Advisory Council for the Elimination of Tuberculosis (ACET), 7870-7871 [2015-02887]
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Federal Register / Vol. 80, No. 29 / Thursday, February 12, 2015 / Notices
Consumer/Patient Representative
Health Plans Representative
Provider Representative (2)
Research Representative
Technical Expertise, Health Exchange
Technical Expertise, Long-Term Care
Technical Expertise, Privacy
Technology Vendor
For more information about the
HITSC please visit: https://healthit.gov/
facas/health-it-standards-committee
Submitting Nominations:
Nominations should be submitted
electronically through the application
database at: https://healthit.gov/facas/
faca-workgroup-membershipapplication . All nominations must be
compiled and submitted in one
complete package. A nomination
package must include: A short bio, a
current CV including contact
information and memberships with
professional organizations/advisory
committees, and two letters of support.
Dated: February 4, 2015.
Michelle Consolazio,
FACA Program Lead, Office of Policy, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. 2015–02885 Filed 2–11–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry; Notice of Intent To
Develop Set 28 Toxicological Profiles
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Notice of development.
AGENCY:
This notice announces the
development of Set 28 Toxicological
Profiles. Set 28 Toxicological Profiles
consists of one updated profile and
three new profiles. These profiles will
be available to the public on or about
October 17, 2015. Electronic access to
these documents will be available at the
ATSDR Web site: https://
www.atsdr.cdc.gov/toxprofiles/
index.asp.
FOR FURTHER INFORMATION CONTACT:
Commander Jessilynn B. Taylor,
Division of Toxicology and Human
Health Sciences, Agency for Toxic
Substances and Disease Registry, 1600
Clifton Road NE., Mail Stop F–57,
Atlanta, GA 30333, telephone 770–488–
3313.
SUPPLEMENTARY INFORMATION: The
Superfund Amendments and
Reauthorization Act of 1986 (SARA)
(42 U.S.C. 9601 et seq.) amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA or Superfund)
(42 U.S.C. 9601 et seq.) by establishing
SUMMARY:
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 (NPL). 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
(www.atsdr.cdc.gov/SPL). 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 May 28, 2014 (79
FR 30613). For prior versions of the list
of substances, see Federal Register
notices dated November 3, 2011 (76 FR
68193); March 6, 2008 (73 FR 12178);
December 7, 2005 (70 FR 72840 ;
November 7, 2003 (68 FR 63098);
October 25, 2001 (66 FR 54014); October
21, 1999 (64 FR 56792); November 17,
1997 (62 FR 61332); April 29, 1996 (61
FR 18744); February 28, 1994 (59 FR
9486); October 28, 1992 (57 FR 48801);
October 17, 1991 (56 FR 52166); October
17, 1990 (55 FR 42067); October 26,
1989 (54 FR 43615); October 20, 1988
(53 FR 41280); and April 17, 1987 (52
FR 12866).
Set 28 Toxicological Profiles
The following toxicological profiles
are being developed:
Name
1
2
3
4
..........................................
..........................................
..........................................
..........................................
Antimony (UPDATE) ....................................................................................................................
Glyphosate ...................................................................................................................................
2-4, Dichlorophenoxyacetic acid ..................................................................................................
Silica .............................................................................................................................................
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Notice of the availability of drafts of
these four toxicological profiles for
public review and comment will be
published in the Federal Register on/or
about October 17, 2015, 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, changes will be
incorporated into each profile.
Dated: February 3, 2015.
Sascha Chaney,
Acting Director, Office of Policy Planning and
Evaluation, National Center for
Environmental Health/, Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2015–02548 Filed 2–11–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Council for the Elimination of
Tuberculosis (ACET)
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 meeting of the
aforementioned committee:
Time and Date: 11:00 a.m.–3:30 p.m.,
March 3, 2015.
Place: This meeting will be accessible by
Web conference. Toll-free +1 (877) 951–7311,
Participant Code: 6816256.
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For Participants: URL: https://
www.mymeetings.com/nc/join/, Conference
number: PW1126518, Audience passcode:
6816256.
Participants can join the event directly at:
https://www.mymeetings.com/nc/join.php?i=
PW1126518&p=6816256&t=c.
Status: Open to the public limited only by
web conference. Participation by web
conference is limited by the number of ports
available. The meeting accommodates 100
ports.
Purpose: This council advises and makes
recommendations to the Secretary of Health
and Human Services, the Assistant Secretary
for Health, and the Director, CDC, regarding
the elimination of tuberculosis. Specifically,
the Council makes recommendations
regarding policies, strategies, objectives, and
priorities; addresses the development and
application of new technologies; and reviews
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Federal Register / Vol. 80, No. 29 / Thursday, February 12, 2015 / Notices
the extent to which progress has been made
toward eliminating tuberculosis.
Matters for Discussion: Agenda items
include the following topics: (1) Update on
Global TB Coordination Activities; (2) Profile
of Foreign-Born TB cases; (3) Impact of
funding cuts on TB programs in the field; and
(4) other tuberculosis-related issues.
Agenda items are subject to change as
priorities dictate. Contact Person for More
Information: Margie Scott-Cseh, Centers for
Disease Control and Prevention, 1600 Clifton
Road NE., M/S E–07, Atlanta, Georgia 30333,
telephone (404) 639–8317; Email:
zkr7@cdc.gov
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register Notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2015–02887 Filed 2–11–15; 8:45 am]
Name of committee
Date of
expiration
Oncologic Drugs Advisory
Committee.
Anti-Infective Drugs Advisory
Committee.
Dermatologic and Ophthalmic
Drugs Advisory Committee.
Cellular, Tissue, and Gene
Therapies Advisory Committee.
Technical Electronic Product
Radiation Safety Standards
Committee.
September 1,
2016.
October 7,
2016.
October 7,
2016.
October 28,
2016.
December 24,
2016.
FOR FURTHER INFORMATION CONTACT:
Michael Ortwerth, Director, Advisory
Committee Oversight and Management
Staff, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–443–0572
or 1–800–741–8138. For further
information related to FDA advisory
committees, please visit us at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
Dated: February 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–02909 Filed 2–11–15; 8:45 am]
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Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2015–N–0001]
Advisory Committee Renewals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
renewal of certain FDA advisory
committees by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
charters of the committees listed in the
following table for an additional 2 years
beyond charter expiration date. The new
charters will be in effect until the dates
of expiration listed in the following
table. This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.).
DATES: Authority for these committees
will expire on the dates indicated in the
following table unless the
Commissioner formally determines that
renewal is in the public interest.
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SUMMARY:
Name of committee
Cardio and Renal Drugs Advisory Committee.
Endocrinologic and Metabolic
Drugs Advisory Committee.
VerDate Sep<11>2014
13:54 Feb 11, 2015
Date of
expiration
August 27,
2016.
August 27,
2016.
Jkt 235001
Food and Drug Administration
[Docket No. FDA–2015–D–0152]
Alcoholism: Developing Drugs for
Treatment; Draft Guidance for
Industry; 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 ‘‘Alcoholism:
Developing Drugs for Treatment.’’ The
purpose of this guidance is to assist
sponsors in the development of drugs
for the treatment of alcoholism.
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 April 13, 2015.
ADDRESSES: 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, 10001 New
SUMMARY:
PO 00000
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Hampshire Ave., Hillandale Bldg., 4th
Floor, Silver Spring, MD 20993. 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:
Rachel Skeete, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3191,
Silver Spring, MD 20993–0002, 301–
796–2280.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Alcoholism: Developing Drugs for
Treatment.’’ There is a need for
additional pharmacologic treatments for
alcoholism. Traditionally, alcoholism
treatments have been assessed based on
the number of patients who refrain from
drinking altogether. Patients who attain
and sustain complete abstinence from
alcohol may be assumed to accrue
clinical benefit. However, other patterns
of drinking also may be valid surrogates
for clinical benefit. This guidance
provides supporting information for
endpoints based on patterns of drinking
that may be considered appropriate
measures of clinical benefit.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the development of drugs for the
treatment of alcoholism and appropriate
endpoints for clinical trials of drugs to
treat alcoholism. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
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Agencies
[Federal Register Volume 80, Number 29 (Thursday, February 12, 2015)]
[Notices]
[Pages 7870-7871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02887]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Advisory Council for the Elimination of Tuberculosis (ACET)
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 meeting of the aforementioned
committee:
Time and Date: 11:00 a.m.-3:30 p.m., March 3, 2015.
Place: This meeting will be accessible by Web conference. Toll-
free +1 (877) 951-7311, Participant Code: 6816256.
For Participants: URL: https://www.mymeetings.com/nc/join/,
Conference number: PW1126518, Audience passcode: 6816256.
Participants can join the event directly at: https://www.mymeetings.com/nc/join.php?i=PW1126518&p=6816256&t=c.
Status: Open to the public limited only by web conference.
Participation by web conference is limited by the number of ports
available. The meeting accommodates 100 ports.
Purpose: This council advises and makes recommendations to the
Secretary of Health and Human Services, the Assistant Secretary for
Health, and the Director, CDC, regarding the elimination of
tuberculosis. Specifically, the Council makes recommendations
regarding policies, strategies, objectives, and priorities;
addresses the development and application of new technologies; and
reviews
[[Page 7871]]
the extent to which progress has been made toward eliminating
tuberculosis.
Matters for Discussion: Agenda items include the following
topics: (1) Update on Global TB Coordination Activities; (2) Profile
of Foreign-Born TB cases; (3) Impact of funding cuts on TB programs
in the field; and (4) other tuberculosis-related issues.
Agenda items are subject to change as priorities dictate.
Contact Person for More Information: Margie Scott-Cseh, Centers for
Disease Control and Prevention, 1600 Clifton Road NE., M/S E-07,
Atlanta, Georgia 30333, telephone (404) 639-8317; Email:
zkr7@cdc.gov
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register Notices pertaining
to announcements of meetings and other committee management
activities, for both the Centers for Disease Control and Prevention
and the Agency for Toxic Substances and Disease Registry.
Catherine Ramadei,
Acting Director, Management Analysis and Services Office, Centers for
Disease Control and Prevention.
[FR Doc. 2015-02887 Filed 2-11-15; 8:45 am]
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