Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 29125 

forthcoming public advisory committee 

meeting of the Tobacco Products 

Scientific Advisory Committee. The 

general function of the committee is to 

provide advice and recommendations to 

the Agency on FDA’s regulatory issues. 

The meeting will be open to the public. 

DATES: The meeting will be held on 

September 13, 2018, from 8:30 a.m. to 

5 p.m. and on September 14, 2018, from 

8 a.m. to 3 p.m. 

ADDRESSES: FDA White Oak Conference 

Center, 10903 New Hampshire Ave., 

Bldg. 31 Conference Center, the Great 

Room (Rm. 1503), Silver Spring, MD 

20993–0002. Answers to commonly 

asked questions including information 

regarding special accommodations due 

to a disability, visitor parking, and 

transportation may be accessed at: 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Caryn Cohen, 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: 

TPSAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: On September 13 and 14, 

2018, the Committee will discuss 

modified risk tobacco product 

applications, submitted by R.J. Reynolds 

Tobacco Company for six products: 

• MR0000068: Camel Snus Frost 

• MR0000069: Camel Snus Frost Large 

• MR0000070: Camel Snus Mellow 

• MR0000071: Camel Snus Mint 

• MR0000072: Camel Snus Robust 

• MR0000073: Camel Snus Winterchill 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before August 29, 2018. 

Oral presentations from the public will 

be scheduled between approximately 8 

a.m. and 9 a.m. on September 14, 2018. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before August 16, 2018. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by August 17, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Caryn Cohen 

at least 7 days in advance of the meeting 

(see, FOR FURTHER INFORMATION

CONTACT). 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our 

website at https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(5 U.S.C. app. 2). 

Dated: June 18, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–13405 Filed 6–21–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 on 

Drug Abuse Special Emphasis Panel; 

Mechanism for Time-Sensitive Drug Abuse 

Research (R21 Clinical Trial Optional). 

Date: June 29, 2018. 

Time: 8:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Hiromi Ono, Ph.D., 

Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, National Institutes 

of Health, DHHS, 6001 Executive Boulevard, 

Room 4238, MSC 9550, Bethesda, MD 20892, 

301–827–5820, hiromi.ono@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 on 

Drug Abuse Special Emphasis Panel; Multisite Clinical Trials. 

Date: July 26–27, 2018. 

Time: 10:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Susan O. McGuire, Ph.D., 

Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, National Institutes 

of Health, DHHS, 6001 Executive Blvd., 

Room 4245, Rockville, MD 20852, (301) 827– 

5817, mcguireso@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos.: 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 


daltland on DSKBBV9HB2PROD with NOTICES
29126 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 

Dated: June 19, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–13417 Filed 6–21–18; 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 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, 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; Source Selection Meeting 

for NIAID IRF at Fort Detrick. 

Date: July 3, 2018. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Dharmendar Rathore, 

Ph.D., Senior Scientific Review Officer, 

Scientific Review Program, Division of 

Extramural Activities, Room 3G30, National 

Institutes of Health/NIAID, 5601 Fishers 

Lane, MSC 9834, Bethesda, MD 20892–9834, 

240–669–5058, rathored@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the urgent 

need to meet timing limitations imposed by 

the intramural research review cycle. 

(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: June 19, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–13415 Filed 6–21–18; 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, 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, Integrated Preclinical/ 

Clinical AIDS Vaccine Development 

Program, (IPCAVD) (U19). 

Date: July 12–13, 2018. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: J. Bruce Sundstrom, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

Room 3G11A, National Institutes of Health/ 

NIAID, 5601 Fishers Lane, MSC 9823, 

Bethesda, MD 20892–9823, 240–669–5045, 

sundstromj@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, NIAID Investigator Initiated 

Program Project Applications (P01). 

Date: July 12, 2018. 

Time: 1:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Priti Mehrotra, Ph.D., 

Chief, Immunology Review Branch, Scientific 

Review Program, Division of Extramural 

Activities, Room #3G40, National Institutes 

of Health/NIAID, 5601 Fishers Lane, MSC 

9823, Bethesda, MD 20892–7616, 240–669– 

5066, pmehrotra@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, NIAID Investigator Initiated 

Program Project Applications (P01). 

Date: July 13, 2018. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Priti Mehrotra, Ph.D., 

Chief, Immunology Review Branch, Scientific 

Review Program, Division of Extramural 

Activities, Room #3G40, National Institutes 

of Health/NIAID, 5601 Fishers Lane, MSC 

9823, Bethesda, MD 20892–7616, 240–669– 

5066, pmehrotra@niaid.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: June 19, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–13414 Filed 6–21–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the Office 

of AIDS Research Advisory Council. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: Office of AIDS 

Research Advisory Council. 

Date: July 12, 2018. 

Time: 11:00 a.m. to 12:30 p.m. 

Agenda: Report to the OAR Director; 

Overview of key upcoming OAR activities; 

Updates of the HHS HIV/AIDS Treatment 

and Prevention Guidelines. 

Place: National Institutes of Health, 5601 

Fishers Lane, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Paul A. Sato, Medical 

Officer, Office of AIDS Research, Office of the 

Director, NIH, 5601 Fishers Lane, Room 2E62 

Rockville, MD 20852, 240–480–2330, 

paul.sato@nih.gov. 

Any interested participants are encouraged 

to join this meeting at the weblink provided, 

at least 30 minutes prior to the scheduled 

start time. Information is also available on 

the Institute’s/Center’s home page: 

www.oar.nih.gov, where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 


daltland on DSKBBV9HB2PROD with NOTICES