Federal Register / Vol. 89, No. 11 / Wednesday, January 17, 2024 / Notices 2957 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: A State Plan is a required 

comprehensive narrative description of 

the nature and scope of a State’s or 

Replacement Designee’s (RD) Refugee 

Resettlement Program and provides 

assurances that the program will be 

administered in conformity with the 

specific requirements stipulated in 45 

CFR 400.4–400.9. The State Plan must 

include all applicable State or RD 

procedures, designations, and 

certifications for each requirement as 

well as supporting documentation. The 

plan assures ORR that the State or RD 

is capable of administering refugee 

assistance and coordinating 

employment and other social services 

for eligible caseloads in conformity with 

specific requirements. 

ORR proposes the following changes 

to the previously approved State Plan 

for Grants to States for Refugee 

Resettlement: 

• streamlining/formatting multiple 

sections of the form, including 

technical corrections 

• enhancing requirements for 

collaboration and engagement and 

expanding the non-discrimination 

aspects 

• standardizing sections of the template 

related to health to reduce burden by 

clarifying text and removing 

duplicative parts 

• streamlining sections related to the 

unaccompanied children to reduce 

burden by providing better options for 

responses and selections and by 

removing unnecessary and confusing 

text to ensure consistency regarding 

assurances 

Respondents: State agencies and RDs 

under 45 CFR 400.301(c) administering 

or supervising the administration of 

programs. 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual number 

of responses 

per respondent 

Average burden 

hours per 

response 

Annual burden 

hours 

State Plan for Grants to States for Refugee Resettlement ..... 59 1 18 1,062 

Authority: 8 U.S.C. 1522 of the 

Immigration and Nationality Act (the 

Act) [title IV, sec. 412 of the Act] for 

each State agency requesting Federal 

funding for refugee resettlement under 8 

U.S.C. 524 [title IV, sec. 414 of the Act] 

Mary Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–00704 Filed 1–16–24; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2780] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Premarket 

Notification for a New Dietary 

Ingredient 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 

16, 2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to 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 OMB 

control number for this information 

collection is 0910–0330. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Premarket Notification for a New 

Dietary Ingredient—21 CFR 190.6 

OMB Control Number 0910–0330— 

Revision 

This information collection supports 

Agency regulation, guidance, and 

associated Form FDA 3880. Under 

section 413(a)(2) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 350b(a)(2)), the manufacturer or 

distributor of a new dietary ingredient 

(NDI) or a dietary supplement that 

contains the NDI, must submit an NDI 

notification (NDIN) to FDA (as delegate 

for the Secretary of Health and Human 

Services) at least 75 days before 

introducing the product into interstate 

commerce, unless the NDI and any other 

dietary ingredients in the dietary 

supplement ‘‘have been present in the 

food supply as an article used for food 

in a form in which the food has not been 

chemically altered’’ (21 U.S.C. 

350b(a)(1)). 

The notification must contain the 

information, including any citation to 

published articles, which provides the 

basis on which the manufacturer or 

distributor of the NDI or dietary 

supplement (the notifier) has concluded 

that the dietary supplement containing 

the NDI will reasonably be expected to 

be safe (21 U.S.C. 350b(a)(2)). If the 

required premarket notification is not 

submitted to FDA, section 413(a) of the 


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2958 Federal Register / Vol. 89, No. 11 / Wednesday, January 17, 2024 / Notices 

FD&C Act provides that the dietary 

supplement containing the NDI is 

deemed to be adulterated under section 

402(f) of the FD&C Act (21 U.S.C. 

342(f)). Even if the notification is 

submitted as required, the dietary 

supplement containing the NDI is 

adulterated under section 402(f) of the 

FD&C Act unless there is a history of 

use or other evidence of safety 

establishing that the NDI, when used 

under the conditions recommended or 

suggested in the labeling of the dietary 

supplement, will reasonably be 

expected to be safe. 

Section 190.6 (21 CFR 190.6) specifies 

the information a notifier must include 

in its NDIN and establishes the 

administrative procedures for these 

notifications. Section 190.6(a) requires 

each manufacturer or distributor of an 

NDI, or of a dietary supplement 

containing an NDI, to submit to the 

Center for Food Safety and Applied 

Nutrition’s (CFSAN’s) Office of Dietary 

Supplement Programs (ODSP) 

notification of the basis for their 

conclusion that said supplement or 

ingredient will reasonably be expected 

to be safe. Section 190.6(b) requires that 

the notification include the following: 

(1) the complete name and address of

the manufacturer or distributor, (2) the

name of the NDI, (3) a description of the

dietary supplement(s) that contain the

NDI, including the level of the new

dietary ingredient in the dietary

supplement and the dietary

supplement’s conditions of use, (4) the

history of use or other evidence of safety

establishing that the dietary ingredient

will reasonably be expected to be safe

when used under the conditions

recommended or suggested in the

labeling of the dietary supplement, and

(5) the signature of a responsible person

designated by the manufacturer or 

distributor. 

These NDIN requirements are 

designed to enable us to monitor the 

introduction into the marketplace of 

NDIs and dietary supplements that 

contain NDIs in order to protect 

consumers from ingredients and 

products whose safety is unknown. We 

use the information collected in the 

NDINs to evaluate more efficiently the 

safety of NDIs in dietary supplements 

and to support regulatory action against 

ingredients and products that are 

potentially unsafe. 

FDA developed guidance to further 

assist industry with NDINs. In the 

Federal Register of July 5, 2011 (76 FR 

39111), we announced the availability 

of a draft guidance for industry entitled 

‘‘Dietary Supplements: New Dietary 

Ingredient Notifications and Related 

Issues’’ (the 2011 draft guidance). We 

gave interested parties an opportunity to 

submit comments on the substance of 

the guidance by October 3, 2011. In the 

Federal Register of September 9, 2011 

(76 FR 55927), we extended the 

comment period to December 2, 2011. 

We received numerous comments on 

the 2011 draft guidance. Based on those 

comments and our meetings with 

industry and other stakeholders, we 

revised the 2011 draft guidance. In the 

Federal Register of August 12, 2016 (81 

FR 53486), we announced the 

availability of a revised draft guidance 

for industry with the same title (the 

2016 revised draft guidance) that 

supersedes the 2011 draft guidance 

(available at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/draft-guidanceindustry-new-dietary-ingredientnotifications-and-related-issues). We 

gave interested parties another 

opportunity to submit comments on the 

substance of the guidance by October 

11, 2016. In the Federal Register of 

October 4, 2016 (81 FR 68434), we 

extended the comment period to 

December 12, 2016. It is with this notice 

that we solicit comments on the 

information collection in the guidance. 

The 2016 revised draft guidance, 

when finalized, is intended to provide 

instruction and further assist industry in 

deciding when a premarket safety 

notification for a dietary supplement 

containing an NDI is necessary and in 

preparing an NDIN. The draft guidance 

discusses in question-and-answer 

format FDA’s views on what qualifies as 

an NDI, when an NDIN is required, the 

types of data and information that 

manufacturers and distributors should 

consider when they evaluate the safety 

of a dietary supplement containing an 

NDI, and what should be included in an 

NDIN as well as other topics. We intend 

to divide the 2016 revised draft 

guidance into discrete sections for ease 

of use, consistent with stakeholder 

requests (including from industry) 

submitted in the form of comments to 

the docket for the draft guidance, and 

issue a series of several guidances. 

These guidances will reflect, among 

other things, public comments 

submitted to the docket in response to 

the 2011 draft guidance and the 2016 

revised draft guidance. Sections of the 

2016 revised draft guidance that FDA is 

prioritizing to issue at this time address 

administrative procedures, identity, 

safety, and master files. Per our standard 

process, FDA will announce guidance 

documents we plan to issue within a 

calendar year via our FDA Foods 

Program Guidance Agenda, available at 

https://www.fda.gov/food/guidancedocuments-regulatory-informationtopic-food-and-dietary-supplements/ 

foods-program-guidance-underdevelopment. The following sections 

discuss the various topics related to 

NDINs, all of which were previously 

referenced or discussed in the 2016 

revised draft guidance. 

1. Administrative Procedures

The recommendations found in

section V, NDI Notification Procedures 

and Timeframes, of the 2016 revised 

draft guidance and certain 

recommendations in section IV.C., 

Other Questions About When an NDI 

Notification Is Necessary, provide 

instruction for certain ways 

manufacturers and distributors can 

reduce the number of NDINs they must 

file and provide some clarification with 

regard to when data and information 

from a previous NDIN may be used in 

a notification. We recommend that 

certain information should be provided 

in list form for ease of reference and to 

help ensure completeness. 

Certain recommendations found in 

the 2016 revised draft guidance, section 

IV.C., Determining Whether a New

Dietary Ingredient (NDI) Notification Is

Required; Other Questions About When

an NDI Notification Is Necessary,

discusses information that should be

included if referring to non-public

information from a previous

notification. Such information to

include with a notification could

involve written authorization to

reference information from another firm.

The option to reference certain

information from a previous notification

should reduce notifiers’ burden for

preparing and submitting identity,

manufacturing, and safety information.

We encourage manufacturers or 

distributors of NDIs to submit their 

NDINs electronically via the CFSAN 

Online Submission Module (COSM). 

Although we encourage electronic 

submission, notifiers also have the 

option of submitting a paper NDIN for 

us to review. The recommendations 

found in the 2016 revised draft 

guidance, section V, Recommended 

Template for Organizing an NDI 

Notification, recommend that 

information in a paper NDIN should be 

organized in a specific manner, and that 

some information should be provided in 

list form, for ease of reference and to 

ensure completeness. Doing so will help 

notifiers provide a complete, wellorganized NDIN, which should facilitate 

an efficient and timely FDA review. 

These sections of the 2016 revised 

draft guidance provide instruction and 

help dietary supplement manufacturers 

and distributors understand what to 


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Federal Register / Vol. 89, No. 11 / Wednesday, January 17, 2024 / Notices 2959 

expect when submitting an NDIN and 

enhance industry’s ability to submit a 

complete notification that FDA can 

efficiently review. 

2. Identity Information About the NDI

and the Dietary Supplement

Certain recommendations found in 

the 2016 revised draft guidance, section 

VI.A., What to Include in an NDI

Notification; Identity Information About

the NDI and the Dietary Supplement,

provide instruction and discuss

information that is important in

describing the identity of an NDI and

the dietary supplement containing the

NDI. We will recommend that certain

information should be provided in table

form for ease of reference and to help

ensure completeness.

3. History of Use or Other Evidence of

Safety

Certain recommendations in the 2016 

revised draft guidance, sections VI.B., 

History of Use or Other Evidence of 

Safety, and VI.C., Summary of the Basis 

for Your Conclusion of Safety, as well 

as table 3, the Safety Testing 

Recommendations Matrix, provide 

instruction and discuss information that 

is important in describing the basis for 

which a dietary supplement containing 

the NDI will reasonably be expected to 

be safe. While the FD&C Act does not 

specify the type or amount of 

information that must be included in an 

NDIN, the notification should include a 

dietary supplement safety narrative 

containing the objective evaluation of 

the history of use or other evidence of 

safety cited in the notification, along 

with an explanation of how the 

evidence of safety provides a basis to 

conclude that the dietary supplement 

containing the NDI, when used under 

the conditions described in the NDIN, 

will reasonably be expected to be safe. 

Once finalized, the recommendations 

will instruct and help dietary 

supplement manufacturers and 

distributors understand what to 

consider when evaluating the safety of 

a dietary supplement containing an NDI 

and what should be included in an 

NDIN in this regard. 

4. Electronic Submission

We developed an electronic portal

that respondents may use to 

electronically submit their notifications 

to ODSP via COSM. COSM assists 

respondents filing regulatory 

submissions and is specifically designed 

to aid users wishing to file submissions 

with CFSAN. COSM allows safety and 

other information to be uploaded and 

submitted online via Form FDA 3880. 

This form provides a standard format to 

describe the history of use or other 

evidence of safety on which the 

manufacturer or distributor bases its 

conclusion that the NDI is reasonably 

expected to be safe under the conditions 

of use recommended or suggested in the 

labeling of the dietary supplement, as 

well as a description of the ingredient 

and other information. Firms that prefer 

to submit a paper notification in a 

format of their own choosing have the 

option to do so; however, Form FDA 

3880 prompts a notifier to input the 

elements of an NDIN in a standard 

format that we will be able to review 

efficiently. Form FDA 3880 may be 

accessed at https://www.fda.gov/food/ 

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

In the Federal Register of August 2, 

2023 (88 FR 50876), FDA published a 

60-day notice requesting public

comment on the proposed collection of

information. We received one comment,

which was not PRA-related, so we will

not address it in this document.

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; type of respondent; citation Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average burden 

per response 

Total 

hours 

NDIN submission; § 190.6 .......................................................................................... 55 1 55 20 ................................ 1,100 

List Form and Template; Administrative Procedures; Section V ............................... 1 1 1 1 .................................. 1 

Written Authority; Master Files; Section IV.C.1 and 4 ............................................... 10 1 10 0.4 (24 minutes) ......... 4 

Table Form; Identity Specifications; Section VI.A ..................................................... 55 1 55 1 .................................. 55 

Manufacturing Process Information; Identity Information; Section VI.B. and C ........ 55 1 55 5 .................................. 275 

Total .................................................................................................................... ........................ ........................ .................. ..................................... 1,435 

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

Our estimate is based on our 

experience with information collections 

related to past NDIN submissions. The 

estimated burden also reflects an 

industry average, although the burden 

associated with individual submissions 

may vary depending on the complexity 

of the notification. Due to a program 

change, we are revising this information 

collection request to include 

recommendations found in the 2016 

revised draft guidance. Therefore, we 

have increased our total burden hour 

estimate by 335. However, the number 

of respondents remains the same. 

We estimate that 55 respondents each 

submits 1 NDIN annually. We estimate 

that extracting and summarizing the 

relevant information from what exists in 

the company’s files and presenting it in 

a format that meets the requirements of 

§ 190.6 will take approximately 20

hours of work per notification. We

believe that the burden of the premarket

notification requirement is reasonable

because we are requesting only safety

and identity information that the

manufacturer or distributor should

already have developed to satisfy itself

that a dietary supplement containing the

NDI is in compliance with the FD&C

Act. If the required premarket

notification is not submitted to FDA,

section 413(a) of the FD&C Act provides

that the dietary supplement containing

the NDI is deemed to be adulterated

under section 402(f) of the FD&C Act.

Even if the notification is submitted as

required, the dietary supplement

containing the NDI is adulterated under

section 402(f) of the FD&C Act unless

there is a history of use or other

evidence of safety establishing that the 

NDI, when used under the conditions 

recommended or suggested in the 

labeling of the dietary supplement, will 

reasonably be expected to be safe. This 

requirement is separate from and 

additional to the requirement to submit 

a premarket notification for the NDI. 

FDA’s regulation on NDINs, 

§ 190.6(a), requires the manufacturer or

distributor of the NDI or dietary

supplement containing the NDI to

submit to FDA the information that

forms the basis for its conclusion that

the NDI, or dietary supplement

containing the NDI, will reasonably be

expected to be safe. Thus, § 190.6 only

requires the manufacturer or distributor

to extract and summarize information

that should have already been

developed to meet the safety


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2960 Federal Register / Vol. 89, No. 11 / Wednesday, January 17, 2024 / Notices 

requirement in section 413(a)(2) of the 

FD&C Act. 

We estimate that 95 percent of 

respondents submit electronically, 

leaving about 3 who submit their NDIN 

in paper format (5% × 55 = 2.75, 

rounded up to 3). However, we have 

seen a trend of decreased paper 

submissions over the past 2 years and 

expect usage to remain low. Thus, we 

estimate only one NDIN will be 

submitted in paper format. We estimate 

that information in this NDIN regarding 

the table of contents, names of contacts, 

and reference lists will be provided in 

list form. Because the underlying 

information should be already readily 

available, we estimate that it will take 

about 60 minutes to prepare the 

information in list form, which would 

create a burden of 1 hour (1 × 1 hour). 

We estimate that 10 notifiers will each 

reference information once from a 

previous notification and will provide 

written authorization to do so. We 

estimate that it will take about 24 

minutes to prepare a written 

authorization. We calculate that the 

burden for this activity will be 4 hours 

annually (10 notifiers × 1 authorization 

× 0.4 hour). 

We estimate that 55 notifiers each will 

provide identity specifications in table 

form with their NDIN submissions. 

Because the underlining information 

should be already readily available, we 

estimate that it will take about 1 hour 

to prepare the information in table form, 

which would create a burden of 55 

hours (55 tables × 1 hour). 

We estimate that 55 notifiers each will 

provide information about the 

manufacturing process with their NDIN 

submissions. We estimate that it will 

take about 5 hours to prepare this 

information, which would create a 

burden of 275 hours (55 manufacturing 

process × 5 hours). 

Dated: January 10, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00732 Filed 1–16–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Heritable Disorders in Newborns and 

Children; Correction 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice; correction. 

SUMMARY: HRSA published a document 

in the Federal Register of January 9, 

2024, concerning a meeting of the 

Advisory Committee on Heritable 

Disorders in Newborns and Children. 

The document contained incorrect 

HRSA contact information for further 

information and an incorrect date for 

requests to provide a written or oral 

statement. The notice originally stated 

that for further information, contact Kim 

Morrison at 301–822–4978. The correct 

contact information should be: Kim 

Morrison at 240–485–8419. The notice 

originally stated that requests for public 

comment were due on Tuesday, January 

17, 2024. The correct date for requests 

for public comment is Thursday, 

January 18, 2024. 

FOR FURTHER INFORMATION CONTACT: Kim 

Morrison, Maternal and Child Health 

Bureau, HRSA, 5600 Fishers Lane, 

Rockville, Maryland, 20857; 240–485– 

8419; or ACHDNC@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of January 9, 

2024, FR Doc. 2024–00264, page 1105, 

column 2, FOR FURTHER INFORMATION

CONTACT section, paragraph 1, correct 

the ‘‘Kim Morrison, Maternal and Child 

Health Bureau, HRSA, 5600 Fishers 

Lane, Room, Rockville, Maryland 20857; 

301–822–4978; or ACHDNC@hrsa.gov’’ 

caption to read: ‘‘Kim Morrison, 

Maternal and Child Health Bureau, 

HRSA, 5600 Fishers Lane, Rockville, 

Maryland 20857; 240–485–8419; or 

ACHDNC@hrsa.gov.’’ 

In the Federal Register of January 9, 

2024, FR Doc. 2024–00264, page 1106, 

column 1, SUPPLEMENTARY INFORMATION

section, paragraph 1, correct the 

‘‘Requests to provide a written 

statement or make oral comments to 

ACHDNC must be submitted via the 

registration website by 12 p.m. ET on 

Tuesday, January 17, 2024’’ caption to 

read: ‘‘Requests to provide a written 

statement or make oral comments to 

ACHDNC must be submitted via the 

registration website by 12 p.m. ET on 

Thursday, January 18, 2024.’’ 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–00739 Filed 1–16–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Rural Health 

Care Coordination Program 

Performance Improvement Measures, 

OMB No. 0906–0024—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than March 18, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Rural Health Care Coordination Program 

Performance Improvement Measures, 

OMB No. 0906–0024—Revision 

Abstract: The Rural Health Care 

Coordination (Care Coordination) 

Program is authorized under 42 U.S.C. 

254c(e) (Section 330A(e) of the Public 

Health Service Act) to promote rural 

health care services outreach by 

improving and expanding delivery of 

health care services through 

comprehensive care coordination 

strategies addressing a primary focus 

area: (1) heart disease, (2) cancer, (3) 

chronic lower respiratory disease, (4) 

stroke, or (5) maternal health. This 

authority permits the Federal Office of 

Rural Health Policy to award grants to 


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