43770 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 

Dated: September 14, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19928 Filed 9–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–3998] 

Flavor Developer and Manufacturer 

Site Tours Program 

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 

voluntary Flavor Developer and 

Manufacturer Site Tours Program. This 

program is intended to give CTP staff an 

opportunity to visit companies that 

develop and/or manufacture flavors 

(including flavor mixtures) that are sold 

to tobacco product manufacturers in 

order to gain a better understanding of 

the development, testing, and 

production of flavors and flavor 

mixtures used in the manufacturing of 

tobacco products. The site tours in this 

program are not intended as regulatory 

inspections. The purpose of this notice 

is to invite parties interested in 

participating in the Flavor Developer 

and Manufacturer Site Tours Program to 

submit requests to CTP. 

DATES: Submit either an electronic or 

written request for participation in this 

program by November 20, 2017. See 

section IV of this document for 

information on requests for 

participation. 

ADDRESSES: If your company is 

interested in offering a site visit, please 

submit a request either electronically to 

https://www.regulations.gov or in 

writing to the Dockets Management Staff 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Karla Price, Office of Science, Center for 

Tobacco Products, Food and Drug 

Administration, Document Control 

Center, 10903 New Hampshire Ave., 

Bldg. 71, Rm. G335, Silver Spring, MD 

20993–0002, 1–877–287–1373, email: 

AskCTP@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act) was enacted on June 22, 2009, 

amending the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) by, among 

other things, adding a new chapter 

(chapter IX) granting FDA the authority 

to regulate tobacco product 

manufacturing, distribution, and 

marketing (Pub. L. 111–31). The 

Tobacco Control Act provides FDA 

authority to regulate cigarettes, cigarette 

tobacco, roll-your-own tobacco, 

smokeless tobacco, and any other 

tobacco products that the Agency by 

regulation deems to be subject to the 

law. On May 10, 2016, FDA published 

a final rule entitled ‘‘Deeming Tobacco 

Products to be Subject to the Federal 

Food, Drug, and Cosmetic Act, as 

Amended by the Family Smoking 

Prevention and Tobacco Control Act; 

Restrictions on the Sale and Distribution 

of Tobacco Products and Required 

Warning Statements for Tobacco 

Products’’ (81 FR 28974), which became 

effective on August 8, 2016. Under this 

rule, all products that meet the statutory 

definition of ‘‘tobacco product’’ set forth 

in section 201(rr) of the FD&C Act (21 

U.S.C. 321(rr)), including components 

and parts, but excluding accessories of 

newly deemed products, are now 

subject to chapter IX of the FD&C Act. 

CTP’s Office of Science is conducting 

the Flavor Developer and Manufacturer 

Site Tours Program to provide its staff 

an opportunity to visit companies that 

develop and/or manufacture flavors 

(including flavor mixtures) that are sold 

to tobacco product manufacturers. 

Flavor developers and manufacturers 

are regulated by FDA if they, among 

other things, manufacture products that 

meet the statutory definition of a 

‘‘tobacco product’’ set forth in section 

201(rr) of the FD&C Act. The site tours 

will aid the Agency in gaining a better 

understanding of the development, 

testing, and production of flavors and 

flavor mixtures used in the 

manufacturing of tobacco products. The 

goal for the Flavor Developer and 

Manufacturer Site Tours Program is for 

CTP staff to gain firsthand exposure to 

how flavors are developed, tested, and 

produced. 

II. Description of Flavor Developer and 

Manufacturer Site Tours Program 

In the Flavor Developer and 

Manufacturer Site Tours Program, small 

groups of CTP staff will observe the 

operations of flavor developers and 

manufacturers, including the 

development, testing, and production of 

flavors that can be used by tobacco 

product manufacturers. The site tours in 

this program are not intended as 

regulatory inspections; rather, the 

program is meant to educate CTP staff 

and improve their understanding of 

flavors used in the manufacturing of 

tobacco products. It is anticipated that 

the site tours will take place in 2018. 

III. Site Selection 

CTP hopes to be able to tour small, 

medium, and large flavor developers 

and manufacturers, as well as 

companies that develop and/or 

manufacture flavors that are used for 

different categories of tobacco products 

(e.g., cigarettes, cigars, smokeless 

tobacco, waterpipe tobacco, e-liquids). 

Final site selections will be based on the 

availability of funds and resources for 

the relevant fiscal year as well as the 

desire to visit a wide variety of flavor 

developers and manufacturers. All FDA 

travel expenses associated with the 

Flavor Developer and Manufacturer site 

tours will be the responsibility of FDA. 

IV. Requests for Participation 

To aid in site selection, your request 

for participation should include the 

following information: 

• A description of your company, 

including the size of the organization; 

• A list of the flavors your company 

develops and/or manufactures and the 

categories of tobacco product (e.g., 

cigarettes, cigars, smokeless tobacco, 

waterpipe tobacco, e-liquids) for which 

your flavors are typically used; 

• The physical address(es) of the 

site(s) for which you are submitting a 

request; and 

• A proposed 1-day tour agenda. 

Identify requests for participation 

with the docket number found in 

brackets in the heading of this 

document. Received requests are 

available for public examination in the 

Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: September 14, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19900 Filed 9–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 43771 

amended, notice is hereby given of a 

meeting of the Clinical Trials Review 

Committee. 

The meeting 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: Heart, Lung, and 

Blood Initial Review Group; Clinical Trials 

Review Committee. 

Date: October 26, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Garden Inn Bethesda, 7301 

Waverly Street, Bethesda, MD 20814. 

Contact Person: Keary A Cope, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7190, Bethesda, MD 20892–7924, 301–827– 

7912, copeka@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: September 13, 2017. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–19858 Filed 9–18–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Mental Health 

Services Research Committee, October 

30, 2018, 8:00 a.m. to October 30, 2018, 

5:00 p.m., Hotel Palomar, 2121 P Street 

NW., Washington, DC, 20036 which was 

published in the Federal Register on 

September 1, 2017, 82FR41631. 

This meeting is being amended to 

correct the meeting date from October 

30, 2018 to October 30, 2017. The 

meeting is closed to the public. 

Dated: September 13, 2017. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–19862 Filed 9–18–17; 8:45 am] 

BILLING CODE 4140–01–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, 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; NIDDK KUH 

Fellowship Review. 

Date: October 6, 2017. 

Time: 8:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Xiaodu Guo, MD, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7023, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–4719, 

guox@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Clinical Small 

Business Applications. 

Date: October 13, 2017. 

Time: 3:00 p.m. to 4:00 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: Ryan G. Morris, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National institutes of Health, 

ROOM 7015, 6707 Democracy Boulevard, 

Bethesda, MD 20892–2542, 301–594–4721, 

ryan.morris@nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK Pilot and 

Feasibility Clinical Trial (R21). 

Date: October 26, 2017. 

Time: 1:00 p.m. to 2:00 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: Jason D. Hoffert, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7343, 6707 Democracy Boulevard, 

Bethesda, MD 20892–2542, 301–496–9010, 

hoffertj@niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; D2D Renewal. 

Date: October 30, 2017. 

Time: 3:00 p.m. to 5:00 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: MIchele L. Barnard, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7353, 6707 Democracy Boulevard, 

Bethesda, MD 20892–2542, (301) 594–8898, 

barnardm@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK Research 

Project Grants. 

Date: October 31, 2017. 

Time: 3:00 p.m. to 4:30 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: Elena Sanovich, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

ROOM 7351, 6707 Democracy Boulevard, 

Bethesda, MD 20892–2542, 301–594–8886, 

sanoviche@mail.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: September 13, 2017. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–19860 Filed 9–18–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center For Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 


asabaliauskas on DSKBBXCHB2PROD with NOTICES