Federal Register / Vol. 89, No. 232 / Tuesday, December 3, 2024 / Notices 95799 

1FDA, ‘‘Food and Drug Administration Report on 

Good Guidance Practices: Improving Efficiency and 

Transparency,’’ available at https://www.fda.gov/ 

media/82644/download. 

2See https://www.fda.gov/about-fda/reports/fdareports-good-guidance-practices. As explained in 

the Draft Report and Plan, FDA will issue a separate 

Report and Plan in accordance with Section 2505(b) 

of the Consolidated Appropriations Act, 2023. 

sponsors and other external parties and 

identifies our current best practices for 

the efficient development, issuance, and 

use of such communications. As a part 

of this draft report and plan, FDA is also 

considering opportunities to advance 

the use of innovative forms of 

communication, to streamline the 

processes for regulatory submissions, 

and to implement innovative 

communication development processes 

and to transition or update 

communication practices used during 

the COVID–19 PHE. Pursuant to section 

2505(c) of the Consolidated 

Appropriations Act, in this Federal 

Register notice announcing the 

availability of this document, FDA is 

seeking public comment on this ‘‘Best 

Practices for FDA Communication with 

Interested Parties: Draft Report for 

Public Comment.’’ 

II. Request for Comments 

FDA is soliciting comments on its 

‘‘Best Practices for FDA Communication 

with Interested Parties: Draft Report for 

Public Comment’’ from interested 

parties. Specifically, we request 

feedback on the following areas of 

communication: 

Communications Questions 

1. Are there communication practices 

that other Federal agencies use to 

communicate with interested parties, 

such as regulated industry, that would 

be consistent with FDA’s statutory and 

regulatory requirements and helpful for 

FDA to consider implementing? 

2. Recognizing that FDA used many 

innovative communications processes 

and practices during the COVID–19 

public health emergency, what types of 

communications were most beneficial/ 

useful during the COVID–19 pandemic 

and why? 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft report and plan at 

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

reports-agency-policies-and-initiatives 

or https://www.regulations.gov. 

Dated: November 25, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28229 Filed 12–2–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5653] 

Food and Drug Administration Report 

and Plan on Best Practices for 

Guidance; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a 

document entitled ‘‘Food and Drug 

Administration Report and Plan on Best 

Practices for Guidance’’ (Report and 

Plan). FDA is publishing this Report and 

Plan in response to the Consolidated 

Appropriations Act, 2023, which directs 

FDA to issue a report identifying best 

practices for the efficient prioritization, 

development, issuance, and use of 

guidance documents and a plan for 

implementation of such best practices. 

DATES: The announcement of the report 

and plan is published in the Federal 

Register on December 3, 2024. 

ADDRESSES: 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. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the 

Report and Plan. 

FOR FURTHER INFORMATION CONTACT: Julie 

Finegan, Office of Policy, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 4252, Silver Spring, 

MD 20993–0002, 301–827–4830. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Clear, concise, and timely 

communication through guidance 

documents is essential to the public 

health mission of FDA. FDA guidance 

documents are prepared for FDA staff, 

industry, and the public to describe the 

Agency’s interpretation of, or policy on, 

a regulatory issue. (21 CFR 10.115(b)). 

Specifically, FDA uses guidance 

documents to assist regulated industry, 

FDA staff, and the public in 

understanding the Agency’s current 

thinking on policy, scientific, medical, 

and regulatory issues, such as: the 

design, manufacturing, and testing of 

regulated products; content and 

evaluation of applications for product 

approvals; and inspection and 

enforcement policies. Timely 

publication of guidance documents 

significantly benefits public health by 

providing transparency and valuable 

insight into approaches that may assist 

industry and other interested parties in 

complying with applicable statutes and 

regulations, ensuring consumer and 

patient safety, and developing new and 

innovative products to improve public 

health. 

As part of FDA’s Transparency 

Initiative, in 2011, FDA publicly 

released a comprehensive report 

entitled ‘‘Food and Drug Administration 

Report on Good Guidance Practices: 

Improving Efficiency and 

Transparency’’ (2011 GGP Report).1 The 

2011 GGP Report identified ‘‘best 

practices’’ and made recommendations 

to streamline the development of 

guidance documents, reduce the time 

between issuing draft and final guidance 

documents, and improve access to 

guidance documents on FDA’s website. 

Since 2011, FDA has made significant 

strides to implement the 

recommendations in the 2011 GGP 

Report and to modernize and enhance 

our best practices for the efficient 

initiation, prioritization, development, 

review, clearance, and issuance of our 

guidance documents. As a result of 

these and other Agency improvement 

efforts, and as explained in the Report 

and Plan, FDA has significantly 

increased the number of guidance 

documents it publishes annually. 

As part of FDA’s reassessment of its 

best practices for guidance and in 

accordance with section 2505(a) of the 

Consolidated Appropriations Act, 2023, 

FDA published a ‘‘Draft Report and Plan 

on Best Practices for Guidance’’ (Draft 

Report and Plan) on our website on 

December 28, 2023.2 Pursuant to section 

2505(c) of the Consolidated 

Appropriations Act, 2023 in a Federal 

Register notice announcing the 

availability of the Draft Report and Plan, 

FDA solicited public comment from a 

broad range of interested parties, 

including researchers; academic 

organizations; pharmaceutical, 

biotechnology, and medical device 

developers; clinical research 


lotter on DSK11XQN23PROD with NOTICES1
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.’’ 


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