95800 Federal Register / Vol. 89, No. 232 / Tuesday, December 3, 2024 / Notices 

3See 89 FR 380 (January 3, 2024), available at 

https://www.federalregister.gov/documents/2024/ 

01/03/2023-28872/food-and-drug-administrationsdraft-report-and-plan-on-best-practices-forguidance-availability. 

organizations; clinical laboratories; 

healthcare providers; food 

manufacturers; and patient and 

consumer groups.3 The 60-day public 

comment period closed on March 4, 

2024. 

FDA received over 30 sets of 

comments on the Draft Report and Plan 

from interested parties, including 

industry and trade groups; healthcare 

providers and entities; patient and 

consumer advocacy groups; researchers, 

scientific, and academic experts; and 

private citizens. The majority of 

comments focused on the following 

topics: (1) general best practices for 

guidance documents; (2) suggestions for 

improving FDA’s current ‘‘Search for 

FDA Guidance Documents’’ web page; 

(3) FDA’s guidance agendas; and (4) 

FDA’s proposal to publish additional 

guidance documents as Level 1 ‘‘for 

immediate implementation’’ and Level 2 

guidance, consistent with applicable 

statutes and regulations. FDA also 

received comments encouraging FDA’s 

continued use of guidance to streamline 

the process for regulatory submissions 

and providing support for further 

Agency use of novel and innovative 

guidance formats. A few comments 

proposed specific topic areas for 

consideration of future guidance 

development. FDA convened a crossAgency workgroup to carefully review, 

discuss, and consider all comments 

received as it prepared this Report and 

Plan. 

FDA carefully considered all relevant 

comments received in developing this 

Report and Plan and is now announcing 

the availability of ‘‘Food and Drug 

Administration Report and Plan on Best 

Practices for Guidance.’’ FDA’s Report 

and Plan addresses many of the themes 

seen across comments received in 

response to the Draft Report and Plan. 

FDA appreciates all the feedback and 

will continue to reassess its best 

practices for guidance and make further 

improvements in the future as 

appropriate. 

II. Electronic Access 

Persons with access to the internet 

may also obtain the report and plan at 

https://www.fda.gov/about-fda/reports/ 

reports-agency-policies-and-initiatives. 

Dated: November 25, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28228 Filed 12–2–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; Avenir 

Award Program for Genetics or Epigenetics of 

Substance Use Disorders. 

Date: February 24–25, 2025. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institute of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Ipolia R. Ramadan, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research, 

National Institute on Drug Abuse, NIH, 

Bethesda, MD 20892, (301) 827–4471, 

ramadanir@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.277, Drug Abuse Scientist 

Development Award for Clinicians, Scientist 

Development Awards, and Research Scientist 

Awards; 93.278, Drug Abuse National 

Research Service Awards for Research 

Training; 93.279, Drug Abuse and Addiction 

Research Programs, National Institutes of 

Health, HHS) 

Dated: November 27, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–28355 Filed 12–2–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research for the benefit 

of the public health. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information may be obtained 

by emailing the licensing contact 

Malabika Ghosh, J.D., Ph.D.; 301–827– 

5414; Malabika.Ghosh@nih.gov, at the 

National Heart, Lung, and Blood, Office 

of Technology Transfer and 

Development, 31 Center Drive Room 

4A25, MSC2479, Bethesda, MD 20892– 

2479. A signed Confidential Disclosure 

Agreement may be required to receive 

any unpublished information. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Analogues of N-Lactoyl-Phenylalanine, 

Methods of Synthesis, and Methods of 

Use 

Available for licensing and 

commercial development are patent 

rights covering N-Lactoyl-Phenylalanine 

(Lac-Phe) analogues having appetite 

suppressant activity, which may be 

useful as therapeutics in the treatment 

of obesity and related secondary 

diseases. The patent rights also cover 

methods of synthesis of the N-LactoylPhenylalanine (Lac-Phe) analogues are 

also disclosed, as well as methods of use 

and treatment of obesity and related 

secondary diseases with the Lac-Phe 

analogues. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Inventors 

• Alan T. Remaley, M.D., Ph.D. NHLBI 

• Anna Wolska, Ph.D. NHLBI 

• Amaury Lucien-Philip Dasseux 

Potential Commercial Applications 

• Therapeutics 

Æ obesity 

Æ obesity co-morbidities 

Development Stage 

• Preclinical (data from compound 

optimization and in vivo validation) 

Intellectual Property 

• NIH Reference No. E–160–2023–0, 

U.S. Provisional Patent Application 

63/585,791 filed September 27, 2023, 

International Patent Application PCT/ 

US2024/048617 filed September 26, 

2024, entitled ‘‘N-LactoylPhenylalanine (Lac-Phe) compound 

derivatives.’’ 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 232 / Tuesday, December 3, 2024 / Notices 95801 

Dated: November 27, 2024. 

Malabika J. Ghosh, 

Technology Transfer and Patent Specialist, 

National Heart, Lung, and Blood Institute, 

Office of Technology Transfer and 

Development. 

[FR Doc. 2024–28329 Filed 12–2–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The purpose of this 

meeting is to evaluate requests for 

preclinical development resources for 

potential new therapeutics for the 

treatment of cancer. The outcome of the 

evaluation will provide information to 

internal NCI committees that will 

decide whether NCI should support 

requests and make available contract 

resources for development of the 

potential therapeutic to improve the 

treatment of various forms of cancer. 

The research proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the 

proposed research projects, the 

disclosure of which would constitute a 

clearly unwarranted invasion of 

personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; OCT2024 

Cycle 48 NExT SEP Committee Meeting. 

Date: December 10, 2024. 

Time: 10:00 a.m. to 3:00 p.m. 

Agenda: To evaluate the NCI Experimental 

Therapeutics Program Portfolio. 

Place: National Institutes of Health, 9000 

Rockville Pike, Building 31, Room 3A44, 

Bethesda, Maryland 20892 (Virtual Meeting). 

Contact Persons: Barbara Mroczkowski, 

Ph.D., Executive Secretary, Discovery 

Experimental Therapeutics Program, 

National Cancer Institute, NIH, 31 Center 

Drive, Room 3A44, Bethesda, Maryland 

20817, 301–496–4291, mroczkoskib@

mail.nih.gov. 

Toby Hecht, Ph.D., Executive Secretary, 

Development Experimental Therapeutics 

Program, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 3W110, 

Rockville, Maryland 20850, 240–276–5683, 

toby.hecht2@nih.gov. 

This notice is being published less than 15 

days from the meeting date due to 

exceptional circumstances. An unanticipated 

number of projects for clinical trial support 

of promising experimental therapeutics 

treating various cancer types, including 

pediatric cancer, were received which 

delayed the identification of panel members 

with the appropriate expertise. If the meeting 

is not held on December 10, 2024, there will 

be a profound negative impact on 

translational cancer research resulting in a 6– 

9-month delay in funding which will 

significantly slow down the initiation of 

meritorious projects/clinical trials by one 

year. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: November 27, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–28356 Filed 12–2–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development Initial Review 

Group Function, Integration, and 

Rehabilitation Sciences Study Section. 

Date: March 17–18, 2025. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, 6710 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Helen Huang, Ph.D., 

Scientific Review Branch, Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development, NIH 6710B 

Rockledge Drive, Room 2137D Bethesda, MD 

20892, (301) 435–8207, Helen.Huang@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: November 26, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–28242 Filed 12–2–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID: FEMA–2023–0009] 

Community Disaster Resilience Zones 

and the National Risk Index 

AGENCY: Federal Emergency 

Management Agency, Department of 

Homeland Security. 

ACTION: Notice. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA) is issuing 

this Notice to provide an update on 

responses to the Community Disaster 

Resilience Zones and the National Risk 

Index request for information and share 

FEMA’s initial designations of census 

tracts as Community Disaster Resilience 

Zones. 

FOR FURTHER INFORMATION CONTACT: 

Samantha A. Medlock, Assistant 

Administrator for Resilience Strategy, 

Federal Emergency Management 

Agency, fema-actionoffice-resiliencestrategy@fema.dhs.gov, 202–212–8007. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Community Disaster Resilience Zones 

Act 

The Community Disaster Resilience 

Zones Act of 2022, Public Law 117–255, 

136 Stat. 2363, amended title II of the 

Robert T. Stafford Disaster Relief and 

Emergency Assistance Act (42 U.S.C. 

5121 et seq.) (Stafford Act) to add a new 

section 206 (42 U.S.C. 5136) that 

requires the: (1) maintenance of a 

natural hazard assessment program and 


lotter on DSK11XQN23PROD with NOTICES1