Healthcare Infection Control Practices Advisory Committee (HICPAC), 50770-50771 [2010-20302]
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50770
Federal Register / Vol. 75, No. 158 / Tuesday, August 17, 2010 / Notices
Hampshire Ave., Bldg. 22, rm. 5426,
Silver Spring, MD 20993–0002, 301–
796–2090.
Food and Drug Administration
[Docket No. FDA–2010–D–0404]
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for small
business entities entitled ‘‘Organ
Specific Warnings: Internal Analgesic,
Antipyretic, and Antirheumatic Drug
Products for Over-the-Counter Use—
Small Entity Compliance Guide.’’ This
guidance is intended to help small
businesses understand and comply with
FDA’s regulation entitled ‘‘OrganSpecific Warnings: Internal Analgesic,
Antipyretic, and Antirheumatic Drug
Products for Over-the-Counter Use;
Final Monograph’’ (74 FR 19385, April
29, 2009).1 The guidance describes the
organ-specific labeling requirements in
plain language and provides answers to
common questions on how to comply
with the rule. This guidance was
prepared in accordance with the Small
Business Regulatory Fairness Act.
DATES: Submit either electronic or
written comments on agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this 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 guidance document.
Submit electronic comments on the
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:
Arlene Solbeck, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
jdjones on DSK8KYBLC1PROD with NOTICES
SUMMARY:
1 As
amended November 25, 2009 (74 FR 61512).
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15:16 Aug 16, 2010
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I. Background
Guidance for Industry on OrganSpecific Warnings: Internal Analgesic,
Antipyretic, and Antirheumatic Drug
Products for Over-the-Counter Human
Use—Small Entity Compliance Guide;
Availability
AGENCY:
Dated: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FDA is announcing the availability of
a new guidance for small business
entities entitled ‘‘Organ-Specific
Warnings: Internal Analgesic,
Antipyretic, and Antirheumatic Drug
Products for Over-the-Counter Human
Use—Small Entity Compliance Guide.’’
This small entity compliance guide
applies to over-the-counter (OTC)
internal analgesic, antipyretic, and
antirheumatic (IAAA) drug products
that contain acetaminophen or
nonsteroidal anti-inflammatory drug
ingredients (NSAIDs). The labeling of
those products must include specific
warnings about the risks of liver injury
when using acetaminophen, and
stomach bleeding when using
nonsteroidal NSAIDs, as well as related
information appearing on the principal
display panel. Manufacturers must be in
compliance with the rule beginning on
April 29, 2010.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on organ-specific
labeling requirements for OTC IAAA
drug products. 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. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Healthcare Infection Control Practices
Advisory Committee (HICPAC)
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: 1:30 p.m.–3 p.m.,
September 8, 2010.
Place: Teleconference.
Status: Open to the public. Teleconference
access limited only by availability of
telephone ports. To participate in the
teleconference please dial 1–888–324–7115
and enter conference code 5959790.
Purpose: The Committee is charged with
providing advice and guidance to the
Secretary, HHS; the Assistant Secretary for
Health; the Director, CDC; and the Director,
National Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), regarding: (1)
The practice of hospital infection control;
strategies for surveillance, prevention, and
control of infections (e.g., nosocomial
infections), antimicrobial resistance, and
related events in settings where healthcare is
provided; and (3) periodic updating of
guidelines and other policy statements
regarding prevention of healthcare-associated
infections and healthcare-related conditions.
Matters To Be Discussed: The agenda will
include a follow up discussion on the Draft
Guideline for the Prevention and Control of
Norovirus Gastroenteritis Outbreaks in
Healthcare Settings. Materials for the call
will be available on the HICPAC Web site,
https://www.cdc.gov/hicpac, no later than
September 6, 2010.
Agenda items are subject to change as
priorities dictate.
Contact Person For More Information:
Michelle King, HICPAC, Division of
Healthcare Quality Promotion, NCEZID, CDC,
1600 Clifton Road, NE., Mailstop A–07,
Atlanta, Georgia 30333; E-mail:
HICPAC@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 CDC and the Agency for Toxic
Substances and Disease Registry.
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Federal Register / Vol. 75, No. 158 / Tuesday, August 17, 2010 / Notices
Dated: August 10, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention (CDC).
[FR Doc. 2010–20302 Filed 8–16–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
jdjones on DSK8KYBLC1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Nanotechnology Administrative
Centers Contract Review.
Date: August 20, 2010.
Time: 1 p.m. to 2 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call)
Contact Person: Shelley S Sehnert, PhD,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7206,
Bethesda, MD 20892–7924, 301–435–0303,
ssehnert@nhlbi.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
HLBI Proteomics Administrative Centers
Contract Review.
Date: August 20, 2010.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call)
Contact Person: Shelley S Sehnert, PhD,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7206,
Bethesda, MD 20892–7924, 301–435–0303,
ssehnert@nhlbi.nih.gov.
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This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Ancillary Studies in Clinical Trials.
Date: August 25, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Chang Sook Kim, PhD,
Scientific Review Officer, Review Branch,
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7190,
Bethesda, MD 20892, 301–435–0287,
carolko@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: August 4, 2010.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–20291 Filed 8–16–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Diabetes and Obesity.
Date: August 24, 2010.
Time: 10 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Michael Knecht, PhD,
Scientific Review Officer, Center for
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Dated: August 10, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–20287 Filed 8–16–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1999–D–2955] (formerly
Docket No. 1999D–4071)
Draft Revised Guidance for Industry on
Residual Solvents in New Veterinary
Medicinal Products, Active Substances
and Excipients (Revision) VICH
GL18(R); Request for Comments;
Availability
AGENCY:
ACTION:
Center for Scientific Review; Notice of
Closed Meeting
Frm 00029
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6176,
MSC 7892, Bethesda, MD 20892, (301) 435–
1046, knechtm@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Food and Drug Administration,
HHS.
National Institutes of Health
PO 00000
50771
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability for comments of a draft
revised guidance for industry (#100)
entitled ‘‘Residual Solvents in New
Veterinary Medicinal Products, Active
Substances and Excipients (Revision)
VICH GL18(R).’’ This draft revised
guidance, which updates a final
guidance on the same topic for which a
notice of availability was published in
the Federal Register of May 22, 2001 (66
FR 28182) (the 2001 final guidance), has
been developed for veterinary use by the
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH).
The guidance is intended to recommend
acceptable amounts of residual solvents
in new animal drugs (referred to as
pharmaceuticals or veterinary medicinal
products in this guidance) for the safety
of the target animal as well as for the
safety of human consumers of products
derived from treated food producing
animals. It is intended to assist in
developing new animal drug
applications (referred to as marketing
applications in this guidance) submitted
SUMMARY:
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]]>Agencies
[Federal Register Volume 75, Number 158 (Tuesday, August 17, 2010)]
[Notices]
[Pages 50770-50771]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20302]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Healthcare Infection Control Practices Advisory Committee
(HICPAC)
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: 1:30 p.m.-3 p.m., September 8, 2010.
Place: Teleconference.
Status: Open to the public. Teleconference access limited only
by availability of telephone ports. To participate in the
teleconference please dial 1-888-324-7115 and enter conference code
5959790.
Purpose: The Committee is charged with providing advice and
guidance to the Secretary, HHS; the Assistant Secretary for Health;
the Director, CDC; and the Director, National Center for Emerging
and Zoonotic Infectious Diseases (NCEZID), regarding: (1) The
practice of hospital infection control; strategies for surveillance,
prevention, and control of infections (e.g., nosocomial infections),
antimicrobial resistance, and related events in settings where
healthcare is provided; and (3) periodic updating of guidelines and
other policy statements regarding prevention of healthcare-
associated infections and healthcare-related conditions.
Matters To Be Discussed: The agenda will include a follow up
discussion on the Draft Guideline for the Prevention and Control of
Norovirus Gastroenteritis Outbreaks in Healthcare Settings.
Materials for the call will be available on the HICPAC Web site,
https://www.cdc.gov/hicpac, no later than September 6, 2010.
Agenda items are subject to change as priorities dictate.
Contact Person For More Information: Michelle King, HICPAC,
Division of Healthcare Quality Promotion, NCEZID, CDC, 1600 Clifton
Road, NE., Mailstop A-07, Atlanta, Georgia 30333; E-mail:
HICPAC@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 CDC and the Agency for Toxic Substances and
Disease Registry.
[[Page 50771]]
Dated: August 10, 2010.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention (CDC).
[FR Doc. 2010-20302 Filed 8-16-10; 8:45 am]
BILLING CODE 4163-18-P
