``Ruby Chocolate'' Deviating From Identity Standard; Temporary Permit for Market Testing, 49548-49549 [2021-19096]
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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
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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.
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
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SUMMARY:
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16:55 Sep 02, 2021
Jkt 253001
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
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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.
E:\FR\FM\03SEN1.SGM
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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
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
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
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/ 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/ to view
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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
Office of Refugee Resettlement
(ORR), Administration for Children and
Families (ACF), Department of Health
and Human Services (HHS).
ACTION: Request for information.
AGENCY:
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
SUMMARY:
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49549
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 https://
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
E:\FR\FM\03SEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49548-49549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19096]
-----------------------------------------------------------------------
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 Sec. 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 (Sec. Sec.
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
Sec. 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 Sec. 130.17(i)).
For information on what to include in the notification to FDA, see
Sec. 130.17(c). Test products must be labeled in accordance with 21
CFR part 101.
[[Page 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
