14814 Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices 

Survey/WEB22EJ4HRZLW9. (FDA has 

verified the Web site address, but we are 

not responsible for any subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) 

Seats are limited and conference 

space will be filled in the order in 

which registrations are received. Onsite 

registration will be available to the 

extent that space is available on the day 

of the conference. 

Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://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 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. 

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 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 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 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices 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 longterm 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 

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 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Ann A. Jerkins, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes Of Health, 

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