Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Proposed Rules 30845 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Policy Regarding Certain New Dietary 

Ingredients and Dietary Supplements 

Subject to the Requirement for PreMarket Notification 

OMB Control Number 0910—NEW 

This draft guidance, when finalized, 

is intended to advise the dietary 

supplement industry of our intent to 

exercise enforcement discretion, for a 

limited time and in limited 

circumstances, regarding the 

requirement to submit an NDI 

notification prior to marketing. The 

purpose of the policy is to encourage 

manufacturers and distributors of 

certain NDI-containing dietary 

supplements to correct any past failures 

to submit an NDI notification as 

required by § 190.6 (21 CFR 190.6). The 

proposed information collection 

requests that manufacturers and 

distributors who submit a late NDI 

notification under the enforcement 

discretion policy in the draft guidance 

supplement the notification with the 

following additional information: (1) A 

copy of the current label for the dietary 

supplement containing the NDI and (2) 

documentation to demonstrate the date 

that the dietary supplement was first 

introduced or delivered for introduction 

into interstate commerce. 

We are developing a new submission 

type in the CFSAN Online Submission 

Module that will be used for late 

notifications submitted under the 

temporary enforcement discretion 

policy if the draft guidance is finalized. 

A draft screenshot of the questions 

specific to late notifications is available 

for comment at https://www.fda.gov/ 

food/new-dietary-ingredients-ndinotification-process/how-submitnotifications-new-dietary-ingredient. 

Description of Respondents: The 

respondents to this collection of 

information are manufacturers and 

distributors in the dietary supplement 

industry; specifically, firms that failed 

to comply with the NDI notification 

requirements in § 190.6 and that wish to 

take advantage of FDA’s temporary 

enforcement discretion policy to submit 

a late NDI notification. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ONE-TIME REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average burden per 

response 

(in hours) 

Total hours 

Submit product label and documentation of date of 

introduction into interstate commerce to FDA.

3,500 1 3,500 0.30 (18 minutes) .... 1,050 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The estimates in table 1 are based on 

our experience with our current NDI 

program. We estimate that 3,500 

respondents will submit their product 

labels and documentation of dates of 

introduction into interstate commerce 

and that each respondent will submit 1 

product label and corresponding 

documentation of date of introduction 

into interstate commerce. We further 

estimate that preparing and submitting 

each response will take approximately 

0.30 hour (18 minutes), resulting in a 

total reporting burden of 1,050 hours 

(3,500 responses × 0.30 hour). This will 

be a temporary collection of 

information, as we expect to conduct 

this program for 6 months. 

This draft guidance also refers to 

previously approved FDA collections of 

information. The collections of 

information in § 190.6 have been 

approved under OMB control number 

0910–0330. 

Dated: May 17, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10942 Filed 5–19–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Parts 1 and 54 

[REG–105954–20] 

RIN 1545–BP82 

Required Minimum Distributions; 

Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correction to a notice of 

proposed rulemaking and notice of 

public hearing. 

SUMMARY: The IRS published a 

document in the Federal Register of 

February 24, 2022, concerning required 

minimum distributions from qualified 

plans; section 403(b) annuity contracts; 

custodial accounts, and retirement 

income accounts; individual retirement 

accounts and annuities; and eligible 

deferred compensation plans under 

section 457. The document contained an 

incomplete phrase. 

DATES: Written or electronic comments 

and outlines for a public hearing are 

still accepted and must be received by 

May 25, 2022. Outlines of topics to be 

discussed at the public hearing 

scheduled for June 15, 2022, at 10 a.m. 

must be received by May 25, 2022. 

ADDRESSES: Commenters are strongly 

encouraged to submit public comments 

electronically. Submit electronic 

submissions via the Federal 

eRulemaking Portal at 

www.regulations.gov (indicate IRS and 

REG–105954–20) by following the 

online instructions for submitting 

comments. Once submitted to the 

Federal eRulemaking Portal, comments 

cannot be edited or withdrawn. The IRS 

expects to have limited personnel 

available to process public comments 

that are submitted on paper through 

mail. Until further notice, any 

comments submitted on paper will be 

considered to the extent practicable. 

The Department of the Treasury 

(Treasury Department) and the IRS will 

publish for public availability any 

comment submitted electronically, and 

to the extent practicable on paper, to its 

public docket. Send paper submissions 

to: CC:PA:LPD:PR (REG–105954–20), 

Room 5203, Internal Revenue Service, 

P.O. Box 7604, Ben Franklin Station, 

Washington, DC 20044. 

FOR FURTHER INFORMATION CONTACT: 

Concerning this correction notice, 

Brandon M. Ford, or Linda S.F. 

Marshall, (202) 317–6700; concerning 

submissions of comments and outlines 

of topics for the public hearing, Regina 

Johnson, (202) 317–5177 (not toll-free 

numbers) or publichearings@irs.gov. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
30846 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Proposed Rules 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of February 

24, 2022, in FR Doc 2022–02522, on 

page 10545, in the second column, 

correct paragraph (o)(6)(iii) to read: 

Total future expected payments. Total 

future expected payments means the 

total future payments expected to be 

made under the annuity contract as of 

the date the contract is annuitized, 

based on the mortality rates contained 

in § 1.401(a)(9)–9(e), and without regard 

to any increases in annuity payments 

after that date. 

Oluwafunmilayo A. Taylor, 

Branch Chief, Publications and Regulations 

Branch, Legal Processing Division, Associate 

Chief Counsel, (Procedure and 

Administration). 

[FR Doc. 2022–10624 Filed 5–19–22; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Parts 100 and 165 

[Docket Number USCG–2022–0374] 

RIN 1625–AA08, AA00 

Special Local Regulation and Safety 

Zone; Back River, Baltimore County, 

MD 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard is proposing 

to establish regulations for certain 

waters of the Back River. This action is 

necessary to provide for the safety of life 

on these navigable waters near 

Baltimore County, MD, during a 

fireworks display on July 16, 2022. This 

proposed rulemaking would prohibit 

persons and vessels from being in the 

regulated area and safety zone unless 

authorized by the Captain of the Port 

Maryland-National Capital Region or a 

designated representative. We invite 

your comments on this proposed 

rulemaking. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before June 21, 2022. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2022–0374 using the Federal Decision 

Making Portal at https://

www.regulations.gov. See the ‘‘Public 

Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this proposed 

rulemaking, call or email MST3 Melissa 

Kelly, U.S. Coast Guard Sector 

Maryland-National Capital Region; 

telephone 410–576–2596, email D05- 

DG-SectorMD-NCR-MarineEvents@

uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of the Port 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

PATCOM Patrol Commander 

§ Section 

U.S.C. United States Code 

II. Background, Purpose, and Legal 

Basis 

On February 8, 2022, Fantastic 

Fireworks, on behalf of Tiki Lee’s Dock 

Bar, notified the Coast Guard that it will 

be conducting a fireworks display 

between 9 and 10 p.m. on July 16, 2022, 

as a part of the ‘‘Shootout on the River’’ 

event activities. The fireworks are to be 

launched from a barge in the Back River 

located near Tiki Lee’s Dock Bar in 

Sparrows Point, MD. Hazards from 

firework displays include accidental 

discharge of fireworks, dangerous 

projectiles, and falling hot embers or 

other debris. The Captain of the Port 

Maryland-National Capital Region 

(COTP) has determined that potential 

hazards associated with the fireworks to 

be used in this display would be a safety 

concern for anyone within a 420 foot 

radius of the barge. The Coast Guard 

anticipates a large spectator fleet for 

these events. 

The purpose of this rulemaking is to 

promote maritime safety and protect 

participants and the boating public in 

the Back River immediately prior to, 

during, and after the scheduled events. 

The regulations will provide for 

controlled passage of spectating vessels 

and a safety buffer around the fireworks 

barge for the benefit of participants and 

spectators. The regulations will impact 

the movement of all vessels operating in 

specified waters of the Back River. The 

Coast Guard is proposing this 

rulemaking under authority in 46 U.S.C. 

70034 (previously 33 U.S.C. 1231). 

III. Discussion of Proposed Rule 

The COTP Maryland-National Capital 

Region is proposing to establish 

temporary regulations (special local 

regulation and safety zone) from 8 p.m. 

to 10:30 p.m. on July 16, 2022. 

The COTP is proposing to establish a 

special local regulation for the area in 

the Back River in which spectating 

vessels will transit and gather. The 

regulated area would cover all navigable 

waters of Back River within an area 

bounded by a line connecting the 

following points: From the shoreline at 

Lynch Point at latitude 39°14′46′′ N, 

longitude 076°26′23′′ W, thence 

northeast to Porter Point at latitude 

39°15′13′′ N, longitude 076°26′11′′ W, 

thence north along the shoreline to 

Walnut Point at latitude 39°17′06′′ N, 

longitude 076°27′04′′ W, thence 

southwest to the shoreline at latitude 

39°16′41′′ N, longitude 076°27′31′′ W, 

thence south along the shoreline to the 

point of origin, located in Baltimore 

County, MD. The regulated area is 

approximately 4,200 yards in length and 

1,200 yards in width. 

In addition to establishing a special 

local regulation, the COTP is proposing 

to establish a temporary safety zone 

around the fireworks discharge site, in 

approximate position latitude 

39°15′35.54′′ N, longitude 76°26′56.62′′ 

W. The safety zone would cover all 

navigable waters within 420 feet of a 

fireworks barge in the Back River 

located near Tiki Lee’s Dock Bar in 

Sparrow’s Point, MD. The duration of 

the zone is intended to ensure the safety 

of vessels and these navigable waters 

before, during, and after the scheduled 

fireworks display. No vessel or person 

would be permitted to enter the safety 

zone without obtaining permission from 

the COTP or a designated 

representative. 

The regulatory text we are proposing 

appears at the end of this document. 

IV. Regulatory Analyses 

We developed this proposed rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive orders, and we discuss First 

Amendment rights of protestors. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

This NPRM has not been designated a 

‘‘significant regulatory action’’ under 

Executive Order 12866. Accordingly, 

the NPRM has not been reviewed by the 

Office of Management and Budget 

(OMB). 

This regulatory action determination 

is based on the size, duration, and timeof-day of the special local regulation 


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