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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14816 Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices 

Room 759, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, 301–594–2242, 

jerkinsa@niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Collaborative 

Interdisciplinary Team Science R24–6. 

Date: April 11, 2012. 

Time: 2 p.m. to 4 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: Lakshmanan Sankaran, 

Ph.D., Scientific Review Officer, Review 

Branch, DEA, NIDDK, National Institutes Of 

Health, Room 755, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 

594–7799, ls38z@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: March 7, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–6019 Filed 3–12–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious 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 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Application (P01). 

Date: March 20, 2012. 

Time: 11 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge 6700, 6700B Rockledge Drive, 

Bethesda, MD 20817, (Telephone Conference 

Call). 

Contact Person: Jane K. Battles, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, Room 3128, Bethesda, MD 

20892–7616, 301–451–2744, 

battlesja@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Applications (PO1). 

Date: April 3, 2012. 

Time: 11 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817, 

(Telephone Conference Call). 

Contact Person: Brenda Lange-Gustafson, 

Ph.D., Scientific Review Officer, NIAID/NIH/ 

DHHS, Scientific Review Program, Room 

3122, 6700–B Rockledge Drive, MSC–7616, 

Bethesda, MD 20892–7616, 301–451–3684, 

bgustafson@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; ‘‘NIH Support for 

Conferences and Scientific Meetings (Parent 

R13/U13)’’ 

Date: April 9–11, 2012. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817, 

(Virtual Meeting). 

Contact Person: Jay R. Radke, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, Room 

2217, 6700B Rockledge Drive MDS–7616, 

Bethesda, MD 20892–7616, 301–496–2550, 

jay.radke@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: March 7, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–6020 Filed 3–12–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

NATIONAL INSTITUTES OF HEALTH 

National Eye Institute 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 Eye Institute 

Special Emphasis Panel; Vision Research 

Grant Applications. 

Date: April 2, 2012. 

Time: 8:30 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Daniel R. Kenshalo, Ph.D., 

Scientific Review Officer, Division of 

Extramural Research, National Eye Institute, 

National Institutes of Health, 5635 Fishers 

Lane, Suite 1300, MSC 9300, 301–451–2020, 

kenshalod@nei.nih.gov. 

Name of Committee: National Eye Institute 

Special Emphasis Panel; Posterior Eye 

Disease, Epidemiology and Genetics. 

Date: April 17, 2012. 

Time: 3 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Eye Institute, National 

Institutes of Health, 5635 Fishers Lane 

(Telephone Conference Call). 

Contact Person: Anne E. Schaffner, Ph.D., 

Chief, Scientific Review Officer, Division of 

Extramural Research, National Eye Institute, 

National Institutes of Health, 5635 Fishers 

Lane, Suite 1300, MSC 9300, 301–451–2020, 

aes@nei.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: March 7, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–6018 Filed 3–12–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the Board 

of Scientific Counselors, National 

Institute of Dental and Craniofacial 

Research. 

The meeting will be closed to the 

public as indicated below in accordance 

mstockstill on DSK4VPTVN1PROD with NOTICES