30740 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

Guidance document entitled ‘‘Labeling of 

Certain Beers Subject to the Labeling 

Jurisdiction of the Food and Drug Administration’’.

12 1 12 1 ................................ 12 

Total .................................................. ............................ ............................ ............................ .................................... 186 

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. Our 

estimate of the number of respondents 

is based on the number of regulatory 

submissions to TTB for beers that do not 

meet the definition of a ‘‘malt beverage’’ 

under the FAA Act. Based on its records 

of submissions received from 

manufacturers of such products, TTB 

estimates the annual number of 

respondents to be 12 and the annual 

number of disclosures to be 24. Thus, 

we adopt TTB’s estimate of 12 annual 

respondents, and an annual number of 

disclosures per respondent of 2 in table 

1. 

Our estimates of the average burden 

per disclosure for each collection 

provision are based on our experience 

with food labeling under the Agency’s 

jurisdiction. The estimated average 

burden per disclosure for §§ 101.3, 

101.4, 101.5, 101.9, 101.22, and 101.105 

in table 1 are equal to, and based upon, 

the estimated average burden per 

disclosure approved by OMB in OMB 

control number 0910–0381. We further 

estimate that the labeling burden of 

section 403(w)(1) of the FD&C Act, 

which specifies requirements for the 

declaration of food allergens, will be 1 

hour based upon the similarity of the 

requirements to that of § 101.4. Finally, 

FDA estimates that a respondent will 

spend 1 hour reading the guidance. 

Thus, we estimate that 12 respondents 

will each label 2 products annually, for 

a total of 24 labels. We estimate that the 

manufacturers will spend 7.25 hours 

(0.5 hours + 1 hour + 0.25 hour + 4 

hours + 0.5 hour + 1 hour = 7.25 hours) 

on each label to comply with our 

labeling regulations and the 

requirements of section 403(w)(1) of the 

FD&C Act, for a total of 174 hours (24 

labels × 7.25 hours = 174 hours). In 

addition, 12 respondents will each 

spend 1 hour reading the guidance 

document, for a total of 12 hours. Thus, 

we estimate the total hour burden of the 

proposed collection of information to be 

186 hours (174 hours + 12 hours = 186 

hours). 

The guidance also refers to previously 

approved collections of information 

found in our regulations. The 

collections of information in §§ 101.3, 

101.4, 101.5, 101.9, 101.22, and 101.105 

have been approved under OMB control 

number 0910–0381. Allergen labeling of 

these beers under section 403(w)(1) of 

the FD&C Act, which was added by the 

Food Allergen Labeling and Consumer 

Protection Act of 2004, has been 

approved under OMB control number 

0910–0792. 

Dated: June 22, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14056 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1129] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; National 

Agriculture and Food Defense Strategy 

Survey 

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 July 30, 

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–NEW and 

title ‘‘National Agriculture and Food 

Defense Strategy Survey.’’ Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

National Agriculture and Food Defense 

Strategy Survey 

OMB Control Number—0910–NEW 

We are seeking OMB approval of the 

National Agriculture and Food Defense 

Strategy (NAFDS) under the FDA Food 

Safety Modernization Act (FSMA), 

section 108. This is a voluntary survey 

of State governments intended to gauge 

government activities in food and 

agriculture defense from intentional 

contamination and emerging threats. 

The collected information will be 

included in the mandatory 2019 NAFDS 

followup Report to Congress. The 

authority for FDA to collect the 

information derives from the 

Commissioner of Food and Drugs’ 

authority provided in section 

1003(d)(2)(c) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(c)). 

Protecting the nation’s food and 

agriculture supply against intentional 

contamination and other emerging 

threats is an important responsibility 

shared by Federal, State, local, tribal, 

and territorial governments as well as 

private sector partners. On January 4, 

2011, the President signed FSMA. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30741 

FSMA focuses on ensuring the safety of 

the U.S. food supply by shifting the 

efforts of Federal regulators from 

response to prevention and recognizes 

the importance of strengthening existing 

collaboration among all stakeholders to 

achieve common public health and 

security goals. FSMA identifies some 

key priorities for working with partners 

in areas such as reliance on Federal, 

State, and local agencies for inspections; 

improving foodborne illness 

surveillance; and leveraging and 

enhancing State and local food safety 

and defense capacities. Section 108 of 

FSMA (NAFDS) requires the U.S. 

Department of Health and Human 

Services (HHS) and the U.S. Department 

of Agriculture (USDA), in coordination 

with the Department of Homeland 

Security (DHS), to work together with 

State, local, territorial, and tribal 

governments to monitor and measure 

progress in food defense. 

In 2015, the initial NAFDS Report to 

Congress detailed the specific Federal 

response to food and agriculture defense 

goals, objectives, key initiatives, and 

activities that HHS, USDA, DHS, and 

other stakeholders planned to 

accomplish to meet the objectives 

outlined in FSMA. The NAFDS charts a 

direction for how the Federal Agencies, 

in cooperation with State, local, 

territorial, and tribal governments and 

private sector partners, protect the 

nation’s food supply against intentional 

contamination. Not later than 4 years 

after the initial NAFDS Report to 

Congress (2015), and every 4 years 

thereafter (i.e., 2019, 2023, 2017, etc.), 

HHS, USDA, and DHS are required to 

revise and submit an updated report to 

the relevant committees of Congress. 

HHS/FDA is primarily responsible for 

obtaining the information from Federal 

and State, local, territorial, and tribal 

partners to complete the NAFDS Report 

to Congress. An interagency working 

group will conduct the survey and 

collect and update the NAFDS as 

directed by FSMA, including 

developing metrics and measuring 

progress for the evaluation process. 

The proposed survey of Federal and 

State partners will be used to determine 

what food defense activities, if any, 

Federal and/or State Agencies have 

completed (or are planning) from 2015 

to 2019. Planning for the local, 

territorial, and tribal information 

collections will commence after the 

collection and reporting of Federal and 

State Agency level data. 

This survey will be repeated 

approximately every 2 to 4 years, as 

described in section 108 of FSMA 

(NAFDS), for the purpose of monitoring 

progress in food and agricultural 

defense by government agencies. 

A purposive sampling strategy will be 

employed, such that the government 

agencies participating in food and 

agricultural defense cooperative 

agreements with FDA (22 State 

Agencies) and USDA (27 State 

Agencies) will be asked to respond to 

the voluntary survey. Food defense 

leaders responsible for conducting food 

defense activities during a food 

emergency for their jurisdiction will be 

identified and will receive an emailed 

invitation to complete the survey 

online; they will be provided with a 

web link to the survey. The survey will 

be conducted electronically on the 

FDA.gov web portal, and results will be 

analyzed by the interagency working 

group. 

In the Federal Register of March 28, 

2018 (83 FR 13284), we published a 

notice inviting public comment on the 

proposed collection of information. 

Although one comment was received, it 

was not responsive to the four collection 

of information topics solicited and 

therefore will not be discussed in this 

document. 

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 

State Survey ............................................ 49 1 49 0.33 (20 minutes) ...... 16.17 

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

The total burden for this collection of 

information, therefore, is 16.17 hours. 

The FDA Office of Partnerships 

reviewed the questionnaire and 

provided the amount of time to 

complete the survey. The total burden is 

based on our previous experiences 

conducting surveys. 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14051 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0025] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Animal Food 

Labeling; Declaration of Certifiable 

Color Additives 

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 July 30, 

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 0910–0721. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 


sradovich on DSK3GMQ082PROD with NOTICES