Outsourcing Facility Fee Rates for Fiscal Year 2015; Correction, 51184 [2014-20331]
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51184
Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Notices
scientific information submitted by the
applicant as well as the scientific
evidence and other information that is
made available to the Agency, including
through public comments.
Section 911(g) of the FD&C Act
describes the demonstrations applicants
must make to obtain an order from FDA
under either section 911(g)(1) or (g)(2).
The applicant, Swedish Match North
America Inc., is seeking an order under
section 911(g)(1) for each of the 10
products that are the subject of the
submitted MRTPAs.
An order under section 911(g)(1) of
the FD&C Act is for a modified risk
tobacco product that significantly
reduces harm and the risk of tobaccorelated disease to individual tobacco
users; and benefits the health of the
population as a whole. A person seeking
an order under section 911(g)(1) of the
FD&C Act must show that the tobacco
product, as it is actually used by
consumers, will significantly reduce
harm and the risk of tobacco-related
disease to individual tobacco users and
will benefit the health of the population
as a whole taking into account both
users of tobacco products and persons
who do not currently use tobacco
products. Section 911(g)(4) of the FD&C
Act describes factors that FDA must take
into account in evaluating whether a
tobacco product benefits the health of
individuals and the population as a
whole.
FDA is issuing this notice to inform
the public that MRTPAs submitted by
Swedish Match North America Inc. for
the following products (identified by
FDA Submission Tracking Numbers
(STN) (MR0000020—MR0000029)) have
been filed and are being made available
for public comment for 180 days:
• MR0000020: General Loose,
smokeless tobacco, loose snus, 1.59 oz
(45g), cardboard can (SKU 4852);
• MR0000021: General Dry Mint
Portion Original Mini, smokeless
tobacco, snus portions, 0.21 oz (6g),
20—0.3g portions, plastic can (SKU
4800);
• MR0000022: General Portion
Original Large, smokeless tobacco, snus
portions, 0.9 oz (24g), 24—1g portions,
plastic can (SKU 4880);
• MR0000023: General Classic Blend
Portion White Large, smokeless tobacco,
snus portions, 0.48 oz (13.5g), 15—0.9g
portions, plastic can (SKU 4877);
• MR0000024: General Classic Blend
Portion White Large, smokeless tobacco,
snus portions, 0.38 oz (10.8g), 12—0.9g
portions, plastic can (SKU 4878);
• MR0000025: General Mint Portion
White Large, smokeless tobacco, snus
portions, 0.9 oz (24g), 24—1g portions,
plastic can (SKU 4352);
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• MR0000026: General Nordic Mint
Portion White Large, smokeless tobacco,
snus portions, 0.48 oz (13.5g), 15—0.9g
portions, plastic can (SKU 4876);
• MR0000027: General Nordic Mint
Portion White Large, smokeless tobacco,
snus portions, 0.38 oz (10.8g), 12—0.9g
portions, plastic can (SKU 4875);
• MR0000028: General Portion White
Large, smokeless tobacco, snus portions,
0.9 oz (24g), 24—1g portions, plastic can
(SKU 4881); and
• MR0000029: General Wintergreen
Portion White Large, smokeless tobacco,
snus portions, 0.9 oz (24g), 24—1g
portions, plastic can (SKU 4882).
FDA believes a 180-day comment
period is appropriate because of the
volume and complexity of the material
being posted in the applications. If you
submit comments that apply to some
but not all 10 of the products, FDA asks
that you identify the applicable
product(s) using the STNs listed in this
document in your comments. To
encourage public participation
consistent with section 911(e) of the
FD&C Act, FDA is placing the MRTPAs
(except for matters in the applications
that are trade secrets or otherwise
confidential commercial information)
that are the subject of this notice on
public display at the Division of Dockets
Management (see DATES and ADDRESSES)
and making them available
electronically (see section III).
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.accessdata.fda.gov/Static/
widgets/tobacco/SMNA_MRTPA_FDA2014-N-1051.html or https://
www.regulations.gov.
Dated: August 22, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–20394 Filed 8–26–14; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0007]
Outsourcing Facility Fee Rates for
Fiscal Year 2015; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Outsourcing Facility Fee Rates
for Fiscal Year 2015’’ that appeared in
the Federal Register of August 1, 2014
(79 FR 44805). The document
announced the rates for fiscal year 2015
for the establishment and reinspection
fees related to human drug
compounding outsourcing facilities that
elect to register under the Federal Food,
Drug, and Cosmetic Act. The document
was published with the incorrect docket
number. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy, Food and
Administration, 10990 New Hampshire
Ave., Bldg. 32, Rm. 3330, Silver Spring,
MD 20993–0002, 301–796–9115.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Friday, August 1,
2014, in FR Doc. 2014–18111, the
following correction is made:
1. On page 44805, in the first column,
in the Docket No. heading, ‘‘[Docket No.
FDA–2013–N–0007]’’ is corrected to
read ‘‘[Docket No. FDA–2014–N–0007]’’.
SUMMARY:
Dated: August 21, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–20331 Filed 8–26–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Small Health Care Provider Quality
Improvement Program
Health Resources and Services
Administration, HHS.
ACTION: Notice of Class Deviation From
Competition Requirements for Small
Health Care Provider Quality
Improvement.
AGENCY:
The Office of Rural Health
Policy (ORHP) will award program
expansion supplemental awards to the
current Small Health Care Provider
SUMMARY:
E:\FR\FM\27AUN1.SGM
27AUN1
]]>Agencies
[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Page 51184]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20331]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0007]
Outsourcing Facility Fee Rates for Fiscal Year 2015; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Outsourcing Facility Fee Rates for Fiscal Year 2015'' that
appeared in the Federal Register of August 1, 2014 (79 FR 44805). The
document announced the rates for fiscal year 2015 for the establishment
and reinspection fees related to human drug compounding outsourcing
facilities that elect to register under the Federal Food, Drug, and
Cosmetic Act. The document was published with the incorrect docket
number. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Food
and Administration, 10990 New Hampshire Ave., Bldg. 32, Rm. 3330,
Silver Spring, MD 20993-0002, 301-796-9115.
SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, August 1,
2014, in FR Doc. 2014-18111, the following correction is made:
1. On page 44805, in the first column, in the Docket No. heading,
``[Docket No. FDA-2013-N-0007]'' is corrected to read ``[Docket No.
FDA-2014-N-0007]''.
Dated: August 21, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20331 Filed 8-26-14; 8:45 am]
BILLING CODE 4164-01-P
