46176 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 

The purpose of the information 

package is to provide Agency staff the 

opportunity to adequately prepare for 

the meeting, including the review of 

relevant data concerning the product. In 

the Agency’s experience, reviewing 

such information is critical to achieving 

a productive meeting. If the information 

package was previously submitted in 

the meeting request, it should be 

revised, as applicable, so that the 

information reflects the most current 

and accurate information available. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Meeting Requests 

Combining and Sending Meeting Request Letters for Manufacturers, Importers, and Researchers .......................... 83 1 83 10 830 

Meeting Information Packages 

Combining and Submitting Meeting Information Packages 

for Manufacturers, Importers, and Researchers .............. 83 1 83 18 1,494 

Total .............................................................................. ........................ ........................ ........................ ........................ 2,324 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA’s estimate of the number of 

respondents for meeting requests in 

table 1 is based on the number of 

meeting requests received and projected 

over the next 3 years. FDA estimates 

that 83 preapplication meetings will be 

requested. 

The hours per response for combining 

and sending meeting request letters are 

estimated at 10 hours each, and the total 

burden hours for meeting requests are 

expected to be 830 hours. Based on 

FDA’s experience, the Agency expects it 

will take respondents this amount of 

time to prepare, gather, copy, and 

submit brief statements about the 

product and a description of the 

purpose and details of the meeting. 

FDA’s estimates that 83 respondents 

will compile meeting information 

packages and submit to FDA at 18 hours 

per response. Based on FDA’s 

experience, the Agency expects that it 

will take respondents 1,494 hours (83 

respondents × 18 hours) to gather, copy, 

and submit brief statements about the 

product, a description of the details of 

the anticipated meeting, and data and 

information that generally would 

already have been generated for the 

planned research and/or product 

development. 

The total number of burden hours for 

this collection of information is 

estimated to be 2,324 hours (830 hours 

to prepare and submit meeting requests 

and 1,494 hours to prepare and submit 

information packages). 

Our estimated burden for the 

information collection reflects an 

overall increase of 16 respondents and 

448 hours. We attribute this adjustment 

to an increase in the number of industry 

meetings as the premarket tobacco 

application compliance deadlines will 

come due in the next 3 years. 

Dated: September 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19743 Filed 9–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Healthcare Delivery 

and Methodologies Integrated Review Group; 

Clinical Management of Patients in 

Community-based Settings Study Section. 

Date: September 27–28, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Warwick Denver, 1776 Grant Street, 

Denver, CO 80203. 

Contact Person: Martha L Hare, Ph.D., RN, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3154, 

MSC 7770, Bethesda, MD 20892, (301) 451– 

8504, harem@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Hypertension and Microcirculation. 

Date: October 2, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW, 

Washington, DC 20015. 

Contact Person: Katherine M. Malinda, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4140, 

MSC 7814, Bethesda, MD 20892, 301–435– 

0912, Katherine_Malinda@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Dental, Microbiology and Oral 

Biology. 

Date: October 3, 2018. 

Time: 12:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Baljit S Moonga, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4214, 

MSC 7806, Bethesda, MD 20892, 301–435– 

1777, moongabs@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–17– 

094: Maximizing Investigators’ Research 

Award (R35). 

Date: October 10–11, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 46177 

Place: Residence Inn Capital View, 2850 

South Potomac Avenue, Arlington, VA 

22202. 

Contact Person: Jonathan Arias, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5170, 

MSC 7840, Bethesda, MD 20892, 301–435– 

2406, ariasj@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 6, 2018. 

David D. Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–19796 Filed 9–11–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Biobehavioral and 

Behavioral Processes Integrated Review 

Group; Biobehavioral Regulation, Learning 

and Ethology Study Section. 

Date: October 4–5, 2018. 

Time: 8:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Zoe, Fisherman’s Wharf, 425 

North Point Street, San Francisco, CA 94133. 

Contact Person: Unja Hayes, Ph.D., 

Scientific Review Officer, National Institutes 

of Health, Center for Scientific Review, 6701 

Rockledge Drive, Bethesda, MD 20892, 301– 

827–6830, unja.hayes@nih.gov. 

Name of Committee: Genes, Genomes, and 

Genetics Integrated Review Group; 

Prokaryotic Cell and Molecular Biology 

Study Section. 

Date: October 4–5, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Kinzie Hotel, 20 West Kinzie Street, 

Chicago, IL 60654. 

Contact Person: Luis Dettin, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2208, 

Bethesda, MD 20892, 301–451–1327, 

dettinle@csr.nih.gov. 

Name of Committee: Biobehavioral and 

Behavioral Processes Integrated Review 

Group; Motor Function, Speech and 

Rehabilitation Study Section. 

Date: October 4, 2018. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Westin Georgetown, 2350 M Street 

NW, Washington, DC 20037. 

Contact Person: Biao Tian, Ph.D., Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 3166, MSC 7848, Bethesda, MD 

20892, 301–402–4411, tianbi@csr.nih.gov. 

Name of Committee: Vascular and 

Hematology Integrated Review Group; 

Atherosclerosis and Inflammation of the 

Cardiovascular System Study Section. 

Date: October 11–12, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The William F. Bolger Center, 9600 

Newbridge Drive, Potomac, MD 20854. 

Contact Person: Natalia Komissarova, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5207, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1206, komissar@mail.nih.gov. 

Name of Committee: Risk, Prevention and 

Health Behavior Integrated Review Group; 

Psychosocial Development, Risk and 

Prevention Study Section. 

Date: October 11–12, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The Fairmont Washington, DC, 2401 

M Street NW, Washington, DC 20037. 

Contact Person: Anna L. Riley, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3114, 

MSC 7759, Bethesda, MD 20892, 301–435– 

2889, rileyann@csr.nih.gov. 

Name of Committee: Immunology 

Integrated Review Group; Hypersensitivity, 

Autoimmune, and Immune-mediated 

Diseases Study Section. 

Date: October 11–12, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites Alexandria Old 

Town, 1900 Diagonal Road, Alexandria, VA 

22314. 

Contact Person: Deborah Hodge, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4207 

MSC 7812, Bethesda, MD 20892, 301–435– 

1238, hodged@mail.nih.gov. 

Name of Committee: Risk, Prevention and 

Health Behavior Integrated Review Group; 

Behavioral Medicine, Interventions and 

Outcomes Study Section. 

Date: October 11–12, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Baltimore Marriott Waterfront, 700 

Aliceanna Street, Baltimore, MD 21202. 

Contact Person: Lee S. Mann, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3224, 

MSC 7808, Bethesda, MD 20892, 301–435– 

0677, mannl@csr.nih.gov. 

Name of Committee: Digestive, Kidney and 

Urological Systems Integrated Review Group; 

Hepatobiliary Pathophysiology Study 

Section. 

Date: October 11–12, 2018. 

Time: 8:00 a.m. to 6:00 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: Jianxin Hu, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2156, 

Bethesda, MD 20892, 301–827–4417, 

jianxinh@csr.nih.gov. 

Name of Committee: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group; Neural Oxidative Metabolism 

and Death Study Section. 

Date: October 11–12, 2018. 

Time: 8:00 a.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crystal Gateway Marriott, 1700 

Jefferson Davis Highway, Arlington, VA 

22202. 

Contact Person: Carol Hamelink, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4192, 

MSC 7850, Bethesda, MD 20892, (301) 213– 

9887, hamelinc@csr.nih.gov. 

Name of Committee: Immunology 

Integrated Review Group; Innate Immunity 

and Inflammation Study Section. 

Date: October 11–12, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Grand at Wild Horse Pass, 

5594 W Wild Horse Pass Boulevard, Phoenix, 

AZ 85226. 

Contact Person: Tina McIntyre, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4202, 

MSC 7812, Bethesda, MD 20892, 301–594– 

6375, mcintyrt@csr.nih.gov. 

Name of Committee: Digestive, Kidney and 

Urological Systems Integrated Review Group; 

Xenobiotic and Nutrient Disposition and 

Action Study Section. 

Date: October 11, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Martha Garcia, Ph.D., 

Scientific Reviewer Officer, Center for 


daltland on DSKBBV9HB2PROD with NOTICES