Guidance 

The Open Public Hearin 

FDA Advisory Committee Meetings 

DRAFT GUIDANCE 

This guidance document is being distributed for comment purposes only. 

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 FederaE Register. 

For questions regarding this document, contact Linda Ann Sherman at 301-827-1220. 

U.S. Department of Health and Human Services 

Food and Drug Administration 

Office of the Commissioner 

[Date] 

Ptwwl 
Guidance 

The Open Public Hearing 

FDA Advisory Committee Meetings 

Additional copies are availablefiom: 

Ofice of External Relations 

Advisory Committee Oversight and Management Staff 

Food and Drug Administration 

5600 Fishers Lane HF-4 

Rockville, MD 20857 

(Tel) 301-827-1220 

U.S. Department of Health and Human Services 

Food and Drug Administration 

Office of the Commissioner 

{Date] 

[Catwwl 

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TABLE OF CONTENTS 

I. INTRODUCTION . . . . . . . . . . . . . . . ..~.....~.........~.~..~..~..~....~..................~~~........~......~.................. 2 

II. ORAL PARTICIPATION IN THE OPEN PUBLIC HEARING (OPH) SESSION 

OF AN FDA ADVISORY COMMITTEE MEETING .............................................. 3 

A. Providing a Request to Speak at an OPH ......................................................... 3 

B. Confirmation to Speak at an OPH ..................................................................... 4 

C. Speaker’s Registration the Day of the Meeting ................................................. 4 

D. Handouts for the Day of the Meeting ................................................................. 4 

E. Logistics of an Oral Presentation ...................................................................... 5 

III. FINANCIAL DISCLOSURE ....................................................................................... 5 

A. Instructive Statement for Particular Matters Meeting .................................... 6 

B. Instructive Statement for General Matters Meeting ........................................ 6 

IV. WEB REFERENCES ................................................................................................... 7 

A. FDA Advisory Committee Home Page .............................................................. 7 

B. FDA Advisory Committee Annual Calendar of Meetings ............................... 7 

C. FDA Advisory Committee Information Line Code Numbers .......................... 7 

D. Code of Federal Regulations (CFR Part 14) ...................................................... 7 

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‘Guidance 

The Open Public Hearing 

FDA Advisory Committee Meetings2 

This guidance represents the Food and Drug Administration’s (FDA’s) 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 staffl call the appropriate 

number listed on the title page of this guidance. 

I. INTRODUCTION 

The Food and Drug Administration (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 8 14.25(a). FDA’s regulation, 21 CFR $ 14.29, requires that 

a minimum of 60 minutes per meeting be dedicated to an open public hearing 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 chair3 may extend the OPH session. 

The time and location of the meeting and the OPH session is published in the Federal Register 

(21 CFR 0 14.20) at least 15 days before a meeting. 

This guidance is intended to answer questions about how the public may participate at an open 

public hearing 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; or professional organizations, societies or 

associations. 

FDA’s guidance documents, including this guidance, do not establish legally enforceable 

responsibilities. Instead, guidances describe the Agency’s 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. 

’ This guidance has been prepared by the Advisory Committee Oversight and Management Staff, Office of External 

Relations, Office of the Commissioner, Food and Drug Administration. 

* This guidance applies to all FDA advisory committees including the panels of the Medical Devices Advisory 

Committee. 

3 The chair is an experienced committee member appointed to preside at committee meetings and ensure that all 

rules of order and conduct are maintained during each session. 21 $ 14.30. 

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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 right to make an oral presentation at 

an advisory committee meeting shall inform FDA orally or in writing before the meeting. 

21 CFR 0 14.29(b). The interested person shall submit the request to the FDA contact 

person designated in the Federal Register (FR) notice by the listed deadline date. 21 CFR 

$ 14.29(b). FDA staff makes every effort to accommodate a speaker’s request. FDA 

recommends that the request be submitted by mail, telephone, facsimile, or e-mail. 

Participation is handled on a first come-first serve basis through the request process. 

The interested person should include the following with the request: 

l Name of the individual or; 

l 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; 

l Contact information (mailing address, e-mail address, telephone and fax 

numbers); 

The interested person shall also include the following in the submission: 

l A description of the general nature of the presentation, pursuant to 21 CFR 

$ 14.29(b). The submitter can include an outline of the presentation to satisfy 

this requirement. Whenever possible, all written information to be discussed 

by that person at the meeting should be furnished in advance to FDA, pursuant 

to 21 CFR (j 14,29(b)(l); See subsection D below. 

l Amount of time requested for the presentation, pursuant to 21 CFR 

4 14.29(b). The allotment time is dependant upon the number of requests. 

FDA usually allots 5 to 10 minutes per person. However, if a large number of 

speakers have requested to address the committee, FDA may reduce the time 

allotment for each speaker pursuant to 21 CFR 0 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 

5 14.29(b)(2). In the interest of fairness, all speakers are asked to adhere to 

their allotted time. 

Audio-visual/media equipment is available at advisory committee meetings. FDA asks that the 

interested person provide a written request for use of the equipment along with an electronic 

version of the power point presentation or any overheads at least one week in advance of the 

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meeting. Please consult with the FDA executive secretary (FDA staff’j4 on issues related to the 

compatibility of software/hardware for your 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 intends to assign a time allocation. In the event of scheduling changes and if 

time permits, FDA staff will contact the speaker concerning these changes, 

3. If the 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 speaker’s statement read 

by a speaker representative; or to have the statement, or a summary of the 

speaker’s statement, made part of the public record via the public docket. 

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 

Executive Secretary and other FDA staff. OPH speakers often have a designated 

seating area. 

2. Please work with the Executive Secretary or other designated FDA staff to 

facilitate your presentation (e.g., slides) and handout distribution. 

D. Handouts for the Day of the Meeting 

1. FDA distributes to the advisory committee before or at the meeting those copies 

of handouts received from public speakers prior to the deadline in the FR notice, 

pursuant to 21 CFR $ 14.29(b)(l). 5 

2. A copy of slide presentations should be given to FDA for posting on the FDA 

web site at http://www.fda.gov/oc/advisory/default.htm. 

3. A copy of the written information will be included in the permanent record of the 

meeting. 21 CFR $ 14.60(b)(3). 

4 The Executive Secretary is the Designated Federal official (DFO) who coordinates the activities of the advisory 

committee, serves as the link between committee members, FDA, industry and the public. 

5 FDA plans to issue draft guidance in the future to address the issue of written material submitted after the deadline 

stated in the Federal Register notice. 

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E. Logistics of an Oral Presentation 

1. A podium or lapel microphone is available or, alternatively, an audience 

microphone is located conveniently on the floor. 

2. A timer is used to monitor the speaker. If the timer is not used at a particular 

meeting, the Committee Chair or the Executive Secretary signals the speaker 

when his or her allotted time has expired. 

3. When the oral presentation concludes, FDA recommends that the speaker remain 

at the podium in case there are questions from the FDA advisory committee. 

4. 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. 

111. FINANCIAL DISCLOSURE 

The law requires that the Food and.Drug Administration’s scientific advisors, who are 

usually special Government employees (SGEs), disclose potential financial interests or 

relationships that they may have with the sponsor and/or competitors of the product under 

discussion at an advisory committee meeting. The financial interests requiring disclosure 

include stock, grants, consulting, teaching, speaking and writing engagements, expert 

testimony, patents, and royalties. In addition, the financial interests of a spouse, minor 

child, and employer are imputed to the committee member. 

As noted in this Guidance, at every advisory committee meeting, at least one hour is set 

aside for an open public hearing. At this time, speakers from the general public may 

make a presentation to the advisory committee. Advisory committee meetings consist of 

either particular or general matters for discussion and consideration. Particular matters 

before an advisory committee relate to a specific regulated product and affect a specific 

manufacturer and its competing products/manufacturers (e.g., NDA, PMA, PLABLA, 

efficacy supplement for new indication). General matters before an advisory committee 

do not relate to a specific regulated product but instead relate to scientific findings or 

regulatory issues that may affect various members of the public and regulated industry. 

At the commencement of each QPH session, the Chair of the particular advisory 

committee meeting reads one of the following statements, addressing the issue of 

financial disclosure for alJ open public hearing speakers. 
Draft 

A. Instructive Statement far Particular Matters Meetings 

Both the Food and Drug Administration (FDA) and the public believe in a 

transparent process for information gathering and decision-making. To ensure such 

transparency at the open public hearing session of the advisory committee meeting, 

FDA believes that it is important to understand the context ofan individual’s 

presentation. For this reason, FDA encourages you, the open public hearing 

speaker, at the beginning ofyour written or oral statement, to advise the committee of 

any financial relationship that you may have with the sponsor, its,I-7roduct, and if 

known, its direct competitors. For example, thisJinancia1 information may include 

the sponsor’s payment of your travel, lodging, or other expenses in connection with 

your attendance at the meeting. Likewise, FDA encourages you at the beginning of 

your statement to advise the committee tfyou do not have any such financial 

relationships. Ifyou choose not to address this issue offinancial relationships at the 

beginning of your statement, it will not preclude you from speaking. 

B. Instructive Statement for General Matters Meetings 

Both the Food and Drug Administration (FDA) and the public believe in a 

transparent process for information gathering and decision-making. To ensure such 

transparency at the open public hearing session of the advisory committee meeting, 

FDA believes that it is important to understand the context of an individual’s 

presentation. For this reason, FDA encourages you, the open public hearing 

speaker, at the beginning of your written or oral statement, to advise the committee of 

any financial relationship that you may have with any company or group that may be 

afleeted by the topic of this meeting. For exumple, the financial information may 

include a company’s or a group’s payment of your travel, lodging2 or other expenses 

in connection with your attendance at the meeting. Likewise, FDA encourages you at 

the beginning ofyour statement to advise the committee ifvou do not have any such 

financial relationships. If you choose not to address this issue offinancial 

relationships at the beginning of your statement, it will not preclude you from 

speaking. 

After each presentation, the Chair or a committee member may question the person 

concerning the scientific content of his or her presentation. However, neither the Chair 

nor any committee member should further question the person regarding any potential 

financial relationships. If the open public hearing participant’s statement contains no 

inforrnation about his or her financial relationships relative to the meeting topic, FDA 

intends to assume that the participant has made a conscious decision not to disclose this 

information. 

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Iv. REFERENCES 

A. FDA Advisory Committee Home Page - 

http://www.fda.p;ov/oc/advisory/default.htm 

B. FDA Advisory Committee Annual Calendar of Meetings - 

http://WWW.fda.nov/oc/advisorv/accalend~/2004/default.htm 

C. FDA Advisory Committee Information Line Code Numbers - 

http://www.fda.nov/ohrms/dockets/ac/listinfo.htm 

D. CODE OF FEDERAL REGULATIONS (CFR PART 14) - 

http://www.access.gpo.aov/nara/cfi/waisidx 03/21cfr14 03.html 

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