpose: The Science and Program Review
Subcommittee (SPRS) provides advice on the
needs, structure, progress and performance of
programs of the National Center for Injury
Prevention and Control (NCIPC).
Matters to be Discussed: The subcommittee
will meet December 11, 2007, to discuss
scientific matters, including but not limited
to, the FY07 extramural research awards, the
research portfolio reviews, and revisions to
the Injury Research Agenda.
Agenda items are subject to change as
priorities dictate.
Name: Advisory Committee for Injury
Prevention and Control.
Times and Dates:
1 p.m.–5:30 p.m., December 11, 2007.
8:30 a.m.–12 p.m., December 12, 2007.
Place: CDC, Global Communications
Center, 1600 Clifton Road, NE, Bldg. 19,
Room B3, Atlanta, GA 30333.
Purpose: The committee advises and makes
recommendations to the Secretary,
Department of Health and Human Services,
the Director, Centers for Disease Control and
E:\FR\FM\13NON1.SGM
13NON1
]]>Agencies
[Federal Register Volume 72, Number 218 (Tuesday, November 13, 2007)]
[Notices]
[Pages 63900-63901]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22178]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); Report on Carcinogens (RoC);
Availability of the Draft Background Documents for Aristolochic Acid
Related Exposures (Two Candidate Substances: Botanical Products
Containing Aristolochic Acid and Aristolochic Acid) and Riddelliine and
Request for Public Comment on the Draft Background Documents;
Announcement of the Aristolochic Acid Related Exposures and Riddelliine
Expert Panel Meeting
AGENCY: National Institute of Environmental Health Sciences (NIEHS);
National Institutes of Health (NIH), Department of Health and Human
Services (HHS).
ACTION: Request for public comments and meeting announcement.
-----------------------------------------------------------------------
SUMMARY: The NTP announces the availability of the draft background
documents for (1) aristolochic acid related exposures (the background
document describes information on two candidate substances: Botanical
products containing aristolochic acid and aristolochic acid) and (2)
riddelliine on November 13, 2007, on the RoC Web site (https://
ntp.niehs.nih.gov/go/10091 see aristolochic acid related exposures or
riddelliine) or in printed text from the RoC (see FOR FURTHER
INFORMATION CONTACT below). The NTP invites the submission of public
comments on the two draft background documents (see SUPPLEMENTARY
INFORMATION below). The expert panel will meet on January 24-25, 2008,
at the Chapel Hill Sheraton Hotel, One Europa Drive, Chapel Hill, North
Carolina 27514, to peer review the draft background documents for
aristolochic acid related exposures and riddelliine and, once
completed, make a recommendation regarding the listing status (i.e.,
known to be a human carcinogen, reasonably anticipated to be a human
carcinogen, or not to list) for botanical products containing
aristolochic acid, for aristolochic acid, and for riddelliine in the
12th Edition of the RoC (12th RoC). The RoC expert panel meeting is
open to the public with time scheduled for oral public comments.
Attendance is limited only by the available meeting room space.
Following the expert panel meeting and completion of the expert panel
report, the NTP will post the final version of the background documents
and the expert panel peer review reports on the RoC Web site.
DATES: The expert panel meeting for aristolochic acid related exposures
and riddelliine will be held on January 24-25, 2008. The draft
background documents for these substances will be available for public
comment on November 13, 2007. The deadline to submit written comments
is January 11, 2008, and the deadline for pre-registration to attend
the meeting and provide oral comments at the meeting is January 18,
2008. Persons needing special assistance, such as sign language
interpretation or other reasonable accommodations in order to attend,
should contact 919-541-2475 (voice), 919-541-4644 TTY (text telephone),
through the Federal TTY Relay System at 800-877-8339, or by e-mail to
niehsoeeo@niehs.nih.gov. Requests should be made at least seven
business days in advance of the event.
ADDRESSES: The RoC expert panel meeting on aristolochic acid related
exposures and riddelliine will be held at the Chapel Hill Sheraton
Hotel, One Europa Drive, Chapel Hill, North Carolina 27514. Access to
on-line registration and materials for the meeting is available on the
RoC Web site (https://ntp.niehs.nih.gov/go/29679). Comments on the draft
background documents should be sent to Dr. C. W. Jameson, RoC Director,
NIEHS, P.O. Box 12233, MD EC-14, Research Triangle Park, NC 27709, Fax:
(919) 541-0144, or jameson@niehs.nih.gov. Courier address: Report on
Carcinogens, 79 T.W. Alexander Drive, Building 4401, Room 3118,
Research Triangle Park, NC 27709.
FOR FURTHER INFORMATION CONTACT: Dr. C. W. Jameson, RoC Director, 919-
541-4096, jameson@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
On April 16, 2007 (72 FR 18999 available at https://
ntp.niehs.nih.gov/go/9732), the NTP announced the RoC review process
for the 12th RoC. An expert panel meeting is being convened on January
24-25, 2008, to review three candidate substances (botanical products
containing aristolochic acid,
[[Page 63901]]
aristolochic acid, and riddelliine) under consideration for possible
listing in the 12th RoC. The available scientific and exposure
information on botanical products containing aristolochic acid and
aristolochic acid overlap is described in one background document
(aristolochic acid related exposures); however, the expert panel will
be asked to make separate recommendations for listing status for each
candidate substance. The draft background documents for aristolochic
acid related exposures and riddelliine will be available on the RoC Web
site on November 13, 2007, or in printed text from the RoC Director
(see ADDRESSES above). Persons can register free-of-charge with the NTP
listserv to receive notification when draft RoC background documents
for other candidate substances for the 12th RoC are made available on
the RoC Web site (https://ntp.niehs.nih.gov/go/231).
Botanical products containing aristolochic acid are used in
traditional folk medicines, particularly in Chinese herbal medicine and
have been used inadvertently as part of a weight-loss regimen.
Aristolochic acid is a generic name for a family of nitrophenanthrene
carboxylic acids that occurs naturally in plants in the
Aristolochiaceae family, primarily of the genera Aristolochia and
Asarum. Riddelliine is a pyrrolizidine alkaloid that occurs in plants
of the genus Senecio that are found in sandy desert areas of the
western United States and other parts of the world. Humans may be
exposed to riddelliine via direct contamination of foodstuffs by parts
of Senecio plants or from indirect introduction of the alkaloid through
products derived from animals that have fed on the plants.
Pyrrolizidine alkaloid residues have been detected in honey.
Request for Comments
The NTP invites written public comments on the draft background
documents on aristolochic acid related exposures and riddelliine. All
comments received will be posted on the RoC Web site prior to the
meeting and distributed to the expert panel and RoC staff for their
consideration in the peer review of the draft background documents and/
or preparing for the expert panel meeting. Persons submitting written
comments are asked to include their name and contact information
(affiliation, mailing address, telephone and facsimile numbers, e-mail,
and sponsoring organization, if any) and send them to Dr. Jameson (see
ADDRESSES above) for receipt by January 11, 2008. Time is set-aside on
January 24-25, 2008, for the presentation of oral public comments at
the expert panel meeting. Seven minutes will be available for each
speaker (one speaker per organization). Persons can register on-line to
present oral comments or contact Dr. Jameson (see ADDRESSES above).
When registering to comment orally, please provide your name,
affiliation, mailing address, telephone and facsimile numbers, e-mail
and sponsoring organization (if any). If possible, send a copy of the
statement or talking points to Dr. Jameson by January 18, 2008. This
statement will be provided to the expert panel to assist them in
identifying issues for discussion and will be noted in the meeting
record. Registration for presentation of oral comments will also be
available at the meeting on January 24-25, 2008, from 7:30-8:30 a.m.
Persons registering at the meeting are asked to bring 25 copies of
their statement or talking points for distribution to the expert panel
and for the record.
Preliminary Agenda, Availability of Meeting Topics and Registration
Preliminary agenda topics include:
Oral public comments on aristolochic acid related
exposures.
Peer review of the background document on aristolochic
acid related exposures.
Recommendation for listing status in the 12th RoC for
botanical products containing aristolochic acid and for aristolochic
acid.
Oral public comments on riddelliine.
Peer review of the background document on riddelliine.
Recommendation for listing status in the 12th RoC for
riddelliine.
The meeting is scheduled for January 24-25, 2008, from 8:30 a.m. to
adjournment each day. The review of riddelliine will immediately follow
the review of aristolochic acid related exposures. A copy of the
preliminary agenda, expert panel roster, and any additional
information, when available, will be posted on the RoC Web site or may
be requested from the RoC Director (see ADDRESSES above). Individuals
who plan to attend the meeting are encouraged to register on-line by
January 18, 2008, to facilitate planning for the meeting.
Background Information on the RoC
The RoC is a congressionally mandated document that identifies and
discusses agents, substances, mixtures, or exposure circumstances
(collectively referred to as ``substances'') that may pose a hazard to
human health by virtue of their carcinogenicity. Substances are listed
in the report as either known or reasonably anticipated human
carcinogens. The NTP prepares the RoC on behalf of the Secretary of
Health and Human Services. Information about the RoC and the nomination
process can be obtained from its homepage (https://ntp.niehs.nih.gov/go/
roc) or by contacting Dr. Jameson (see FOR FURTHER INFORMATION CONTACT
above). The NTP follows a formal, multi-step process for review and
evaluation of selected chemicals. The formal evaluation process is
available on the RoC Web site (https://ntp.niehs.nih.gov/go/15208) or in
printed copy from the RoC Director.
Dated: October 30, 2007.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E7-22178 Filed 11-9-07; 8:45 am]
BILLING CODE 4140-01-P
