List of Rules To Be Reviewed Pursuant to the Regulatory Flexibility Act, 70918 [2023-22605]
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70918
Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Proposed Rules
significant economic impact on a
substantial number of small entities, but
excludes rules that previously have
17 CFR Chapter II
been reviewed, rules that have been
substantially changed since adoption,
[Release Nos. 33–11252; 34–98699; IA–
rules that are minor amendments to
6454; IC–35030; File No. S7–17–23]
previously adopted rules, and rules that
List of Rules To Be Reviewed Pursuant are ministerial, procedural, or technical
in nature. Based upon an analysis of the
to the Regulatory Flexibility Act
rules adopted by the Commission in
AGENCY: Securities and Exchange
2014, the Commission has determined
Commission.
that no such rules are required to be
ACTION: Publication of list of rules
reviewed pursuant to the RFA during
scheduled for review.
the succeeding 12 months. Accordingly,
the agency is publishing a list that
SUMMARY: The Regulatory Flexibility Act
reflects that there are no rules to be
(‘‘RFA’’) requires an agency to publish
reviewed pursuant to the RFA during
in the Federal Register, each year, a list the succeeding 12 months.
of rules that are to be reviewed in
By the Commission.
accordance with the RFA during the
Dated: October 6, 2023.
succeeding 12 months. Based upon its
J. Lynn Taylor,
review of rules potentially subject to
review under the RFA during the
Assistant Secretary.
succeeding 12 months, the Securities
[FR Doc. 2023–22605 Filed 10–12–23; 8:45 am]
and Exchange Commission
BILLING CODE 8011–01–P
(‘‘Commission’’) has determined that no
such rules are required to be reviewed.
Accordingly, the agency is not
DEPARTMENT OF HEALTH AND
publishing a list of rules to be reviewed
HUMAN SERVICES
pursuant to the RFA during the
succeeding 12 months.
Food and Drug Administration
DATES: October 13, 2023.
21 CFR Part 172
FOR FURTHER INFORMATION CONTACT:
Sandra Sojka, General Attorney, Office
[Docket No. FDA–2023–F–4332]
of the General Counsel, 202–551–4928.
Kerry Ingredients and Flavours Ltd.;
SUPPLEMENTARY INFORMATION: The
Filing of Food Additive Petition
Regulatory Flexibility Act (‘‘RFA’’),
codified at 5 U.S.C. 601 through 612,
AGENCY: Food and Drug Administration,
requires an agency to review its rules
HHS.
that have a significant economic impact
ACTION
: Notification of petition.
upon a substantial number of small
entities within 10 years of the
SUMMARY: The Food and Drug
publication of such rules as final rules.
Administration (FDA or we) is
5 U.S.C. 610(a). The purpose of the
announcing that we have filed a
review is ‘‘to determine whether such
petition, submitted by Kerry Ingredients
rules should be continued without
and Flavours Ltd., proposing that the
change, or should be amended or
food additive regulations be amended to
rescinded . . . to minimize any
provide for the safe use of vitamin D3 as
significant economic impact of the rules a nutrient supplement in powdered
upon a substantial number of such small drink mixes added to water or
entities.’’ 5 U.S.C. 610(a).
carbonated water, excluding drinks or
The RFA further requires an agency to drink mixes that are specially
publish in the Federal Register, each
formulated or processed for infants.
year, a list of the rules that are to be
DATES: The food additive petition was
reviewed in accordance with the RFA
filed on April 26, 2023.
during the succeeding 12 months. 5
ADDRESSES
: For access to the docket to
U.S.C. 610(c). In determining which
read background documents or
rules to include in each year’s rule
comments received, go to https://
review list, the Commission analyzes
rules adopted in the ninth calendar year www.regulations.gov and insert the
docket number found in brackets in the
prior to the year the rule review list is
heading of this document into the
published, and those rules included in
‘‘Search’’ box and follow the prompts,
the rule review list are reviewed in
and/or go to the Dockets Management
accordance with the RFA during the
calendar year following the year the rule Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
review list is published. The
Commission includes in its rule review
FOR FURTHER INFORMATION CONTACT:
lists any rules that may have a
Lane A. Highbarger, Center for Food
lotter on DSK11XQN23PROD with PROPOSALS1
SECURITIES AND EXCHANGE
COMMISSION
VerDate Sep<11>2014
16:00 Oct 12, 2023
Jkt 262001
PO 00000
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Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1204.
Under
section 409(b)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
348(b)(5)), we are giving notice that we
have filed a food additive petition (FAP
2A4834), submitted on behalf of Kerry
Ingredients and Flavours Ltd. by Hogan
Lovells US LLP, Columbia Square, 555
13th Street NW, Washington, DC 20004.
The petition proposes to amend the food
additive regulations in 21 CFR 172.380
‘‘Vitamin D3,’’ to provide for the safe use
of vitamin D3 as a nutrient supplement
in powdered drink mixes added to
water or carbonated water at levels not
to exceed 180 international units per
360 milliliters (mL) as consumed,
excluding drinks or drink mixes that are
specially formulated or processed for
infants (Refs. 1 and 2). If calcium is
added, calcium is present at levels
greater than or equal to 150 milligrams
of calcium per 360 mL as consumed
(Refs. 1 and 2).
The petitioner has claimed that this
action is categorically excluded under
21 CFR 25.32(k) because the substance
is intended to remain in food through
ingestion by consumers and is not
intended to replace macronutrients in
food. In addition, the petitioner has
stated that, to their knowledge, no
extraordinary circumstances exist that
would warrant an environmental
assessment (see 21 CFR 25.21). If FDA
determines a categorical exclusion
applies, neither an environmental
assessment nor an environmental
impact statement is required. If FDA
determines a categorical exclusion does
not apply, we will request an
environmental assessment and make it
available for public inspection.
SUPPLEMENTARY INFORMATION:
References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. Emails from M. Gradison, to L. Highbarger,
March 8, 2023, and March 30, 2023.
2. FDA Memorandum from L. Highbarger,
Regulatory Review Branch, March 30,
2023.
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[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Proposed Rules]
[Page 70918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22605]
[[Page 70918]]
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SECURITIES AND EXCHANGE COMMISSION
17 CFR Chapter II
[Release Nos. 33-11252; 34-98699; IA-6454; IC-35030; File No. S7-17-23]
List of Rules To Be Reviewed Pursuant to the Regulatory
Flexibility Act
AGENCY: Securities and Exchange Commission.
ACTION: Publication of list of rules scheduled for review.
-----------------------------------------------------------------------
SUMMARY: The Regulatory Flexibility Act (``RFA'') requires an agency to
publish in the Federal Register, each year, a list of rules that are to
be reviewed in accordance with the RFA during the succeeding 12 months.
Based upon its review of rules potentially subject to review under the
RFA during the succeeding 12 months, the Securities and Exchange
Commission (``Commission'') has determined that no such rules are
required to be reviewed. Accordingly, the agency is not publishing a
list of rules to be reviewed pursuant to the RFA during the succeeding
12 months.
DATES: October 13, 2023.
FOR FURTHER INFORMATION CONTACT: Sandra Sojka, General Attorney, Office
of the General Counsel, 202-551-4928.
SUPPLEMENTARY INFORMATION: The Regulatory Flexibility Act (``RFA''),
codified at 5 U.S.C. 601 through 612, requires an agency to review its
rules that have a significant economic impact upon a substantial number
of small entities within 10 years of the publication of such rules as
final rules. 5 U.S.C. 610(a). The purpose of the review is ``to
determine whether such rules should be continued without change, or
should be amended or rescinded . . . to minimize any significant
economic impact of the rules upon a substantial number of such small
entities.'' 5 U.S.C. 610(a).
The RFA further requires an agency to publish in the Federal
Register, each year, a list of the rules that are to be reviewed in
accordance with the RFA during the succeeding 12 months. 5 U.S.C.
610(c). In determining which rules to include in each year's rule
review list, the Commission analyzes rules adopted in the ninth
calendar year prior to the year the rule review list is published, and
those rules included in the rule review list are reviewed in accordance
with the RFA during the calendar year following the year the rule
review list is published. The Commission includes in its rule review
lists any rules that may have a significant economic impact on a
substantial number of small entities, but excludes rules that
previously have been reviewed, rules that have been substantially
changed since adoption, rules that are minor amendments to previously
adopted rules, and rules that are ministerial, procedural, or technical
in nature. Based upon an analysis of the rules adopted by the
Commission in 2014, the Commission has determined that no such rules
are required to be reviewed pursuant to the RFA during the succeeding
12 months. Accordingly, the agency is publishing a list that reflects
that there are no rules to be reviewed pursuant to the RFA during the
succeeding 12 months.
By the Commission.
Dated: October 6, 2023.
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. 2023-22605 Filed 10-12-23; 8:45 am]
BILLING CODE 8011-01-P
