Food and Drug Administration Report and Plan on Best Practices for Guidance; Availability, 95799-95800 [2024-28228]

Download as PDF Federal Register / Vol. 89, No. 232 / Tuesday, December 3, 2024 / Notices 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. lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:09 Dec 02, 2024 Jkt 265001 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. 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: SUMMARY: 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 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 95799 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 1 FDA, ‘‘Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency,’’ available at https://www.fda.gov/ media/82644/download. 2 See 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. E:\FR\FM\03DEN1.SGM 03DEN1 95800 Federal Register / Vol. 89, No. 232 / Tuesday, December 3, 2024 / Notices 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. 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 Dated: November 25, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. lotter on DSK11XQN23PROD with NOTICES1 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health [FR Doc. 2024–28228 Filed 12–2–24; 8:45 am] Government-Owned Inventions; Availability for Licensing BILLING CODE 4164–01–P 3 See 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. VerDate Sep<11>2014 17:09 Dec 02, 2024 Jkt 265001 AGENCY: National Institutes of Health, HHS. ACTION: PO 00000 Notice. Frm 00069 Fmt 4703 Sfmt 4703 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. SUMMARY: 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.’’ E:\FR\FM\03DEN1.SGM 03DEN1

Agencies

[Federal Register Volume 89, Number 232 (Tuesday, December 3, 2024)]
[Notices]
[Pages 95799-95800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28228]


-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \1\ FDA, ``Food and Drug Administration Report on Good Guidance 
Practices: Improving Efficiency and Transparency,'' available at 
https://www.fda.gov/media/82644/download.
---------------------------------------------------------------------------

    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

[[Page 95800]]

organizations; clinical laboratories; healthcare providers; food 
manufacturers; and patient and consumer groups.\3\ The 60-day public 
comment period closed on March 4, 2024.
---------------------------------------------------------------------------

    \2\ See https://www.fda.gov/about-fda/reports/fda-reports-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.
    \3\ See 89 FR 380 (January 3, 2024), available at https://www.federalregister.gov/documents/2024/01/03/2023-28872/food-and-drug-administrations-draft-report-and-plan-on-best-practices-for-guidance-availability.
---------------------------------------------------------------------------

    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 
cross-Agency 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
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