Advisory Committee for Women's Services; Notice of Meeting, 25272-25273 [2010-10778]
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Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices
I. Background
In the Federal Register of March 19,
2010 (75 FR 13225), FDA published
final regulations restricting the sale and
distribution of cigarettes and smokeless
tobacco to protect children and
adolescents. This guidance document
discusses FDA’s intended enforcement
policies with respect to two provisions
of the final regulations restricting the
sale and distribution of cigarettes and
smokeless tobacco to protect children
and adolescents.
One provision, § 1140.16(a) (21 CFR
1140.16(a)), specifies that manufacturers
may not use a trade or brand name of
a nontobacco product as the trade or
brand name for a cigarette or smokeless
tobacco product unless the trade or
brand name was on both the tobacco
product and a nontobacco product sold
in the United States on January 1, 1995.
FDA is aware of concerns regarding this
provision and is considering what
changes, if any, would be appropriate to
address those concerns.1 While FDA has
this issue under consideration, it
intends to exercise its enforcement
discretion concerning § 1140.16(a) (21
CFR 1140.16(a)) not to commence
enforcement actions under this
provision for the duration of its
consideration where:
(1) The trade or brand name of the
cigarettes or smokeless tobacco product
was registered, or the product was
marketed, in the United States on or
before June 22, 2009; or
(2) The first marketing or registration
in the United States of the tobacco
product occurs before the first
marketing or registration in the United
States of the nontobacco product
bearing the same name; provided,
however, that the tobacco and
nontobacco product are not owned,
manufactured, or distributed by the
same, related, or affiliated entities
(including as a licensee).
The second provision is § 1140.32(a)
(21 CFR 1140.32(a)). Under this section
of the final rule, manufacturers,
distributors, and retailers must use only
black text on a white background for
labeling or advertising (with certain
exceptions). The United States District
Court for the Western District of
Kentucky recently issued an order
permanently enjoining FDA from
enforcing § 1140.32(a) (formerly 21 CFR
897.32(a) of the 1996 final rule that
published in the Federal Register of
August 28, 1996 (61 FR 44396))
1 Under section 102(a)(3)-(4) of the Family
Smoking Prevention and Tobacco Control Act (21
U.S.C. 387a-1(a)(3)-(4)), FDA may amend the final
rule after issuing a proposed rule for notice and
comment.
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(Commonwealth Brands, Inc. v. United
States, No. 1:09-CV-117-M (W.D. Ky.
Jan. 4, 2010)). As required by section
102 of the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act), the effective date for
§ 1140.32(a) is June 22, 2010. At this
time, however, in light of the court’s
order in Commonwealth Brands, FDA
intends to exercise its enforcement
discretion concerning § 1140.32(a) not
to commence enforcement actions under
this provision during the pendency of
the litigation irrespective of whether the
entity is a party to the pending lawsuit
or located in the Western District of
Kentucky.
FDA intends that the exercise of
enforcement discretion expressed in this
guidance document for §§ 1140.16(a)
and 1140.32(a) begin upon the effective
date of the final rule (June 22, 2010). In
accordance with FDA’s GGP regulation
(§ 10.115 (21 CFR 10.115)), you may
comment on this guidance at any time.
The agency will consider your
comments and determine whether to
revise the guidance at a later date.
II. Significance of Guidance
FDA is issuing this guidance
document as a level 1 guidance
consistent with FDA’s GGP regulation
(§ 10.115). This guidance document is
being implemented immediately
without prior public comment under
§ 10.115(g)(2) because the agency has
determined that prior public
participation is not feasible or
appropriate. This document provides
guidance on regulations that are
required by statute (section 102 of the
Tobacco Control Act); moreover, the
statute directs that the regulations take
effect on June 22, 2010 (section
102(a)(2)(F) of the Tobacco Control Act).
It is important that FDA explain its
enforcement policy for these two
provisions before that date.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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.
IV. Electronic Access
An electronic version of the guidance
document is available on the Internet at
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https://www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: May 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Advisory Committee for Women’s
Services; Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given of a meeting of
the Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Advisory Committee for Women’s
Services (ACWS) on May 26–27 at
SAMHSA.
The meeting is open to the public. It
will include reports from the SAMHSA
Administrator and the ACWS Chair,
Updates from ACWS members, and a
discussion of SAMHSA’s strategic
initiatives.
Attendance by the public will be
limited to space available. Public
comments are welcome. The meeting
can also be accessed via Webstream. To
obtain the access information, to
register, to submit written or brief oral
comments, or to request special
accommodations for persons with
disabilities, please register at the
SAMHSA Committee’s Web site at
https://nac.samhsa.gov/Registration/
meetingsRegistration.aspx or
communicate with the Designated
Federal Officer for the ACWS, Ms.
Nevine Gahed (see contact information
below). Substantive meeting
information and a roster of Committee
members may be obtained either by
accessing the SAMHSA Committee’s
Web site at https://nac.samhsa.gov/
WomenServices/index.aspx, or by
contacting Ms. Gahed. The transcript for
the meeting will be available on the
SAMHSA Committee’s Web site within
three weeks after the meeting.
Committee Name: SAMHSA’s Advisory
Committee for Women’s Services.
Date/Time/Type: Wednesday, May 26,
2010 from 9 a.m. to 5 p.m. EST: OPEN.
Thursday, May 27, 2010 from 9 a.m. to 12
noon EST: OPEN.
Place: 1 Choke Cherry Road, Seneca
Conference Room, Rockville, Maryland
20857.
Contact: Nevine Gahed, Designated Federal
Officer, SAMHSA Advisory Committee for
Women’s Services, 1 Choke Cherry Road,
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Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices
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Room 8–1112, Rockville, Maryland 20857,
Telephone: (240) 276–2331; Fax: (240) 276–
2220 and E-mail:
nevine.gahed@samhsa.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
National Institutes of Health
Toian Vaughn,
Committee Management Officer, Substance
Abuse and Mental Health Services
Administration.
National Center on Minority and Health
Disparities; Notice of Closed Meeting
Name of Committee: National Institute on
Aging Special Emphasis Panel, Basis of
Myocardial Injury in the Elderly.
Date: May 27, 2010.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Bita Nakhai, PhD,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, Gateway
Bldg., 2C212, 7201 Wisconsin Avenue,
Bethesda, MD 20814. 301–402–7701.
nakhaib@nia.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. 93.866, Aging Research,
National Institutes of Health, HHS)
[FR Doc. 2010–10778 Filed 5–6–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
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.
jlentini on DSKJ8SOYB1PROD with NOTICES
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel—NIBIB Training
SEP.
Date: July 7–9, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Manana Sukhareva, PhD,
Scientific Review Officer, National Institute
of Biomedical Imaging & Bioeng, National
Institutes of Health, 6707 Democracy
Boulevard, Suite 959, Bethesda, MD 20892,
301–451–3397, sukharem@mail.nih.gov.
Dated: April 30, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–10892 Filed 5–6–10; 8:45 am]
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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 materials,
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 Center on
Minority Health and Health Disparities
Special Emphasis Panel, Faith Based R21.
Date: June 29–July 1, 2010.
Time: 5 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Prabha L. Atreya, PhD,
Chief, Office of Scientific Review, National
Center on Minority Health and Health
Disparities, 6707 Democracy Boulevard,
Suite 800, Bethesda, MD 20892, (301) 594–
8696, atreyapr@mail.nih.gov.
Dated: April 30, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–10889 Filed 5–6–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
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
PO 00000
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Dated: April 29, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–10888 Filed 5–6–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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: Brain Disorders and
Clinical Neuroscience Integrated Review
Group, Clinical Neuroplasticity and
Neurotransmitters Study Section.
Date: June 3–4, 2010.
Time: 8 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Melrose Hotel, 2430
Pennsylvania Avenue, NW., Washington, DC
20037.
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Agencies
[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25272-25273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10778]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Advisory Committee for Women's Services; Notice of Meeting
Pursuant to Public Law 92-463, notice is hereby given of a meeting
of the Substance Abuse and Mental Health Services Administration's
(SAMHSA) Advisory Committee for Women's Services (ACWS) on May 26-27 at
SAMHSA.
The meeting is open to the public. It will include reports from the
SAMHSA Administrator and the ACWS Chair, Updates from ACWS members, and
a discussion of SAMHSA's strategic initiatives.
Attendance by the public will be limited to space available. Public
comments are welcome. The meeting can also be accessed via Webstream.
To obtain the access information, to register, to submit written or
brief oral comments, or to request special accommodations for persons
with disabilities, please register at the SAMHSA Committee's Web site
at https://nac.samhsa.gov/Registration/meetingsRegistration.aspx or
communicate with the Designated Federal Officer for the ACWS, Ms.
Nevine Gahed (see contact information below). Substantive meeting
information and a roster of Committee members may be obtained either by
accessing the SAMHSA Committee's Web site at https://nac.samhsa.gov/WomenServices/index.aspx, or by contacting Ms. Gahed. The transcript
for the meeting will be available on the SAMHSA Committee's Web site
within three weeks after the meeting.
Committee Name: SAMHSA's Advisory Committee for Women's
Services.
Date/Time/Type: Wednesday, May 26, 2010 from 9 a.m. to 5 p.m.
EST: OPEN. Thursday, May 27, 2010 from 9 a.m. to 12 noon EST: OPEN.
Place: 1 Choke Cherry Road, Seneca Conference Room, Rockville,
Maryland 20857.
Contact: Nevine Gahed, Designated Federal Officer, SAMHSA
Advisory Committee for Women's Services, 1 Choke Cherry Road,
[[Page 25273]]
Room 8-1112, Rockville, Maryland 20857, Telephone: (240) 276-2331;
Fax: (240) 276-2220 and E-mail: nevine.gahed@samhsa.hhs.gov.
Toian Vaughn,
Committee Management Officer, Substance Abuse and Mental Health
Services Administration.
[FR Doc. 2010-10778 Filed 5-6-10; 8:45 am]
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