Guidance for the Public, FDA Advisory 
Committee Members, and FDA Staff: 
Public Availability of Advisory 
Committee Members' Financial Interest 
Information and Waivers 
 
 
 
 
 
   
FINAL GUIDANCE 
 
 
 
Comments and suggestions may be submitted at any time 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 on the content of this guidance, contact Advisory Committee Oversight and 
Management Staff, at 301-796-8220.  
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
 
March 2014 
 
 
   
Guidance for the Public, 
FDA Advisory Committee 
Members, and FDA Staff: 
 
 
Public Availability of Advisory 
Committee Members' Financial Interest 
Information and Waivers  
 
 
 
 
 
Additional copies are available from: 
Advisory Committee Oversight and Management Staff 
Office of Special Medical Programs, OMPT 
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 
 
March 2014 
 
 
   
Table of Contents 
 
 
I.  INTRODUCTION .....................................................................................................1 
II.  APPLICABILITY .....................................................................................................2 
III. BACKGROUND AND PURPOSE ..........................................................................2 
IV. LEGAL FRAMEWORK ..........................................................................................5 
V.  DISCLOSURE OF CERTAIN FINANCIAL INTERESTS AND WAIVERS ....6 
APPENDIX 1 .....................................................................................................................10 
Food and Drug Administration Advisory Committee Member Acknowledgement  
of Disclosure of Financial Interests .............................................................................10 
APPENDIX 2 .....................................................................................................................12 
  Waiver to Allow Participation in a Food and Drug Administration Advisory 
  Committee Meeting .....................................................................................................12 
 
 
 
 
 
 
   
Guidance for the Public, FDA Advisory Committee Members, and FDA 
Staff:  Public Availability of Advisory Committee Members' Financial 
Interest Information and Waivers1  
 
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking 
on this topic.  It does not create or 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 appropriate FDA staff.  If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of 
this guidance. 
 
 
I.  INTRODUCTION 
This guidance is intended to help the public, Food and Drug Administration 
(FDA) advisory committee members, and FDA staff to understand and implement 
statutory requirements and FDA policy regarding public availability of information about 
financial interests and waivers2 granted by FDA to permit individuals to participate in 
advisory committee meetings subject to the Federal Advisory Committee Act (FACA) (5 
U.S.C. App.). This guidance describes the basis and provides a format for public 
disclosure of certain financial interests by special Government employees (SGEs) and 
regular Government employees participating in these advisory committee meetings, and 
provides a format for FDA waivers allowing participation in these meetings.3  This 
                                                           
1 This guidance has been prepared by the Advisory Committee Oversight and Management Staff in the 
Office of the Commissioner at the Food and Drug Administration.   
2 For purposes of this guidance, the term "waiver" refers to determinations and certifications that the 
Agency is authorized to issue under 18 U.S.C.  208(b)(1) and (b)(3), respectively. 
3 See Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for 
Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees, 
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm.  That document describes FDAs 
policy for considering whether an individual invited to participate in an FDA advisory committee meeting 
 
1 
   
guidance also explains how and when these documents will be made publicly available 
by FDA. 
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. 
 
II.  APPLICABILITY 
This guidance applies to SGEs and regular Government employees invited to 
participate in FDA advisory committees subject to FACA.  The types of advisory 
committee meetings within the scope of this guidance are meetings involving particular 
matters as defined in regulations issued by the Office of Government Ethics (OGE).  See 
5 CFR  2640.103(a)(1).4   
 
III.  BACKGROUND AND PURPOSE 
Advisory committees provide independent, expert advice on scientific, technical, 
and policy matters related to the development and evaluation of products regulated by 
FDA, such as human and animal drugs, biological products, medical devices, foods, 
cosmetics, and tobacco products.  The advisory committee system enhances FDAs 
                                                                                                                                                                             
has a potential conflict of interest under 18 U.S.C. 208 and whether, under the statute, a waiver to allow 
participation in an advisory committee meeting is appropriate.  
4  Particular matters involve deliberation, decision, or action that is focused upon the interests of specific 
persons or a discrete and identifiable class of persons, and include matters involving specific parties and 
matters of general applicability.  See also 5 CFR  2640.102(l)-(m).   
 
2 
   
ability to protect and promote the public health and maintain the public trust by enabling 
the agency to obtain the benefit of independent, professional expertise.  Although 
advisory committees provide recommendations to FDA, final decisions are made by 
FDA.  See 5 U.S.C. App. 2  9(b); 21 CFR  14.5. 
Most FDA advisory committee members are appointed as SGEs.  Advisory 
committee members may also be regular Government employees; for example, FDA may 
request participation by employees of the United States Department of Agriculture, the 
Centers for Disease Control and Prevention, or other Federal agencies for matters where 
such employees expertise is needed.   
FDA implements a rigorous process for soliciting and vetting candidates for 
advisory committee meetings to minimize any potential for financial conflicts of interest.  
In preparation for advisory committee meetings involving particular matters, SGEs 
invited to participate in the meetings are required to report to FDA any financial interests 
related to the subject matter of the advisory committee meeting.  See 5 CFR  
2634.904(a)(2).  Regular Government employees also report financial interests on a 
yearly basis and/or just prior to the advisory committee meeting they are planning to 
attend.  See 5 CFR  2634.202 and 2634.904(a)(1).  FDA reviews these reports, called 
Confidential Financial Disclosure Reports5 in advance of each upcoming meeting, once 
                                                           
5 In rare cases, an individual who is a regular Government employee may file a Public Financial Disclosure 
Report. 
 
3 
   
the meeting topics have been identified, to determine whether any financial conflicts of 
interest may exist for these individuals.6   
FDA seeks to identify all potential financial conflicts related to the particular 
matter before a committee.  FDA reviews not only the financial interests of a potential 
advisory committee participant and his immediate family, but also the financial interests, 
of which he has knowledge, of the participant's business partners, organizations for which 
he serves as officer, director, trustee, general partner, or employee, and any prospective 
employer of the member (if there are ongoing employment negotiations or an agreement 
regarding future employment).  See 18 U.S.C.  208(a).   
FDA is authorized by statute to grant waivers to allow individuals with potentially 
conflicting financial interests to participate in meetings where it concludes, after close 
scrutiny, that certain criteria are met.  See 18 U.S.C.  208(b)(1) and (b)(3).  The Agency 
has also issued a guidance document describing our policy for considering eligibility for 
advisory committee participation.7   
This document contains revisions to reflect the statutory changes in FDAs 
authority after the implementation of the Food and Drug Administration Safety and 
Innovation Act of 2012 (FDASIA), and replaces previous guidance of the same title.8  
                                                           
6 In addition, FDA screens advisory committee members broadly for covered relationships that could 
present even the appearance that they have conflicts of interest that could affect their impartiality.  See 5 
CFR   2635.502.  This guidance does not address this screening process. 
7 See FDA's "Guidance for The Public, FDA Advisory Committee Members, and FDA Staff on Procedures 
for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees" 
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm.  All guidance documents relevant 
to Advisory Committee matters may be accessed at:  
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm  
8 Section 712 of the FD&C Act requires that FDA review its disclosure guidance at least every 5 years, and 
update guidances as appropriate.  This revision is a result of that review. 
 
 
4 
   
 
IV.  LEGAL FRAMEWORK 
Members of FDAs advisory committees are subject to government wide conflict 
of interest statutes and standards of ethical conduct regulations.  A federal conflict of 
interest statute, 18 U.S.C.  208, prohibits an SGE or regular Government employee with 
a financial interest that can be affected by the particular matter before the advisory 
committee from participating in the advisory committee meeting unless a waiver is 
granted or the financial interest is covered by one of the regulatory exemptions found at 5 
CFR Part 2640.  The statute is applicable government-wide, and specifies the 
circumstances under which FDA may grant waivers to permit participation in specific 
meetings.  An additional statutory requirement applies to FDA advisory committees.  
FDA is directed to disclose on its website the type, nature, and magnitude of the financial 
interests of each advisory committee member who has received a waiver under 18 U.S.C. 
 208 and the reasons for granting each waiver prior to the advisory committee meeting, 
including, as appropriate, the public health interest in having the expertise of the member 
with respect to the particular matter.9  A waiver for an SGE must be based on a 
determination that the need for the SGEs service outweighs the potential for a conflict of 
                                                           
9 This statutory disclosure requirement has changed over time.  For example, under  505(n)(4) of the 
FD&C Act, enacted as part of the Food and Drug Administration Modernization and Accountability Act of 
1997, advisory committee members serving on panels related to new drugs could only receive a waiver of a 
conflict of interest requirement upon public disclosure of such conflict of interest if such waiver is 
necessary to afford the panel essential expertise.  The Food and Drug Administration Amendments Act of 
2007 repealed  505(n)(4) and enacted  712.  As enacted at that time,  712 also contained provisions 
regarding waivers of conflicts of interests and public disclosures of such waivers.  It had several differences 
from  505(n)(4), including that it extended its conflict of interest rules to all FDA advisory committee 
members.  In 2012, Congress enacted FDASIA, which amended  712, including by removing the 
essential expertise agency-specific waiver standard.  The requirement to make disclosures of waivers is 
now in  712(c). 
 
 
5 
   
interest.  This information must be published within specified time frames before 
advisory committee meetings.  See  712(c) of the FD&C Act.   
In addition to these statutory requirements regarding the disclosure of information 
about financial interests and corresponding waivers, FDA also has the authority to 
establish policies regarding the operation of advisory committees and participation of 
advisory committee members.  See 21 U.S.C.  393; 41 CFR  102-3.105 and 102-
3.130.   
 
V.  DISCLOSURE OF CERTAIN FINANCIAL INTERESTS AND WAIVERS 
To increase the transparency, consistency, and clarity of the advisory committee 
process, consistent with the requirements of  712(c) of the FD&C Act described above, 
FDA has concluded that it is desirable to implement agency-wide procedures regarding 
disclosure of financial interest information that apply to all SGE and regular Government 
employees invited to participate in FDA advisory committee meetings subject to FACA.  
In preparation for each advisory committee meeting, to ensure individuals understand 
what information about their financial interests will be made public, FDA intends to 
request that individuals within the scope of this guidance acknowledge that FDA intends 
to publicly disclose the type, nature, and magnitude of any waived financial interests.  
FDA further intends to make the individuals participation in advisory committee 
meetings contingent upon their acknowledgement of FDAs intention to publicly disclose 
this information.  
 
6 
   
To facilitate such disclosure, FDA plans to prepare a document listing the 
financial interests for which a waiver is sought.  A template that FDA intends to use 
when preparing this document, based on information already submitted by the 
individual,10 is found in Appendix 1.  Using the template format, FDA will list personal 
and immediate family interests separately from other imputed interests.  Other imputed 
financial interests are those that are attributed to the individual through his employer (i.e., 
the employer has a relevant financial interest) or through his position as an officer, 
director, trustee, or general partner.  Even though the individual may have no personal 
involvement in these interests, imputed financial interests that can be affected by the 
particular matter before the advisory committee are considered conflicts of interest under 
the applicable law.   
First, FDA will identify the type of interest.  The template provides several 
examples, such as stocks/investments and employment.  Second, FDA will identify the 
nature of the interest.  The template instructs that the name of the company or institution 
be identified, along with indicating whether the firm is the sponsor, a competing firm, or 
other affected entity.  Third, FDA will indicate the magnitude of an interest by a dollar 
range, such as $0 to 5000.  The agency will request that the individual in need of a waiver 
review the document and acknowledge his/her understanding that FDA will publicly 
disclose the information.   
FDA does not intend to publicly disclose financial interest information if the 
information is exempt from disclosure under the Freedom of Information Act or 
                                                           
10 See section III above. 
 
 
7 
   
otherwise protected from disclosure by statute or regulation, except if necessary to 
describe the type, nature, and magnitude of the financial conflict being waived.  For 
example, FDA would not disclose the name of a company or institution in which the 
committee member has a financial interest if doing so would reveal that companys 
confidential commercial information. 
In addition, FDA is providing a template of the waivers that the agency grants 
(Appendix 2).  FDA intends to write the waivers in a manner to ensure that information 
protected from disclosure by statute or regulation does not appear in the waivers.  The 
waivers would therefore not typically require redaction when publicly disclosed as 
described in the following paragraph.  However, if confidential information appears in 
other documents submitted, completed, or generated in the course of FDAs review of 
financial interests and waiver requests, this information will continue to be protected 
from public disclosure in accordance with applicable statutory and regulatory 
requirements.  See, e.g., 21 CFR Part 20.   
For waivers that are granted, the disclosure statement will be posted on FDAs 
website, along with the agencys waiver.  FDA will post these documents on the FDA 
website11 at least 15 days prior to the relevant advisory committee meeting, except for 
financial conflicts of interest that do not become known to FDA until shortly before the 
meeting.  For conflicts of interest that FDA becomes aware of less than 30 days prior to 
the meeting and for which a waiver is issued, FDA will post the documents as soon as 
practicable and no later than the day of the meeting.  These time frames are consistent 
                                                           
11 http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/default.htm 
 
8 
   
with the requirements of section 712(c) of the FD&C Act.  The agency also plans to 
make the disclosure statements and waiver documents public at corresponding advisory 
committee meetings. 
Additionally, FDA plans to post a roster12 of all advisory committee members 
expected to attend a specific meeting at the same time briefing materials for that meeting 
are posted. See FDAs Guidance for Industry: Advisory Committee Meetings  
Preparation and Public Availability of Information Given to Advisory Committee 
Members.13  
 
                                                           
12 http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/default.htm 
13 http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm   
 
 
9 
   
Appendix 1 
Food and Drug Administration Advisory Committee Member 
Acknowledgment of Disclosure of Financial Interests  
 
 
Name of Advisory Committee Member: 
 
Committee: 
 
Meeting Date: 
 
I acknowledge that my participation in the advisory committee meeting described above 
is contingent upon public disclosure of the following financial interest(s) related to the 
agenda item:  [Describe relevant agenda item],  
 
Type of Interest       Nature       Magnitude 
 
I.  Personal/Immediate Family  
 
[Describe type of interest; e.g.:  [Describe nature    [Describe magnitude  
Stocks/investments;       of interest; i.e.:    of interest; e.g.: 
Employment;        name of company     $0  5,000; 
Work as consultant/advisor;    or institution and    $5001  10,000; 
Contracts/grants;      whether it is the sponsor,  $10,001  25,000; 
Patents/royalties/trademarks    a competing firm, or    $25,001  50,000] 
Work as an expert witness    other affected entity] 
Teaching/speaking/writing] 
 
II.   Other Imputed Interests14 
 
[Describe type of interest; e.g.:  [Describe nature    [Describe magnitude  
Stocks/investments;       of interest; i.e.:    of interest; e.g.: 
Employment;        name of company    $0  50,000; 
Work as consultant/advisor;    or institution and     $50,001  100,000; 
Contracts/grants;      whether it is the sponsor,  $100,001  300,000; 
Patents/royalties/trademarks    a competing firm, or    over $300,000] 
Work as an expert witness    other affected entity] 
Teaching/speaking/writing] 
 
   
                                                           
14 Other imputed interests include those that are attributed to the individual through his employer (i.e., the 
employer has a relevant financial interest) or through his position as an officer, director, trustee, or general 
partner. 
 
10 
   
 
 
I hereby acknowledge that FDA will make this information publicly available if the 
agency grants a waiver15 allowing me to participate in the meeting described above.  I 
understand that without public disclosure of these interests, I will not participate in the 
advisory committee meeting described above. 
 
 
____________________________      _______________________ 
Signature            Date 
                                                           
15 Includes determinations under 18 U.S.C.  208(b)(1) and certifications under 18 U.S.C.  208(b)(3). 
 
11 
   
Appendix 2 
 
Waiver to Allow Participation in a Food and Drug 
Administration Advisory Committee Meeting  
 
Name of Advisory Committee Member:   
 
Committee: 
 
Meeting Date: 
 
Description of the Facts on Which the Waiver is Based: 
Type, Nature, and Magnitude of Financial Interest(s): 
 
Description of the Particular Matter to Which the Waiver Applies: 
 
Additional Facts (if any): 
 
Basis for Granting the Waiver: 
 
Certification: [Use one of the first two statements when describing a waiver granted 
under 18 U.S.C.  208(b), depending on whether the individual is a regular Government 
employee or SGE.] 
 
 
________ The individual may participate, pursuant to 18 U.S.C. 208(b)(1)  The regular 
Government employees financial interest is not so substantial as to be deemed likely to 
affect the integrity of the services provided by that individual.   
 
________ The individual may participate, pursuant to 18 U.S.C. 208(b)(3)  The need 
for the individuals services outweighs the potential for a conflict of interest created by 
the financial interest involved. 
 
 
Limitations on the Regular Government Employee or Special Government Employees 
Ability to Act:  
  ____Non-voting 
  ____Other (specify) 
 
 
_________________________    __________________________ 
Signature          Date 
Authorized FDA Official 
 
 
12