Listening Session: Optimizing the Food and Drug Administration's Use of and Processes for Advisory Committees; Public Meeting; Request for Comments, 34254-34256 [2024-09014]

Download as PDF 34254 Federal Register / Vol. 89, No. 84 / Tuesday, April 30, 2024 / Notices lotter on DSK11XQN23PROD with NOTICES1 Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled ‘‘Considerations for the Use of Humanand Animal-Derived Materials and Components in the Manufacture of Cell and Gene Therapy and TissueEngineered Medical Products; Draft Guidance for Industry.’’ The use of human- and animal-derived materials to manufacture CGT products and TEMPs raises several key issues to consider, including transmission of adventitious agents, material lot-to-lot consistency, and material identity, as well as general material qualification considerations. The draft guidance document provides manufacturers of CGT products and TEMPs with recommendations regarding assuring the safety, quality, and identity of materials of human and animal origin used in the manufacture of these products. In addition, recommendations are provided regarding the CMC information submitted in an IND relating to the use of human- and animal-derived materials. Human- and animal-derived materials may be used directly during manufacturing of a drug substance and a drug product. In addition, human- and animal-derived materials may be used in the manufacture of reagents or substrates used in manufacturing, such as cell banks, viral stocks, antibodies, and other proteins. Some common examples of human- and animal-derived materials include human or animal blood, antibodies produced in sera from animal hybridoma cells, and cytokines produced in insect cell lines. Use of human- and animal-derived materials during product manufacturing may increase risks of infectious disease transmission, and raises potential safety concerns, such as the possible introduction of adventitious agents or other impurities into CGT products and TEMPs. Human- and animal-derived materials can also contribute to product variability by affecting the reproducibility of the manufacturing process or the quality of the final product. The draft guidance, when finalized, is intended to supplement the following two final guidances: ‘‘Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Guidance for Industry’’ dated January 2020, and ‘‘Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, VerDate Sep<11>2014 18:52 Apr 29, 2024 Jkt 262001 and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)’’ dated April 2008. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of another human gene therapy final guidance document entitled ‘‘Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry.’’ This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Considerations for the Use of Human- and Animal-Derived Materials and Components in the Manufacture of Cell and Gene Therapy and TissueEngineered Medical Products.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in 21 CFR part 312 pertaining to the submission of investigational new drug applications have been approved under OMB control number 0910–0014. The collections of information in 21 CFR part 211 pertaining to current good manufacturing practice for finished pharmaceuticals have been approved under OMB control number 0910–0139. The collections of information in 21 CFR part 601 pertaining to biologics license applications have been approved under OMB control number 0910–0338. The collections of information in 21 CFR parts 610, 630, and 640 pertaining to current good manufacturing practice for blood and blood components have been approved under OMB control number 0910–0116. The collections of information in 21 CFR part 1271 pertaining to human cells, tissues, and cellular and tissue-based products have been approved under OMB control number 0910–0543. The collections of information in FDA’s guidance entitled ‘‘Formal Meetings Between the FDA and Sponsors or Applicants’’ have been approved under OMB control number 0910–0001. The collections of information in FDA’s guidance entitled, PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 ‘‘PHS Guideline on Infectious Disease Issues in Xenotransplantation’’ have been approved under OMB control number 0910–0456. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: April 25, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–09286 Filed 4–29–24; 8:45 am] BILLING CODE 4164–01–P 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. Notice of public meeting; request for comments. ACTION: 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/fdameetings-conferences-and-workshops/ public-meeting-optimizing-fdas-useSUMMARY: E:\FR\FM\30APN1.SGM 30APN1 Federal Register / Vol. 89, No. 84 / Tuesday, April 30, 2024 / Notices and-processes-advisory-committees06132024. 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. lotter on DSK11XQN23PROD with NOTICES1 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: VerDate Sep<11>2014 17:27 Apr 29, 2024 Jkt 262001 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-201509-18/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: ACfeedback@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 34255 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: a. What are the categories of expertise, viewpoints, or voices that are particularly important for representation on advisory committees? 1 E.g., 21 U.S.C. 387q (detailing requirements for composition of the Tobacco Products Scientific Advisory Committee). E:\FR\FM\30APN1.SGM 30APN1 34256 Federal Register / Vol. 89, No. 84 / Tuesday, April 30, 2024 / Notices 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? lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:27 Apr 29, 2024 Jkt 262001 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-conferencesand-workshops/public-meetingoptimizing-fdas-use-and-processesadvisory-committees-06132024. Nonspeaking 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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 p.m. EDT. If selected for presentation, any presentation materials must be emailed to ACfeedback@fda.hhs.gov (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] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–4066] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by May 30, 2024. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0249. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: E:\FR\FM\30APN1.SGM 30APN1

Agencies

[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.

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

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:
---------------------------------------------------------------------------

    \1\ E.g., 21 U.S.C. 387q (detailing requirements for composition 
of the Tobacco Products Scientific Advisory Committee).
---------------------------------------------------------------------------

    a. What are the categories of expertise, viewpoints, or voices that 
are particularly important for representation on advisory committees?

[[Page 34256]]

    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]
BILLING CODE 4164-01-P

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