Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices 42845 

Devices.’’ It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products or from the 

Center for Biologics Evaluation and 

Research at https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances. This 

guidance document is also available at 

https://www.regulations.gov and https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Remanufacturing of 

Medical Devices’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 17048 and complete title to 

identify the guidance you are 

requesting. 

Dated: July 30, 2021. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2021–16695 Filed 8–4–21; 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; 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, 

Health and Human Services (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: Submit written comments 

(including recommendations) on the 

collection of information by September 

7, 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 0910–0799. 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— 

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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42846 Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices 

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 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., 

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 23 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. 


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Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices 42847 

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 

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—‘‘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 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 × 3 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. This 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 February 

18, 2021 (86 FR 10087), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment. 

(Comment) An interested citizen 

submitted the following comment: 

a. The previous 10-year study 

conducted by FDA did not mention 

negative trends in the ‘‘other’’ category, 

which included information about 

contamination risk factors as they relate 

to food or color additives, poisonous or 

toxic materials, or storage of poisonous 

or toxic materials for retail sale. This 

negative trend should be reported. 

b. In the 2013 to 2014 report on 

restaurants the ‘‘other’’ contamination 

risk factor did not appear in the report. 

This should remain the same as the 

previous 10-year study for comparison 

purposes. 

c. FDA should keep chemicals as a 

risk factor for future research on the 

occurrence of foodborne illness risk 

factors. 

(Response) FDA acknowledges the 

submission of the question from a 

concerned citizen and provides the 

following response: 


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a. FDA acknowledges the 

commenter’s concern on a perceived 

lack of reporting on negative trends 

within the previous 10-year study. 

b. FDA report on the results of the 

2013 to 2014 data collection was the 

first report with the new study design of 

the 10-year study. One of the significant 

design changes from the 1998 to 2008 

Study is the reduction of the number of 

data items from 42 to 10. The focus on 

the 10 primary data items provides the 

opportunity to obtain enough 

observations of food safety practices and 

procedures to report statistically 

significant study conclusions and 

correlations. 

In an effort to focus messaging on the 

most prevalent food safety practices and 

behaviors found out of compliance, 

secondary data items (items 11–19) were 

not reported at that time. FDA focused 

the report on the primary 10 data items 

that directly correspond with the 

foodborne illness risk factors included 

in the study. The new study design 

includes ‘‘Other Areas of Interest’’ that 

support the primary data items or track 

an area that is not likely to have a 

sufficient enough number of 

observations for statistical purposes but 

is an important food safety practice 

within the retail segment of the 

industry—such as Item 18, ‘‘Toxic 

materials are identified, used, and 

stored properly as outlined in the 

marking instructions’’, (Attachment B). 

The current data collection continues to 

collect information on the provisions 

within the food code that address the 

safe storage, handling, and use of toxic 

and poisonous substances. If significant 

findings occur, FDA is committed to 

reporting those findings. From the 2015 

data collection forward, FDA will be 

publishing a topline summary report to 

include information on data items 11– 

18. These reports can be accessed at 

https://www.fda.gov/retailfoodrisk

factorstudy. 

c. While not listed as one of the five 

main foodborne illness risk factors in 

the current study design, controlling 

chemicals and toxic substances in food 

service facilities is important to prevent 

injury and illness and FDA recognizes 

this. The information gathered in Data 

Item 18 as described above helps FDA 

keep a pulse on risky behaviors 

surrounding toxic or poisonous 

materials in retail facilities. The purpose 

of the current 10-year study is primarily 

to collect information on the five 

foodborne illness risk factors and study 

to elucidate relationships between the 

foodborne illness risk factors and food 

safety management systems, and 

certified food protection managers. 

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 

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 CollectionCompletion of Section 2— 

All Facility Types.

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

2023–2024 Data CollectionEntry 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 (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. ‘‘Report of the FDA Retail Food Program 

Database of Foodborne Illness Risk 


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Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices 42849 

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/FoodborneIllness

RiskFactorReduction/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/RetailFood

Protection/FoodborneIllnessRiskFactor

Reduction/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/RetailFood

Protection/FoodborneIllnessRiskFactor

Reduction/ucm223293.htm. 

5. ‘‘FDA Food Code.’’ Available at: https://

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

fda-food-code. 

Dated: July 28, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16700 Filed 8–4–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0771] 

Advancing the Development of 

Pediatric Therapeutics Complex 

Innovative Trial Design; Public 

Workshop 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

following public workshop entitled 

‘‘Advancing the Development of 

Pediatric Therapeutics (ADEPT 7) 

Complex Innovative Trial Design.’’ The 

purpose of the public workshop is to 

discuss applications of complex and 

innovative trial designs in pediatric 

clinical trials. 

DATES: The public workshop will be 

held virtually on September 1, 2021 

(Day 1), from 10 a.m. to 3 p.m. Eastern 

Time and September 2, 2021 (Day 2), 

from 10 a.m. to 3 p.m. Eastern Time. See 

the SUPPLEMENTARY INFORMATION section 

for registration information. 

ADDRESSES: The public workshop will 

be held in virtual format only. Please 

note that due to the impact of this 

COVID–19 pandemic, all meeting 

participants will be joining this public 

meeting via an online teleconferencing 

platform and will not be held at a 

specific location. 

FOR FURTHER INFORMATION CONTACT: 

Evangela Covert, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5234, 

Silver Spring, MD 20993, 301–796– 

4075, Evangela.Covert@fda.hhs.gov; or 

Denise Pica-Branco, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6402, 

Silver Spring, MD 20993, 301–796– 

4075, Denise.Picabranco@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Over the last two decades, great 

advances have been made in pediatric 

drug development. In addition, there is 

a growing recognition that complex and 

innovative trial designs have the 

potential to optimize drug development 

in small populations. Innovations that 

have been proposed include Bayesian 

and other methods of utilizing external 

historical information from previous 

pediatric trials or other populations 

(such as adults), adaptive designs, 

bridging biomarkers, etc. These designs 

tend to require more extensive 

discussion and collaboration between 

drug developers and regulators to 

implement effectively. 

The Complex Innovative Trial Design 

Pilot Meeting Program (CID Program) 

facilitates and advances the use of these 

types of designs by providing for 

increased interactions between staff in 

the Center for Drug Evaluation and 

Research and the Center for Biologics 

Evaluation and Research and sponsors 

accepted into the program. Several 

pediatric study designs have been 

accepted into the CID Program. This 

workshop is being organized in 

collaboration with the CID Program. 

II. Topics for Discussion at the Public 

Workshop 

The main objective of the ‘‘Advancing 

the Development of Pediatric 

Therapeutics (ADEPT 7) Complex 

Innovative Trial Design’’ workshop is to 

discuss opportunities for leveraging 

complex and innovative trial designs, 

understand the challenges with their 

applications, and develop solutions on 

how challenges in the designs can be 

overcome. The workshop will 

specifically focus on two topics of 

interest: Bridging biomarkers in 

pediatric extrapolation and Bayesian 

techniques in pediatric studies. In 

addition, the workshop will allow for an 

open dialogue around the use of these 

approaches among regulators, industry, 

academia, and patient organizations. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit the following 

website: https://go.umd.edu/ADEPT7. 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Early registration is 

recommended because space is limited; 

therefore, FDA may limit the number of 

participants from each organization. 

If you need special accommodations 

due to a disability, please contact 

Evangela Covert or Denise PicaBranco (see FOR FURTHER INFORMATION

CONTACT) no later than August 18, 2021, 

by 5 p.m. Eastern Time. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast at the following site: 

https://collaboration.fda.gov/adept7. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the website addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

Dated: August 2, 2021. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2021–16709 Filed 8–4–21; 8:45 am] 

BILLING CODE 4164–01–P 


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