Tobacco Product Manufacturing Facility Visits, 48992-48993 [2012-19992]
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Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Always
access an FDA document using the FDA
Web site listed previously to find the
most current version of the guidance.
Dated: August 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20038 Filed 8–14–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSK4SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Endocrinologic
and Metabolic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
DATES: Date and Time: The meeting will
be held on October 17, 2012, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Paul Tran, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
EMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), to find out
further information regarding FDA
advisory committee information. A
notice in the Federal Register about last
minute modifications that impact a
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17:49 Aug 14, 2012
Jkt 226001
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site at
https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application (NDA) 203858,
lomitapide capsules, by Aegerion
Pharmaceuticals, Inc. The proposed
indication (use) is as an adjunct to a
low-fat diet and other lipid-lowering
drugs with or without low-density
lipoprotein (LDL) apheresis to reduce
LDL cholesterol, total cholesterol,
apolipoprotein B, and triglycerides in
patients with homozygous familial
hypercholesterolemia. (Apheresis is a
laboratory technology used to remove
LDL from the bloodstream.)
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 2, 2012.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
September 24, 2012. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
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notify interested persons regarding their
request to speak by September 25, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Paul Tran at
least 7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20013 Filed 8–14–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0853]
Tobacco Product Manufacturing
Facility Visits
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA), Center for
Tobacco Products (CTP) is announcing
an invitation for participation in its
Tobacco Product Manufacturing Facility
Visits. This program is intended to give
FDA staff an opportunity to visit
facilities involved in the manufacturing
of tobacco products, including any
related laboratory testing, and observe
the manufacturing operations of the
tobacco industry. The purpose of this
notice is to invite parties interested in
participating in Tobacco Product
Manufacturing Facility Visits to submit
requests to CTP.
DATES: Submit either an electronic or
written request for participation by
October 15, 2012. See section IV of this
document for information on requests
for participation.
ADDRESSES: If your facility is interested
in participating in Tobacco Product
SUMMARY:
E:\FR\FM\15AUN1.SGM
15AUN1
Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
Manufacturing Facility Visits, please
submit a request either electronically to
https://www.regulations.gov or in writing
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Lindsay Tobias, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 877–287–1373,
email: lindsay.tobias@fda.hhs.gov
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (Public Law 111–31; 123
Stat. 1776) was signed into law,
amending the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) and giving
FDA authority to regulate tobacco
product manufacturing, distribution,
and marketing. The new provisions
include, among other things, the
authority to issue regulations related to
tobacco product manufacturing practice
in order to protect the public health and
to assure that tobacco products are in
compliance with the FD&C Act.
Specifically, section 906(e) of the FD&C
Act (21 U.S.C. 387f(e)) provides that ‘‘in
applying manufacturing restrictions to
tobacco, the Secretary shall * * *
prescribe regulations (which may differ
based on the type of tobacco product
involved) requiring that the methods
used in, and the facilities and controls
used for, the manufacture,
preproduction design validation
(including a process to assess the
performance of a tobacco product),
packing, and storage of a tobacco
product conform to current good
manufacturing practice, or hazard
analysis and critical control point
methodology.’’
CTP is instituting Tobacco Product
Manufacturing Facility Visits to provide
FDA staff with the opportunity to:
• Observe tobacco product
manufacturing operations—from the
receipt of raw materials to the
distribution of finished products, and
• Learn about the manufacturing
practices and processes unique to your
facility and regulated tobacco products.
This program will also inform FDA
staff as they implement the tobacco
provisions of the FD&C Act.
II. Description of the Tobacco Product
Manufacturing Facility Visits
In this program, groups of FDA staff
plan to observe the following facilities
and their operations:
• Manufacturing facilities, including
facilities that process, package, label,
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17:49 Aug 14, 2012
Jkt 226001
and distribute different types of
regulated tobacco products (cigarettes,
cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco products),
• Laboratory facilities that perform
tobacco testing (whether third-party or
in-house),
• Manufacturing facilities for
components, parts, and accessories
(including, but not limited to, cigarette
paper, tipping paper, filters), and
• Manufacturing facilities for
materials used for further processing in
finished tobacco products (including,
but not limited to, flavors, casings).
Please note that Tobacco Product
Manufacturing Facility Visits are not
intended to include or replace official
FDA inspections of facilities to
determine compliance with the FD&C
Act; rather, these facility visits are
meant to educate FDA staff and improve
their understanding of the tobacco
industry and its manufacturing
operations.
III. Site Selection
CTP plans to select one or more of
each of the following:
• Cigarette manufacturers,
• Cigarette tobacco and roll-your-own
tobacco manufacturers,
• Smokeless tobacco manufacturers,
• Tobacco laboratories,
• Importers of finished tobacco
products,
• Distributors and wholesalers of
regulated tobacco products,
• Manufacturers of components,
parts, accessories, and
• Manufacturers of materials used for
further processing in finished tobacco
products.
Final site selections will be based on
the availability of CTP funds and
resources for the relevant fiscal year, as
well as the following factors, as
applicable: (1) Compliance status of the
requesting facility and affiliated firm; (2)
whether the requesting facility is in
arrears for user fees; and (3) whether the
requesting facility will be engaged in
active manufacturing or processing
during the proposed time of the visit.
All travel expenses associated with
Tobacco Product Manufacturer Facility
Visits will be the responsibility of CTP.
IV. Requests for Participation
The request for participation should
include the following identification
information:
• The name and contact information
(including address, phone number, and
email) of your point of contact for the
request,
• The physical address(es) of the
site(s) for which you are submitting a
request,
PO 00000
Frm 00046
Fmt 4703
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48993
• The type of processes (e.g.,
manufacturing, laboratory practices,
packaging, labeling, and distribution
activities) performed at your facility,
• The type of tobacco products tested,
processed, or manufactured at your
facility, and
• A proposed program agenda.
Requests are to be identified with the
docket number found in brackets in the
heading of this document. Requests
received by the Agency are available for
public examination in the Division of
Dockets Management (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: August 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–19992 Filed 8–14–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health/National
Institute of Environmental Health
Sciences
Proposed Collection; Comment
Request; The Sister Study: A
Prospective Study of the Genetic and
Environmental Risk Factors for Breast
Cancer
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Environmental
Health Sciences (NIEHS), the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: The Sister
Study: A Prospective Study of the
Genetic and Environmental Risk Factors
for Breast Cancer. Type of Information
Collection Request: Revision. Need and
Use of Information Collection: This is to
continue the Phase II follow-up of the
Sister Study—a study of genetic and
environmental risk factors for the
development of breast cancer in a highrisk cohort of sisters of women who
have had breast cancer. The etiology of
breast cancer is complex, with both
genetic and environmental factors likely
playing a role. Environmental risk
factors, however, have been difficult to
identify. By focusing on genetically
susceptible subgroups, more precise
estimates of the contribution of
environmental and other non-genetic
factors to disease risk may be possible.
SUMMARY:
E:\FR\FM\15AUN1.SGM
15AUN1
]]>Agencies
[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48992-48993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19992]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0853]
Tobacco Product Manufacturing Facility Visits
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco
Products (CTP) is announcing an invitation for participation in its
Tobacco Product Manufacturing Facility Visits. This program is intended
to give FDA staff an opportunity to visit facilities involved in the
manufacturing of tobacco products, including any related laboratory
testing, and observe the manufacturing operations of the tobacco
industry. The purpose of this notice is to invite parties interested in
participating in Tobacco Product Manufacturing Facility Visits to
submit requests to CTP.
DATES: Submit either an electronic or written request for participation
by October 15, 2012. See section IV of this document for information on
requests for participation.
ADDRESSES: If your facility is interested in participating in Tobacco
Product
[[Page 48993]]
Manufacturing Facility Visits, please submit a request either
electronically to https://www.regulations.gov or in writing to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lindsay Tobias, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 877-287-1373, email: lindsay.tobias@fda.hhs.gov
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Public Law 111-31; 123 Stat. 1776) was signed into law, amending
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA
authority to regulate tobacco product manufacturing, distribution, and
marketing. The new provisions include, among other things, the
authority to issue regulations related to tobacco product manufacturing
practice in order to protect the public health and to assure that
tobacco products are in compliance with the FD&C Act. Specifically,
section 906(e) of the FD&C Act (21 U.S.C. 387f(e)) provides that ``in
applying manufacturing restrictions to tobacco, the Secretary shall * *
* prescribe regulations (which may differ based on the type of tobacco
product involved) requiring that the methods used in, and the
facilities and controls used for, the manufacture, preproduction design
validation (including a process to assess the performance of a tobacco
product), packing, and storage of a tobacco product conform to current
good manufacturing practice, or hazard analysis and critical control
point methodology.''
CTP is instituting Tobacco Product Manufacturing Facility Visits to
provide FDA staff with the opportunity to:
Observe tobacco product manufacturing operations--from the
receipt of raw materials to the distribution of finished products, and
Learn about the manufacturing practices and processes
unique to your facility and regulated tobacco products.
This program will also inform FDA staff as they implement the
tobacco provisions of the FD&C Act.
II. Description of the Tobacco Product Manufacturing Facility Visits
In this program, groups of FDA staff plan to observe the following
facilities and their operations:
Manufacturing facilities, including facilities that
process, package, label, and distribute different types of regulated
tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco products),
Laboratory facilities that perform tobacco testing
(whether third-party or in-house),
Manufacturing facilities for components, parts, and
accessories (including, but not limited to, cigarette paper, tipping
paper, filters), and
Manufacturing facilities for materials used for further
processing in finished tobacco products (including, but not limited to,
flavors, casings).
Please note that Tobacco Product Manufacturing Facility Visits are
not intended to include or replace official FDA inspections of
facilities to determine compliance with the FD&C Act; rather, these
facility visits are meant to educate FDA staff and improve their
understanding of the tobacco industry and its manufacturing operations.
III. Site Selection
CTP plans to select one or more of each of the following:
Cigarette manufacturers,
Cigarette tobacco and roll-your-own tobacco manufacturers,
Smokeless tobacco manufacturers,
Tobacco laboratories,
Importers of finished tobacco products,
Distributors and wholesalers of regulated tobacco
products,
Manufacturers of components, parts, accessories, and
Manufacturers of materials used for further processing in
finished tobacco products.
Final site selections will be based on the availability of CTP
funds and resources for the relevant fiscal year, as well as the
following factors, as applicable: (1) Compliance status of the
requesting facility and affiliated firm; (2) whether the requesting
facility is in arrears for user fees; and (3) whether the requesting
facility will be engaged in active manufacturing or processing during
the proposed time of the visit. All travel expenses associated with
Tobacco Product Manufacturer Facility Visits will be the responsibility
of CTP.
IV. Requests for Participation
The request for participation should include the following
identification information:
The name and contact information (including address, phone
number, and email) of your point of contact for the request,
The physical address(es) of the site(s) for which you are
submitting a request,
The type of processes (e.g., manufacturing, laboratory
practices, packaging, labeling, and distribution activities) performed
at your facility,
The type of tobacco products tested, processed, or
manufactured at your facility, and
A proposed program agenda.
Requests are to be identified with the docket number found in
brackets in the heading of this document. Requests received by the
Agency are available for public examination in the Division of Dockets
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: August 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19992 Filed 8-14-12; 8:45 am]
BILLING CODE 4160-01-P
