Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Proposed Rules 30843 

(i) New Revision of the Existing Maintenance 

or Inspection Program 

Except as specified in paragraph (j) of this 

AD: Comply with all required actions and 

compliance times specified in, and in 

accordance with, European Union Aviation 

Safety Agency (EASA) AD 2021–0248, dated 

November 15, 2021 (EASA AD 2021–0248). 

Accomplishing the revision of the existing 

maintenance or inspection program required 

by this paragraph terminates the 

requirements of paragraph (g) of this AD. 

(j) Exceptions to EASA AD 2021–0248 

(1) Where EASA AD 2021–0248 refers to its 

effective date, this AD requires using the 

effective date of this AD. 

(2) The requirements specified in 

paragraphs (1) and (2) of EASA AD 2021– 

0248 do not apply to this AD. 

(3) Paragraph (3) of EASA AD 2021–0248 

specifies revising ‘‘the approved AMP’’ 

within 12 months after its effective date, but 

this AD requires revising the existing 

maintenance or inspection program, as 

applicable, within 90 days after the effective 

date of this AD. 

(4) The initial compliance time for doing 

the tasks specified in paragraph (3) of EASA 

2021–0248 is at the applicable ‘‘associated 

thresholds,’’ as incorporated by the 

requirements of paragraph (3) of EASA AD 

2021–0248, or within 90 days after the 

effective date of this AD, whichever occurs 

later. 

(5) The provisions specified in paragraphs 

(4) and (5) of EASA AD 2021–0248 do not 

apply to this AD. 

(6) The ‘‘Remarks’’ section of EASA AD 

2021–0248 does not apply to this AD. 

(k) New Provisions for Alternative Actions 

and Intervals 

After the existing maintenance or 

inspection program has been revised as 

required by paragraph (i) of this AD, no 

alternative actions (e.g., inspections) and 

intervals are allowed unless they are 

approved as specified in the provisions of the 

‘‘Ref. Publications’’ section of EASA AD 

2021–0248. 

(l) Additional FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Large Aircraft 

Section, International Validation Branch, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 

found in 14 CFR 39.19. In accordance with 

14 CFR 39.19, send your request to your 

principal inspector or responsible Flight 

Standards Office, as appropriate. If sending 

information directly to the Large Aircraft 

Section, International Validation Branch, 

send it to the attention of the person 

identified in paragraph (m)(2) of this AD. 

Information may be emailed to: 9-AVS-AIR730-AMOC@faa.gov. 

(i) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the responsible Flight Standards Office. 

(ii) AMOCs approved previously for AD 

2019–21–02 are approved as AMOCs for the 

corresponding provisions of EASA AD 2021– 

0248 that are required by paragraph (g) of this 

AD. 

(2) Contacting the Manufacturer: For any 

requirement in this AD to obtain instructions 

from a manufacturer, the instructions must 

be accomplished using a method approved 

by the Manager, Large Aircraft Section, 

International Validation Branch, FAA; or 

EASA; or Airbus SAS’s EASA Design 

Organization Approval (DOA). If approved by 

the DOA, the approval must include the 

DOA-authorized signature. 

(m) Related Information 

(1) For EASA AD 2021–0248, contact 

EASA, Konrad-Adenauer-Ufer 3, 50668 

Cologne, Germany; telephone +49 221 8999 

000; email ADs@easa.europa.eu; internet 

www.easa.europa.eu. You may find this 

EASA AD on the EASA website at https://

ad.easa.europa.eu. 

(2) For more information about this AD, 

contact Vladimir Ulyanov, Aerospace 

Engineer, Large Aircraft Section, FAA, 

International Validation Branch, 2200 South 

216th St., Des Moines, WA 98198; telephone 

206–231–3229; email vladimir.ulyanov@

faa.gov. 

(3) For Airbus service information 

identified in this AD, contact Airbus SAS, 

Airworthiness Office-EAL, Rond-Point Emile 

Dewoitine No: 2, 31700 Blagnac Cedex, 

France; telephone +33 5 61 93 36 96; fax +33 

5 61 93 45 80; email airworthiness.A330- 

A340@airbus.com; internet https://

www.airbus.com. You may view this service 

information at the FAA, Airworthiness 

Products Section, Operational Safety Branch, 

2200 South 216th St., Des Moines, WA. For 

information on the availability of this 

material at the FAA, call 206–231–3195. 

Issued on May 16, 2022. 

Gaetano A. Sciortino, 

Deputy Director for Strategic Initiatives, 

Compliance & Airworthiness Division, 

Aircraft Certification Service. 

[FR Doc. 2022–10775 Filed 5–19–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 190 

[Docket No. FDA–2022–D–0281] 

Policy Regarding Certain New Dietary 

Ingredients and Dietary Supplements 

Subject to the Requirement for PreMarket Notification; Draft Guidance for 

Industry; Availability; Agency 

Information Collection Activities; 

Proposed Collection; Comment 

Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Policy 

Regarding Certain New Dietary 

Ingredients and Dietary Supplements 

Subject to the Requirement for Premarket Notification.’’ The draft 

guidance, when finalized, will 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 a new dietary 

ingredient (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 a required NDI 

notification. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 19, 2022 to ensure that we 

consider your comment on the draft 

guidance before we begin work on the 

final version of the guidance. Submit 

written comments (including 

recommendations) on the collection of 

information under the Paperwork 

Reduction Act of 1995 by July 19, 2022. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 


khammond on DSKJM1Z7X2PROD with PROPOSALS
30844 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Proposed Rules 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–D–0281 for ‘‘Policy Regarding 

Certain New Dietary Ingredients and 

Dietary Supplements Subject to the 

Requirement for Pre-market 

Notification.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper 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, 240–402–7500. 

Submit comments on the information 

collection under the Paperwork 

Reduction Act of 1995 to the Office of 

Management and Budget (OMB) at 

https://www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. The title of this 

proposed collection is ‘‘Policy 

Regarding Certain New Dietary 

Ingredients and Dietary Supplements 

Subject to the Requirement for Premarket Notification; Draft Guidance for 

Industry.’’ 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the Office 

of Dietary Supplement Programs, Center 

for Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740. 

Send two self-addressed 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: 

With regard to the draft guidance: Laura 

Rich, Office of Dietary Supplement 

Programs (HFS–810), Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–8152; 

or Alexandra Jurewitz, Office of 

Regulations and Policy (HFS–024), 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

With regard to the proposed collection 

of information: Domini Bean, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

5733, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a draft guidance for industry entitled 

‘‘Policy Regarding Certain New Dietary 

Ingredients and Dietary Supplements 

Subject to the Requirement for Premarket Notification.’’ We are issuing the 

draft guidance consistent with our good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA 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. 

The draft guidance, when finalized, 

will advise manufacturers and 

distributors of certain NDI-containing 

dietary supplements (namely, those that 

are subject to the premarket notification 

requirement and are being marketed 

without such a notification) of FDA’s 

intent to exercise enforcement 

discretion for such firms to submit a late 

NDI notification for a limited time and 

in limited circumstances. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/FoodGuidances, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

III. Paperwork Reduction Act 

Under the Paperwork Reduction Act 

of 1995 (PRA) (44 U.S.C. 3501–3521), 

Federal Agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 


khammond on DSKJM1Z7X2PROD with PROPOSALS
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