Food Additives Permitted in Feed and Drinking Water of Animals; Pichia Pastoris Dried Yeast, 72315 [2024-19856]
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Federal Register / Vol. 89, No. 172 / Thursday, September 5, 2024 / Rules and Regulations
(4) You may view this material at the FAA,
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Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the
availability of this material at the FAA, call
206–231–3195.
(5) You may view this material at the
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action is being taken to improve the
accuracy of the regulations.
Publication of this document
constitutes final action under the
Administrative Procedure Act (5 U.S.C.
553). FDA has determined that notice
and public comment are unnecessary
because this amendment to the
regulations provides only technical
changes including updating scientific
nomenclature and is nonsubstantive.
Issued on August 21, 2024.
Suzanne Masterson,
Deputy Director, Integrated Certificate
Management Division, Aircraft Certification
Service.
List of Subjects in 21 CFR Part 573
[FR Doc. 2024–20111 Filed 9–3–24; 4:15 pm]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Animal feeds, Food additives.
Therefore, under the Federal Food,
Drug, and Cosmetic Act, and the Public
Health Service Act, and under the
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 573 is
amended as follows:
PART 573—FOOD ADDITIVES
PERMITTED IN FEED AND DRINKING
WATER OF ANIMALS
Food and Drug Administration
1. The authority citation for part 573
continues to read as follows:
■
21 CFR Part 573
Authority: 21 U.S.C. 321, 342, 348.
[Docket No. FDA–2024–F–3882]
Food Additives Permitted in Feed and
Drinking Water of Animals; Pichia
Pastoris Dried Yeast
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
food additive regulations to update the
organism Pichia pastoris which has
been renamed as Komagataella pastoris.
Additionally, the food additive
regulation is being updated to include
language to clarify that the yeast is nonviable in the market formulation. This
action is being taken to improve the
accuracy of the regulations.
DATES: This rule is effective September
5, 2024.
FOR FURTHER INFORMATION CONTACT:
Chelsea Cerrito, Center for Veterinary
Medicine, Division of Animal Food
Ingredients, Food and Drug
Administration, 12225 Wilkins Ave.,
Rockville, MD 20852, 240–402–6729,
Chelsea.Cerrito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the food additive regulation
at 21 CFR 573.750 Pichia pastoris dried
yeast for use in animal feed to update
the organism Pichia pastoris which has
been renamed as Komagataella pastoris.
Additionally, the food additive
regulation is being updated to include
language to clarify that the yeast is nonviable in the market formulation. This
khammond on DSKJM1Z7X2PROD with RULES
21:04 Sep 04, 2024
Jkt 262001
[Redesignated as § 573.587]
2. Redesignate § 573.750 as § 573.587.
■ 3. Amend newly redesignated
§ 573.587 by revising the section
heading and paragraph (a) to read as
follows:
■
§ 573.587
yeast.
SUMMARY:
VerDate Sep<11>2014
§ 573.750
Komagataella pastoris dried
(a) Identity. The food additive
Komagataella pastoris dried yeast is
non-viable and may be used in feed
formulations of broiler chickens as a
source of protein not to exceed 10
percent by weight of the total
formulation.
*
*
*
*
*
Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19856 Filed 9–4–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 864
[Docket No. FDA–2024–N–3971]
Medical Devices; Hematology and
Pathology Devices; Classification of
the Heparin and Direct Oral Factor Xa
Inhibitor Drug Test System
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
ACTION:
72315
Final amendment; final order.
The Food and Drug
Administration (FDA or we) is
classifying the heparin and direct oral
factor Xa inhibitor drug test system into
class II (special controls). The special
controls that apply to the device type
are identified in this order and will be
part of the codified language for the
heparin and direct oral factor Xa
inhibitor drug test system’s
classification. We are taking this action
because we have determined that
classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices.
DATES: This order is effective September
5, 2024. The classification was
applicable on September 17, 2020.
FOR FURTHER INFORMATION CONTACT: Min
Wu, Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 3459, Silver Spring, MD 20993–
0002, 301–348–1886, Min.Wu@
fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
heparin and direct oral factor Xa
inhibitor drug test system as class II
(special controls), which we have
determined will provide a reasonable
assurance of safety and effectiveness.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act (see 21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
device by means of the procedures for
E:\FR\FM\05SER1.SGM
05SER1
]]>Agencies
[Federal Register Volume 89, Number 172 (Thursday, September 5, 2024)]
[Rules and Regulations]
[Page 72315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19856]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2024-F-3882]
Food Additives Permitted in Feed and Drinking Water of Animals;
Pichia Pastoris Dried Yeast
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to update the organism Pichia pastoris which has
been renamed as Komagataella pastoris. Additionally, the food additive
regulation is being updated to include language to clarify that the
yeast is non-viable in the market formulation. This action is being
taken to improve the accuracy of the regulations.
DATES: This rule is effective September 5, 2024.
FOR FURTHER INFORMATION CONTACT: Chelsea Cerrito, Center for Veterinary
Medicine, Division of Animal Food Ingredients, Food and Drug
Administration, 12225 Wilkins Ave., Rockville, MD 20852, 240-402-6729,
[email protected].
SUPPLEMENTARY INFORMATION: FDA is amending the food additive regulation
at 21 CFR 573.750 Pichia pastoris dried yeast for use in animal feed to
update the organism Pichia pastoris which has been renamed as
Komagataella pastoris. Additionally, the food additive regulation is
being updated to include language to clarify that the yeast is non-
viable in the market formulation. This action is being taken to improve
the accuracy of the regulations.
Publication of this document constitutes final action under the
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that
notice and public comment are unnecessary because this amendment to the
regulations provides only technical changes including updating
scientific nomenclature and is nonsubstantive.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and the
Public Health Service Act, and under the authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 573 is amended as follows:
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS
0
1. The authority citation for part 573 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348.
Sec. 573.750 [Redesignated as Sec. 573.587]
0
2. Redesignate Sec. 573.750 as Sec. 573.587.
0
3. Amend newly redesignated Sec. 573.587 by revising the section
heading and paragraph (a) to read as follows:
Sec. 573.587 Komagataella pastoris dried yeast.
(a) Identity. The food additive Komagataella pastoris dried yeast
is non-viable and may be used in feed formulations of broiler chickens
as a source of protein not to exceed 10 percent by weight of the total
formulation.
* * * * *
Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19856 Filed 9-4-24; 8:45 am]
BILLING CODE 4164-01-P
