Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 10087 

or any future superseding electronic 

system, unless FDA has granted a 

request for waiver of this requirement 

prior to the date on which the 

information is due (21 CFR 607.22(a)). 

Waiver requests must be submitted in 

writing and must include, among other 

information, the specific reasons why 

electronic submission is not reasonable 

for the registrant (21 CFR 607.22(b)). 

Establishment registration and product 

listing information assists FDA in its 

inspections of facilities, among other 

uses, and its collection is essential to 

the overall regulatory scheme designed 

to ensure the safety of the Nation’s 

blood supply. 

Description of Respondents: 

Respondents to this collection of 

information are human blood and 

plasma donor centers, blood banks, 

certain transfusion services, other blood 

product manufacturers, independent 

laboratories that engage in quality 

control and testing for registered blood 

product establishments and 

manufacturers of devices licensed under 

section 351 of the Public Health Service 

Act. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; information collection activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 

(in hours) 

Total hours 

607.20(a), 607.21, 607.22, 607.25, 607.40; Initial registration.152 1 152 1 ........................... 152 

607.21, 607.22, 607.25, 607.26, 607.31, 607.40; Annual registration.2,557 1 2,557 0.5 (30 minutes) ... 1,279 

607.21, 607.25, 607.30(a), 607.31, 607.40; Product 

listing update.

256 1 256 0.25 (15 minutes) 64 

607.22(b); Waiver request ............................................. 1 1 1 1 ........................... 1 

Total ....................................................................... ........................ ........................ ........................ .............................. 1,496 

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

Based on our evaluation of Fiscal Year 

2019 data from CBER’s Blood 

Establishment Registration and Product 

Listing system, we have adjusted the 

currently approved burden estimate we 

attribute to establishment registration 

and product listing to reflect a slight 

increase in submissions; however, the 

overall burden has not changed. 

Dated: February 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03249 Filed 2–17–21; 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; Proposed Collection; 

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 or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the Survey on the 

Occurrence of Foodborne Illness Risk 

Factors in Selected Institutional 

Foodservice and Retail Food Stores 

Facility Types. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 19, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before April 19, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 19, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

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.’’ 


jbell on DSKJLSW7X2PROD with NOTICES
10088 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–0270 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Survey 

on the Occurrence of Foodborne Illness 

Risk Factors in Selected Institutional 

Foodservice and Retail Food Stores 

Facility Types.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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: 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: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Survey on the Occurrence of Foodborne 

Illness Risk Factors in Selected 

Institutional Foodservice and Retail 

Food Stores Facility Types 

OMB Control Number 0910–0799— 

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 were 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, which were 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 to 2014, FDA 

initiated a new study period. This study 

will span 10 years. FDA completed the 

baseline data collection in select 

healthcare, schools, and retail food store 

facility types in 2015 to 2016, and these 

data are being evaluated for trends and 

significance. A second data collection 

began in 2019 to 2020 and will be 

completed if it is safe to do so (pending 

COVID–19 pandemic), and an 

additional data collection is planned for 

2023 to 2024 (the subject of this 

information collection request 

extension). Three data collections are 

necessary to trend the data. 

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: 


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

Facility type Description 

• 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: 

• Seafood department/operation—Areas in a retail food store where seafood is cut, prepared, stored, or displayed for sale to the consumer. In retail food stores where the seafood department is combined with another department (e.g., meat), the data collector will only assess the procedures and practices associated 

with the processing of seafood. 

• Produce department/operation—Areas in a retail food store where produce is cut, prepared, stored, or displayed for sale to the consumer. A produce operation may include salad bars or juice stations that are 

managed by the produce manager. 

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 

select retail food establishments 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 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., 

establishments 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 25 Regional 

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. 


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The sample for each data collection 

period is evenly distributed among 

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 institutional 

foodservice, school, or retail food store 

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 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 hand washing. 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 hand washing. 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 establishment 

identifying 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 to 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 

FDA 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 incorporating 

use of 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 2023 to 2024 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 healthcare 

facility, school, or supermarket/grocery 

store); and (2) the program director (or 

designated individual) of the respective 

regulatory authority. 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 three 

facility types. Therefore, the total 

number of responses will be 2,400 (400 

data collections x 3 facility types x 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. This burden includes the 

time it will take to answer the data 

collectors’ questions and is the same 

regardless of the facility type. 

To calculate the estimate of the hours 

per response, FDA uses the average data 

collection duration for similar facility 

types during the FDA’s 2008 Risk Factor 

Study (Ref. 3) plus an additional 30 

minutes (0.5 hours) for the information 

related to Section 3, Part B of the form. 

FDA estimates that it will take the 

persons in charge of healthcare facility 

types, schools, and retail food stores 150 

minutes (2.5 hours), 120 minutes (2 

hours), and 180 minutes (3 hours), 

respectively, to accompany the data 

collectors while they complete Sections 

1 and 3 of the form. 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 

healthcare facility types is 180 minutes 

(150 + 30) (3 hours), in schools is 150 

minutes (120 + 30) (2.5 hours), and 

retail food stores is 210 minutes (180 + 

30) (3.5 hours). 

Based on the number of entry refusals 

from the 2015 to 2016 baseline data 

collection, we estimate a refusal rate of 

2 percent for the data collections within 

healthcare, school, and retail food store 

facility types. The estimate of the time 

per non-respondent is 5 minutes (0.08 

hours) for the person in charge to listen 


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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 

non-respondents 

Number of 

responses per 

non-respondent 

Total annual 

non-responses 

Average burden 

per response 

Total 

hours 

2023–2024 Data Collection (Healthcare Facilities)—Completion of Sections 1 and 3.400 1 400 ............................ .......................... .......................... 2.5 .......................... 1,000 

2023–2024 Data Collection (Schools)—Completion of Sections 1 and 3.400 1 400 ............................ .......................... .......................... 2 ............................. 800 

2023–2024 Data Collection (Retail Food Stores)— 

Completion of Sections 1 and 3.

400 1 400 ............................ .......................... .......................... 3 ............................. 1,200 

2023–2024 Data Collection-Completion of Section 

2—All Facility Types.

1,200 1 1,200 ............................ .......................... .......................... 0.5 (30 minutes) ..... 600 

2023–2024 Data Collection-Entry Refusals—All 

Facility Types.

...................... .......................... ...................... 24 1 24 0.08 (5 minutes) ..... 1.92 

Total ................................................................. 3,601.92 .......................... ...................... ............................ .......................... .......................... ................................ ................

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 (see ADDRESSES) 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. ‘‘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 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 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 Food Code.’’ Available at: https://

www.fda.gov/food/retail-food-protection/ 

fda-food-code. 

Dated: February 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03248 Filed 2–17–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute on 

Aging Special Emphasis Panel, March 

15, 2021, 10:00 a.m. to March 15, 2021, 

07:00 p.m., National Institute on Aging, 

Gateway Building, 7201 Wisconsin 

Avenue, Bethesda, MD 20892, which 

was published in the Federal Register 

on February 04, 2021, 86 FR 8215. 

The meeting notice is amended to 

change the date of the meeting from 

March 1, 2021 to March 15, 2021. The 

meeting is closed to the public. 

Dated: February 12, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–03255 Filed 2–17–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Meeting of the National Advisory 

Council for Healthcare Research and 

Quality 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of public meeting. 

SUMMARY: This notice announces a 

meeting of the National Advisory 

Council for Healthcare Research and 

Quality. 

DATES: The meeting will be held on 

Thursday, March 18, 2021, from 10:00 

a.m. to 2:00 p.m. 

ADDRESSES: The meeting will be held 

virtually. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Zimmerman, Designated 

Management Official, at the Agency for 

Healthcare Research and Quality, 5600 

Fishers Lane, Mail Stop 06E37A, 

Rockville, Maryland, 857, (301) 427– 

1456. For press-related information, 

please contact Bruce Seeman at (301) 

427–1998 or Bruce.Seeman@

AHRQ.hhs.gov. 

Closed captioning will be provided 

during the meeting. If another 

reasonable accommodation for a 

disability is needed, please contact the 

Food and Drug Administration (FDA) 

Office of Equal Employment 

Opportunity and Diversity Management 

on (301) 827–4840, no later than 

Monday, March 1, 2021. The agenda, 

roster, and minutes will be available 

from Ms. Heather Phelps, Committee 

Management Officer, Agency for 

Healthcare Research and Quality, 5600 

Fishers Lane, Rockville, Maryland, 

20857. Ms. Phelps’ phone number is 

(301) 427–1128. 

SUPPLEMENTARY INFORMATION: 


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