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
46500 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 

Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food— 

21 CFR Part 117 

OMB Control Number 0910–0751— 

Extension 

This information collection supports 

FDA regulations. As amended by the 

FDA Food Safety Modernization Act 

(FSMA) (Pub. L. 111–353), the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) enables the Agency to better protect 

the public health by helping to ensure 

the safety and security of the food 

supply. It enables FDA to focus more on 

preventing food safety problems rather 

than relying primarily on reacting to 

problems after they occur. FSMA 

recognizes the important role industry 

plays in ensuring the safety of the food 

supply, including the adoption of 

modern systems of preventive controls 

in food production. Specifically, section 

418 of the FD&C Act (21 U.S.C. 350g) 

sets forth requirements for hazard 

analysis and risk-based preventive 

controls for facilities that produce food 

for human consumption. To implement 

these provisions, regulations were 

codified under 21 CFR part 117— 

Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food. 

The regulations establish requirements 

for a written food safety plan; hazard 

analysis preventive controls; 

monitoring; corrective actions and 

corrections; verification; supply-chain 

program; recall plan; and associated 

records, and became effective November 

16, 2015. Currently, we continue to 

evaluate burden associated with the 

information collection requirements; 

however, for purposes of extending the 

information collection, we retain the 

currently approved figures as shown in 

the tables below. 

In the Federal Register of June 1, 2018 

(83 FR 25466), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

One comment was received stating that 

our estimate of burden associated with 

creating a food safety plan was too low 

and suggested a much higher figure. We 

appreciate this comment. However, 

because the annual burden is based on 

an industry average and because we 

continue to evaluate this relatively new 

collection, we are not adjusting our 

current estimate. At the same time, we 

continue to invite comment so that we 

might better refine our estimates for all 

elements of the collection. 

Our estimate of the burden for the 

information collection is as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per response Total hours 

117.201(e); qualified facility ................................................................................. 37,134 0.5 18,567 0.5 (30 minutes) ............. 9,284 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

117.126(c) and 117.170(d); food safety plan and reanalysis ...................... 46,685 1 46,685 110 .................................. 5,135,350 

117.136; assurance records ........................................................................ 16,285 1 16,285 0.25 (15 minutes) ........... 4,071 

117.145(c); monitoring records .................................................................... 8,143 730 5,944,390 0.05 (3 minutes) ............. 297,220 

117.150(d); corrective actions and corrections records .............................. 16,285 2 32,570 1 ...................................... 32,570 

117.155(b); verification records ................................................................... 8,143 244 1,986,892 0.05 (3 minutes) ............. 99,345 

117.160; validation records .......................................................................... 3,677 6 22,062 0.25 (15 minutes) ........... 5,515 

117.475(c)(7)–(9); supplier records ............................................................. 16,285 10 162,850 4 ...................................... 651,400 

117.180(d); training records for preventive controls qualified individual ..... 46,685 1 46,685 0.25 (15 minutes) ........... 11,671 

Total ...................................................................................................... ........................ ........................ .................... ......................................... 6,237,142 

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

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

117.201(e); disclosure of food manufacturing facility address ................................................. 37,134 1 37,134 0.25 (15 

minutes) 

9,284 

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

As stated previously, we retain the 

currently approved burden for the 

information collection. These figures are 

based on our regulatory impact analysis 

in support of the final rule on 

preventive controls for human food, 

which published in the Federal Register 

of September 17, 2015 (80 FR 55908). 

Using Agency data, we estimated the 

number of food facilities that we believe 

are subject to the regulations. We base 

our estimate of the time necessary for 

the individual reporting, recordkeeping, 

and third-party disclosure activities on 

our experience with similar information 

collections. 

Dated: September 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19911 Filed 9–12–18; 8:45 am] 

BILLING CODE 4164–01–P 


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