[Federal Register Volume 89, Number 2 (Wednesday, January 3, 2024)]
[Notices]
[Pages 380-382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28872]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-5653]


Food and Drug Administration's Draft Report and Plan on Best 
Practices for Guidance; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability, request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Food and Drug 
Administration's Draft Report and Plan on Best Practices for 
Guidance.'' This draft report responds to the Consolidated 
Appropriations Act of 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. It also directs FDA to publish a 
draft report and plan no later than 1 year after enactment of the 
Consolidated Appropriations Act and to consult with stakeholders in 
developing the report and implementation plan.

DATES: Submit either electronic or written comments on the draft report 
and plan by March 4, 2024.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2023-N-5653 for ``Draft Report and Plan on Best Practices for 
Guidance.'' Received comments 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 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> 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.'' The Agency 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 to 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 this 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.
    See the SUPPLEMENTARY INFORMATION section for electronic access to 
the draft 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.

[[Page 381]]


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 regulated industry, FDA staff, and the 
public to describe the Agency's interpretation of, or policy on, a 
regulatory issue. (Sec.  10.115(b) (21 CFR 10.115(b))). Unlike statutes 
and regulations, guidance documents generally do not establish legally 
enforceable rights or responsibilities (Sec.  10.115(d)), and are thus 
exempt from notice and comment requirements applicable to most 
rulemaking under the Administrative Procedure Act. (5 U.S.C. 553(b)(A); 
(d)(2)). However, the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
and FDA's Good Guidance Practices (GGP) regulation (Sec.  10.115) 
require FDA to provide an opportunity for public comment prior to 
implementation for all Level 1 guidance documents (i.e., guidance 
documents that include initial interpretations of a statute or 
regulation, changes in interpretation or policy that are of more than a 
minor nature, complex scientific issues, or highly controversial 
issues), unless FDA determines that prior public participation is not 
feasible or appropriate. (21 U.S.C.371(h)(1)(C)(i); 10.115(g)). If FDA 
decides that public participation is not feasible or appropriate prior 
to implementation of a guidance document, FDA must provide for public 
comment upon publication and take such comment into consideration. (21 
U.S.C. 371(h)(1)(C)(i); 10.115(g)(3)). For Level 2 guidance documents 
(i.e., guidance documents that set forth existing practices or minor 
changes in policy), the FD&C Act and FDA's GGP regulation require that 
FDA provide for public comment upon implementation. (21 U.S.C. 
371(h)(1)(D); 10.115(g)(4)).
    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, available at https://www.fda.gov/about-fda/transparency/transparency-initiative). 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 continued to make 
significant strides to modernize and improve our best practices for the 
efficient prioritization, development, review, clearance, and issuance 
of our guidance documents.
    The Coronavirus Disease 2019 (COVID-19) Public Health Emergency 
(PHE) pushed us to consider innovative approaches to streamline 
guidance issuance and regulatory submissions to reach a broad audience 
in an expedited manner. The facts and circumstances surrounding COVID-
19 and the COVID-19 PHE enabled FDA to rapidly disseminate Agency 
recommendations and policies related to COVID-19 to industry and other 
interested parties, FDA staff, and the public, including patients and 
consumers. The Agency used Paperwork Reduction Act waivers, issuance of 
Level 1 guidance documents without prior public participation, and 
expedited external review of guidance documents, which translated into 
significant time savings. These tools were critical to the significant 
work FDA accomplished during the COVID-19 pandemic. Now that the PHE 
determined under section 319 of the Public Health Service Act is over, 
FDA is considering the lessons learned from that experience and 
reassessing our current best practices for guidance to look for 
additional areas for improvement consistent with our statutory and 
regulatory framework.
    In accordance with section 2505(a) of the Consolidated 
Appropriations Act of 2023 (Pub. L. 117-328), FDA's ``Draft Report and 
Plan on Best Practices for Guidance'' identifies our current best 
practices for the efficient prioritization, development, issuance, and 
use of guidance documents. As a part of this draft report and plan, FDA 
is also considering opportunities to streamline processes for 
regulatory submissions through the revision and issuance of guidance 
documents and to implement innovative guidance development processes 
and practices. 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 
``Draft Report and Plan on Best Practices for Guidance.''

II. Request for Comments

    FDA is soliciting comments on its ``Draft Report and Plan on Best 
Practices for Guidance'' from a broad range of commenters, including 
regulated industry; researchers; academic organizations; 
pharmaceutical, biotechnology, and medical device developers; clinical 
research organizations; clinical laboratories; healthcare providers; 
food manufacturers; and consumer and patient groups. We are 
particularly interested in feedback on the following areas:
    1. FDA regularly considers its processes for the development, 
clearance, and issuance of guidance documents, with a goal of 
streamlining these processes and making the best use of Agency 
resources. The draft report summarizes FDA's current best practices for 
the initiation, prioritization, development, review, clearance, and 
issuance of guidance documents that FDA has implemented in response to 
the 2011 report and other continual improvement efforts not described 
in the 2011 report. The draft report also proposes additional 
initiatives that FDA could consider to further improve its processes 
for the issuance of guidance documents. FDA solicits input on whether 
there are additional or revised practices, consistent with our 
statutory and regulatory framework, for the Agency to consider.
    2. Level 1 guidance documents are guidance documents that include 
initial interpretations of a statute or regulation, changes in 
interpretation or policy that are of more than a minor nature, complex 
scientific issues, or highly controversial issues. Level 2 guidance 
documents describe existing practices or minor changes in 
interpretation or policy. Pursuant to FDA's statutory and regulatory 
requirements, while the public may comment on a guidance document at 
any time, public participation is directly solicited prior to the 
implementation of Level 1 guidance documents unless we determine that 
such prior public participation is not feasible or appropriate. In the 
preamble to the final GGP rule, we noted that we anticipated that this 
exception would generally be applicable when there are public health 
reasons for the immediate implementation of the guidance document; 
there is a statutory requirement, executive order, or court order that 
requires immediate implementation; or the guidance document presents a 
less burdensome policy that is consistent with public health.\1\ 
Issuing more guidance documents either as Level 1 guidance documents 
for immediate implementation, as FDA did during the COVID-19 PHE, or as 
Level 2 guidance documents would allow FDA to allocate its limited 
resources more efficiently, which would help FDA keep pace with rapid 
scientific developments and better serve the public health. In 
addition,

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FDA's GGP regulation provides that the public may comment on any 
guidance at any time, including Level 1 guidance documents for 
immediate implementation and Level 2 guidance documents, and FDA may 
delay implementation of any guidance document.
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    \1\ 65 FR 56468 at 56472 (September 19, 2000).
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    a. In light of the above, we seek input on whether there are any 
additional circumstances, categories of guidance documents, or topics 
for guidance for which it may be appropriate and consistent with the 
FD&C Act and FDA's GGP regulation for FDA to consider issuance as a 
Level 1 guidance document for immediate implementation without prior 
public comment.
    b. We also seek comment on whether there are additional categories 
or types of guidance documents that FDA should consider issuing as 
Level 2 guidance documents to streamline the guidance process and allow 
the Agency to better leverage its resources for the timely development 
of more guidance documents.
    3. FDA requests comment on any novel guidance document formats that 
would be of particular utility, such as use of templates to accompany a 
guidance document, Q&A formats, flowcharts, etc., that are used in FDA 
guidance documents or that were used in guidance documents issued in 
response to the COVID-19 PHE.
    4. FDA makes robust use of guidance documents to assist industry in 
making regulatory submissions. As described in the report, examples of 
such guidances include device-specific guidance documents, disease or 
indication specific guidance documents that include recommendations on 
developing drugs intended to treat a specific disease or for a specific 
indication to support submissions of New Drug Applications (NDAs) or 
Supplemental NDAs, product specific guidances for generic drug 
development to support submission of Abbreviated New Drug Applications 
(ANDAs), Data Technical Conformance Guides to accompany guidance 
documents, and guidance documents that provide assistance with 
registration and listing requirements. FDA requests comment on the 
utility of guidances in streamlining regulatory submissions and whether 
there are additional categories or types of guidance that would be 
helpful to streamline processes for regulatory submissions to the 
Agency.
    5. Currently, FDA's GGP regulation (Sec.  10.115) provides that 
interested persons can suggest areas for guidance document development 
and that such suggestions should address why a guidance document is 
necessary. (Sec.  10.115(f)(2)). In addition, proposed guidance 
documents can be submitted to a specified docket for FDA consideration. 
(Sec.  10.115(f)(3)). FDA requests comments on whether the currently 
available mechanisms for submitting suggested areas for guidance 
development and proposed guidance documents are useful and sufficient 
or whether additional mechanisms, for example, a Center-specific or 
Office-specific mailbox for such suggestions would ease the process for 
such submissions.
    6. FDA Centers publish guidance agendas on their web pages to give 
interested parties and the public notice of the areas in which FDA is 
considering upcoming guidance. We request comment on the utility of 
these guidance agendas and what, if any, modifications to these agendas 
would be helpful for the Agency to consider.

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: December 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28872 Filed 1-2-24; 8:45 am]
BILLING CODE 4164-01-P