National Center for Injury Prevention and Control, Initial Review Group, (NCIPC, IRG), 18733 [E9-9470]
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Federal Register / Vol. 74, No. 78 / Friday, April 24, 2009 / Notices
mstockstill on PROD1PC66 with NOTICES
alcohol during prescription use.8 FDA
was informed by the National
Association of Boards of Pharmacy that,
as of February 2008, no states had
implemented regulations related to the
request.
In December 2006, FDA issued
proposed regulations for OTC labeling
for acetaminophen containing products
to require inclusion of new safety
information and that the container and
outer carton identify acetaminophen
when it is an ingredient.9 The final
version of the regulation is currently
under review.
In 2007, the Director of FDA’s Center
for Drug Evaluation and Research
(CDER) convened a multidisciplinary
working group in CDER to continue to
evaluate the issues associated with
acetaminophen-related liver injury and
consider additional steps FDA could
take to decrease the number of cases of
acetaminophen-related liver injury. The
working group considered detailed
reviews of the issues from the Office of
Nonprescription Products, the Office of
Surveillance and Epidemiology and the
Division of Anesthesia and Analgesic
and Rheumatology Drug Products as
part of its deliberations. The working
group considered the full range of
options proposed and made
recommendations to the Center Director
regarding which should be considered
for implementation. Given the complex
nature of the underlying problem of
acetaminophen liver toxicity, the Center
Director and the Working Group agreed
that the options should be presented for
public discussion prior to taking further
action. The report of the Working Group
will be available by or around May 22,
2009, at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2009 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons and
Sponsors (representatives from
industry) may present data, information,
or views, orally or in writing, on issues
pending before the committee.
All electronic and written
submissions submitted to the Docket
(see above section: Addresses) on or
8 Letter from Steven Galson to State Boards of
Pharmacy, Acetaminophen Hepatotoxicity and
Nonsteroidal Anti-Inflammatory Drug (NSAID)Related Gastrointestinal and Renal Toxicity
(January 22, 2004), available on FDA’s Web site at
https://www.fda.gov/cder/drug/analgesics/
letter.htm.)
9 Internal Analgesic, Antipyretic, and
Antirheumatic Drug Products for Over-the Counter
Human Use: Proposed Amendment of the Tentative
Final Monograph: Required Warnings and Other
Labeling, 71 FR 77314–52 (December 26, 2006)
(Docket No.1977N–0094L) (amending 21 CFR
201.66, 201.322, 201.325, 343.50).
VerDate Nov<24>2008
16:20 Apr 23, 2009
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before June 8, 2009, will be provided to
the committees.
Oral presentations from the public
(excluding Sponsors) will be scheduled
between approximately 1 p.m. to 2 p.m.
on both days. Persons desiring to make
formal oral presentations during this
time should notify the contact person
and submit a brief statement of the
general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before June 1,
2009. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak at the open public
hearing session by June 3, 2009.
FDA will work with sponsors of
acetaminophen products who wish to
make presentations to ensure that
adequate time, separate from the 1 p.m.
to 2 p.m. time slots for the general Open
Public Hearing, is provided. Sponsors
interested in making formal
presentations to the committees should
notify the contact person on or before
June 1, 2009. Sponsors with common
interest are urged to coordinate their
oral presentations.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Elaine
Ferguson at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app.).
18733
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Center for Injury Prevention
and Control, Initial Review Group,
(NCIPC, IRG)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), CDC announces the
following meeting of the
aforementioned review group:
Times and Dates:
10 a.m.–10:10 a.m., May 18, 2009 (Open).
10:10 a.m.–4 p.m., May 18, 2009 (Closed).
Place: Teleconference, Toll Free: (877)
468–4185, Participant Passcode: 4475689.
Status: Portions of the meetings will be
closed to the public in accordance with
provisions set forth in Section 552b(c)(4) and
(6), Title 5, U.S.C., and the Determination of
the Director, Management Analysis and
Services Office, CDC, pursuant to Section
10(d) of Public Law 92–463.
Purpose: This group is charged with
providing advice and guidance to the
Secretary, Department of Health and Human
Services, and the Director, CDC, concerning
the scientific and technical merit of grant and
cooperative agreement applications received
from academic institutions and other public
and private profit and nonprofit
organizations, including State and local
government agencies, to conduct specific
research that focuses on prevention and
control.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of applications submitted in
response to Fiscal Year 2009 Requests for
Applications related to the following
individual research announcement: TS09001,
Libbey Montana Amphibole Epidemiology
Research Program (R01) and TS09002,
Disease Progression in persons Exposed to
Asbestos Contaminated Vermiculite Ore in
Marysville, Ohio (R01).
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Lisa
T. Garbarino, B.S., NCIPC, Division of Injury
Response, CDC, 4770 Buford Highway, NE.,
M/S F62, Atlanta, Georgia 30341, Telephone
(440) 723–1527. 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.
Dated: April 16, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–9380 Filed 4–23–09; 8:45 am]
Dated: April 16, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–9470 Filed 4–23–09; 8:45 am]
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[Federal Register Volume 74, Number 78 (Friday, April 24, 2009)]
[Notices]
[Page 18733]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9470]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Center for Injury Prevention and Control, Initial Review
Group, (NCIPC, IRG)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), CDC announces the following meeting of
the aforementioned review group:
Times and Dates:
10 a.m.-10:10 a.m., May 18, 2009 (Open).
10:10 a.m.-4 p.m., May 18, 2009 (Closed).
Place: Teleconference, Toll Free: (877) 468-4185, Participant
Passcode: 4475689.
Status: Portions of the meetings will be closed to the public in
accordance with provisions set forth in Section 552b(c)(4) and (6),
Title 5, U.S.C., and the Determination of the Director, Management
Analysis and Services Office, CDC, pursuant to Section 10(d) of
Public Law 92-463.
Purpose: This group is charged with providing advice and
guidance to the Secretary, Department of Health and Human Services,
and the Director, CDC, concerning the scientific and technical merit
of grant and cooperative agreement applications received from
academic institutions and other public and private profit and
nonprofit organizations, including State and local government
agencies, to conduct specific research that focuses on prevention
and control.
Matters To Be Discussed: The meeting will include the review,
discussion, and evaluation of applications submitted in response to
Fiscal Year 2009 Requests for Applications related to the following
individual research announcement: TS09001, Libbey Montana Amphibole
Epidemiology Research Program (R01) and TS09002, Disease Progression
in persons Exposed to Asbestos Contaminated Vermiculite Ore in
Marysville, Ohio (R01).
Agenda items are subject to change as priorities dictate.
Contact Person for More Information: Lisa T. Garbarino, B.S.,
NCIPC, Division of Injury Response, CDC, 4770 Buford Highway, NE.,
M/S F62, Atlanta, Georgia 30341, Telephone (440) 723-1527. 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.
Dated: April 16, 2009.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E9-9470 Filed 4-23-09; 8:45 am]
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