70918 Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Proposed Rules 

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rescinded .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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 172 

[Docket No. FDA–2023–F–4332] 

Kerry Ingredients and Flavours Ltd.; 

Filing of Food Additive Petition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of petition. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that we have filed a 

petition, submitted by Kerry Ingredients 

and Flavours Ltd., proposing that the 

food additive regulations be amended to 

provide for the safe use of vitamin D3 as 

a nutrient supplement in powdered 

drink mixes added to water or 

carbonated water, excluding drinks or 

drink mixes that are specially 

formulated or processed for infants. 

DATES: The food additive petition was 

filed on April 26, 2023. 

ADDRESSES: For access to the docket to 

read background documents or 

comments received, go to https://

www.regulations.gov and insert the 

docket number found in brackets in the 

heading of this document into the 

‘‘Search’’ box and follow the prompts, 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Lane A. Highbarger, Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1204. 

SUPPLEMENTARY INFORMATION: 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. 

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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