Federal Register / Vol. 89, No. 13 / Friday, January 19, 2024 / Notices 3667 

• Grant recipients have a policy in 

place for appropriate separation of 

duties and internal controls 

• Other, describe 

• 10.7—Rewrite the question as 

‘‘Describe how you select local agencies 

for monitoring reviews. Attach a risk 

assessment if subrecipients are 

utilized.’’ 

• 10.8—Add boxes ‘‘Annually,’’ ‘‘Biannually,’’ ‘‘Tri-annually,’’ and ‘‘Other.’’ 

Please attach a monitoring schedule if 

one has been developed. 

• 10.9 and 10.10—Remove. 

• 10.11—Revise the question to ‘‘How 

many local agencies are currently on 

corrective action plans?’’ 

• 10.12—Remove. 

Section 11—Timely and Meaningful 

Public Participation 

• 11.1—Add explanation that Tribes 

do not need to hold a public hearing but 

must ensure participation through other 

means. 

• 11.2—Remove. Removing because 

question is duplicative of 11.6. 

• 11.3—Insert an option to add rows 

for additional dates and locations that 

they held public hearings on the 

proposed use and distribution of their 

LIHEAP funds. 

• 11.6—Revise the question as 

follows: ‘‘What changes did you make to 

your LIHEAP plan as a result of public 

participation and solicitation of input?’’ 

Section 12—Fair Hearing 

• 12.4—Change question: ‘‘Describe 

your fair hearing procedures for 

households whose applications are 

denied and/or not acted upon in a 

timely manner.’’ 

• 12.5—Remove. 

• 12.6—Remove. 

Section 13—Reduction of Home Energy 

Needs 

• 13.3—Add the following 

instructional sentence: ‘‘Impact can be 

measured in many different ways by 

using: logic model, data tracking system, 

process evaluation, impact evaluation, 

number of households served vs 

applied, and performance management, 

etc.’’ 

• 13.4—Add a space between ‘‘of’’ 

and ‘‘direct’’ 

• 13.5—Remove. 

Section 14—Leveraging Incentive 

Program 

• 14.3—Add a space between ‘‘of’’ 

and ‘‘45’’ 

Section 15—Training 

• 15.1a-c—Change question to be 

consistent with each entity type (grant 

recipient, local agency, vendor) 

Æ Formal training provided virtually, 

on-site, and/or formal training 

conference 

• Annually 

• Biannually 

• As needed 

• Other, describe. 

Section 17—Program Integrity 

• 17.1b—Add ‘‘Posted in local 

administering agencies offices.’’ 

• 17.4—Change ‘‘aliens’’ to ‘‘qualified 

non-citizens’’ in intro text. The second 

option in the question is phrased as 

‘‘legal residence’’ but it needs to be 

changed to ‘‘U.S. Citizen or Qualified 

Non-Citizen.’’ The second box option 

should read ‘‘Client’s submission of 

certain Social Security Administration 

cards is accepted as proof of U.S. 

Citizen or Qualified Non-Citizen.’’ 

• 17.4—Rewrite the question as 

‘‘What are your procedures for ensuring 

LIHEAP recipients are U.S. citizens or 

qualified non-citizens who are eligible 

to receive LIHEAP benefits?’’ 

• 17.6—Should also include how 

electronic files are protected in a secure 

location. 

Section 19—Certification Regarding 

Drug-Free Workplace Requirements 

• 19.1—Place of Performance: Add 

instructional sentence that this must be 

physical address. No PO Boxes allowed. 

Section 21—New Change Assurances to 

Section 21 

• 21.1—Add the following 

acknowledgment statement and a check 

box: ‘‘By checking this box, the 

prospective primary participant is 

agreeing to the Assurances set out 

above.’’ 

Section 22—Attachments 

Add optional attachment section for 

the following items: Policy Manual; 

Subrecipient Contract; Model Plan 

Participation Notes for Tribes. 

Respondents: States, the District of 

Columbia, U.S. territories, and tribal 

governments. 

Annual Burden Estimates 

The estimated time per response for 

the FY 2025 Model Plan has been 

increased based on the revisions. The 

estimated time per response for the FY 

2026 Model Plan will reduce back after 

revisions are in place and respondents 

can duplicate response in OLDC. 

Instrument 

Total annual 

number of 

respondents 

Total annual 

number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Annual burden 

hours for 

each form 

LIHEAP Detailed Model Plan—FY24 .............................................................. 207 1 .5 103.5 

LIHEAP Detailed Model Plan—FY25 .............................................................. 207 1 1 207 

LIHEAP Detailed Model Plan FY26 ................................................................. 207 1 .5 103.5 

Estimated Total Burden Hours ................................................................. ........................ ........................ ........................ 414 

Authority: 42 U.S.C. 8621. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–00965 Filed 1–18–24; 8:45 am] 

BILLING CODE 4184–80–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5745] 

Medical Imaging Drugs Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Medical Imaging Drugs 

Advisory Committee (the Committee). 

The general function of the Committee 

is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 


ddrumheller on DSK120RN23PROD with NOTICES1
3668 Federal Register / Vol. 89, No. 13 / Friday, January 19, 2024 / Notices 

DATES: The meeting will be held on 

March 5, 2024, from 9 a.m. to 5:30 p.m. 

Eastern Time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings, may be accessed 

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

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2023–N–5745. 

The docket will close on March 4, 2024. 

Please note that late, untimely filed 

comments will not be considered. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of March 4, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Comments received on or before 

February 20, 2024, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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’’). 

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– 

2023–N–5745 for ‘‘Medical Imaging 

Drugs Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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.’’ FDA 

will review this copy, including the 

claimed confidential information, in its 

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 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 the 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. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Seo, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–7699, email: 

MIDAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check 

FDA’s website at https://www.fda.gov/

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing and/or video 

conferencing platform. The Committee 

will discuss efficacy and safety data 

submitted in support of a new drug 

application (NDA) 214511 for 

pegulicianine for injection, the optical 

imaging drug constituent of a drug/ 

device combination product, submitted 

by Lumicell, Inc. The proposed 

indication for pegulicianine is for use in 

patients with breast cancer to assist in 

the detection of cancerous tissue within 

the lumpectomy cavity following 

removal of the primary specimen during 

lumpectomy surgery. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at https://

www.fda.gov/AdvisoryCommittees/ 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 13 / Friday, January 19, 2024 / Notices 3669 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio and 

video components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before February 20, 

2024, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled between 

approximately 2:30 p.m. and 3:30 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

9, 2024. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 12, 2024. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Jessica Seo 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

The conditions for issuance of a waiver 

under 21 CFR 10.19 are met. 

Dated: January 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01016 Filed 1–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Notice of Proposed Purchased/ 

Referred Care Delivery Area 

Redesignation for the Mashantucket 

Pequot Tribal Nation in the State of 

Connecticut 

AGENCY: Indian Health Service, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: This Notice advises the public 

that the Indian Health Service (IHS) 

proposes to expand the geographic 

boundaries of the Purchased/Referred 

Care Delivery Area (PRCDA) for the 

Mashantucket Pequot Tribal Nation to 

include the counties of Fairfield, 

Hartford, Litchfield, Middlesex, New 

Haven, Tolland, and Windham in the 

State of Connecticut. The current 

PRCDA for the Mashantucket Pequot 

Tribal Nation includes the Connecticut 

county of New London. Mashantucket 

Pequot Tribal Nation members residing 

outside of the PRCDA are eligible for 

direct care services, however, they are 

not eligible for Purchased/Referred Care 

(PRC) services. The sole purpose of this 

expansion would be to authorize 

additional Mashantucket Pequot Tribal 

Nation members and IHS beneficiaries 

to receive PRC services. 

DATES: Comments must be submitted by 

February 20, 2024. 

ADDRESSES: Because of staff and 

resource limitations, we cannot accept 

comments by facsimile (FAX) 

transmission. You may submit 

comments in one of four ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit

electronic comments on this regulation 

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

the ‘‘Submit a Comment’’ instructions. 

2. By regular mail. You may mail

written comments to the following 

address ONLY: Carl Mitchell, Director, 

Division of Regulatory and Policy 

Coordination, Indian Health Service, 

5600 Fishers Lane, Mail Stop: 09E70, 

Rockville, Maryland 20857. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You

may send written comments to the 

above address. 

4. By hand or courier. If you prefer,

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to the address 

above. If you intend to deliver your 

comments to the Rockville address, 

please call telephone number (301) 443– 

1116 in advance to schedule your 

arrival with a staff member. 

FOR FURTHER INFORMATION CONTACT: 

CAPT John Rael, Director, Office of 

Resource Access and Partnerships, 

Indian Health Service, 5600 Fishers 

Lane, Mail Stop: 10E85C, Rockville, 

Maryland 20857. Telephone (301) 443– 

0969 (This is not a toll free number). 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. 

Background: The IHS provides 

services under regulation in effect as of 

September 15, 1987, and republished at 

42 CFR part 136, subparts A–C. Subpart 

C defines a Contract Health Service 

Delivery Area (CHSDA), now referred to 

as PRCDA, as the geographic area within 

which PRC will be made available by 

the IHS to members of an identified 

Indian community who reside in the 

PRCDA. Residence within a PRCDA by 

a person who is within the scope of the 

Indian health program, as set forth in 42 

CFR 136.12, creates no legal entitlement 

to PRC but only potential eligibility for 

services. Services needed, but not 

available at an IHS/Tribal facility, are 

provided under the PRC program 

depending on the availability of funds, 

the relative medical priority of the 

services to be provided, and the actual 

availability and accessibility of alternate 

resources in accordance with the 

regulations. 

The regulations at 42 CFR part 136, 

subpart C provide that, unless otherwise 

designated, a PRCDA shall consist of a 

county which includes all or part of a 

reservation and any county or counties 

which have a common boundary with 

the reservation. 42 CFR 136.22(a)(6). 

The regulations also provide that after 

consultation with the Tribal governing 

body or bodies on those reservations 

included within the PRCDA, the 

Secretary may, from time to time, 


ddrumheller on DSK120RN23PROD with NOTICES1