Tobacco Products Scientific Advisory Committee; Amendment of Notice, 36432 [2010-15554]
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36432
Federal Register / Vol. 75, No. 122 / Friday, June 25, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Tobacco Products Scientific Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the Tobacco
Products Scientific Advisory
Committee. This meeting was
announced in the Federal Register of
May 19, 2010 (75 FR 28027). The
amendment is being made to reflect a
change in the Agenda and Procedure
portions of the document. The Agenda
portion is changed to cancel Topic 1
regarding dissolvable tobacco products.
This portion of the meeting has been
cancelled. The Procedure portion is
changed to a 1-hour open public hearing
from 10 a.m. to 11 a.m. on July 16, 2010.
There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Cristi Stark, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd,
Rockville, MD 20850, 1–877–287–1373
(choose Option 4), e-mail:
TPSAC@fda.hhs.gov or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington DC area), code 8732110002.
Please call the Information Line for upto-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 19, 2010 (75 FR
28027), FDA announced that a meeting
of the Tobacco Products Scientific
Advisory Committee would be held on
July 15 and 16, 2010. On page 28027, in
the first column, the Agenda portion of
the document is changed to read as
follows:
Agenda: On July 15, 2010, the
committee will: (1) Receive updates on
upcoming committee business related to
menthol, including Agency requests for
information from industry on menthol
cigarettes in order to prepare for the
Tobacco Products Scientific Advisory
Committee’s required report to the
Secretary of Health and Human Services
regarding the impact of use of menthol
in cigarettes on the public health and (2)
hear and discuss industry presentations
on menthol in cigarettes as they relate
to the following five topics:
Characterization of menthol, clinical
effects of menthol, biomarkers of disease
risk, marketing data, and population
effects.
VerDate Mar<15>2010
16:23 Jun 24, 2010
Jkt 220001
On page 28027, in the third column,
the Agenda portion of the document is
changed to read as follows:
Agenda: On July 16, 2010, the
committee will continue discussion on
topic 2.
On page 28028, in the first column,
the Procedure portion of the document
is changed to read as follows:
Procedure: Oral presentations from
the public (excluding the tobacco
industry) will be scheduled between
approximately 10 a.m. and 11 a.m. on
July 16, 2010.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: June 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–15554 Filed 6–23–10; 11:15 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2009–N–0276, FDA–
2009–N–0277, FDA–2009–N–0278, and FDA–
2009–N–0521]
Termination of Declarations Justifying
Emergency Use Authorizations of
Certain In Vitro Diagnostic Devices,
Antiviral Drugs, and Personal
Respiratory Protection Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is issuing this
notice, under the Federal Food, Drug,
and Cosmetic Act (the act), of the
termination of the declarations of
emergency justifying Emergency Use
Authorizations (EUAs) of certain in
vitro diagnostic devices, personal
respiratory protection devices, and
antiviral products that were issued in
response to the public health emergency
involving 2009 H1N1 Influenza.
Advance notice of the termination of the
declarations was provided under the
act.
DATES: The Authorizations are
terminated as of June 23, 2010.
FOR FURTHER INFORMATION CONTACT:
RADM Boris Lushniak, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
4140, Silver Spring, MD 20993, 301–
796–8510.
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
I. Background
On April 26, 2009, the then Acting
Secretary of the Department of Health
and Human Services (DHHS)
determined, under section 564(b)(1)(C)
of the act (21 U.S.C. 360bbb-3(b)(1)(C))
that a public health emergency exists
involving Swine Influenza A (now
known as 2009 H1N1 Influenza) that
affects, or has significant potential to
affect, national security. The
determination was renewed four times:
March 26, 2010, December 28, 2009,
October 1, 2009, and July 24, 2009. On
March 26, 2010, the Secretary of DHHS
renewed the declarations justifying the
authorization for the emergency use of
certain in vitro diagnostic devices,
antiviral drugs, and personal respiratory
protection devices. For additional
background information on the
declarations, see the April 2, 2010,
renewal notice (75 FR 16810).
For additional background
information on the products authorized
for emergency use in response to the
public health emergency involving 2009
H1N1 Influenza, see the following
Federal Register notices:
• For certain personal respiratory
protection devices: 74 FR 38644, August
4, 2009;
• For certain antiviral drug products:
74 FR 38648, August 4, 2009; 75 FR
20430, April 19, 2010; 74 FR 56640,
November 2, 2009; and 75 FR 20437,
April 19, 2010; and
• For certain in vitro diagnostic
devices: 74 FR 38636, August 4, 2009;
75 FR 20441, April 19, 2010; and 75 FR
35045, June 21, 2010.
II. Advance Notice of Termination
FDA is issuing this notice, under
section 564(b)(4) of the act, of the
termination of the declarations of
emergency justifying EUAs of certain in
vitro diagnostic devices, personal
respiratory protection devices, and
antiviral products that were issued in
response to the public health emergency
involving 2009 H1N1 Influenza. Under
section 564(b)(3) of the act, the
Commissioner of Food and Drugs
provided advance notice of the
termination of the declaration of
emergency to the EUA requestor for
each product authorized for emergency
use in response to the public health
emergency involving 2009 H1N1
Influenza. The June 21, 2010, letters
notifying the EUA requestors of the
termination of the declaration of
emergency follow:
E:\FR\FM\25JNN1.SGM
25JNN1
]]>Agencies
[Federal Register Volume 75, Number 122 (Friday, June 25, 2010)]
[Notices]
[Page 36432]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15554]
[[Page 36432]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Tobacco Products Scientific Advisory Committee; Amendment of
Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Tobacco Products Scientific Advisory
Committee. This meeting was announced in the Federal Register of May
19, 2010 (75 FR 28027). The amendment is being made to reflect a change
in the Agenda and Procedure portions of the document. The Agenda
portion is changed to cancel Topic 1 regarding dissolvable tobacco
products. This portion of the meeting has been cancelled. The Procedure
portion is changed to a 1-hour open public hearing from 10 a.m. to 11
a.m. on July 16, 2010. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Cristi Stark, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd, Rockville,
MD 20850, 1-877-287-1373 (choose Option 4), e-mail: TPSAC@fda.hhs.gov
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington DC area), code 8732110002. Please call the
Information Line for up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 19, 2010 (75
FR 28027), FDA announced that a meeting of the Tobacco Products
Scientific Advisory Committee would be held on July 15 and 16, 2010. On
page 28027, in the first column, the Agenda portion of the document is
changed to read as follows:
Agenda: On July 15, 2010, the committee will: (1) Receive updates
on upcoming committee business related to menthol, including Agency
requests for information from industry on menthol cigarettes in order
to prepare for the Tobacco Products Scientific Advisory Committee's
required report to the Secretary of Health and Human Services regarding
the impact of use of menthol in cigarettes on the public health and (2)
hear and discuss industry presentations on menthol in cigarettes as
they relate to the following five topics: Characterization of menthol,
clinical effects of menthol, biomarkers of disease risk, marketing
data, and population effects.
On page 28027, in the third column, the Agenda portion of the
document is changed to read as follows:
Agenda: On July 16, 2010, the committee will continue discussion on
topic 2.
On page 28028, in the first column, the Procedure portion of the
document is changed to read as follows:
Procedure: Oral presentations from the public (excluding the
tobacco industry) will be scheduled between approximately 10 a.m. and
11 a.m. on July 16, 2010.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: June 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-15554 Filed 6-23-10; 11:15 am]
BILLING CODE 4160-01-S
