Open Public Hearings

FDA Advisory Committee Meetings

Frequently Asked Questions

 

The Food and Drug Administration (FDA) encourages participation from the public in the open public hearing (OPH) session of all FDA advisory committee meetings. At every meeting, it is required that FDA reserve 60 minutes for the public to express their views before the committee.

If you would like to make a comment in the open public hearing, you may have questions concerning how you might participate. We hope that the following information will be helpful. If you have further questions, please contact the appropriate Executive Secretary from the list provided at the end of this document.

 

How do I request to participate in an FDA Advisory Committee Open Public Hearing?

 

1.       Provide an oral or written request to the FDA contact person listed in the Federal Register (FR) notice. You may send your request by telephone, facsimile, or e-mail no later than the deadline date listed in the FR notice.1

2.       Include

1 FDA staff will make every effort to accommodate requests to speak that are received after the deadline listed in the Federal Register notice. However, this may not always be possible. It depends upon the number of individuals that have already registered to speak.

2 If you are a member of a group that wishes to be heard, please provide the name of the group, the spokesperson for the group, and a list of other individuals who are also being represented. If you are speaking on behalf of a group, please provide a brief description of your organization and its purpose.

3 FDA regulations permit FDA staff to ask speakers with similar viewpoints to consolidate their presentations. In addition, please rehearse your presentation as time allotted is strictly enforced.

4 According to Federal regulations, FDA may distribute this material to the Advisory Committee prior to the meeting date. If you have materials to distribute, please provide 50 100 copies to the Executive Secretary.


How is my request to speak confirmed?

 

1.       FDA staff will contact speakers by e-mail, facsimile, or telephone to confirm participation.

2.       A time allocation will be assigned (depending upon the number of requests that have been received). FDA staff will contact those individuals who have registered to make a public comment in the event of any scheduling changes.

Note: Please contact the designated FDA staff person if you arrive late to the meeting or if you cannot attend the open public hearing during the time scheduled. If you would still like to make a presentation, it may be possible to arrange for you to speak at another time during the meeting; to have your statement read by a representative; or to have your complete or summarized statement included in the record. 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 and only if time permits.

 

What should I do when I arrive at the meeting?

 

1.       Check-in at the registration table. Ask if you are to sit in a reserved seat. (This is sometimes necessary for meetings with large audiences). If you have not been given an assigned seat, you may sit where you wish.

2.       If you have handouts, inform the staff at the registration table. Please bring enough copies (50 100) to distribute to committee members and to the public. A copy of your written information will be included in the permanent record of the meeting. Please also note that your oral statement will be included in a verbatim transcript of the meeting. All transcripts including your oral statement and/or written information will be posted on the FDAs web page.

3.       The FDA staff is available to help you. However, the priority of the Executive Secretary is the successful coordination of the meeting and it may not be possible for him or her to spend a great deal of time with you.

 

How is the meeting space set up for speaker presentations?

 

1.       Usually, a podium or lapel microphone is available or, alternatively, an audience microphone is located on the floor in the middle of the aisle.

2.       At the podium, a three light system may be used to guide your presentation time: Green (begin), Yellow (near end of time), Red (time has expired). If you are at the audience aisle microphone, the Committee Chair or the Executive Secretary will signal you when your allotted time is expiring.

3.       Audio-visual/media equipment is available. However, all arrangements for such equipment should be made in advance. Your material should be made available to the Executive Secretary before the start of the topic discussion or during a meeting break not at the beginning of the open public hearing session.

4.      When you have completed your statement, FDA advisory committee members may choose to ask you questions. Please remain at the microphone until all questions are answered.

 


What do I need to know about Financial Disclosure?

 

The law requires that the Food and Drug Administration's scientific advisors, who are special Government employees, 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.

 

At every advisory committee meeting, an hour is set aside for an open public hearing (OPH). At this time, speakers from the general public may make a presentation to the advisory committee. At the commencement of each OPH session, the Chair of the particular advisory committee meeting reads verbatim the following instructive statement addressing the issue of financial disclosure for all public speakers.

 

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 the sponsor, its product, and if known, its direct competitors. For example, this financial 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 if you do not have any such financial relationships. If you choose not to address this issue of financial relationships at the beginning of your statement, it will not preclude you from speaking.

 

After the public presentation, the Chair or a committee member may question a person concerning the scientific content of that person's presentation. However, neither the Chair nor any committee member may further question the participant about any potential financial relationships. If the open public hearing participant's statement contains no information about his or her financial relationships relative to the meeting topic, FDA will assume that the participant has made a conscious decision not to disclose this information.

 

 

Contact Numbers for FDA Executive Secretaries:

 

Center for Biologics Evaluation and Research: 301-827-0314 (FAX: 301-827-0294)

Center for Drug Evaluation and Research: 301-827-7001 (FAX: 301-827-6776)

Center for Devices and Radiological Health: 301-594-2022 (FAX: 301-594-2510)

Center for Food Safety and Applied Nutrition: 301-436-2397 (FAX: 301-436-2633)

Center for Veterinary Medicine: 301-827-4515 (FAX: 301-827-3957)

National Center for Toxicological Research: 301-827-6696 (FAX: 301-443-3019)

Office of the Commissioner: 301-827-3450 (FAX: 301-827-3410)

 

You may call the FDA advisory committee hotline for up-to-date meeting information at 1-800-741-8138. The following page includes a list of 5-digit numbers for accessing specific committees and panels.

 

FDA Advisory Committees

OFFICE OF THE COMMISSIONER

Information Line Code Numbers

Science Board to the FDA

12603

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

 

Allergenic Products Advisory Committee

12388

Biological Response Modifiers Advisory Committee

12389

Blood Products Advisory Committee

19516

Transmissible Spongiform Encephalopathies Advisory Committee

12392

Vaccines and Related Biological Products Advisory Committee 

12391

CENTER FOR DRUG EVALUATION AND RESEARCH

 

Anesthetic and Life Support Drugs Advisory Committee 

12529

Anti-Infective Drugs Advisory Committee 

12530

Antiviral Drugs Advisory Committee 

12531

Arthritis Advisory Committee 

12532

Cardiovascular and Renal Drugs Advisory Committee

12533

Dermatologic and Ophthalmic Drugs Advisory Committee

12534

Drug Safety and Risk Management Advisory Committee

(Formerly Drug Abuse Advisory Committee)

12535

Endocrinologic and Metabolic Drugs Advisory Committee 

12536

Gastrointestinal Drugs Advisory Committee 

12538

Nonprescription Drugs Advisory Committee 

12541

Oncologic Drugs Advisory Committee

12542

Peripheral and Central Nervous System Drugs Advisory Committee

12543

Pharmaceutical Science, Advisory Committee for  

12539

Psychopharmacologic Drugs Advisory Committee 

12544

Pulmonary-Allergy Drugs Advisory Committee

12545

Reproductive Health Drugs, Advisory Committee for 

12537

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

 

Food Advisory Committee - Full Committee

10564

Additives and Ingredients Subcommittee

 

Biotechnology Subcommittee

 

Contaminants and Natural Toxicants Subcommittee

 

Dietary Supplements Subcommittee

 

Infant Formula Subcommittee

 

Nutrition Subcommittee

 

[Note: The charter and roster for the full committee covers the full committee and its subcommittees.]

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

 

Device Good Manufacturing Practice Advisory Committee

12398

Medical Devices Advisory Committee (Comprised of 18 Panels)

NA

Anesthesiology and Respiratory Therapy Devices Panel

12624

Circulatory System Devices Panel

12625

Clinical Chemistry and Clinical Toxicology Devices Panel

12514

Dental Products Panel

12518

Ear, Nose, and Throat Devices Panel

12522

Gastroenterology-Urology Devices Panel

12523

General and Plastic Surgery Devices Panel

12519

General Hospital and Personal Use Devices Panel

12520

Hematology and Pathology Devices Panel

12515

Immunology Devices Panel

12516

Medical Devices Dispute Resolution Panel 

10232

Microbiology Devices Panel

12517

Molecular and Clinical Genetics Panel

10231

Neurological Devices Panel

12513

Obstetrics-Gynecology Devices

12524

Ophthalmic Devices Panel

12396

Orthopedic and Rehabilitation Devices Panel

12521

Radiological Devices Panel

12526

National Mammography Quality Assurance Advisory Committee

12397

Technical Electronic Product Radiation Safety Standards Committee

12399

CENTER FOR VETERINARY MEDICINE

 

Veterinary Medicine Advisory Committee 

12548

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

 

Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants

12560

Science Advisory Board to NCTR 

12559