Cheese Products Deviating From Identity Standard; Temporary Permit for Market Testing, 31508-31509 [2023-10438]
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Federal Register / Vol. 88, No. 95 / Wednesday, May 17, 2023 / Notices
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18:34 May 16, 2023
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You may submit comments on any
guidance at any time (see 21 CFR
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Submit written requests for single
copies of the draft guidance to Office of
Compliance (HFS–605), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance.
FOR FURTHER INFORMATION CONTACT:
Yinqing Ma, Office of Compliance
(HFS–605), Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2479,
email: Yinqing.ma@fda.hhs.gov; or
Denise See, 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.
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information. Therefore, clearance by the
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www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidance.
Dated: May 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–10523 Filed 5–16–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
I. Background
[Docket No. FDA–2020–N–2226]
We are announcing the availability of
a draft Compliance Policy Guide (CPG)
entitled ‘‘Sec. 555.250 Major Food
Allergen Labeling and Cross-contact.’’
This draft CPG would update and
replace existing guidance for FDA staff
on FDA’s enforcement policy regarding
major food allergen labeling and crosscontact. The content of current CPG Sec.
555.250 was written before the
enactment of three major laws that are
the foundation of FDA’s regulatory
framework for major food allergens:
Food Allergen Labeling and Consumer
Protection Act (2004), FDA Food Safety
Modernization Act (2011), and the Food
Allergy Safety, Treatment, Education
and Research Act (2021). The current
CPG Sec. 555.250 also does not reflect
requirements in our regulation entitled
‘‘Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Human Food’’
(now codified at 21 CFR part 117).
We are issuing the draft guidance
consistent with our good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent our current thinking on this
topic. It does not establish any rights for
any person and is not binding on FDA
or the public. You can use an alternate
approach if it satisfies the requirements
of the applicable statutes and
regulations.
Cheese Products Deviating From
Identity Standard; Temporary Permit
for Market Testing
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
draft guidance contains no collection of
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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 Bongards
Creameries (the applicant) to market test
several pasteurized standardized
cheeses that deviate from the U.S.
standards of identity for cheese
products. The extension allows the
applicant to continue to evaluate
commercial viability of the products
and to collect data on consumer
acceptance of the products, in support
of a petition to amend the standard of
identity for cheese products. 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 amending the standard of
identity of cheese products 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.
SUPPLEMENTARY INFORMATION: In
accordance with § 130.17 (21 CFR
SUMMARY:
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 95 / Wednesday, May 17, 2023 / Notices
130.17), we issued a temporary permit
to Bongards Creameries, 250 Lake Drive
East, Chanhassen, MN 55317, to market
test products that deviate from the
standards of identity for cheese
products under §§ 133.167, 133.169,
133.170, and 133.173 (21 CFR 133.167,
133.169, 133.170, and 133.173) (85 FR
80118, December 11, 2020). We issued
the permit to facilitate market testing of
products that deviate from the
requirements of the standard of identity
for cheese 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 cheese products.
The test products deviate from the
standards of identity for cheese
products under §§ 133.167, 133.169,
133.170, and 133.173. For the purpose
of this permit, natamycin, which is not
permitted under the standards of
identity for these cheese products,
would be added as a mold inhibitor in
the standardized cheeses. The inhibitor
would be incorporated into blended and
processed cheese just prior to
pasteurization and further cast into
slices (or packaging into loaves or other
final forms as in the case of pasteurized
process cheese spread). Natamycin,
which is stable under typical thermal
processing conditions for pasteurized
cheeses, would be added directly to
cheese blends just prior to
pasteurization, as is done with other
mold inhibitors such as sorbic acid,
sodium propionate, and their approved
variants. The final concentration of
natamycin would not exceed 20 parts
per million and would be effective at
producing process and blended slices
with a shelf life of up to 150 days before
seeing mold growth.
The test products meet all the
requirements of the standard with the
exception of this deviation.
On December 22, 2022, the applicant
asked us to extend the temporary permit
so the applicant could have more time
to market test the cheese products and
gain additional consumer acceptance in
support of the petition to amend the
standard for cheese products. We find
that it is in the interest of consumers to
extend the permit for continued market
testing of the cheese products to gain
additional information on consumer
expectations and acceptance. Therefore,
under § 130.17(i), we are extending the
temporary permit granted to Bongards
Creameries for temporary marketing of a
maximum of 100 million pounds
(45,359,237 kilograms) of cheese
products to provide continued market
testing of the specified amount of
product for the applicant on an annual
basis. The new expiration date of the
VerDate Sep<11>2014
18:34 May 16, 2023
Jkt 259001
permit will be either the effective date
of a final rule amending the standard of
identity for cheese products 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
must 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, via
FDAFoodsProgramTMP@fda.hhs.gov.
The notification must describe the test
products and the area of distribution,
specify and justify the amount
requested, and include the labeling that
will be used for the test product (i.e., a
draft label for each size of container and
each brand of product to be market
tested) (see § 130.17(c)). The
information panels on the labels of the
test products must bear nutrition
labeling in accordance with 21 CFR
101.9. Each of the ingredients used in
the food must be declared on the label
as required by 21 CFR part 101.
Dated: May 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–10438 Filed 5–16–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990-new]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before July 17, 2023.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–New–60D
SUMMARY:
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31509
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Critical
Infrastructure Protection Healthcare and
Public Health (HPH) Partnership Data
Collection.
Type of Collection: NEW.
OMB No.: 0990–new.
Abstract: The Administration for
Strategic Preparedness and Response’s
(ASPR) Office of Critical Infrastructure
Protection (CIP) serves as the (HPH)
Sector Risk Management Agency
(SRMA) designee on behalf of the
Department of Health and Human
Services (HHS) as codified by the 2021
National Defense Authorization Act
(NDAA), supporting the HPH Sector to
prepare for future threats, manage risks,
coordinate effective response, and
recover from human-caused and
naturally occurring threats and hazards.
CIP promotes resilience of the
nation’s health critical infrastructure by
working directly with public and
private sector partners to establish risk
assessment tools, foster information
sharing, provide technical resources and
assistance, and lead programs to prepare
for, respond to, and recover from
human-caused and naturally occurring
threats and hazards. CIP specifically
manages the (HPH) Sector Critical
Infrastructure Protection Partnership
(HPH Partnership), a coordinating body
of more than 300 private sector
organizations and federal and state,
tribal, local, and territorial (STLT)
government entities. CIP relies on a
strong partnership federal and STLT
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(GCC) and with critical infrastructure
owners and operators through the
private Sector Coordinating Council
(SCC). Together, the councils of the
HPH Partnership form a private-public
network that promotes situational
awareness, coordination, capacity-
E:\FR\FM\17MYN1.SGM
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Agencies
[Federal Register Volume 88, Number 95 (Wednesday, May 17, 2023)]
[Notices]
[Pages 31508-31509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10438]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2226]
Cheese Products 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 Bongards Creameries (the
applicant) to market test several pasteurized standardized cheeses that
deviate from the U.S. standards of identity for cheese products. The
extension allows the applicant to continue to evaluate commercial
viability of the products and to collect data on consumer acceptance of
the products, in support of a petition to amend the standard of
identity for cheese products. 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 amending the standard of identity of
cheese products 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.
SUPPLEMENTARY INFORMATION: In accordance with Sec. 130.17 (21 CFR
[[Page 31509]]
130.17), we issued a temporary permit to Bongards Creameries, 250 Lake
Drive East, Chanhassen, MN 55317, to market test products that deviate
from the standards of identity for cheese products under Sec. Sec.
133.167, 133.169, 133.170, and 133.173 (21 CFR 133.167, 133.169,
133.170, and 133.173) (85 FR 80118, December 11, 2020). We issued the
permit to facilitate market testing of products that deviate from the
requirements of the standard of identity for cheese 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
cheese products.
The test products deviate from the standards of identity for cheese
products under Sec. Sec. 133.167, 133.169, 133.170, and 133.173. For
the purpose of this permit, natamycin, which is not permitted under the
standards of identity for these cheese products, would be added as a
mold inhibitor in the standardized cheeses. The inhibitor would be
incorporated into blended and processed cheese just prior to
pasteurization and further cast into slices (or packaging into loaves
or other final forms as in the case of pasteurized process cheese
spread). Natamycin, which is stable under typical thermal processing
conditions for pasteurized cheeses, would be added directly to cheese
blends just prior to pasteurization, as is done with other mold
inhibitors such as sorbic acid, sodium propionate, and their approved
variants. The final concentration of natamycin would not exceed 20
parts per million and would be effective at producing process and
blended slices with a shelf life of up to 150 days before seeing mold
growth.
The test products meet all the requirements of the standard with
the exception of this deviation.
On December 22, 2022, the applicant asked us to extend the
temporary permit so the applicant could have more time to market test
the cheese products and gain additional consumer acceptance in support
of the petition to amend the standard for cheese products. We find that
it is in the interest of consumers to extend the permit for continued
market testing of the cheese products to gain additional information on
consumer expectations and acceptance. Therefore, under Sec. 130.17(i),
we are extending the temporary permit granted to Bongards Creameries
for temporary marketing of a maximum of 100 million pounds (45,359,237
kilograms) of cheese products to provide continued market testing of
the specified amount of product for the applicant on an annual basis.
The new expiration date of the permit will be either the effective date
of a final rule amending the standard of identity for cheese products
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 must 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, via [email protected]. The
notification must describe the test products and the area of
distribution, specify and justify the amount requested, and include the
labeling that will be used for the test product (i.e., a draft label
for each size of container and each brand of product to be market
tested) (see Sec. 130.17(c)). The information panels on the labels of
the test products must bear nutrition labeling in accordance with 21
CFR 101.9. Each of the ingredients used in the food must be declared on
the label as required by 21 CFR part 101.
Dated: May 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10438 Filed 5-16-23; 8:45 am]
BILLING CODE 4164-01-P