[Federal Register Volume 89, Number 84 (Tuesday, April 30, 2024)]
[Notices]
[Pages 34254-34256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09014]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1809]
Listening Session: Optimizing the Food and Drug Administration's
Use of and Processes for Advisory Committees; Public Meeting; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following virtual public meeting entitled ``Listening
Session: Optimizing FDA's Use of and Processes for Advisory
Committees.'' The purpose of the listening session is to solicit
feedback on the Agency's use of and processes for its advisory
committee system.
DATES: The virtual listening session will be held on June 13, 2024,
from 9 a.m. to 4 p.m. Eastern Daylight Time (EDT) or until after the
last public commenter has spoken, whichever occurs first. Submit
requests to make oral presentations at the listening session by 3 p.m.
EDT, May 13, 2024. Electronic or written comments on this listening
session must be submitted to the docket by August 13, 2024. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: Additional details, such as registration information, are
available at: https://www.fda.gov/news-events/fda-meetings-conferences-
and-workshops/public-meeting-optimizing-fdas-use-
[[Page 34255]]
and-processes-advisory-committees-06132024.
FDA is establishing a public docket for this listening session. You
may submit comments as follows. Please note that late, untimely filed
comments may not be considered. Electronic comments must be submitted
on or before August 13, 2024. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. EDT on
August 13, 2024. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
Electronic Submissions
Submit electronic comments in the following way:
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.
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:
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.
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-2024-N-1809 for ``Listening Session: Optimizing FDA's Use of and
Processes for Advisory Committees.'' Received comments, those filed in
a timely manner (see ADDRESSES), 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.
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.
FOR FURTHER INFORMATION CONTACT: Jill Wasserman, Stakeholder Engagement
Staff, Office of External Affairs, Office of the Commissioner, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5367,
Silver Spring, MD 20993, 240-623-6945, (this is not a toll-free
number), email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Advisory committees comprised of external advisors support FDA's
mission of protecting and promoting the public health by providing us
with independent advice on scientific, technical, and policy matters.
FDA makes the final decisions on any matters considered by an advisory
committee.
Committees are either mandated by statute or established at FDA's
discretion. Advisory committees must meet the requirements set forth in
the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.). General
procedures for FDA advisory committees are included in FDA's
regulations at 21 CFR part 14.
The products that FDA regulates can impact the daily lives of the
American public, and advisory committee are an important part of FDA's
regulatory processes. While the Agency hears frequently from certain
groups about advisory committees, we are interested in more broadly
hearing from all parties interested in the advisory committee process
and how advisory committees inform FDA's decisions. We are hosting this
virtual public meeting to give an open and transparent platform for
feedback on advisory committees.
II. Topics for Comment at the Public Meeting
We have listed the specific topics on which FDA is seeking input
below. Input may be provided orally, during the virtual public meeting
on June 13, 2024, or via written comments to the docket referenced
above. In all cases, FDA encourages respondents to provide the specific
rationale and basis for their comments, including any available
supporting data and information. Respondents need not address all
topics listed. Please identify your answers as responses to a specific
topic.
A. Topic 1: Composition of Advisory Committees
1. The membership of a committee, which is set by each committee's
charter, typically varies depending on the focus of the committee and
topics for particular meetings. In some cases, the composition of a
particular committee may be set by law.\1\ To the extent there is
flexibility in determining the composition of a committee or the
expertise present at particular meetings:
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\1\ E.g., 21 U.S.C. 387q (detailing requirements for composition
of the Tobacco Products Scientific Advisory Committee).
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a. What are the categories of expertise, viewpoints, or voices that
are particularly important for representation on advisory committees?
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b. What are the categories of expertise, viewpoints, or voices that
may not be relevant given the topic or product type that is the focus
of the committee?
2. Are there ways that FDA can better ensure that a variety of
diverse perspectives and experiences are incorporated into advisory
committee meetings, and if so, how?
3. In some cases, there is a legal requirement to include a
consumer or patient representative on advisory committees. In other
cases, the charter of an advisory committee may allow for there to be a
consumer or patient representative who is a voting member of the
committee. Consumers and patients may also participate in the open
public hearing or submit written comments to the docket for a
particular advisory committee meeting. Are there ways that FDA can
better incorporate the consumer or patient voice into advisory
committee meetings, and if so, how?
B. Topic 2: Service on an Advisory Committee as a Special Government
Employee (SGE)
4. Service on an advisory committee as an SGE gives individuals an
opportunity to provide advice and recommendations on decisions that are
often critical to protecting public health, but we understand that
administrative burdens (e.g., amount of onboarding paperwork and
processing time) are sometimes a deterrent to SGE service. FDA is
exploring ways to streamline the administrative requirements on SGEs
for initial hiring and meeting preparation. While FDA must remain in
compliance with federal laws around federal service, how might we
mitigate administrative barriers to service for SGEs?
5. How can FDA otherwise improve the experience of advisory
committee members?
C. Topic 3: Public Perception and Understanding of Advisory Committees
6. What do you perceive to be the public's awareness and
understanding of the role of FDA advisory committees?
7. What steps can FDA take to improve public awareness and
understanding of advisory committees and their role in providing advice
and recommendations for FDA to consider in its decision-making?
8. How can FDA better communicate with the public about advisory
committee meetings?
9. FDA's regulatory decisions are often, but not always, aligned
with advisory committee recommendations. What steps can FDA take to
clarify for the public that its regulatory decisions take the
committee's recommendation into account, but that the committee's
recommendations are only one of several factors considered?
10. There appears to be a persistent misconception that advisory
committee votes are the final decision of the Agency on the matter
considered by the committee. Is there a way that FDA could adjust the
processes for discussion and/or voting that would improve public
understanding of how FDA receives external advice through the exchange
of information at advisory committee meetings, and the ultimate import
of the advisory committee's discussion?
III. Participating in the Public Meeting
Registration: To register for the free public meeting, please visit
the following website: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/public-meeting-optimizing-fdas-use-and-processes-advisory-committees-06132024. Non-speaking attendees may
register any time before or during the listening session. Individuals
who wish to make presentations at the public meeting must register by
the deadline described below.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in making an oral
presentation at this public meeting must register by 3 p.m. EDT on May
13, 2024. Early registration is recommended. FDA may limit the number
of participants from each organization due to technology constraints on
the total number of participants. Registrants will receive confirmation
when they have been accepted.
Information on requests for special accommodations due to a
disability will be provided during registration.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during the listening session and which
topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations and request time for a joint presentation. Following the
deadline to register to make an oral presentation, we will determine
the amount of time allotted to each presenter (which we expect to be
approximately 5 minutes), the approximate time each oral presentation
is to begin, and will select and notify participants by June 3, 2024.
All requests to make oral presentations must be received by May 13,
2024, at 3 p.m. EDT. If selected for presentation, any presentation
materials must be emailed to [email protected] (see FOR FURTHER
INFORMATION CONTACT) no later than June 7, 2024. No commercial or
promotional material will be permitted to be presented or distributed
at the public meeting.
Dated: April 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09014 Filed 4-29-24; 8:45 am]
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