Guidance for the Public, FDA Advisory 
Committee Members, and FDA Staff: The Open 
Public Hearing at FDA Advisory Committee 
Meetings 
 
FINAL GUIDANCE 
 
 
Comments and suggestions may be submitted at anytime for agency consideration to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with 
the docket number listed in the notice of availability that is published in the Federal 
Register. 
For questions regarding this document, contact Michael Ortwerth at 301-796-8220. 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of the Commissioner 
May 15, 2013
   
Guidance for the Public, FDA 
Advisory Committee Members, and 
FDA Staff: The Open Public Hearing 
at FDA Advisory Committee Meetings 
 
 
Additional copies are available from: 
Office of Special Medical Programs 
Office of the Commissioner 
Food and Drug Administration 
10903 New Hampshire Avenue,  
Building 32, rm. 5103 
Silver Spring, Maryland 20993 
 
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
 
May 15, 2013 
   
 
TABLE OF CONTENTS 
I.  INTRODUCTION ...................................................................................................... 1 
II.  ORAL PARTICIPATION IN AN FDA ADVISORY COMMITTEE OPEN 
PUBLIC HEARING ................................................................................................... 3 
A. Providing a Request to Speak at the OPH ............................................................... 3 
B. Confirmation to Speak at the OPH .......................................................................... 5 
C. Confirmed Speaker Check-In the Day of the Meeting ............................................ 6 
D. Submissions and Presentations ............................................................................... 6 
E. Logistics of an Oral Presentation ............................................................................ 6 
III.  FINANCIAL DISCLOSURE ..................................................................................... 7 
A. Instructive Statement for Particular Matters Involving Specific Parties Meetings . 8 
B. Instructive Statement on Particular Matters of General Applicability Meetings .... 9 
IV.  REFERENCES .......................................................................................................... 10 
   
 
Guidance for the Public, FDA Advisory Committee Members, 
and FDA Staff: The Open Public Hearing at FDA Advisory 
Committee Meetings1 
 
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking on 
this topic. It does not create nor confer any rights for or on any person and does not operate 
to bind FDA or the public. You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations. If you want to discuss an 
alternative approach, contact the FDA staff responsible for implementing this guidance. If 
you cannot identify the appropriate FDA staff, call the appropriate number listed on the 
title page of this guidance. 
 
I.  INTRODUCTION   
The Food and Drug Administrations (FDAs) advisory committees play an essential 
role in FDAs activities to protect and promote public health through the regulation of 
human and animal drugs, biological products, medical devices, foods, and tobacco 
products.  FDAs advisory committees provide independent expert advice and 
recommendations to the Agency on scientific, technical, and policy matters related to 
FDA-regulated products.  Advisory committees enhance FDAs ability to protect and 
promote public health by ensuring FDA has access to such advice through the public 
hearing process as provided in existing laws and regulations.  Although advisory 
committees provide recommendations to FDA, FDA makes the final decisions on any 
matters considered by an advisory committee.  General procedures for FDA advisory 
committees are described at 21 CFR Part 14.  
                                                 
1 This guidance applies to all FDA advisory committees including the panels of the Medical Devices 
Advisory Committee.  This guidance has been prepared by the Office of Special Medical Programs in the 
Office of the Commissioner at the Food and Drug Administration. 
1   
FDA encourages participation from all public stakeholders in its decision-making 
processes.  Every advisory committee meeting includes an open public hearing (OPH) 
session, during which interested persons may present relevant information or views orally 
or in writing (21 CFR 14.25(a)).  FDAs regulation, 21 CFR 14.29, requires that a 
minimum of 60 minutes per meeting be dedicated to an OPH session for oral 
presentations, unless public participation does not last that long.  For meetings that 
extend more than 1 day and/or meetings with multiple topics, the OPH session can be 
divided into multiple parts.  If there is an overwhelming interest by the advisory 
committee in a specific topic, then the committee chair2 may extend the OPH session.   
The time and location of the meeting and the OPH session is published in the Federal 
Register (21 CFR 14.20) at least 15 days before a meeting.  
This guidance is intended to answer questions about how the public may participate 
at an OPH session.  This includes, but is not limited to, general members of the public; 
individuals or spokespersons from the regulated industry (except the sponsor whose 
product is under review); consumer advocacy groups; and professional organizations, 
societies, or associations. 
FDAs guidance documents, including this guidance, do not establish legally 
enforceable responsibilities.  Instead, guidances describe the Agencys current thinking 
on a topic and should be viewed only as recommendations, unless specific regulatory or 
statutory requirements are cited.  The use of the word should in Agency guidances means 
that something is suggested or recommended, but not required.  
                                                 
2 The chair is a committee member appointed to preside at committee meetings and ensure that all rules of 
order and conduct are maintained during each session (21 CFR 14.30).  He or she is typically an 
experienced committee member.   
2   
II.  ORAL PARTICIPATION IN AN FDA ADVISORY COMMITTEE OPEN 
PUBLIC HEARING 
A. Providing a Request to Speak at the OPH 
An interested person who wishes to be assured of the opportunity to make an oral 
presentation at an advisory committee meeting should inform FDA orally or in writing 
before the meeting (21 CFR 14.29(b)).  The interested person should submit the request 
to the FDA contact person designated in the Federal Register (FR) notice announcing the 
advisory committee meeting by the listed deadline date (21 CFR 14.29(b)).  FDA staff 
makes every effort to accommodate a speakers request. FDA recommends that the 
request be submitted by mail, telephone, facsimile, or e-mail. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated during the 
scheduled open public hearing session, FDA may conduct a lottery to determine the 
speakers for the scheduled open public hearing session.  FDA staff intends to contact 
speakers regarding their request to speak at least one week prior to the deadline for 
written submissions announced in the FR notice.    
The interested person should include the following with the request: 
  Name of the individual or; 
  Name of the group, including the name of the spokesperson making the 
presentation, a description of the constituency that the group represents, and a 
brief mission statement of the group; and 
  Contact information (mailing address, e-mail address, telephone, and fax 
numbers). 
3   
The interested person shall also include the following in the submission: 
  A description of the general nature of the presentation, pursuant to 21 CFR 
14.29(b)(1). The submitter may include an outline of the presentation to satisfy 
this requirement.  Whenever possible, all written information to be discussed 
by the submitter at the meeting should be furnished in advance to FDA, 
pursuant to 21 CFR14.29(b)(1) (see II.D below). 
  Amount of time requested for the presentation, pursuant to 21 CFR 
14.29(b)(1).  The time that FDA allocates to each person who wishes to make a 
presentation is dependent upon the number of requests.  FDA usually allots 5 
to 10 minutes per person.  However, if a large number of people have 
requested to address the committee, FDA may reduce the time allotment for 
each speaker pursuant to 21 CFR 14.29(b)(2) and/or extend the time of the 
OPH session.  In the interest of obtaining as many points of view as possible, 
FDA may require speakers with similar statements to consolidate their 
presentations into a single presentation, pursuant to 21 CFR 14.29(b)(2).  
Alternatively, individuals and/or groups may choose to make a joint 
presentation.  In the interest of fairness, all speakers are asked to adhere to 
their allotted time.  If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled OPH session, 
FDA may conduct a lottery to determine the speakers for the OPH session.  If 
necessary, FDA may choose to extend the time for the OPH session to 
accommodate registrants. 
4   
Audio-visual/media equipment is available at advisory committee meetings.  FDA 
asks that an interested person provide a written request for use of the equipment along 
with an electronic version of the presentation or any overheads at least one week in 
advance of the meeting.  The interested person should consult with the FDA Designated 
Federal Officer (DFO)3 on issues related to the compatibility of software/hardware for his 
or her presentation. 
B.  Confirmation to Speak at the OPH 
1.  FDA staff intends to contact speakers by e-mail, facsimile, or telephone to 
confirm their participation. 
2.  FDA may decline a request to speak at an OPH if the person wishes to address 
a matter that is unrelated to the advisory committees work (21 CFR 14.25(a)). 
3.  As discussed in II.A above, FDA intends to assign a time allocation to each 
speaker.  In the event of scheduling changes and if time permits, FDA staff 
intends to contact speakers concerning these changes. 
4.  If a speaker is delayed or is unable to attend the meeting, FDA recommends 
that an FDA representative be contacted.  If the speaker would still like to 
make a presentation and time and resources permit, it may be possible to 
arrange for an alternative time to speak during the meeting, to have the 
speakers statement read by a speaker representative, or to have the statement, 
or a summary of the speakers statement, made part of the public record via the 
public docket.  If the confirmed speaker would like a representative to speak 
                                                 
3 The DFO who coordinates the activities of the advisory committee serves as the link between committee 
members, FDA, industry, and the public. 
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on his or her behalf, the confirmed speaker should provide a written 
authorization to the designated FDA staff for the substitution.  However, once 
the public hearing portion of the meeting has ended, further oral comments 
from the public will only be accepted at the discretion of the FDA advisory 
committee chair. 
C.  Confirmed Speaker Check-In the Day of the Meeting 
1.  Check-in is at the registration table.  Speakers should introduce themselves to 
the DFO or other FDA staff.  FDA intends to provide a designated seating area 
for OPH speakers.  
2.  Speakers should work with the DFO or other designated FDA staff to facilitate 
their presentation (e.g., slides). Any handouts should be submitted by the 
deadline listed in the Federal Register Notice for the meeting.   
D.  Submissions and Presentations 
1.  FDA distributes to the advisory committee before or at the meeting those 
copies of handouts received from public speakers prior to the deadline 
announced in the FR notice, pursuant to 21 CFR 14.29(b)(1).  
A copy of the written information provided by the speakers is included in the permanent 
record of the meeting (see 21 CFR 14.60(b)(3)). 
E.  Logistics of an Oral Presentation 
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1.  FDA recommends that the Chair make a statement at the beginning of the 
OPH session encouraging committee members that it is appropriate to ask 
questions of OPH speakers if doing so might lead to information that is helpful 
to the committees deliberations.  The Chair should remind the public and 
members of the importance of the OPH session to the advisory committee 
process and that all speakers should be treated in a courteous and respectful 
manner. 
2.  FDA generally will make available to speakers a podium or lapel microphone.  
3.  A timer is used to monitor each speaker.  A visual signal (e.g., 
green/yellow/red light system), the Committee Chair, or the DFO should alert 
the speaker when his or her allotted time has nearly expired.  If the allotted 
time ends before the speaker has concluded his or her presentation, the Chair 
or DFO should advise the speaker to complete his or her final remarks and 
conclude the presentation. In the event that the speaker chooses not to 
conclude the presentation after being asked to do so, the microphone may be 
turned off to end the presentation.   
4.  When the speakers presentation concludes, the Chair may ask the speaker to 
remain at the podium for questions from the advisory committee.  
5.  All oral statements are recorded in the transcript of the meeting.  Meeting 
transcripts are posted on the FDA web site approximately three to four weeks 
after the meeting takes place. 
III.  FINANCIAL DISCLOSURE 
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The law requires that FDAs advisory committee members who are special 
Government employees (SGEs) or regular Government employees (RGEs) disclose to 
FDA potential financial interests related to the topic of the advisory committee meeting, 
including relationships that they may have with the sponsor and competitors of the 
product(s) under discussion, when the committee addresses a particular matter involving 
specific parties4 or a particular matter of general applicability5.  The financial interests 
that must be reported include stocks, grants, consulting, teaching, speaking and writing 
engagements, expert testimony, patents, and royalties.  In addition, the financial interests 
of a spouse, minor child, employer, officer, director, trustee, or partner are imputed to the 
committee member.6   
Likewise, FDA encourages OPH speakers to disclose financial relationships they may 
have with the topic of the meeting and parties (e.g., sponsor and competitors of the 
product(s) under discussion).  At the commencement of each OPH session, the Chair of 
the advisory committee meeting should read one of the statements set forth in III.A and 
III.B below, addressing the issue of financial disclosure for all open public hearing 
speakers.  
A.  Instructive Statement for Particular Matters Involving Specific Parties 
Meetings 
                                                 
4 See 5 CFR 2640.102(l) 
5 See 5 CFR 2640.102(m)  
6 If a SGE or RGE has certain financial interests, he or she may not participate in the meeting unless granted a waiver 
for conflict of interest, see 18 U.S.C. 208(b)(1) and  (b)(3).  The basis for granting a waiver will include, as appropriate, 
the public health interest in having the expertise of the member with respect to a particular matter.  21 U.S.C. 379(d)-1. 
When a member is granted a waiver, the financial interest(s) associated with the waiver are posted on FDAs website 
and read into the transcript of the meeting.  See, Guidance for the Public, FDA Advisory Committee Members, and 
FDA Staff:  Public Availability of Advisory Committee Members' Financial Interest Information and Waivers,  
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/LawsRegulationsGuidance/default.htm. 
 
 
8   
Welcome to the Open Public Hearing.  Please state your name, and your 
affiliation if relevant to this meeting.  The Food and Drug Administration (FDA) 
believes that the Agency and public benefit from a transparent process that helps 
ensure that FDA decisions are well-informed by the advice and information FDA 
receives from its advisory committees.  If you have any financial interests relevant 
to this meeting, FDA encourages you to state the interest as you begin.  Such 
interests may include a company's or group's payment of your travel or other 
expenses, or grant money that your organization receives from the sponsor or a 
competitor. If you do not have any such interests, you may wish to state that for 
the record. If you prefer not to address financial interests, you can still give your 
comments.     
B.  Instructive Statement on Particular Matters of General Applicability 
Meetings 
Welcome to the Open Public Hearing.  Please state your name, and your 
affiliation if relevant to this meeting.  The Food and Drug Administration (FDA) 
believes that the Agency and public benefit from a transparent process that helps 
ensure that FDA decisions are well-informed by the advice and information FDA 
receives from its advisory committees.  If you have any financial interests relevant 
to this meeting, such as a financial relationship with any company or group that 
may be affected by the topic of this meeting, FDA encourages you to state the 
interest as you begin.  If you do not have any such interests, you may wish to state 
9   
that for the record. If you prefer not to address financial interests, you can still 
give your comments.   
After each presentation, the Chair or a committee member may question the person 
concerning his or her presentation.  However, neither the Chair nor any committee 
member should further question the person regarding any potential financial 
relationships. 
IV.  REFERENCES 
A.  FDA Advisory Committee Home Page  
http://www.fda.gov/AdvisoryCommittees/default.htm  
 
B.  FDA Advisory Committee Annual Calendar of Meetings (Most current calendar 
year link can be found on the FDA Advisory Committee Home Page)  
 
C.  CODE OF FEDERAL REGULATIONS (21 CFR PART 14)  
http://www.gpo.gov/fdsys/bulkdata/CFR/2013 
 
 
 
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