49548 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 

requested to make their presentation on 

or before October 5, 2021. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 6, 2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact She-Chia Chen 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 30, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19024 Filed 9–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–4844] 

‘‘Ruby Chocolate’’ Deviating From 

Identity Standard; Temporary Permit 

for Market Testing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the extension of a 

temporary permit issued to Barry 

Callebaut U.S.A. LLC (the applicant) to 

market test products (designated as 

‘‘ruby chocolate’’) that deviate from the 

U.S. standards of identity for cacao 

products. The extension allows the 

applicant to continue to evaluate 

commercial viability of the product and 

to collect data on consumer acceptance 

of the product in support of a petition 

to establish a standard of identity for 

‘‘ruby chocolate.’’ We also invite other 

interested parties to participate in the 

market test. 

DATES: The new expiration date of the 

permit will be either the effective date 

of a final rule establishing a standard of 

identity for ‘‘ruby chocolate’’ that may 

result from the petition or 30 days after 

denial of the petition. 

FOR FURTHER INFORMATION CONTACT: 

Marjan Morravej, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

2371; or Carrol Bascus, Center for Food 

Safety and Applied Nutrition, Office of 

Regulations and Policy (HFS–024), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

2378. 

SUPPLEMENTARY INFORMATION: In 

accordance with § 130.17 (21 CFR 

130.17), we issued a temporary permit 

to Barry Callebaut U.S.A. LLC, 600 West 

Chicago Ave, Suite 860, Chicago, IL 

60654, to market test products identified 

as ‘‘ruby chocolate’’ that deviate from 

the requirements of the standards of 

identity for cacao products in part 163 

(21 CFR part 163) (84 FR 64541, 

November 22, 2019). We issued the 

permit to facilitate market testing of 

products that deviate from the 

requirements of the standard of identity 

for cacao products issued under section 

401 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 341). The 

permit covers limited interstate 

marketing tests of products identified as 

‘‘ruby chocolate.’’ These test products 

deviate from the U.S. standards of 

identity for cacao products (§§ 163.111, 

163.123, 163.124, 163.130, 163.135, 

163.140, and 163.145). 

For the purpose of this permit, ‘‘ruby 

chocolate’’ is the solid or semi-plastic 

food prepared by mixing and grinding 

cacao fat with one or more of the cacao 

ingredients (namely, chocolate liquor, 

breakfast cocoa, cocoa, and low-fat 

cocoa), citric acid, one or more of 

optional nutritive carbohydrate 

sweeteners. ‘‘Ruby chocolate’’ contains 

not less than 1.5 percent nonfat cacao 

solids, not less than 2.5 percent by 

weight of milk fat, not less than 12 

percent by weight of total milk solids, 

not more than 1.5 percent of 

emulsifying agents, and not more than 

5 percent of whey or whey products. It 

may also contain other ingredients such 

as antioxidants approved for food use, 

spices, natural and artificial flavorings, 

and other seasonings. However, these 

other ingredients cannot imitate the 

flavor of chocolate, milk, butter, berry, 

or another fruit. Additionally, ‘‘ruby 

chocolate’’ contains no added coloring. 

The test product ‘‘ruby chocolate’’ 

contains the principal ingredients used 

in most of the current standards for 

cacao products under part 163; 

however, it deviates from the current 

standard of identify for chocolate 

products in terms of its final 

composition, taste, and color. 

On February 19, 2021, the applicant 

asked us to extend the temporary permit 

so the applicant could have more time 

to market test the ‘‘ruby chocolate’’ and 

gain additional consumer acceptance in 

support of the petition to establish a 

standard for ‘‘ruby chocolate.’’ We find 

that it is in the interest of consumers to 

extend the permit for continued market 

testing of ‘‘ruby chocolate’’ to gain 

additional information on consumer 

expectations and acceptance. Therefore, 

under § 130.17(i), we are extending the 

temporary permit granted to Barry 

Callebaut U.S.A. LLC for temporary 

marketing of approximately 60 million 

pounds (27,215,540 kilograms) of ‘‘ruby 

chocolate’’ to provide continued market 

testing of the specified amount of 

product for the applicant on an annual 

basis. The test products will bear the 

name ‘‘ruby chocolate.’’ The new 

expiration date of the permit will be 

either the effective date of a final rule 

establishing a standard of identity for 

‘‘ruby chocolate’’ that may result from 

the petition or 30 days after denial of 

the petition. All other conditions and 

terms of this permit remain the same. 

In addition, we invite interested 

persons to participate in the market test 

under the conditions of the permit, 

except for the designated area of 

distribution. Any person who wishes to 

participate in the extended market test 

should notify, in writing, the Branch 

Chief, Product Evaluation Labeling 

Branch, Division of Food Labeling and 

Standards, Office of Nutrition and Food 

Labeling, Center for Food Safety and 

Applied Nutrition (HFS–820), Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740. The 

notification must describe the amount to 

be distributed, the area of distribution, 

and include the labeling that will be 

used for the test product (see 

§ 130.17(i)). For information on what to 

include in the notification to FDA, see 

§ 130.17(c). Test products must be 

labeled in accordance with 21 CFR part 

101. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 49549 

Dated: August 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy 

[FR Doc. 2021–19096 Filed 9–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Advisory Committee on 

Blood and Tissue Safety and 

Availability 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The U.S. Department of 

Health and Human Services is hereby 

giving notice that the Advisory 

Committee on Blood and Tissue Safety 

and Availability (ACBTSA) will hold a 

virtual meeting. The meeting will be 

open to the public. The committee will 

discuss and vote on recommendations 

to improve the supply chain and data 

infrastructure that supports the blood 

industry, especially during public 

health emergencies. This meeting will 

build upon the presentations and 

discussions held during the 53rd 

ACBTSA meeting from August 17–18, 

2021. 

DATES: The meeting will take place 

virtually on Thursday, September 23, 

2021 from approximately 1:00 p.m.–4:00 

p.m. Eastern Time (ET). Meeting times 

are tentative and subject to change. The 

confirmed times and agenda items for 

the meeting will be posted on the 

ACBTSA web page at https://

www.hhs.gov/oidp/advisory-committee/ 

blood-tissue-safety-availability/ 

meetings/2021-09-23/index.html when 

this information becomes available. 

FOR FURTHER INFORMATION CONTACT: 

James Berger, Designated Federal Officer 

for the ACBTSA; Office of Infectious 

Disease and HIV/AIDS Policy, Office of 

the Assistant Secretary for Health, 

Department of Health and Human 

Services, Mary E. Switzer Building, 330 

C Street SW, Suite L600, Washington, 

DC 20024. Email: ACBTSA@hhs.gov. 

SUPPLEMENTARY INFORMATION: ACBTSA 

is a discretionary Federal advisory 

committee. ACBTSA The Committee is 

governed by the provisions of the 

Federal Advisory Committee Act 

(FACA), Public Law 92–463, as 

amended (5 U.S.C. app), which sets 

forth standards for the formation and 

use of advisory committees. On the day 

of the meeting, please go to https://

www.hhs.gov/live/index.html to view 

the meeting. The public will have an 

opportunity to present their views to the 

ACBTSA by submitting a written public 

comment. Comments should be 

pertinent to the meeting discussion. 

Persons who wish to provide written 

public comment should review 

instructions at https://www.hhs.gov/ 

oidp/advisory-committee/blood-tissuesafety-availability/meetings/2021-09-23/ 

index.html and respond by midnight 

September 16, 2021, ET. Written public 

comments will be accessible to the 

public on the ACBTSA web page prior 

to the meeting. 

ACBTSA functions to provide advice 

to the Secretary through the Assistant 

Secretary for Health on a range of policy 

issues to include: (1) Identification of 

public health issues through 

surveillance of blood and tissue safety 

issues with national survey and data 

tools; (2) identification of public health 

issues that affect availability of blood, 

blood products, and tissues; (3) broad 

public health, ethical, and legal issues 

related to the safety of blood, blood 

products, and tissues; (4) the impact of 

various economic factors (e.g., product 

cost and supply) on safety and 

availability of blood, blood products, 

and tissues; (5) risk communications 

related to blood transfusion and tissue 

transplantation; and (6) identification of 

infectious disease transmission issues 

for blood, organs, blood stem cells and 

tissues. The Committee has met 

regularly since its establishment in 

1997. 

Dated: August 27, 2021. 

James J. Berger, 

Designated Federal Officer, Advisory 

Committee on Blood and Tissue Safety and 

Availability, Office of Infectious Disease and 

HIV/AIDS Policy. 

[FR Doc. 2021–19026 Filed 9–2–21; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Federal Licensing of Office of Refugee 

Resettlement Facilities Request for 

Information 

AGENCY: Office of Refugee Resettlement 

(ORR), Administration for Children and 

Families (ACF), Department of Health 

and Human Services (HHS). 

ACTION: Request for information. 

SUMMARY: The Unaccompanied Children 

(UC) Program is responsible for the 

administration of childcare facilities 

throughout the country that care for 

unaccompanied children arriving in the 

United States prior to those children 

being placed with viable sponsors in the 

United States. To inform a strategic and 

impactful plan for the administration of 

these facilities HHS is issuing this 

Request for Information (RFI). The RFI 

solicits specific input regarding options 

for a Federal licensure process to ensure 

continued program operations. 

DATES: To be considered, public 

comments must be received 

electronically no later than October 4, 

2021. 

ADDRESSES: Public comments should be 

submitted online at http://

www.regulations.gov. All submissions 

must be submitted to the Docket named 

ACF–2021–0001 to ‘‘Request for 

Information (RFI) from Non-Federal 

Stakeholders: Federal Licensing of ORR 

Facilities.’’ Comments submitted 

electronically, including attachments, 

will be posted to the docket unchanged 

and available to view by the public. 

Evidence and information supporting 

your comment can be submitted as 

attachments. Please provide your 

contact information or organization 

name on the web-based form for 

possible follow up from HHS. There is 

a 5,000-character limit on comments 

and maximum number (10) of attached 

files and maximum size (10 MB) of each 

attached file. 

FOR FURTHER INFORMATION CONTACT: 

Toby Biswas, Senior Supervisory Policy 

Counsel, Division of Policy and 

Procedures, Office of Refugee 

Resettlement, Administration for 

Children and Families, Department of 

Health and Human Services, 

Washington, DC, (202) 205–4440 or 

ucpolicy@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: ORR 

facilities are currently administered 

through a nationwide network of 

grantee providers that care for 

unaccompanied children on a day-today basis. These facilities are subject to 

Federal ORR policies and regulations 

regarding their operations as well as 

applicable State-based licensure 

regulations regarding the operation of 

childcare facilities in each jurisdiction. 

The Flores Settlement Agreement 

(FSA) generally requires that ORR 

promptly place unaccompanied 

children into a State licensed child-care 

program. As of July 2021, ORR operates 

over 200 licensed care provider facilities 

in 22 states under approximately 50 

separate grants executed under 

Cooperative Agreements between ORR 

and the grantee care providers. Each 

State has its own State licensing 

standards. 

The Director of ORR and the Secretary 

of HHS have broad authority to oversee 

policies for the care of unaccompanied 

children, including by identifying a 


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