Development of Set 24 Toxicological Profiles, 54889 [2010-22439]
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Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–22394 Filed 9–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[ATSDR–265]
Development of Set 24 Toxicological
Profiles
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (DHHS).
ACTION: Notice.
AGENCY:
Profiles will be available to the
public on or about October 17, 2010.
SUMMARY: The Agency for Toxic
Substances and Disease Registry
(ATSDR) of the Department of Health
and Human Services is developing Set
24 Toxicological Profiles. Set 24
Toxicological Profiles consists of one
new draft and one updated draft.
Electronic access to these documents
will be available at the ATSDR Web site:
https://www.atsdr.cdc.gov/toxpro2.html.
DATES:
Set 24 Toxicological Profiles
The following toxicological profiles
are now being developed:
Toxicological profile
Toxaphene ............................
Trichlorobenzene*
1,2,3–Trichlorobenzene
1,2,4–Trichlorobenzene
1,3,5–Trichlorobenzene
Trichlorobenzene ....
FOR FURTHER INFORMATION CONTACT:
Commander Jessilynn B. Taylor,
Division of Toxicology and
Environmental Medicine, Agency for
CAS number
Toxic Substances and Disease Registry,
8001–35–2 1600 Clifton Road, NE., Mail Stop F–62,
Atlanta, GA 30333; telephone (770)
87–61–6 488–3313; e-mail: JBTaylor@cdc.gov.
120–82–1
108–70–3
12002–48–1
* Denotes new profile.
The
Superfund Amendments and
Reauthorization Act of 1986 (42 U.S.C.
9601 et seq.) amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA) (42 U.S.C. 9601
et seq.) by establishing certain
requirements for ATSDR and the U.S.
Environmental Protection Agency (EPA)
mstockstill on DSKH9S0YB1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
17:24 Sep 08, 2010
with regard to hazardous substances
that are most commonly found at
facilities on the CERCLA National
Priorities List. Among these statutory
requirements is a mandate for the
Administrator of ATSDR to prepare
toxicological profiles for each substance
included on the Priority List of
Hazardous Substances (https://
www.atsdr.cdc.gov/cercla/07list.html).
This list names 275 hazardous
substances that pose the most
significant potential threat to human
health as determined by ATSDR and
EPA. The availability of the revised list
of the 275 priority substances was
announced in the Federal Register on
March 6, 2008 (73 FR 12178). For prior
versions of the list of substances, see
Federal Register notices dated April 17,
1987 (52 FR 12866); October 20, 1988
(53 FR 41280); October 26, 1989 (54 FR
43619); October 17, 1990 (55 FR 42067);
October 17, 1991 (56 FR 52166); October
28, 1992 (57 FR 48801); February 28,
1994 (59 FR 9486); April 29, 1996 (61
FR 18744; November 17, 1997 (62 FR
61332); October 21, 1999 (64 FR 56792);
October 25, 2001 (66 FR 54014);
November 7, 2003 (68 FR 63098); and
December 7, 2005 (70FR 70284).
Notice of the availability of drafts of
one updated and one new toxicological
profile for public review and comment
will be published in the Federal
Register on or about October 17, 2010,
with notice of a 90-day public comment
period for each profile, starting from the
actual release date. Following the close
of the comment period, chemicalspecific comments will be addressed,
and where appropriate, revisions will be
incorporated into each profile.
Jkt 220001
Dated: September 3, 2010.
Ken Rose,
Associate Director, Office of Policy, Planning
and Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2010–22439 Filed 9–8–10; 8:45 am]
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54889
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0451]
Draft Guidance for Industry on
Suicidality: Prospective Assessment of
Occurrence in Clinical Trials;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Suicidality:
Prospective Assessment of Occurrence
in Clinical Trials.’’ The purpose of this
guidance is to assist sponsors in
prospectively assessing the occurrence
of treatment-emergent suicidality in
clinical trials of drug and biological
products. Specifically, this guidance
addresses FDA’s current thinking
regarding the importance of suicidality
assessment in psychiatric and
nonpsychiatric drug trials and the
general principles for how best to
accomplish this assessment during drug
development.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 8,
2010.
SUMMARY:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Thomas Laughren, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4114,
Silver Spring, MD 20993–0002, 301–
796–2260.
ADDRESSES:
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 75, Number 174 (Thursday, September 9, 2010)]
[Notices]
[Page 54889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22439]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[ATSDR-265]
Development of Set 24 Toxicological Profiles
AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR),
Department of Health and Human Services (DHHS).
ACTION: Notice.
-----------------------------------------------------------------------
DATES: Profiles will be available to the public on or about October 17,
2010.
SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR)
of the Department of Health and Human Services is developing Set 24
Toxicological Profiles. Set 24 Toxicological Profiles consists of one
new draft and one updated draft. Electronic access to these documents
will be available at the ATSDR Web site: https://www.atsdr.cdc.gov/toxpro2.html.
Set 24 Toxicological Profiles
The following toxicological profiles are now being developed:
------------------------------------------------------------------------
Toxicological profile CAS number
------------------------------------------------------------------------
Toxaphene............................................... 8001-35-2
Trichlorobenzene*
1,2,3-Trichlorobenzene.............................. 87-61-6
1,2,4-Trichlorobenzene.............................. 120-82-1
1,3,5-Trichlorobenzene.............................. 108-70-3
Trichlorobenzene................................ 12002-48-1
------------------------------------------------------------------------
* Denotes new profile.
SUPPLEMENTARY INFORMATION: The Superfund Amendments and Reauthorization
Act of 1986 (42 U.S.C. 9601 et seq.) amended the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980
(CERCLA) (42 U.S.C. 9601 et seq.) by establishing certain requirements
for ATSDR and the U.S. Environmental Protection Agency (EPA) with
regard to hazardous substances that are most commonly found at
facilities on the CERCLA National Priorities List. Among these
statutory requirements is a mandate for the Administrator of ATSDR to
prepare toxicological profiles for each substance included on the
Priority List of Hazardous Substances (https://www.atsdr.cdc.gov/cercla/07list.html). This list names 275 hazardous substances that pose the
most significant potential threat to human health as determined by
ATSDR and EPA. The availability of the revised list of the 275 priority
substances was announced in the Federal Register on March 6, 2008 (73
FR 12178). For prior versions of the list of substances, see Federal
Register notices dated April 17, 1987 (52 FR 12866); October 20, 1988
(53 FR 41280); October 26, 1989 (54 FR 43619); October 17, 1990 (55 FR
42067); October 17, 1991 (56 FR 52166); October 28, 1992 (57 FR 48801);
February 28, 1994 (59 FR 9486); April 29, 1996 (61 FR 18744; November
17, 1997 (62 FR 61332); October 21, 1999 (64 FR 56792); October 25,
2001 (66 FR 54014); November 7, 2003 (68 FR 63098); and December 7,
2005 (70FR 70284).
Notice of the availability of drafts of one updated and one new
toxicological profile for public review and comment will be published
in the Federal Register on or about October 17, 2010, with notice of a
90-day public comment period for each profile, starting from the actual
release date. Following the close of the comment period, chemical-
specific comments will be addressed, and where appropriate, revisions
will be incorporated into each profile.
FOR FURTHER INFORMATION CONTACT: Commander Jessilynn B. Taylor,
Division of Toxicology and Environmental Medicine, Agency for Toxic
Substances and Disease Registry, 1600 Clifton Road, NE., Mail Stop F-
62, Atlanta, GA 30333; telephone (770) 488-3313; e-mail:
JBTaylor@cdc.gov.
Dated: September 3, 2010.
Ken Rose,
Associate Director, Office of Policy, Planning and Evaluation, National
Center for Environmental Health/Agency for Toxic Substances and Disease
Registry.
[FR Doc. 2010-22439 Filed 9-8-10; 8:45 am]
BILLING CODE 4163-70-P
