Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Notices 74965 

implementation, support, and scale up 

of the NEICE. The NEICE is a national 

electronic system for quickly and 

securely exchanging the data and 

documents required by the Interstate 

Compact on the Placement of Children 

(ICPC) to place children with foster, 

adoptive, and kinship families across 

state lines. APHSA has been the 

recipient of funding from the ACYF/CB 

for the development and national 

implementation of the NEICE since its 

inception as a pilot project funded by 

the Partnership Fund for Program 

Integrity Innovation at the Office of 

Management and Budget and 

administered by CB in November 2013. 

This 20-month pilot proved successful 

and led to a new sole source cooperative 

agreement for the expansion of the pilot 

to all 52 jurisdictions of the AAICPC 

nationwide. This funding was further 

extended and supplemented to continue 

to support the expansion of the project 

nationally with the current funding 

period expiring September 29, 2024. 

This within scope awarding agencyinitiated non-competitive supplement 

with extension is essential to allow the 

remaining states to join the system and 

to provide ongoing support and 

upgrades necessary for an electronic 

system. In addition, the Family First 

Prevention Services Act of 2018 requires 

all states to join an electronic exchange 

system by October 1, 2027, and NEICE 

is on track to support states in meeting 

this requirement. 

It is CB’s intention to provide funding 

of up to $1,600,000 beginning 

September 30, 2024. The state members 

of the AAICPC contribute annual 

membership and connection fees; 

however, these are currently not 

adequate to meet the full operational 

costs of managing the national system. 

The APHSA is well-positioned to 

continue to scale the project nationally 

and to assure the continued optimal 

maintenance of the NEICE. 

Statutory Authority: Title II, section 

203(b) of the Child Abuse Prevention 

and Treatment and Adoption Reform 

Act of 1978 (42 U.S.C. 5113(b)(3)), as 

most recently amended by CAPTA 

Reauthorization Act of 2010. 

Anthony Petruccelli, 

Senior Grants Policy Specialist, Office of 

Grants Policy, Office of Administration. 

[FR Doc. 2024–20827 Filed 9–12–24; 8:45 am] 

BILLING CODE 4184–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4057] 

General and Plastic Surgery Devices 

Panel of the Medical Devices Advisory 

Committee; Notice of Meeting; 

Establishment of Public Docket; 

Request for Comments—ProSense 

Cryoablation System 

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 General and Plastic 

Surgery Devices Panel of the Medical 

Devices Advisory Committee (the 

Committee). The general function of the 

Committee is to provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. The meeting 

will be open to the public. FDA is 

establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on 

November 7, 2024, from 9 a.m. to 6 p.m. 

eastern time. 

ADDRESSES: Holiday Inn Gaithersburg, 

Two Montgomery Village Ave., 

Gaithersburg, MD 20879. The hotel’s 

telephone number is 301–948–8900. 

The hotel’s link can be found at: https:// 

www.ihg.com/holidayinn/hotels/us/en/ 

gaithersburg/wasrv/hoteldetail. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings may be accessed at: 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–4057. 

The docket will close on December 9, 

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 December 9, 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 

October 17, 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– 

2024–N–4057 for ‘‘General and Plastic 

Surgery Devices Panel of the Medical 

Devices 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 


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74966 Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Notices 

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: 

Candace Nalls, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5214, Silver Spring, 

MD 20993–0002, 301–636–0510, 

Candace.Nalls@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 the 

Agency’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 coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: Agenda: 

On November 7, 2024, the Committee 

will discuss, make recommendations, 

and vote on clinical information related 

to a De Novo request for the ProSense 

Cryoablation System sponsored by 

IceCure Medical Ltd. The discussion 

will focus on the sponsor’s proposed 

indication: ‘‘for use in the treatment of 

patients with early stage, low-risk breast 

cancer for the treatment of breast cancer 

with adjuvant endocrine therapy.’’ 

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, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

material will be available at the location 

of the advisory committee meeting and 

at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

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 October 17, 

2024, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled on November 

7, 2024, between approximately 1:45 

p.m. and 2:45 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 October 10, 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 

October 15, 2024. Persons attending 

FDA’s advisory committee meetings are 

advised that FDA is not responsible for 

providing access to electrical outlets. 

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 Ann Marie 

Williams at Annmarie.Williams@

fda.hh.gov or 301–796–5966 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/ 

AdvisoryCommittees/AboutAdvisory

Committees/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.). 

Dated: September 10, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20889 Filed 9–12–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3878] 

New Drugs Regulatory Program 

Modernization: Integrated Assessment 

of Marketing Applications and 

Integrated Review Documentation; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

seeking public comments on the ‘‘New 

Drugs Regulatory Program 

Modernization: Integrated Assessment 

of Marketing Applications and 

Integrated Review Documentation.’’ The 

purpose is to seek public comments/ 

feedback on the Integrated Review 

documentation generated by the 

Integrated Assessment of Marketing 

Applications for new drug products 

developed as part of the New Drugs 

Regulatory Program Modernization. The 

Agency hopes to receive public 

feedback on how this Integrated Review 

documentation can continue supporting 

our stakeholders’ needs. 

DATES: Submit either electronic or 

written comments on the notice by 

December 12, 2024. 


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