Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco; Availability, 32481-32482 [2010-13819]
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Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices
1. Funding Instrument Type
3. Submission Dates and Times
To receive consideration, applications
must be submitted by 11:59 Eastern time
by the deadline listed in the ‘‘Dates’’
section at the beginning of this Notice.
These awards will be made in the
form of grants to Title VI Native
American Programs.
V. Responsiveness Criteria
Does not apply.
2. Anticipated Total Priority Area
Funding per Budget Period
VI. Application Review Information
Does not apply.
AoA intends to make available, under
this program announcement, grant
awards for $1,000 to 246 projects at a
federal share of approximately $246,000
total for a project period of 1 year.
VII. Agency Contacts
Direct inquiries regarding
programmatic issues to U.S. Department
of Health and Human Services,
Administration on Aging, Office for
American Indian, Alaskan Native, and
Native Hawaiian Programs, Washington,
DC 20201, attention: Yvonne Jackson or
by calling 202–357–3501, or by e-mail at
Yvonne.jackson@aoa.hhs.gov.
www.aoa.gov/doingbus/fundopp/
fundopp.aspx
II. Award Information
III. Eligibility Criteria and Other
Requirements
1. Eligible Applicants
Only current Older Americans Act
Title VI Native American Program
grantees are eligible to apply for this
funding.
Dated: May 18, 2010.
Kathy Greenlee,
Assistant Secretary for Aging.
2. Cost Sharing or Matching
[FR Doc. 2010–13651 Filed 6–7–10; 8:45 am]
BILLING CODE 4154–01–P
Cost Sharing does not apply.
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entities. The D–U–N–S number is free
and easy to obtain from https://
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4. Intergovernmental Review
Executive Order 12372,
Intergovernmental Review of Federal
Programs, is not applicable to these
grant applications.
2. Address for Application Submission
emcdonald on DSK2BSOYB1PROD with NOTICES
Guidance for Industry: Enforcement
Policy Concerning Rotational Warning
Plans for Smokeless Tobacco;
Availability
ACTION:
Application kits are available by
writing to the U.S. Department of Health
and Human Services, Administration on
Aging, Office for American Indian,
Alaskan Native, and Native Hawaiian
Programs, Washington, DC 20201,
attention: Yvonne Jackson or by calling
202–357–3501, or online at https://
www.grants.gov.
Applications may be submitted by
e-mail to grants.office@aoa.hhs.gov, by
fax to 202–357–3467 or in hard copy by
overnight delivery to the U.S.
Department of Health and Human
Services, Administration on Aging,
Office of Grants Management,
Washington, DC 20201, Attn. Sean
Lewis.
Jkt 220001
[Docket No. FDA–2010–D–0276]
AGENCY:
1. Address to Request Application
16:31 Jun 07, 2010
Food and Drug Administration
Food and Drug Administration,
HHS.
IV. Application and Submission
Information
VerDate Mar<15>2010
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Enforcement Policy
Concerning Rotational Warning Plans
for Smokeless Tobacco Products.’’ The
guidance is intended to provide
information relating to FDA’s
enforcement policy concerning section 3
of the Comprehensive Smokeless
Tobacco Health Education Act
(Smokeless Tobacco Act), as amended
by the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act). This guidance will be
implemented immediately, but remains
subject to comment in accordance with
the agency’s good guidance practices
(GGPs).
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on agency
guidance documents are welcome at any
time.
PO 00000
Frm 00127
Fmt 4703
Sfmt 4703
32481
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Enforcement Policy
Concerning Rotational Warning Plans
for Smokeless Tobacco Products’’ to the
Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850–3229. Send
one self-addressed adhesive label to
assist that office in processing your
request or include a fax number to
which the guidance may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to
guidance.
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. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Gail
Schmerfeld, Center for Tobacco
Products, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 240–276–
1717, e-mail:
Gail.Schmerfeld@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President
signed the Tobacco Control Act (Public
Law 111–31) into law. The Tobacco
Control Act grants FDA authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect public health generally and to
reduce tobacco use by minors. Section
204 of the Tobacco Control Act
amended section 3 of the Smokeless
Tobacco Act (15 U.S.C. 4402) to
prescribe new requirements for health
warning labels that must appear on
smokeless tobacco product packages
and advertising, and to require that
rotational warning plans for packaging
and advertising for smokeless tobacco
products be submitted to FDA, rather
than to the Federal Trade Commission
(FTC).
The new warning labels required by
section 3 of the Smokeless Tobacco Act
must begin to rotate in advertising for
smokeless tobacco products beginning
on June 22, 2010, and must be
distributed and displayed on the
packaging of smokeless tobacco
products manufactured on or after June
22, 2010, as set forth in section 3(b)(3)
of the Smokeless Tobacco Act (section
204(b) of the Tobacco Control Act and
section 3(b)(3) of the Smokeless Tobacco
Act). In addition, on or after July 22,
2010, manufacturers may not introduce
any smokeless tobacco product into
E:\FR\FM\08JNN1.SGM
08JNN1
32482
Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices
domestic commerce unless its packaging
complies with section 3 of the
Smokeless Tobacco Act (Id.). Among the
requirements in section 3(b)(3) is that
the rotation of label statements on
packaging and advertising for each
brand of smokeless tobacco must be ‘‘in
accordance with a plan submitted by the
tobacco product manufacturer, importer,
distributor, or retailer’’ to, and approved
by, FDA (Id.).
At this time, as an exercise of
enforcement discretion, FDA does not
intend to commence or recommend
enforcement of the requirement that a
smokeless tobacco manufacturer,
distributor, importer, or retailer must
have an FDA-approved rotational
warning plan, so long as a rotational
warning plan has been submitted to
FDA by July 22, 2010. FDA believes that
allowing additional time for the review
of rotational warning plans will permit
an orderly transition of regulatory
authority from FTC to FDA to review
and approve rotational warning plans.
During such transition between June 22,
2010, and July 22, 2010, affected
companies may wish to contact FDA to
discuss the submission of their
rotational warning plans in order to
make the subsequent approval process
more orderly and efficient. FDA intends
to provide further public notice prior to
revising or rescinding this enforcement
policy after the transition from FTC to
FDA has been accomplished for the
submission and review of rotational
warning plans. This enforcement policy
pertains only to the requirement that
smokeless tobacco manufacturers,
distributors, importers, or retailers must
have an FDA-approved rotational
warning plan. FDA expects compliance
with regard to all other requirements of
section 3 of the Smokeless Tobacco Act,
including the requirements relating to
size, formatting, location, and use of
required warning statements.
emcdonald on DSK2BSOYB1PROD with NOTICES
II. Significance of Guidance
FDA is issuing this guidance
document as a level 1 guidance
consistent with FDA’s good guidance
practices regulations (21 CFR 10.115).
This guidance 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 statutory provisions that
take effect June 22, 2010. It is important
that FDA explain its enforcement policy
concerning the submission and approval
of rotational warning plans for
smokeless tobacco products before that
date.
VerDate Mar<15>2010
16:31 Jun 07, 2010
Jkt 220001
III. 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.
IV. Electronic Access
An electronic version of this guidance
document is available on the Internet at
https://www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–13819 Filed 6–4–10; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0247]
Investigational New Drug Applications;
Co-development of Investigational
Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice; establishment of docket;
request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is establishing a
public docket to obtain input on
methods to co-develop two or more
distinct investigational drugs intended
to be used in combination to treat a
disease or condition. FDA is planning to
develop guidance for industry and other
affected parties on the co-development
of two or more novel drugs intended to
be used in combination (but not as not
fixed-dose combinations) and is seeking
public input to identify the affected
parties’ information needs concerning
such co-development. Accordingly,
FDA is seeking comment on general
methodologic and regulatory issues that
arise in various scenarios when codeveloping two or more investigational
drugs intended to be used in
combination. FDA is also seeking
comment on methodologic and
regulatory issues when co-developing
two or more investigational drugs
PO 00000
Frm 00128
Fmt 4703
Sfmt 4703
intended to be used in combination for
specific therapeutic areas, including
oncology, anti-infectives, seizure
disorders, cardiovascular diseases, and
any other therapeutic category in which
such co-development is likely to occur.
DATES: Submit either electronic or
written comments by September 7,
2010.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Colleen L. Locicero, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4200,
Silver Spring, MD 20993–0002, 301–
796–2270.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is aware of growing interest in
co-developing two or more distinct,
novel investigational drugs intended to
be used in combination to treat a disease
or condition (but not as fixed-dose
combinations under 21 CFR 300.50). At
a September 2009 conference co-hosted
by the ‘‘Friends of Cancer Research’’ in
partnership with the Engelberg Center
for Health Care Reform at the Brookings
Institution, and supported by the
American Society for Clinical Oncology
(ASCO), the American Association for
Cancer Research (AACR) Susan G.
Komen for the Cure, and the Lance
Armstrong Foundation (Brookings
Conference), which was attended by
FDA scientists, there was considerable
interest in approaches to developing
new oncology therapies intended to be
used in combination. In addition, on
April 30, 2010, FDA held a public
hearing in accordance with part 15 (21
CFR part 15) devoted, in part, to
obtaining information about study
designs and appropriate populations for
developing two or more novel, directacting antivirals intended to be used in
combination for the treatment of chronic
hepatitis C. FDA is also aware of efforts
to try to develop two or more
investigational drugs intended to be
used in combination to treat
tuberculosis. FDA is further aware of
general uncertainty about the
evidentiary requirements and regulatory
criteria applicable to such codevelopment efforts. Accordingly, FDA
is planning to develop generally
applicable guidance (not restricted to
oncology or any other specific
therapeutic category) to address
E:\FR\FM\08JNN1.SGM
08JNN1
Agencies
[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32481-32482]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13819]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0276]
Guidance for Industry: Enforcement Policy Concerning Rotational
Warning Plans for Smokeless Tobacco; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Enforcement Policy
Concerning Rotational Warning Plans for Smokeless Tobacco Products.''
The guidance is intended to provide information relating to FDA's
enforcement policy concerning section 3 of the Comprehensive Smokeless
Tobacco Health Education Act (Smokeless Tobacco Act), as amended by the
Family Smoking Prevention and Tobacco Control Act (Tobacco Control
Act). This guidance will be implemented immediately, but remains
subject to comment in accordance with the agency's good guidance
practices (GGPs).
DATES: Submit either electronic or written comments on this guidance
at any time. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Enforcement Policy Concerning Rotational
Warning Plans for Smokeless Tobacco Products'' to the Center for
Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229. Send one self-addressed adhesive label to
assist that office in processing your request or include a fax number
to which the guidance may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to guidance.
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. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Center for Tobacco
Products, 9200 Corporate Blvd., Rockville, MD 20850-3229, 240-276-1717,
e-mail: Gail.Schmerfeld@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President signed the Tobacco Control Act
(Public Law 111-31) into law. The Tobacco Control Act grants FDA
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect public health generally and to reduce
tobacco use by minors. Section 204 of the Tobacco Control Act amended
section 3 of the Smokeless Tobacco Act (15 U.S.C. 4402) to prescribe
new requirements for health warning labels that must appear on
smokeless tobacco product packages and advertising, and to require that
rotational warning plans for packaging and advertising for smokeless
tobacco products be submitted to FDA, rather than to the Federal Trade
Commission (FTC).
The new warning labels required by section 3 of the Smokeless
Tobacco Act must begin to rotate in advertising for smokeless tobacco
products beginning on June 22, 2010, and must be distributed and
displayed on the packaging of smokeless tobacco products manufactured
on or after June 22, 2010, as set forth in section 3(b)(3) of the
Smokeless Tobacco Act (section 204(b) of the Tobacco Control Act and
section 3(b)(3) of the Smokeless Tobacco Act). In addition, on or after
July 22, 2010, manufacturers may not introduce any smokeless tobacco
product into
[[Page 32482]]
domestic commerce unless its packaging complies with section 3 of the
Smokeless Tobacco Act (Id.). Among the requirements in section 3(b)(3)
is that the rotation of label statements on packaging and advertising
for each brand of smokeless tobacco must be ``in accordance with a plan
submitted by the tobacco product manufacturer, importer, distributor,
or retailer'' to, and approved by, FDA (Id.).
At this time, as an exercise of enforcement discretion, FDA does
not intend to commence or recommend enforcement of the requirement that
a smokeless tobacco manufacturer, distributor, importer, or retailer
must have an FDA-approved rotational warning plan, so long as a
rotational warning plan has been submitted to FDA by July 22, 2010. FDA
believes that allowing additional time for the review of rotational
warning plans will permit an orderly transition of regulatory authority
from FTC to FDA to review and approve rotational warning plans. During
such transition between June 22, 2010, and July 22, 2010, affected
companies may wish to contact FDA to discuss the submission of their
rotational warning plans in order to make the subsequent approval
process more orderly and efficient. FDA intends to provide further
public notice prior to revising or rescinding this enforcement policy
after the transition from FTC to FDA has been accomplished for the
submission and review of rotational warning plans. This enforcement
policy pertains only to the requirement that smokeless tobacco
manufacturers, distributors, importers, or retailers must have an FDA-
approved rotational warning plan. FDA expects compliance with regard to
all other requirements of section 3 of the Smokeless Tobacco Act,
including the requirements relating to size, formatting, location, and
use of required warning statements.
II. Significance of Guidance
FDA is issuing this guidance document as a level 1 guidance
consistent with FDA's good guidance practices regulations (21 CFR
10.115). This guidance 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 statutory provisions that take effect
June 22, 2010. It is important that FDA explain its enforcement policy
concerning the submission and approval of rotational warning plans for
smokeless tobacco products before that date.
III. 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.
IV. Electronic Access
An electronic version of this guidance document is available on the
Internet at https://www.regulations.gov and https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13819 Filed 6-4-10; 4:15 pm]
BILLING CODE 4160-01-S