Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices 38151 

regulation for investigational use. 

Section 409(b) of the FD&C Act (21 

U.S.C. 348(b)) specifies the information 

that must be submitted by a petitioner 

to establish the safety of a food additive 

and to secure the issuance of a 

regulation permitting its use. 

To implement the provisions of § 409 

of the FD&C Act, we issued procedural 

regulations under 21 CFR part 571. 

These procedural regulations are 

designed to specify more thoroughly the 

information that must be submitted to 

meet the requirement set down in 

broader terms by the FD&C Act. The 

regulations add no substantive 

requirements to those indicated in the 

FD&C Act, but attempt to explain these 

requirements and provide a standard 

format for submission to speed 

processing of the petition. Labeling 

requirements for food additives 

intended for animal consumption are 

also set forth in various regulations 

contained in 21 CFR parts 501, 573, and 

579. The labeling regulations are 

considered by FDA to be crossreferenced to § 571.1, which is the 

subject of this same OMB clearance for 

food additive petitions. 

With regard to the investigational use 

of food additives, § 409(j) of the FD&C 

Act (§ 409(j)) (21 U.S.C. 348(j)) provides 

that any food additive, or any food 

bearing or containing such an additive, 

may be exempted from the requirements 

of this section if intended solely for 

investigational use by qualified experts. 

Investigational use of a food additive is 

typically to address the safety and/or 

intended physical or technical effect of 

the additive. 

To implement the provisions of 

§ 409(j), we issued regulations under 21 

CFR 570.17. These regulations are 

designed to specify more thoroughly the 

information that must be submitted to 

meet the requirement set down in broad 

terms by the FD&C Act. Labeling 

requirements for investigational food 

additives are also set forth in various 

regulations contained in 21 CFR 501. 

The labeling regulations are considered 

by FDA to be cross-referenced to 

§ 570.17, which is the subject of this 

same OMB clearance for investigational 

food additive files. 

The information collected is 

necessary to protect the public health. 

We use the information submitted by 

food manufacturers or food additive 

manufacturers to ascertain whether the 

data establish the identity of the 

substance, justify its intended effect in/ 

on the food, and establish that its 

intended use in/on food is safe. 

Description of Respondents: 

Respondents to this collection of 

information are food manufacturers or 

food additive manufacturers. 

FDA estimates the burden of this 

collection of information 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 

Food Additive Petitions: 

571.1(c) Moderate Category ......................................... 12 1 12 3,000 36,000 

571.1(c) Complex Category .......................................... 12 1 12 10,000 120,000 

571.6 Amendment of Petition ....................................... 2 1 2 1,300 2,600 

Investigational Food Additive Files: 

570.17 Moderate Category ........................................... 4 1 4 1,500 6,000 

570.17 Complex Category ............................................ 5 1 5 5,000 25,000 

Total Hours ............................................................ ........................ ........................ ........................ ........................ 189,600 

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

We base our estimate of the total 

annual responses on submissions 

received during fiscal years 2016 and 

2017. We base our estimate of the hours 

per response upon our experience with 

the petition and filing processes. 

§ 571.1(c) Moderate Category: For a 

food additive petition without complex 

chemistry, manufacturing, efficacy or 

safety issues, the estimated time 

requirement per petition is 

approximately 3,000 hours. We estimate 

that, annually, 12 respondents will each 

submit 1 such petition, for a total of 

36,000 hours. 

§ 571.1(c) Complex Category: For a 

food additive petition with complex 

chemistry, manufacturing, efficacy and/ 

or safety issues, the estimated time 

requirement per petition is 

approximately 10,000 hours. We 

estimate that, annually, 12 respondents 

will each submit 1 such petition, for a 

total of 120,000 hours. 

§ 571.6: For a food additive petition 

amendment, the estimated time 

requirement per petition is 

approximately 1,300 hours. We estimate 

that, annually, two respondents will 

each submit one such amendment, for a 

total of 2,600 hours. 

§ 570.17 Moderate Category: For an 

investigational food additive file 

without complex chemistry, 

manufacturing, efficacy, or safety issues, 

the estimated time requirement per file 

is approximately 1,500 hours. We 

estimate that, annually, four 

respondents will each submit one such 

file, for a total of 6,000 hours. 

§ 570.17 Complex Category: For an 

investigational food additive file with 

complex chemistry, manufacturing, 

efficacy, and/or safety issues, the 

estimated time requirement per file is 

approximately 5,000 hours. We estimate 

that, annually, five respondents will 

each submit one such file, for a total of 

25,000 hours. 

The burden for this information 

collected has not changed since the last 

OMB approval. 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16616 Filed 8–2–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0405] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Recall Authority 

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 


amozie on DSK3GDR082PROD with NOTICES1
38152 Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices 

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 September 

4, 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 0910–0432. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

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 

collection of information to OMB for 

review and clearance. 

Medical Device Recall Authority 

OMB Control Number 0910–0432— 

Extension 

This collection of information 

implements section 518(e) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360h(e)) and part 

810 (21 CFR part 810), mandatory 

medical device recall authority 

provisions. Section 518(e) of the FD&C 

Act provides FDA with the authority to 

issue an order requiring an appropriate 

person, including manufacturers, 

importers, distributors, and retailers of a 

device, if FDA finds that there is 

reasonable probability that the device 

intended for human use would cause 

serious adverse health consequences or 

death, to: (1) Immediately cease 

distribution of such device and (2) 

immediately notify health professionals 

and device-user facilities of the order 

and to instruct such professionals and 

facilities to cease use of such device. 

FDA will then provide the person 

named in the cease distribution and 

notification order with the opportunity 

for an informal hearing on whether the 

order should be amended to require a 

mandatory recall of the device. 

If, after providing the opportunity for 

an informal hearing, FDA determines 

that such an order is necessary, the 

Agency may amend the order to require 

a mandatory recall. 

FDA issued part 810 to implement the 

provisions of section 518 of the FD&C 

Act. The information collected under 

the mandatory recall authority 

provisions will be used by FDA to 

implement mandatory recalls. 

In the Federal Register of February 

22, 2018 (83 FR 7740), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Collection activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Collections Specified in the Order—810.10(d) .................... 2 1 2 8 16 

Request for Regulatory Hearing—810.11(a) ....................... 1 1 1 8 8 

Written Request for Review—810.12(a)–(b) ....................... 1 1 1 8 8 

Mandatory Recall Strategy—810.14 .................................... 2 1 2 16 32 

Periodic Status Reports—810.16(a)–(b) .............................. 2 12 24 40 960 

Termination Request—810.17(a) ......................................... 2 1 2 8 16 

Total Hours ................................................................... ........................ ........................ ........................ ........................ 1,040 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Collection activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Documentation of Notifications to Recipients—810.15(b) ... 2 1 2 8 16 

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

Collection activity/21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Notification to Recipients—810.15(a)–(c) ............................ 2 1 2 12 24 

Notification to Recipients; Follow-up—810.15(d) ................ 2 1 2 4 8 

Notification of Consignees by Recipients—810.15(e) ......... 10 1 10 1 10 

Total .............................................................................. ........................ ........................ ........................ ........................ 42 

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


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices 38153 

The burden estimate has not changed 

for information collection related to 

section 518(e) of the FD&C Act and part 

810 since the last OMB approval. 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16618 Filed 8–2–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0270] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Survey on the 

Occurrence of Foodborne Illness Risk 

Factors in Selected Institutional 

Foodservice and Retail Food Stores 

Facility Types 

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 September 

4, 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 0910–0799. 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. 

Survey on the Occurrence of Foodborne 

Illness Risk Factors in Selected 

Institutional Foodservice and Retail 

Food Stores Facility Types 

OMB Control Number 0910–0799— 

Reinstatement 

I. Background 

From 1998 to 2008, FDA’s National 

Retail Food Team conducted a study to 

measure trends in the occurrence of 

foodborne illness risk factors, 

preparation practices, and employee 

behaviors most commonly reported to 

the Centers for Disease Control and 

Prevention as contributing factors to 

foodborne illness outbreaks at the retail 

level. Specifically, data was collected by 

FDA specialists in retail and foodservice 

establishments at 5-year intervals (1998, 

2003, and 2008) to observe and 

document trends in the occurrence of 

the following foodborne illness risk 

factors: 

• Food from Unsafe Sources, 

• Poor Personal Hygiene, 

• Inadequate Cooking, 

• Improper Holding/Time and 

Temperature, and 

• Contaminated Equipment/CrossContamination. 

FDA developed reports summarizing 

the findings for each of the three data 

collection periods (1998, 2003, and 

2008) (Refs. 1 to 3). Data from all three 

data collection periods were analyzed to 

detect trends in improvement or 

regression over time and to determine 

whether progress had been made toward 

the goal of reducing the occurrence of 

foodborne illness risk factors in selected 

retail and foodservice facility types (Ref. 

4). 

Using this 10-year survey as a 

foundation, in 2013 to 2014, FDA 

initiated a new study in full service and 

fast food restaurants. This study will 

span 10 years with additional data 

collections planned for 2017 to 2018 

and 2021 to 2022. 

FDA recently completed the baseline 

data collection in select healthcare, 

school, and retail food store facility 

types in 2015 to 2016. This proposed 

study will also span 10 years with 

additional data collections planned for 

2019 to 2020 (the subject of this 

information collection request 

reinstatement) and 2023 to 2024 (which 

will be posted in the Federal Register at 

the next renewal). 

TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY

Facility type Description 

Healthcare Facilities ............. Hospitals and long-term care facilities foodservice operations that prepare meals for highly susceptible populations as defined as follows: 

• Hospitals—A foodservice operation that provides for the nutritional needs of inpatients by preparing meals and 

transporting them to the patient’s room and/or serving meals in a cafeteria setting (meals in the cafeteria may 

also be served to hospital staff and visitors). 

• Long-term care facilities—A foodservice operation that prepares meals for the residents in a group care living 

setting such as nursing homes and assisted living facilities. 

Note: For the purposes of this study, healthcare facilities that do not prepare or serve food to a highly susceptible 

population, such as mental healthcare facilities, are not included in this facility type category. 

Schools (K–12) ..................... Foodservice operations that have the primary function of preparing and serving meals for students in one or more 

grade levels from kindergarten through grade 12. A school foodservice may be part of a public or private institution. 

Retail Food Stores ............... Supermarkets and grocery stores that have a deli department/operation as described as follows:

• Deli department/operation—Areas in a retail food store where foods, such as luncheon meats and 

cheeses, are sliced for the customers and where sandwiches and salads are prepared onsite or received 

from a commissary in bulk containers, portioned, and displayed. Parts of deli operations may include: 

• Salad bars, pizza stations, and other food bars managed by the deli department manager. 

• Areas where other foods are cooked or prepared and offered for sale as ready-to-eat and are managed by the deli department manager. 

Data will also be collected in the following areas of a supermarket or grocery store, if present: 


amozie on DSK3GDR082PROD with NOTICES1