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[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]

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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.

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