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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