26700 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Interstate Shellfish Dealer’s Certificate 

OMB Control Number 0910–0021— 

Extension 

Under Section 243 of the Public 

Health Service Act (42 U.S.C. 243), FDA 

is required to cooperate with and aid 

State and local authorities in the 

enforcement of their health regulations 

and are authorized to assist States in the 

prevention and suppression of 

communicable diseases. Under this 

authority, FDA participates with State 

regulatory agencies, some foreign 

nations, and the molluscan shellfish 

industry in the National Shellfish 

Sanitation Program (NSSP). 

NSSP is a voluntary, cooperative 

program to promote the safety of 

molluscan shellfish by providing for the 

classification and patrol of shellfish 

growing waters and for the inspection 

and certification of shellfish processors. 

Each participating State and foreign 

nation monitors its molluscan shellfish 

processors and issues certificates for 

those that meet the State or foreign 

shellfish control authority’s criteria. 

Each participating State and nation 

provides a certificate of its certified 

shellfish processors to FDA on Form 

FDA 3038, ‘‘Interstate Shellfish Dealer’s 

Certificate.’’ FDA uses this information 

to publish the ‘‘Interstate Certified 

Shellfish Shippers List,’’ a monthly 

comprehensive listing of all molluscan 

shellfish processors certified under the 

cooperative program. If FDA did not 

collect the information necessary to 

compile this list, participating States 

would not be able to identify and keep 

out shellfish processed by uncertified 

processors in other States and foreign 

nations. Consequently, NSSP would not 

be able to control the distribution of 

uncertified and possibly unsafe shellfish 

in interstate commerce, and its 

effectiveness would be nullified. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity FDA Form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average burden 

per response Total hours 

Submission of Interstate Shellfish Dealer’s Certificate.3038 40 57 2,280 0.10 (6 minutes) ............. 228 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. We 

estimate that 40 respondents will 

submit 2,280 Interstate Shellfish 

Dealer’s Certificates annually, for a total 

burden of 228 hours (2,280 submissions 

× 0.10 hours = 228 hours). This estimate 

is based on our experience with this 

information collection and the number 

of certificates received in the past 3 

years, which has remained constant. 

Dated: June 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12340 Filed 6–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Sciences; 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 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 Center for 

Advancing Translational Sciences Special 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26701 

Emphasis Panel; R13 Conference Grants 

Review. 

Date: July 10, 2018. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, One 

Democracy Plaza, Room 1037, 6701 

Democracy Boulevard, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Rahat Khan, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Center for Advancing 

Translational Sciences, 6701 Democracy 

Blvd., Rm 1078, Bethesda, MD 20892, 301– 

594–7319, khanr2@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.350, B—Cooperative 

Agreements; 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: June 5, 2018. 

David D. Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–12402 Filed 6–7–18; 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: Center for Scientific 

Review Special Emphasis Panel; CNBT Study 

Section Special Emphasis Panel. 

Date: June 7, 2018. 

Time: 8:00 a.m. to 6:00 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: Samuel C. Edwards, Ph.D., 

Chief, Brain Disorders and Clinical 

Neuroscience, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 5210, MSC 7846, Bethesda, MD 

20892, (301) 435–1246, edwardss@

csr.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: Center for Scientific 

Review Special Emphasis Panel; PAR 

Review: Intervening with Caregivers and 

Integrated Cancer-Related Behavioral 

Research. 

Date: June 29, 2018. 

Time: 2:00 p.m. to 6:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: John H. Newman, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3222, 

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

0628, newmanjh@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: Risk, Prevention and Health 

Behavior. 

Date: July 9–10, 2018. 

Time: 8:00 a.m. to 6:00 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: Martha M. Faraday, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3110, 

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

3575, faradaym@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Secondary 

Analyses of Existing Datasets in Heart, Lung, 

and Blood Diseases and Sleep Disorders. 

Date: July 9–10, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Lorien Hotel & Spa, 1600 King 

Street, Alexandria, VA 22314. 

Contact Person: Delia Olufokunbi Sam, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3158, 

MSC 7770, Bethesda, MD 20892, 301–435– 

0684, olufokunbisamd@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Neural Basis of Neurodegenerative 

Disorders and SCI. 

Date: July 9, 2018. 

Time: 11:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Paula Elyse Schauwecker, 

Ph.D., Scientific Review Officer, National 

Institutes of Health, Center for Scientific 

Review, 6701 Rockledge Drive, Room 5211, 

Bethesda, MD 20892, 301–760–8207, 

schauweckerpe@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: June 4, 2018. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–12401 Filed 6–7–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; 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 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 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel; Alcohol Research Center 

Reviews (RFA AA18–001). 

Date: July 26, 2018. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, 6700B Rockledge Drive, 

Bethesda, MD 20892 (Telephone Conference 

Call). 

Contact Person: Ranga Srinivas, Ph.D., 

Chief, Extramural Project Review Branch, 

National Institute on Alcohol Abuse and 

Alcoholism, National Institutes of Health, 

5365 Fishers Lane, Room 2085, Rockville, 

MD 20852, (301) 451–2067, srinivar@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards, National 

Institutes of Health, HHS) 


amozie on DSK3GDR082PROD with NOTICES1