[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]


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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.

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    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 http://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 http://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 http://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