Tobacco Product Analysis; Scientific Workshop; Request for Comments, 14814-14815 [2012-6037]
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Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices
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to the White Oak Campus must enter
through Bldg. 1.
Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–6038 Filed 3–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0212]
Tobacco Product Analysis; Scientific
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
The Food and Drug Administration
(FDA), Center for Tobacco Products is
announcing a scientific workshop to
solicit feedback on analysis of tobacco
products. The analyses of tobacco
products often involve tobacco reference
products, which are used primarily as
controls to ensure that the results of the
analyses are reliable and accurate. This
scientific workshop will focus on
understanding how tobacco reference
products are used and the testing
methods used to analyze tobacco
products. FDA will invite speakers to
address scientific and technical matters
relating to the testing of tobacco
reference products and the analytical
methods used to measure constituent
levels in tobacco products and smoke.
FDA is also opening a public docket to
receive comments on these topics.
DATES: Dates and Time: The public
workshop will be held on April 11,
2012, from 8:30 a.m. to 5:30 p.m., and
on April 12, 2012, from 8:30 a.m. to 4
VerDate Mar<15>2010
18:29 Mar 12, 2012
Jkt 226001
p.m. Individuals who wish to attend the
public workshop must register by close
of business on March 30, 2012. Submit
either electronic or written comments to
the docket by May 11, 2012.
Location: The public workshop will
be held at 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373.
Contact Person: Anuja Patel, Center
for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD, 20850, 1–877–287–1373,
FAX: 240–276–3761, email:
workshop.CTPOS@fda.hhs.gov.
Registration to Attend the Workshop
and Requests for Oral Presentations: If
you wish to attend the workshop or
make an oral presentation at the
workshop, please email your
registration to
workshop.CTPOS@fda.hhs.gov by close
of business on March 30, 2012. Those
without email access may register by
contacting Anuja Patel (see Contact
Person). Please provide contact
information for each attendee, including
name, title, affiliation, address, email
address, and telephone number.
Registration is free and will be on a firstcome, first-served basis. Early
registration is recommended because
seating is limited. FDA may limit the
number of participants from each
organization as well as the total number
of participants based on space
limitations. Registrants will receive
confirmation once they have been
accepted for the workshop. Onsite
registration on the day of the workshop
will be based on space availability. If
registration reaches maximum capacity,
FDA will post a notice closing
registration for the workshop at https://
www.fda.gov/TobaccoProducts/
NewsEvents/ucm238308.htm.
There will be opportunities for
audience participation at this workshop.
FDA has included topics for comment
in section II of this document. FDA will
do its best to accommodate requests to
speak during the workshop sessions,
although questions from the audience
may be limited. In addition, we strongly
encourage submitting comments to the
docket (see Comments).
If you need special accommodations
because of disability, please contact
Anuja Patel (see Contact Person) at least
7 days before the workshop.
Comments: Regardless of attendance
at the public workshop, interested
persons may submit either electronic or
written comments on any of the topics
for discussion in section II of this
document by May 11, 2012. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. 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.
SUPPLEMENTARY INFORMATION:
I. Background and Workshop Topics
The purpose of this scientific
workshop is to obtain information and
comments from appropriate scientific
experts on analysis of tobacco products.
Such experts could include, but are not
limited to, scientists from academia,
tobacco product manufacturers, and
contract testing laboratories. The
workshop will include scientific experts
who will present scientific and
technical information on testing of
tobacco reference products for different
types of tobacco products. The types of
tobacco reference products to be
discussed include, but are not limited
to, smoked tobacco products, smokeless
tobacco products, and other tobacco
products not classified as either smoked
or smokeless products. FDA would like
to discuss how the tobacco reference
products are used for testing purposes to
ensure accuracy of analysis of tobacco
products. Tobacco reference products
are analyzed alongside test tobacco
products (i.e., during every step of the
analysis). Tobacco reference products
are intended for use during analysis of
tobacco products and are not intended
for human consumption. Tobacco
reference products are finished tobacco
products and are distinct from internal
reference standards, which are
chemicals or mixtures of chemicals.
Internal reference standards are used
during only certain steps of the analysis
of test tobacco products (e.g., when
running samples).
The scientific workshop will include
discussion of analytical methods for
measuring certain constituents in
tobacco products and smoke. The
aspects of analytical methods that will
be discussed include extraction,
separation, and detection methods. For
example, FDA would like to get input
from scientific experts on how tobaccospecific nitrosamines (TSNAs) are
extracted from smokeless tobacco
products and cigarette smoke particulate
matter and what instrumentation (e.g.,
gas chromatography-mass spectrometry)
is used to measure the levels of TSNAs.
FDA is interested in receiving
substantive scientific input at the
workshop and in the docket. The input
from the scientific workshop may assist
us in developing future scientific
E:\FR\FM\13MRN1.SGM
13MRN1
Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices
workshops regarding analysis of tobacco
products.
II. Workshop Topics for Discussion
FDA will explore all or some of the
following topics during this scientific
workshop:
1. Availability, Manufacture, and
Characterization of Tobacco Reference
Products
A. Discuss the current availability of
tobacco reference products for different
types of tobacco products and what new
products would be beneficial.
B. Discuss the types and blends of
tobacco used in reference products.
What additional blends or other product
characteristics should be most
applicable for all products, both those
currently and those expected to be
introduced on the market?
C. Describe the storage conditions for
tobacco reference products to ensure
shelf life. Please provide data that
shows product changes under different
storage conditions. What storage
conditions are most critical in
maintaining product integrity? What
precautions should be taken to ensure
product integrity?
D. Discuss the stability of the tobacco
reference products and methods used to
verify product stability. What
precautions are taken to maximize
product stability? What product
characteristics are most stable and
which are least stable?
E. Describe any ongoing work to
develop tobacco reference products that
are not currently available for laboratory
use. Discuss considerations made when
determining the need and developing a
new tobacco reference product.
mstockstill on DSK4VPTVN1PROD with NOTICES
2. Uses of Reference Products During
Analysis of Tobacco Products
A. Discuss the physical and chemical
measurements performed on tobacco
reference products during analysis of
tobacco products. Please provide data.
How are reference products used in
research and manufacturing?
B. Discuss the advantages and
disadvantages of using one or multiple
tobacco reference products when
performing analysis of a given tobacco
product type.
C. Discuss the procedures used when
transitioning from using one tobacco
reference product to using another
tobacco reference product for the same
tobacco product type to ensure longterm consistency in findings.
D. Discuss the policies, procedures,
and frequency related to discarding data
for reference products due to
unacceptable analytical results.
VerDate Mar<15>2010
18:29 Mar 12, 2012
Jkt 226001
E. Discuss the policies and procedures
used in research and manufacturing
when no tobacco reference product is
available for a specific type of tobacco
product. Is there a policy of using a
similar product when the specific
reference product is not available? What
considerations are applied?
F. Describe characteristics of a
tobacco reference product that would
provide advantages or disadvantages
over another.
3. Variability Observed in
Measurements of Tobacco Reference
Products
A. Provide data that address the
variability that exists in the chemical
measures of a reference product
analyzed within the same laboratory.
Describe how measures compare
between different laboratories.
B. Provide data that address the
variability that exists in the physical
measures of a reference product
analyzed within the same laboratory.
Describe how measures compare
between different laboratories.
C. Describe any other factors that
affect the variability of a tobacco
reference product when analyzed using
analytical measurements.
D. Discuss the procedures or methods
that have been used or may be used to
reduce the tobacco reference product
variability.
4. Methods Suitable for Measuring the
Following in Smoked and Smokeless
Tobacco Products: pH, Tobacco-Specific
Nitrosamines, Polycyclic Aromatic
Hydrocarbons, Carbon Monoxide, and
Metals
A. Discuss the sample preparation or
extraction methods for measuring the
analytes.
B. Discuss the analytical
methodologies (gas chromatography,
thermal energy analyzer, liquid
chromatography, mass spectrometry,
etc.) used for quantifying analytes.
C. Discuss the statistical or other
mathematical procedures for
quantification.
D. Discuss the availability and use of
internal reference standards to quantify
the analytes.
E. Discuss the approaches and testing
methods which are intended to combine
measuring of multiple analytes within
the same class of constituents into a
single analysis. Particularly discuss the
benefits in reference to sample
throughput and the loss in terms of
sensitivity, selectivity, or other
analytical terms of reference.
F. Discuss the approaches and testing
methods which are intended to measure
analytes across different classes of
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
14815
constituents. Particularly discuss the
benefits in reference to sample
throughput and the loss in terms of
sensitivity, selectivity, or other
analytical terms of reference.
III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see Comments). A transcript will also
be available in either hard copy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–6037 Filed 3–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases 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: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; PAR11–350
Research Using Biosamples from Selected
Type 1 Diabetes Clinical Studies (DP3).
Date: April 2, 2012.
Time: 2:30 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
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Place: National Institutes of Health, Two
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Conference Call).
Contact Person: Ann A. Jerkins, Ph.D.,
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DEA, NIDDK, National Institutes Of Health,
E:\FR\FM\13MRN1.SGM
13MRN1
]]>Agencies
[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14814-14815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6037]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0212]
Tobacco Product Analysis; Scientific Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA), Center for Tobacco Products
is announcing a scientific workshop to solicit feedback on analysis of
tobacco products. The analyses of tobacco products often involve
tobacco reference products, which are used primarily as controls to
ensure that the results of the analyses are reliable and accurate. This
scientific workshop will focus on understanding how tobacco reference
products are used and the testing methods used to analyze tobacco
products. FDA will invite speakers to address scientific and technical
matters relating to the testing of tobacco reference products and the
analytical methods used to measure constituent levels in tobacco
products and smoke. FDA is also opening a public docket to receive
comments on these topics.
DATES: Dates and Time: The public workshop will be held on April 11,
2012, from 8:30 a.m. to 5:30 p.m., and on April 12, 2012, from 8:30
a.m. to 4 p.m. Individuals who wish to attend the public workshop must
register by close of business on March 30, 2012. Submit either
electronic or written comments to the docket by May 11, 2012.
Location: The public workshop will be held at 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-287-1373.
Contact Person: Anuja Patel, Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate Blvd., Rockville, MD, 20850, 1-877-
287-1373, FAX: 240-276-3761, email: workshop.CTPOS@fda.hhs.gov.
Registration to Attend the Workshop and Requests for Oral
Presentations: If you wish to attend the workshop or make an oral
presentation at the workshop, please email your registration to
workshop.CTPOS@fda.hhs.gov by close of business on March 30, 2012.
Those without email access may register by contacting Anuja Patel (see
Contact Person). Please provide contact information for each attendee,
including name, title, affiliation, address, email address, and
telephone number. Registration is free and will be on a first-come,
first-served basis. Early registration is recommended because seating
is limited. FDA may limit the number of participants from each
organization as well as the total number of participants based on space
limitations. Registrants will receive confirmation once they have been
accepted for the workshop. Onsite registration on the day of the
workshop will be based on space availability. If registration reaches
maximum capacity, FDA will post a notice closing registration for the
workshop at https://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm.
There will be opportunities for audience participation at this
workshop. FDA has included topics for comment in section II of this
document. FDA will do its best to accommodate requests to speak during
the workshop sessions, although questions from the audience may be
limited. In addition, we strongly encourage submitting comments to the
docket (see Comments).
If you need special accommodations because of disability, please
contact Anuja Patel (see Contact Person) at least 7 days before the
workshop.
Comments: Regardless of attendance at the public workshop,
interested persons may submit either electronic or written comments on
any of the topics for discussion in section II of this document by May
11, 2012. 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. 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.
SUPPLEMENTARY INFORMATION:
I. Background and Workshop Topics
The purpose of this scientific workshop is to obtain information
and comments from appropriate scientific experts on analysis of tobacco
products. Such experts could include, but are not limited to,
scientists from academia, tobacco product manufacturers, and contract
testing laboratories. The workshop will include scientific experts who
will present scientific and technical information on testing of tobacco
reference products for different types of tobacco products. The types
of tobacco reference products to be discussed include, but are not
limited to, smoked tobacco products, smokeless tobacco products, and
other tobacco products not classified as either smoked or smokeless
products. FDA would like to discuss how the tobacco reference products
are used for testing purposes to ensure accuracy of analysis of tobacco
products. Tobacco reference products are analyzed alongside test
tobacco products (i.e., during every step of the analysis). Tobacco
reference products are intended for use during analysis of tobacco
products and are not intended for human consumption. Tobacco reference
products are finished tobacco products and are distinct from internal
reference standards, which are chemicals or mixtures of chemicals.
Internal reference standards are used during only certain steps of the
analysis of test tobacco products (e.g., when running samples).
The scientific workshop will include discussion of analytical
methods for measuring certain constituents in tobacco products and
smoke. The aspects of analytical methods that will be discussed include
extraction, separation, and detection methods. For example, FDA would
like to get input from scientific experts on how tobacco-specific
nitrosamines (TSNAs) are extracted from smokeless tobacco products and
cigarette smoke particulate matter and what instrumentation (e.g., gas
chromatography-mass spectrometry) is used to measure the levels of
TSNAs.
FDA is interested in receiving substantive scientific input at the
workshop and in the docket. The input from the scientific workshop may
assist us in developing future scientific
[[Page 14815]]
workshops regarding analysis of tobacco products.
II. Workshop Topics for Discussion
FDA will explore all or some of the following topics during this
scientific workshop:
1. Availability, Manufacture, and Characterization of Tobacco Reference
Products
A. Discuss the current availability of tobacco reference products
for different types of tobacco products and what new products would be
beneficial.
B. Discuss the types and blends of tobacco used in reference
products. What additional blends or other product characteristics
should be most applicable for all products, both those currently and
those expected to be introduced on the market?
C. Describe the storage conditions for tobacco reference products
to ensure shelf life. Please provide data that shows product changes
under different storage conditions. What storage conditions are most
critical in maintaining product integrity? What precautions should be
taken to ensure product integrity?
D. Discuss the stability of the tobacco reference products and
methods used to verify product stability. What precautions are taken to
maximize product stability? What product characteristics are most
stable and which are least stable?
E. Describe any ongoing work to develop tobacco reference products
that are not currently available for laboratory use. Discuss
considerations made when determining the need and developing a new
tobacco reference product.
2. Uses of Reference Products During Analysis of Tobacco Products
A. Discuss the physical and chemical measurements performed on
tobacco reference products during analysis of tobacco products. Please
provide data. How are reference products used in research and
manufacturing?
B. Discuss the advantages and disadvantages of using one or
multiple tobacco reference products when performing analysis of a given
tobacco product type.
C. Discuss the procedures used when transitioning from using one
tobacco reference product to using another tobacco reference product
for the same tobacco product type to ensure long-term consistency in
findings.
D. Discuss the policies, procedures, and frequency related to
discarding data for reference products due to unacceptable analytical
results.
E. Discuss the policies and procedures used in research and
manufacturing when no tobacco reference product is available for a
specific type of tobacco product. Is there a policy of using a similar
product when the specific reference product is not available? What
considerations are applied?
F. Describe characteristics of a tobacco reference product that
would provide advantages or disadvantages over another.
3. Variability Observed in Measurements of Tobacco Reference Products
A. Provide data that address the variability that exists in the
chemical measures of a reference product analyzed within the same
laboratory. Describe how measures compare between different
laboratories.
B. Provide data that address the variability that exists in the
physical measures of a reference product analyzed within the same
laboratory. Describe how measures compare between different
laboratories.
C. Describe any other factors that affect the variability of a
tobacco reference product when analyzed using analytical measurements.
D. Discuss the procedures or methods that have been used or may be
used to reduce the tobacco reference product variability.
4. Methods Suitable for Measuring the Following in Smoked and Smokeless
Tobacco Products: pH, Tobacco-Specific Nitrosamines, Polycyclic
Aromatic Hydrocarbons, Carbon Monoxide, and Metals
A. Discuss the sample preparation or extraction methods for
measuring the analytes.
B. Discuss the analytical methodologies (gas chromatography,
thermal energy analyzer, liquid chromatography, mass spectrometry,
etc.) used for quantifying analytes.
C. Discuss the statistical or other mathematical procedures for
quantification.
D. Discuss the availability and use of internal reference standards
to quantify the analytes.
E. Discuss the approaches and testing methods which are intended to
combine measuring of multiple analytes within the same class of
constituents into a single analysis. Particularly discuss the benefits
in reference to sample throughput and the loss in terms of sensitivity,
selectivity, or other analytical terms of reference.
F. Discuss the approaches and testing methods which are intended to
measure analytes across different classes of constituents. Particularly
discuss the benefits in reference to sample throughput and the loss in
terms of sensitivity, selectivity, or other analytical terms of
reference.
III. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see Comments). A transcript will
also be available in either hard copy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6037 Filed 3-12-12; 8:45 am]
BILLING CODE 4160-01-P
