46498 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Science Board to the 

Food and Drug Administration. The 

Science Board provides advice to the 

Commissioner of Food and Drugs and 

other appropriate officials on specific, 

complex scientific and technical issues 

important to FDA and its mission, 

including emerging issues within the 

scientific community. Additionally, the 

Science Board provides advice to the 

Agency on keeping pace with technical 

and scientific developments including 

in regulatory science, input into the 

Agency’s research agenda, and on 

upgrading its scientific and research 

facilities and training opportunities. It 

will also provide, where requested, 

expert review of Agency sponsored 

intramural and extramural scientific 

research programs. The meeting will be 

open to the public. 

DATES: The meeting will be held on 

October 22, 2018, from 8:30 a.m. to 4:30 

p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503, section A), Silver Spring, MD 

20993. For those unable to attend in 

person, the meeting will also be 

webcast. The link for the webcast is 

available at https://collaboration.

fda.gov/scienceboard2018/. 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/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Rakesh Raghuwanshi, Office of the 

Chief Scientist, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 3309, Silver Spring, 

MD 20993, 301–796–4769, 

rakesh.raghuwanshi@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: The Science Board will hear 

a response from the Center for 

Veterinary Medicine (CVM) to the 

recommendations made by the Science 

Board’s 2017 review of CVM’s National 

Antibiotic Resistance Monitoring 

System program. The Science Board 

will also discuss potential hazards and 

nutritional considerations in the 

production of food derived from animal 

cell culture technologies. 

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 October 15, 2018. 

Oral presentations from the public will 

be scheduled between approximately 

3:30 p.m. and 4:30 p.m. 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 October 5, 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 October 9, 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 Rakesh 

Raghuwanshi at least 7 days in advance 

of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

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: September 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19906 Filed 9–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–1984] 

Request for Nominations on the 

Tobacco Products Scientific Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting that any small business 

tobacco manufacturing industry 

organizations interested in participating 

in the selection of a nonvoting industry 

representative to serve on the Tobacco 

Products Scientific Advisory Committee 

for the Center for Tobacco Products 

notify FDA in writing. FDA is also 

requesting nominations for nonvoting 

industry representatives to be included 

in a pool of individuals to represent the 

interests of the small business tobacco 

manufacturing industry on the Tobacco 

Products Scientific Advisory 

Committee. A nominee may either be 

self-nominated or nominated by an 

organization to serve as a nonvoting 

industry representative. This position 

may be filled on a rotating, sequential 

basis by representatives of different 

small business tobacco manufacturers 

based on areas of expertise relevant to 

the topics being considered by the 

Advisory Committee. Nominations will 

be accepted for current vacancies 

effective with this notice. 

DATES: Any small business tobacco 

manufacturing industry organization 

interested in participating in the 

selection of appropriate nonvoting 

members to represent industry interests 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46499 

must send a letter stating that interest to 

FDA by October 15, 2018, (see sections 

I and II of this document for further 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by October 15, 

2018. 

ADDRESSES: All statements of interest 

from small business tobacco 

manufacturing industry organizations 

interested in participating in the 

selection process of nonvoting industry 

representative nominations should be 

sent to Caryn Cohen (see FOR FURTHER

INFORMATION CONTACT). All nominations 

for nonvoting industry representatives 

may be submitted electronically by 

accessing the FDA Advisory Committee 

Membership Nomination Portal at: 

https://www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at: https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Caryn Cohen, Office of Science, Center 

for Tobacco Products, Food and Drug 

Administration, Center for Tobacco 

Products Document Control Center, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. G335, Silver Spring, MD 20993– 

0002, 1–877–287–1373 (choose Option 

5), TPSAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency intends to add a nonvoting 

industry representative to represent the 

interests of the small business tobacco 

manufacturing industry to the following 

advisory committee: 

I. Tobacco Products Scientific Advisory 

Committee 

The Tobacco Products Scientific 

Advisory Committee (the Committee) 

advises the Commissioner of Food and 

Drugs (the Commissioner) or designee in 

discharging responsibilities related to 

the regulation of tobacco products. The 

Committee reviews and evaluates safety, 

dependence, and health issues relating 

to tobacco products and provides 

appropriate advice, information, and 

recommendations to the Commissioner. 

The Committee includes three 

nonvoting members who represent 

industry interests. These members 

include one representative of the 

interests of the tobacco manufacturing 

industry; one representative of the 

interests of tobacco growers; and one 

representative of the interests of the 

small business tobacco manufacturing 

industry, which may be filled on a 

rotating, sequential basis by 

representatives of different small 

business tobacco manufacturers based 

on areas of expertise relevant to the 

topics being considered by the Advisory 

Committee. 

With this notice, nominations are 

sought for a pool of individuals, with 

varying areas of expertise, to represent 

the interests of the small business 

tobacco manufacturing industry on a 

rotating, sequential basis. 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for the committee. The 

interested organizations are not bound 

by the list of nominees in selecting a 

candidate. However, if no individual is 

selected within 60 days, the 

Commissioner will select the nonvoting 

member to represent industry interests. 

III. Application Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Contact 

information, a current curriculum vitae, 

and the name of the committee of 

interest should be sent to the FDA 

Advisory Committee Membership 

Nomination Portal (see ADDRESSES) 

within 30 days of publication of this 

document (see DATES). FDA will forward 

all nominations to the organizations 

expressing interest in participating in 

the selection process for the committee. 

(Persons who nominate themselves as 

nonvoting industry representatives will 

not participate in the selection process). 

FDA seeks to include the views of 

women, and men, members of all racial 

and ethnic groups and individuals with 

and without disabilities on its advisory 

committees and, therefore encourages 

nominations of appropriately qualified 

candidates from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: September 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19922 Filed 9–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0920] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 15, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0751. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 


daltland on DSKBBV9HB2PROD with NOTICES