40856 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 

1Under section 745A(a) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 

379k–1(a)), at least 24 months after the issuance of 

a final guidance document in which FDA has 

specified the electronic format for submitting 

certain submission types to the Agency, such 

content must be submitted electronically and in the 

format specified by FDA. 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–1216 for ‘‘Electronic Study Data 

Submission; Data Standards; Technical 

Rejection Criteria for Study Data 

Effective Date.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Resnick, Center for Drug 

Evaluation and Research (CDER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 3160, 

Silver Spring, MD 20993–0002, 301– 

796–7997, Jonathan.Resnick@

fda.hhs.gov, or Stephen Ripley, Center 

for Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 7301, Silver Spring, MD 20993– 

0002, 240–402–7911, Stephen.Ripley@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

accordance with the guidance 1 for 

industry ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Standardized Study Data,’’ submissions 

that are not submitted electronically and 

electronic submissions that are not in a 

format that FDA can process, review, 

and archive will not be filed or received, 

unless they have an exemption or 

waiver from the electronic submission 

requirements. The Agency can process, 

review, and archive electronic 

submissions of study data that use the 

standards specified in the Data 

Standards Catalog posted to FDA’s 

Study Data Standards Resources web 

page (https://www.fda.gov/industry/fdaresources-data-standards/study-datastandards-resources). 

The technical rejection criteria are 

automated validations by the CDER or 

CBER inbound processing system using 

the specifications set forth in FDA’s 

‘‘Specifications for eCTD Validation 

Criteria’’ to determine compliance with 

the requirement to submit electronic 

standardized study data. The eCTD 

validations referenced in FDA’s TRC 

will become effective on September 15, 

2021. Starting September 15, 2021, FDA 

will reject submissions that contain any 

high validation errors included in the 

TRC. The latest version of the TRC is 

available on FDA’s web page on Study 

Data for Submission to CDER and CBER 

(https://www.fda.gov/industry/studydata-standards-resources/study-datasubmission-cder-and-cber). 

Dated: July 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16187 Filed 7–28–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0547] 

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 Retail and 

Foodservice Facility Types 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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: Submit written comments 

(including recommendations) on the 

collection of information by August 30, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0744. 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. 


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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 40857 

Survey on the Occurrence of Foodborne 

Illness Risk Factors in Selected Retail 

and Foodservice Facility Types 

OMB Control Number 0910–0744— 

Extension 

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) in order 

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, released in 2000, 

2004, and 2009 (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 2013–2014, FDA initiated 

a new study in full-service and fast-food 

restaurants. This study will span 10 

years with data collections completed in 

2013–2014 and 2017–2018, and an 

additional collection planned for 2021– 

2022. Three data collections are 

necessary to trend the data. Data 

collected in 2013–2014 is published, 

and data from 2017–2018 is currently 

being evaluated for trends and 

significance. 

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

Facility type Description 

Full-Service Restaurants ................. A restaurant where customers place their orders at their tables, are served their meals at the tables, receive the services of the wait staff, and pay at the end of the meals. 

Fast-Food Restaurants ................... A restaurant that is not a full-service restaurant. This includes restaurants commonly referred to as quickservice restaurants and fast, casual restaurants. 

The results of this 10-year study 

period will be used to: 

• Develop retail food safety 

initiatives, policies, and targeted 

intervention strategies focused on 

controlling foodborne illness risk 

factors; 

• Provide technical assistance to 

State, local, tribal, and territorial 

regulatory professionals; 

• Identify FDA retail work plan 

priorities; and 

• Inform FDA resource allocation to 

enhance retail food safety nationwide. 

The statutory basis for FDA 

conducting this study is derived from 

the Public Health Service Act (PHS Act) 

(42 U.S.C. 243, section 311(a)). 

Responsibility for carrying out the 

provisions of the PHS Act relative to 

food protection was transferred to the 

Commissioner of Food and Drugs in 

1968 (21 CFR 5.10(a)(2) and (4)). 

Additionally, the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 301 et seq.) 

and the Economy Act (31 U.S.C. 1535) 

require FDA to provide assistance to 

other Federal, State, and local 

government bodies. 

The objectives of this study are to: 

• Identify the least and most often 

occurring foodborne illness risk factors 

and food safety behaviors/practices in 

restaurants within the United States; 

• Determine the extent to which Food 

Safety Management Systems and the 

presence of a Certified Food Protection 

Manager impact the occurrence of 

foodborne illness risk factors and food 

safety behaviors/practices; and 

• Determine whether the occurrence 

of foodborne illness risk factors and 

food safety behaviors/practices in delis 

differs based on an establishment’s risk 

categorization and status as a single-unit 

or multiple-unit operation (e.g., 

restaurants that are part of an operation 

with two or more units). 

The methodology to be used for this 

information collection is described as 

follows. To obtain a sufficient number 

of observations to conduct statistically 

significant analysis, FDA will conduct 

approximately 400 data collections in 

each facility type. This sample size has 

been calculated to provide for sufficient 

observations to be 95 percent confident 

that the compliance percentage is 

within 5 percent of the true compliance 

percentage. 

A geographical information system 

database containing a listing of 

businesses throughout the United States 

provides the establishment inventory for 

the data collections. FDA samples 

establishments from the inventory based 

on the descriptions in table 1. FDA does 

not intend to sample operations that 

handle only prepackaged food items or 

conduct low-risk food preparation 

activities. The ‘‘FDA Food Code’’ 

contains a grouping of establishments 

by risk, based on the type of food 

preparation that is normally conducted 

within the operation (Ref. 5). The intent 

is to sample establishments that fall 

under risk categories 2 through 4. 

FDA has approximately 23 Retail 

Food Specialists (Specialists) who serve 

as the data collectors for the 10-year 

study. The Specialists are 

geographically dispersed throughout the 

United States and possess technical 

expertise in retail food safety and a solid 

understanding of the operations within 

each of the facility types to be surveyed. 

The Specialists are also standardized by 

FDA’s Center for Food Safety and 

Applied Nutrition personnel in the 

application and interpretation of the 

FDA Food Code (Ref. 5). 

Sampling zones have been established 

that are equal to the 175-mile radius 

around a Specialist’s home location. 

The sample is selected randomly from 

among all eligible establishments 

located within these sampling zones. 

The Specialists are generally located in 

major metropolitan areas (i.e., 

population centers) across the 

contiguous United States. Population 

centers usually contain a large 

concentration of the establishments 

FDA intends to sample. Sampling from 

the 175-mile radius sampling zones 

around the Specialists’ home locations 

provides three advantages to the study: 

1. It provides a cross-section of urban 

and rural areas from which to sample 

the eligible establishments. 

2. It represents a mix of small, 

medium, and large regulatory entities 

having jurisdiction over the eligible 

establishments. 

3. It reduces overnight travel and, 

therefore, reduces travel costs incurred 

by the Agency to collect data. 

The sample for each data collection 

period is evenly distributed among 


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40858 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 

Specialists. Given that participation in 

the study by industry is voluntary and 

the status of any given randomly 

selected establishment is subject to 

change, substitute establishments have 

been selected for each Specialist for 

cases where the restaurant facility is 

misclassified, closed, or otherwise 

unavailable, unable, or unwilling to 

participate. 

Prior to conducting the data 

collection, Specialists contact the State 

or local jurisdiction that has regulatory 

responsibility for conducting retail food 

inspections for the selected 

establishment. The Specialist verifies 

with the jurisdiction that the facility has 

been properly classified for the 

purposes of the study and is still in 

operation. The Specialist ascertains 

whether the selected facility is under 

legal notice from the State or local 

regulatory authority. If the selected 

facility is under legal notice, the 

Specialist will not conduct a data 

collection, and a substitute 

establishment will be used. An 

invitation is extended to the State or 

local regulatory authority to accompany 

the Specialist on the data collection 

visit. 

A standard form is used by the 

Specialists during each data collection. 

The form is divided into three sections: 

Section 1—‘‘Establishment 

Information’’; Section 2—‘‘Regulatory 

Authority Information’’; and Section 3— 

‘‘Foodborne Illness Risk Factor and 

Food Safety Management System 

Assessment.’’ The information in 

Section 1 ‘‘Establishment Information’’ 

of the form is obtained during an 

interview with the establishment owner 

or person in charge by the Specialist 

and includes a standard set of questions. 

The information in Section 2— 

‘‘Regulatory Authority Information’’ is 

obtained during an interview with the 

program director of the State or local 

jurisdiction that has regulatory 

responsibility for conducting 

inspections for the selected 

establishment. 

Section 3—‘‘Foodborne Illness Risk 

Factor and Food Safety Management 

System Assessment’’ includes three 

parts: Part A for tabulating the 

Specialists’ observations of the food 

employees’ behaviors and practices in 

limiting contamination, proliferation, 

and survival of food safety hazards; Part 

B for assessing the food safety 

management system being implemented 

by the facility; and Part C for assessing 

the frequency and extent of food 

employee handwashing. The 

information in Part A is collected from 

the Specialists’ direct observations of 

food employee behaviors and practices. 

Infrequent, nonstandard questions may 

be asked by the Specialists if 

clarification is needed on the food safety 

procedure or practice being observed. 

The information in Part B is collected by 

making direct observations and asking 

followup questions of facility 

management to obtain information on 

the extent to which the food 

establishment has developed and 

implemented food safety management 

systems. The information in Part C is 

collected by making direct observations 

of food employee handwashing. No 

questions are asked in the completion of 

Section 3, Part C of the form. 

FDA collects the following 

information associated with the 

establishment’s identity: Establishment 

name, street address, city, State, ZIP 

Code, county, industry segment, and 

facility type. The establishmentidentifying information is collected to 

ensure the data collections are not 

duplicative. Other information related 

to the nature of the operation, such as 

seating capacity and number of 

employees per shift, is also collected. 

Data will be consolidated and reported 

in a manner that does not reveal the 

identity of any establishment included 

in the study. 

FDA has collaborated with the Food 

Protection and Defense Institute to 

develop a web-based platform in 

FoodSHIELD to collect, store, and 

analyze data for the Retail Risk Factor 

Study. This platform is accessible to 

State, local, territorial, and tribal 

regulatory jurisdictions to collect data 

relevant to their own risk factor studies. 

For the 2015–2016 data collection, FDA 

piloted the use of hand-held technology 

for capturing the data onsite during the 

data collection visits. The tablets that 

were made available for the data 

collections were part of a broader 

Agency initiative focused on internal 

uses of hand-held technology. The 

tablets provided for the data collection 

presented several technical and 

logistical challenges and increased the 

time burden associated with the data 

collection as compared to the manual 

entry of data collections. For these 

reasons, FDA will not be further 

evaluating hand-held technology in 

subsequent data collections during the 

10-year study period. 

When a data collector is assigned a 

specific establishment, he or she 

conducts the data collection and enters 

the information into the web-based data 

platform. The interface will support the 

manual entering of data, as well as the 

ability to directly enter information in 

the database via a web browser. 

The burden for the 2021–2022 data 

collection is as follows. For each data 

collection, the respondents will include: 

(1) The person in charge of the selected 

facility (whether it be a fast- food or fullservice restaurant); and (2) the program 

director (or designated individual) of 

the respective regulatory authority. In 

order to provide the sufficient number 

of observations needed to conduct a 

statistically significant analysis of the 

data, FDA has determined that 400 data 

collections will be required in each of 

the two restaurant facility types. 

Therefore, the total number of responses 

will be 1,600 (400 data collections × 2 

facility types × 2 respondents per data 

collection). 

The burden associated with the 

completion of Sections 1 and 3 of the 

form is specific to the persons in charge 

of the selected facilities. The burden 

includes the time it will take the person 

in charge to accompany the data 

collector during the site visit and 

answer the data collector’s questions. 

The burden related to the completion of 

Section 2 of the form is specific to the 

program directors (or designated 

individuals) of the respective regulatory 

authorities. The burden includes the 

time it will take to answer the data 

collectors’ questions and is the same 

regardless of the facility type. 

In the Federal Register of March 16, 

2021 (86 FR 14433), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received two 

comments; only one comment we 

received was responsive to the four 

collection of information topics 

solicited. 

(Comment) The Academy of Nutrition 

and Dietetics (the Academy) commented 

that they support the proposed 

information collection for the survey on 

the occurrence of foodborne illness risk 

factors in various settings. The Academy 

provided comments pertaining to the 

following general areas of the study: 

a. Question whether 90 minutes is 

adequate for surveying larger facilities. 

b. Request FDA evaluate the impact of 

conducting surveys during peak hours 

of operation. 

c. Suggest that the use of gloves is not 

adequately addressed in the survey. 

d. Encourage continued efforts to 

simplify and standardize expiration 

dates. 

Related to foodservice operations at 

the retail level, the Academy provided 

the following comments: 

e. FDA consider modifying the survey 

to account for new foods and new 

means of conveying food. 

The Academy provided the following 

comment specific to pandemic-related 

considerations: 


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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 40859 

f. FDA consider modifying the survey 

to include trends for hot-holding and 

online delivery due to the COVID–19 

pandemic. 

The Academy also provided 

comments related to statistical analysis 

and data sharing: 

g. FDA make the dataset public for 

further analysis. 

h. FDA consider peer review of the 

report. 

(Response) FDA thanks the submitter 

for their comments and appreciates their 

support. Regarding general areas of the 

study, FDA provides the following 

responses: 

a. The current 10-year study estimates 

90 minutes as the average time needed 

to adequately collect necessary 

information, taking into account both 

small and large facilities. This average 

time is consistent with the amount of 

time burden estimated for the previous 

data collection periods and provides a 

sufficient timeframe to observe food 

safety practices and procedures that are 

the focus of the study. 

b. Based on the methodology of the 

study, the information collection is 

performed during hours of operation of 

the randomly selected facility. Data 

collections are scheduled at times that 

provide the best opportunity to observe 

food preparation activities, which often 

include peak operations. 

c. Information collection related to 

handwashing and no bare hand contact 

with ready-to-eat foods, which may 

include use of gloves, is based on 

assessment of observations against the 

most current addition of the FDA Model 

Food Code. Provisions of the FDA Food 

Code identify when handwashing and 

no bare hand contact with ready-to-eat 

food are required during food 

preparation and service. The current 

FDA Food Code does not recognize the 

use of hand antiseptics in lieu of 

handwashing during food preparation 

and service. 

d. The scope of this data collection 

focuses on foodborne illness risk factors 

and does not include assessment of 

expiration dates of manufactured foods 

as part of this research assessment. 

Related to foodservice operations at 

the retail level, FDA provides the 

following responses: 

e. The study design accounts for a 

variety of food conveyances in the retail 

food setting. The study includes four 

major segments of the retail and 

foodservice industries that account for 

over a million varied and diverse types 

of operations in the United States: 

• Restaurants 

• Healthcare Facilities 

• Schools (K–12) 

• Retail Food Stores 

Related to the Academy’s comments 

on pandemic-related considerations, 

FDA provides the following response: 

f. The study design is based on 

operations regardless of extenuating 

circumstances. While there is utility in 

investigating the trends in food service, 

this study must focus its efforts 

throughout the 10-year period to ensure 

data can be adequately trended. Two of 

the three data collections for this 

trending were already complete before 

the pandemic and a singular data point 

with these new metrics would not be of 

much utility. FDA fully supports the 

New Era of Smarter Food Safety 

blueprint and endeavors to collect data 

to support that effort. 

Regarding statistical analysis and data 

sharing, FDA provides the following 

responses: 

g. FDA strives to ensure the data is 

available to parties upon request. 

Additionally, a new Topline Summary 

is published to https://www.fda.gov/ 

food/retail-food-protection/retail-foodrisk-factor-study along with the 

technical report, with much of the data 

commonly requested for independent 

analysis. 

h. FDA acknowledges the benefit of 

peer review. For any manuscripts 

published resulting from the dataset, 

peer review is sought. For the technical 

report of the data, FDA will continue to 

utilize the format which is familiar to 

and accepted by our stakeholders. 

To calculate the estimate of the hours 

per response, FDA will use the average 

data collection duration for the same 

facility types during the 2015–2016 data 

collection. FDA estimates that it will 

take the persons in charge of full-service 

restaurants and fast-food restaurants 104 

minutes (1.73 hours) and 82 minutes 

(1.36 hours), respectively, to accompany 

the data collectors while they complete 

Sections 1 and 3 of the form. In 

comparison, for the 2017–2018 data 

collection, the burden estimate was 106 

minutes (1.76 hours) in full-service 

restaurants and 73 minutes (1.21 hours) 

in fast-food restaurants. FDA estimates 

that it will take the program director (or 

designated individual) of the respective 

regulatory authority 30 minutes (0.5 

hours) to answer the questions related to 

Section 2 of the form. This burden 

estimate is unchanged from the last data 

collection. Hence, the total burden 

estimate for a data collection in a fullservice restaurant, including both the 

program director’s and the person in 

charge’s responses, is 134 minutes (104 

+ 30) (2.23 hours). The total burden 

estimate for a data collection in a fastfood restaurant, including both the 

program director’s and the person in 

charge’s responses, is 112 minutes (82 + 

30) (1.86 hours). 

Based on the number of entry refusals 

from the 2017–2018 data collection, we 

estimate a refusal rate of 2 percent for 

the data collections within restaurant 

facility types. The estimate of the time 

per non-respondent is 5 minutes (0.08 

hours) for the person in charge to listen 

to the purpose of the visit and provide 

a verbal refusal of entry. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Number 

of nonrespondents 

Number of 

responses 

per nonrespondent 

Total 

annual nonresponses 

Average 

burden per 

response 

Total 

hours 

2021–2022 Data Collection (Fast-Food Restaurants)—Completion 

of Sections 1 and 3 ...... 400 1 400 .................... .................... .................... 1.36 544 

2021–2022 Data Collection (Full-Service Restaurants)—Completion 

of Sections 1 and 3 ...... 400 1 400 .................... .................... .................... 1.73 692 


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40860 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Number 

of nonrespondents 

Number of 

responses 

per nonrespondent 

Total 

annual nonresponses 

Average 

burden per 

response 

Total 

hours 

2021–2022 Data Collection-Completion of Section 2—All Facility 

Types ............................ 800 1 800 .................... .................... .................... 0.5 (30 

minutes) 

400 

2021–2022 Data Collection-Entry Refusals—All 

Facility Types ............... .................... .................... .................... 16 1 16 0.08 (5 

minutes) 

1.28 

Total Hours ............... .................... .................... .................... .................... .................... .................... .................... 1,637.28 

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. 

II. References 

The following references are on 

display in the Dockets Management 

Staff (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500 and are available for viewing by 

interested persons between 9 a.m. and 4 

p.m., Monday through Friday; they are 

also available electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA, ‘‘Report of the FDA Retail Food 

Program Database of Foodborne Illness 

Risk Factors (2000).’’ Available at 

https://wayback.archive-it.org/7993/ 

20170406023019/https://www.fda.gov/ 

downloads/Food/GuidanceRegulation/ 

UCM123546.pdf. 

2. FDA, ‘‘FDA Report on the Occurrence of 

Foodborne Illness Risk Factors in 

Selected Institutional Foodservice, 

Restaurant, and Retail Food Store 

Facility Types (2004).’’ Available at 

https://wayback.archive-it.org/7993/ 

20170406023011/https://www.fda.gov/ 

downloads/Food/GuidanceRegulation/ 

RetailFoodProtection/ 

FoodborneIllnessRiskFactorReduction/ 

UCM423850.pdf. 

3. FDA, ‘‘FDA Report on the Occurrence of 

Foodborne Illness Risk Factors in 

Selected Institutional Foodservice, 

Restaurant, and Retail Food Store 

Facility Types (2009).’’ Available at 

https://wayback.archive-it.org/7993/ 

20170406023004/https://www.fda.gov/ 

Food/GuidanceRegulation/ 

RetailFoodProtection/ 

FoodborneIllnessRiskFactorReduction/ 

ucm224321.htm. 

4. FDA National Retail Food Team, ‘‘FDA 

Trend Analysis Report on the 

Occurrence of Foodborne Illness Risk 

Factors in Selected Institutional 

Foodservice, Restaurant, and Retail Food 

Store Facility Types (1998–2008).’’ 

(2010). Available at https://

wayback.archive-it.org/7993/ 

20170406022950/https://www.fda.gov/ 

Food/GuidanceRegulation/ 

RetailFoodProtection/ 

FoodborneIllnessRiskFactorReduction/ 

ucm223293.htm. 

5. FDA, ‘‘FDA Food Code.’’ Available at 

https://www.fda.gov/FoodCode. 

Dated: July 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16199 Filed 7–28–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–New] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before September 27, 

2021. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–New–60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, or call (202) 

795–7714 the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Institutional 

Review Board (IRB) Records for HHS/ 

OASH Consultation Process. 

Type of Collection: New. 

OMB No.: OS–0990–New. 

Abstract: The Office of the Assistant 

Secretary for Health, Office for Human 

Research Protections is requesting a new 

approval from the Office of Management 

and Budget of the Office for Human 

Research Protections (OHRP) 

requirement that Institutional Review 

Board records be submitted when an 

IRB or its institution request an HHS 

consultation process, for proposed 

research involving, respectively: (1) 

Pregnant women, human fetuses and 

neonates; (2) prisoners; or, (3) children, 

as subjects that are not otherwise 

approval by an IRB. The Office of the 

Assistant Secretary for Health, on behalf 

of the Secretary of HHS, may determine 

that such research can be conducted or 

supported by HHS after consulting with 

experts and allowing for public review 

of, and comment on, the proposed 

research. 

Likely Respondents: Institutional 

Review Boards (IRBs). 


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