Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents; Availability, 32791-32792 [2010-13922]
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32791
Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices
MATERNAL AND CHILD HEALTH BUREAU SELECTED GRANT PROGRAMS
[Extensions with funding]
Grantee/organization name
State
Raising Special Kids .......................................................................................................................
Support for Families of Children w/Disabilities ...............................................................................
Family Voices of District of Columbia, Inc. ....................................................................................
Family Institute for Family Involvement ..........................................................................................
Parent to Parent of Georgia, Inc. ...................................................................................................
Hawaii Pediatric Association Research & Education Foundation ..................................................
The Arc of Illinois ............................................................................................................................
About Special Kids, Inc. .................................................................................................................
Bayou Land Families Helping Families ..........................................................................................
Federation for Children With Special Needs ..................................................................................
The Parent’s Place of MD ..............................................................................................................
Maine Parent Federation ................................................................................................................
Pacer Center Inc. ............................................................................................................................
University of Southern Mississippi ..................................................................................................
Exceptional Children’s Assistance Center ......................................................................................
Family Voices of North Dakota, Inc ................................................................................................
PTI Nebraska ..................................................................................................................................
Statewide Parent Advocacy Network of New Jersey .....................................................................
Parents Reaching Out To Help ......................................................................................................
Family TIES of Nevada, Inc ...........................................................................................................
Parent to Parent of NYS .................................................................................................................
Oregon Family Support Network ....................................................................................................
Parent Education & Advocacy Leadership Center .........................................................................
Rhode Island Parent Information Network, Inc. .............................................................................
South Dakota Parent Connection, Inc. ...........................................................................................
Tennessee Disability Coalition .......................................................................................................
Texas Parent to Parent ..................................................................................................................
Utah Parent Center .........................................................................................................................
Parent to Parent of Vermont ..........................................................................................................
The Arc Wisconsin Disability Association ......................................................................................
AZ ................
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FL .................
GA ................
HI .................
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IN .................
LA .................
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ME ................
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MS ................
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OR ................
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RI .................
SD ................
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VT ................
WI .................
Dated: June 3, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010–13788 Filed 6–8–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0277]
Draft Guidance for Industry:
Compliance With Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to
Protect Children and Adolescents;
Availability
AGENCY:
Food and Drug Administration,
HHS.
erowe on DSK5CLS3C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Draft Guidance for
Industry: Compliance with Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents.’’ The
draft guidance is intended to help small
VerDate Mar<15>2010
15:10 Jun 08, 2010
Jkt 220001
entities comply with the final
regulations restricting the sale and
distribution of cigarettes and smokeless
tobacco in order to protect children and
adolescents.
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 July 31, 2010.
ADDRESSES: The draft guidance for
industry entitled ‘‘Draft Guidance for
Industry: Compliance with Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents’’ is
available on the Internet at https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm, or a paper
copy may be ordered free of charge by
calling 1–877–287–1373.
Submit electronic comments 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. Identify
comments with the docket number
PO 00000
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FY 2009
authorized
funding level
$95,700
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95,700
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95,700
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95,700
95,700
95,700
95,700
Revised
project end
date
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Kathleen K. Quinn, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 240–276–
1717, Kathleen.Quinn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act) (Public Law 111–31; 123 Stat.
1776) was enacted on June 22, 2009,
amending the Federal Food, Drug, and
Cosmetic Act (FFDCA) and providing
FDA with the authority to regulate
tobacco products. Section 102 of the
Tobacco Control Act requires FDA to
publish final regulations regarding
cigarettes and smokeless tobacco which
are identical in their provisions to the
regulations promulgated by FDA in
1996 (1996 final regulations) on August
28, 1996 (61 FR 44396), with certain
specified exceptions. In the Federal
Register of March 19, 2010 (75 FR
13225), FDA published its final
regulations entitled ‘‘Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
E:\FR\FM\09JNN1.SGM
09JNN1
32792
Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices
Protect Children and Adolescents,’’ at 21
CFR part 1140. The final regulations
apply to manufacturers, distributors,
and retailers who make, distribute, or
sell cigarettes or smokeless tobacco
products.
Beginning on June 22, 2010, these
Federal regulations will prohibit
retailers from selling cigarettes, cigarette
tobacco, or smokeless tobacco to
persons under the age of 18, and will
require retailers to verify the age of all
customers under the age of 27 by
checking a photographic identification
that includes the bearer’s date of birth.
FDA is announcing the availability of
a draft guidance document, which is
intended to help small businesses
comply with the requirements of the
new regulations. FDA is soliciting
comments on the draft guidance
document and may amend the guidance
document periodically as a result of
comments received.
II. Significance of Guidance
FDA is issuing this draft guidance
document 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 ‘‘Compliance with
Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless
Tobacco To Protect Children and
Adolescents.’’ 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 statute
and regulations.
erowe on DSK5CLS3C1PROD with NOTICES
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. 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.
IV. Electronic Access
An electronic version of the guidance
document is available on the Internet at
https://www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
VerDate Mar<15>2010
15:10 Jun 08, 2010
Jkt 220001
Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–13922 Filed 6–7–10; 11:15 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Office of Public Health Support;
Division of Planning, Evaluation &
Research Native American Research
Centers for Health (NARCH) V
Evidence-Based Interventions for
Tribal Communities Against AIDS and
STDs
Announcement Type: Competitive
Supplements.
Funding Announcement Number:
HHS–2010–IHS–NARCH–0001.
Catalog of Federal Domestic
Assistance Number: 93.933.
Key Dates
Application Deadline Date: June 30,
2010.
Review Date: July 15, 2010.
Earliest Anticipated Start Date:
September 1, 2010.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting competitive supplemental
grant applications from existing Native
American Research Centers for Health
(NARCH) V grantees to establish and
test Evidence-Based Interventions for
Tribal Communities Against Acquired
Immune Deficiency Syndrome (AIDS)
and sexually transmitted diseases
(STDs). This program is authorized
under: the Snyder Act, 25 U.S.C. 13, the
Public Health Service Act, 42 U.S.C. 241
as amended, and the Indian Health Care
Improvement Act, 25 U.S.C.
1602(a)(b)(16). This program is
described in the Catalog of Federal
Domestic Assistance under 93.933.
Background
The NARCH V program supports
partnerships between Federally
recognized American Indian and Alaska
Native (AI/AN) Tribes or Tribal
organizations (including national and
area Indian health boards, and Tribal
colleges meeting the definition of a
Tribal organization as defined by 25
U.S.C. 1603(d) or (e)) and institutions
that conduct intensive academic-level
biomedical, behavioral and health
services research. These partnerships
are called Native American Research
Centers for Health (NARCH). Due to the
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
complexity of factors contributing to the
health and disease of AI/ANs, and to
their health disparities compared with
other Americans, the collaborative
efforts of the agencies of the Department
of Health and Human Services (HHS)
and the collaboration of academic
researchers and AI/AN communities are
needed to achieve significant
improvements in the health status of AI/
AN people. To accomplish this goal, in
addition to objectives set by the Tribes,
Tribal organizations or Indian health
boards, the IHS NARCH program
pursues the following program
objectives:
To develop a cadre of AI/AN
scientists and health professionals—
Opportunities are needed to develop
more AI/AN scientists and health
professionals engaged in research, and
to conduct biomedical, clinical,
behavioral and health services research
that is responsive to the needs of the AI/
AN community and the goals of this
initiative. Faculty/researchers and
students at each proposed NARCH
develop investigator-initiated,
scientifically meritorious research
projects, including pilot research
projects, and will be supported through
science education projects designed to
increase the numbers of, and to improve
the research skills of, AI/AN
investigators and investigators involved
with AI/ANs.
To enhance partnerships and reduce
distrust of research by AI/AN
communities—Recent community-based
participatory research suggests that AI/
AN communities can work
collaboratively in partnership with
health researchers to further the
research needs of AI/ANs. Fully
utilizing all cultural and scientific
knowledge, strengths, and
competencies, such partnerships can
lead to better understanding of the
biological, genetic, behavioral,
psychological, cultural, social, and
economic factors either promoting or
hindering improved health status of AI/
ANs, and generate the development and
evaluation of interventions to improve
their health status. Community distrust
of research and researchers will be
reduced by offering the Tribe greater
control over the research process.
Purpose
The purpose of this opportunity for
supplementing the existing NARCH V
program is to determine the feasibility
of adapting and implementing HIV
evidence based interventions (EBI)(s)
supported by the CDC for effective use
within AI/AN communities, and to
contribute to, and document, a
successful adaption and implementation
E:\FR\FM\09JNN1.SGM
09JNN1
Agencies
[Federal Register Volume 75, Number 110 (Wednesday, June 9, 2010)]
[Notices]
[Pages 32791-32792]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13922]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0277]
Draft Guidance for Industry: Compliance With Regulations
Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco to Protect Children and Adolescents; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Draft Guidance
for Industry: Compliance with Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless Tobacco To Protect Children
and Adolescents.'' The draft guidance is intended to help small
entities comply with the final regulations restricting the sale and
distribution of cigarettes and smokeless tobacco in order to protect
children and adolescents.
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 July 31, 2010.
ADDRESSES: The draft guidance for industry entitled ``Draft Guidance
for Industry: Compliance with Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless Tobacco To Protect Children
and Adolescents'' is available on the Internet at https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm, or
a paper copy may be ordered free of charge by calling 1-877-287-1373.
Submit electronic comments 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. Identify comments with the docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Kathleen K. Quinn, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229, 240-276-1717, Kathleen.Quinn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Public Law 111-31; 123 Stat. 1776) was enacted on June
22, 2009, amending the Federal Food, Drug, and Cosmetic Act (FFDCA) and
providing FDA with the authority to regulate tobacco products. Section
102 of the Tobacco Control Act requires FDA to publish final
regulations regarding cigarettes and smokeless tobacco which are
identical in their provisions to the regulations promulgated by FDA in
1996 (1996 final regulations) on August 28, 1996 (61 FR 44396), with
certain specified exceptions. In the Federal Register of March 19, 2010
(75 FR 13225), FDA published its final regulations entitled
``Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco To
[[Page 32792]]
Protect Children and Adolescents,'' at 21 CFR part 1140. The final
regulations apply to manufacturers, distributors, and retailers who
make, distribute, or sell cigarettes or smokeless tobacco products.
Beginning on June 22, 2010, these Federal regulations will prohibit
retailers from selling cigarettes, cigarette tobacco, or smokeless
tobacco to persons under the age of 18, and will require retailers to
verify the age of all customers under the age of 27 by checking a
photographic identification that includes the bearer's date of birth.
FDA is announcing the availability of a draft guidance document,
which is intended to help small businesses comply with the requirements
of the new regulations. FDA is soliciting comments on the draft
guidance document and may amend the guidance document periodically as a
result of comments received.
II. Significance of Guidance
FDA is issuing this draft guidance document 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
``Compliance with Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To Protect Children and Adolescents.''
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
statute and regulations.
III. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. 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.
IV. Electronic Access
An electronic version of the guidance document is available on the
Internet at https://www.regulations.gov and https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13922 Filed 6-7-10; 11:15 am]
BILLING CODE 4160-01-S