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
30742 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

collection of information to OMB for 

review and clearance. 

Animal Food Labeling; Declaration of 

Certifiable Color Additives 

OMB Control Number 0910–0721— 

Extension 

This information collection is 

associated with requirements under 

§ 501.22(k) (21 CFR 501.22(k)) in which 

animal food manufacturers must declare 

the presence of certified and 

noncertified color additives in their 

animal food products on the product 

label. We issued this regulation in 

response to the Nutrition Labeling and 

Education Act of 1990 (Pub. L. 101–535) 

to make animal food regulations 

consistent with the regulations 

regarding the declaration of color 

additives on human food labels and to 

provide animal owners with 

information on the color additives used 

in animal food. Animal owners use the 

information to become knowledgeable 

about the foods they purchase for their 

animals. Color additive information 

enables a consumer to comparison shop 

and to avoid substances to which their 

animals may be sensitive. 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers of pet 

food products that contain color 

additives. In the Federal Register of 

February 20, 2018 (83 FR 7198), FDA 

published a 60-day notice requesting 

public comment on the proposed 

collection of information. 

(Comment) One comment was 

received that supported FDA’s need for 

the information collection and 

characterized the burden of the 

information collection as low compared 

to the importance of informative food 

labels. The comment did not suggest 

revising our estimate of the burden. 

However, it suggested we should 

provide greater detail about how we 

estimated the number of respondents 

and the flow of new products. 

(Response) We based our estimate of 

the number of respondents on the 

number of pet food manufacturers 

subject to this regulation. The figure of 

3,120 used in table 1 was derived from 

the number of establishments listed 

under North American Industrial 

Classification System codes 311111 and 

311119, including very small 

establishments. As noted in the 60-day 

notice, we based our estimate of the 

flow of new products on A.C. Nielsen 

data for the number of animal food 

product units for sale (for which sales 

of the products are greater than zero) in 

the latest year for which data is 

available, stated to be 25,874. Then, we 

assumed that the flow of new products 

would be 10 percent per year, for a 

figure of 2,587 new products per year. 

That figure was used in table 1 as our 

estimate of the total annual disclosures. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR Section/activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden per 

disclosure Total hours 

501.22(k); labeling of color additive or 

lake of color additive; labeling of color 

additives not subject to certification.

3,120 0.8292 2,587 0.25 (15 minutes) ...... 647 

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

The requirement became effective 

November 18, 2013; thus, we estimate 

that the burden associated with the 

labeling requirements under § 501.22(k) 

applies only to new product labels. 

Because the vast majority of animal food 

products that contain certified color 

additives are pet foods, we limit our 

burden estimate to reviewing labels for 

the use of certified color additives to pet 

food manufacturers subject to this 

regulation. Based on A.C. Nielsen data, 

we estimate that the number of animal 

food product units subject to § 501.22(k) 

for which sales of the products are 

greater than zero is 25,874. Assuming 

that the flow of new products is 10 

percent per year, then 2,587 new animal 

food products subject to § 501.22(k) will 

become available on the market each 

year. We also estimate that there are 

approximately 3,120 manufacturers of 

pet food subject to either § 501.22(k)(1) 

or (2). Assuming the approximately 

2,587 new products are split equally 

among the firms, then each firm would 

prepare labels for approximately 0.8292 

new products per year (2,587 new 

products—3,120 firms is approximately 

0.8292 labels per firm). We expect that 

firms prepare the required labeling for 

their products in a manner that takes 

into account at one time all information 

required to be disclosed on their 

product labels. Based on our experience 

with reviewing pet food labeling, we 

estimate that firms would require less 

than 0.25 hour (15 minutes) per product 

to comply with the requirement to 

include the color additive information 

pursuant to § 501.22(k). The total 

burden of this activity is 647 hours 

(2,587 labels × 0.25 hour/label is 

approximately 647 hours). The burden 

for this information collection has not 

changed since the last OMB approval. 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14059 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–2398] 

Development of Non-Traditional 

Therapies for Bacterial Infections; 

Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Development of 

Non-Traditional Therapies for Bacterial 

Infections.’’ The purpose of the public 

workshop is to discuss the general 

development considerations of nontraditional therapies, including preclinical development, early clinical 

studies, and phase 3 clinical trial 

designs to evaluate safety and efficacy. 

DATES: The public workshop will be 

held on August 21, 2018, from 8:30 a.m. 

to 4:30 p.m. and August 22, 2018, from 


sradovich on DSK3GMQ082PROD with NOTICES