Guidance for Industry 
Advisory Committee Meetings  
Preparation and Public Availability 
of Information Given to Advisory 
Committee Members 
 
 
 
 
For questions regarding this document, please contact the Advisory Committee Oversight 
Staff at 301-827-1220. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
 
August 2008 
 
  Guidance for Industry 
Advisory Committee Meetings  
Preparation and Public Availability of 
Information Given to Advisory 
Committee Members 
   
Additional copies are available from: 
 
Office of Policy, Office of the Commissioner 
Food and Drug Administration 
(HF-11) 
5600 Fishers Lane 
Rockville, MD 20857 
301-827-3360 
http://www.fda.gov 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
 
  August 2008 
  Contains Nonbinding Recommendations 
 
 
I.  INTRODUCTION...............................................................................................................................4 
II.  BACKGROUND.................................................................................................................................5 
A.  RELEVANT STATUTES AND REGULATIONS........................................................................................5 
B.  ADVISORY COMMITTEE MEETINGS  GENERAL INFORMATION.........................................................5 
III.  MAKING BRIEFING MATERIALS AVAILABLE TO THE PUBLIC..................................6 
A.  SCOPE OF BRIEFING MATERIALS SUBJECT TO THIS GUIDANCE.........................................................6 
B.  TIMELINES FOR SUBMITTING AND MAKING BRIEFING MATERIALS PUBLICLY AVAILABLE..............6 
C.  POSTPONING THE PUBLIC RELEASE OF BRIEFING MATERIALS..........................................................7 
IV.  PREPARING BRIEFING MATERIALS....................................................................................8 
A.  GENERAL RECOMMENDATIONS ON PREPARING BRIEFING MATERIALS.............................................8 
B.  INFORMATION IN BRIEFING MATERIALS THAT TYPICALLY WILL BE DISCLOSABLE UNDER FOIA...9 
C.  INFORMATION IN BRIEFING MATERIALS THAT WILL TYPICALLY BE EXEMPT FROM DISCLOSURE.10 
D.  FULLY RELEASABLE SPONSOR BRIEFING MATERIALS....................................................................11 
E.  SPONSOR BRIEFING MATERIALS THAT CONTAIN INFORMATION CLAIMED TO BE EXEMPT FROM 
DISCLOSURE.............................................................................................................................................11 
F.  FDA-PREPARED ADVISORY COMMITTEE BRIEFING MATERIALS....................................................13 
G.  POSTING BRIEFING MATERIALS ON FDAS WEB SITE....................................................................14 
APPENDIX A. TIMELINE FOR OPEN FDA ADVISORY COMMITTEE MEETINGS INVOLVING 
FDA BRIEFING MATERIALS AND SPONSOR BRIEFING MATERIALS THAT THE SPONSOR 
STATES ARE FULLY RELEASABLE......................................................................................................17 
APPENDIX B.  TIMELINE FOR OPEN FDA ADVISORY COMMITTEE MEETINGS INVOLVING 
FDA BRIEFING MATERIALS AND SPONSOR BRIEFING MATERIALS THAT THE SPONSOR 
ASSERTS ARE NOT FULLY RELEASABLE...........................................................................................19 
 
3 Contains Nonbinding Recommendations 
 
1
        Guidance for Industry   
Advisory Committee Meetings  Preparation and Public 
Availability of Information Given to Advisory Committee 
Members 
 
 
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 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 
 
This document provides guidance to industry sponsors, applicants, and petitioners 
(referred to collectively as sponsors) who develop, prepare, or submit briefing materials 
that will be given to advisory committee members as background information before an 
open FDA advisory committee meeting.2  This guidance will help sponsors develop, 
organize, and submit advisory committee briefing materials for public release and should 
help minimize the time and resources spent in preparing these materials for public 
availability.  The guidance also describes the process FDA intends to follow when we 
make briefing materials available to the public.  In addition, the Appendices provide 
recommended timelines for preparing and submitting briefing materials to us.3     
 
An important goal of this guidance is to help ensure that briefing materials are made 
available to the public as provided under section 10(b) of the Federal Advisory 
Committee Act (FACA) (5 U.S.C. App. 2).  The guidance includes recommendations on 
                                                 
1 This guidance has been prepared by a working group with members from across FDA.  
 
2 Most FDA advisory committee meetings are open to the public.  However, sometimes a portion of a 
meeting will be closed to the public under 21 C.F.R.  14.27. This guidance only applies to briefing 
materials prepared for open advisory committee meetings or for the open portions of such meetings.    
 
3 This guidance, which applies to all FDA open advisory committee meetings or open portions of such 
meetings, replaces three previously issued draft guidances: 1) "Guidance for Industry: Disclosing 
Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings 
Related to the Testing or Approval of New Drugs and Convened by the Center for Drug Evaluation and 
Research, Beginning on January 1, 2000" (dated December 1999); 2) "Guidance for Industry: Disclosing 
Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings 
Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics 
Evaluation and Research" (dated February 2001); and 3) "Availability of Information Given to Advisory 
Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry 
and FDA Staff" (dated July 18,  2001). 
 
4 Contains Nonbinding Recommendations 
 
how to identify information that is exempt from public disclosure under the Freedom of 
Information Act (FOIA) (5 U.S.C.  552).   
 
Our guidance documents do not establish legally enforceable responsibilities.  Instead, 
guidances describe our 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 our guidances means that something is suggested or recommended, 
but not required.  
 
II. BACKGROUND  
 
A.  Relevant Statutes and Regulations 
 
As stated earlier, under section 10(b) of FACA, any materials made available to an 
advisory committee also must be made available to the public.  The public availability of 
these materials, however, is subject to FOIA, and FOIA exempts certain types of 
information from public disclosure.  We interpret FACA to require that, with respect to 
any open advisory committee meeting convened pursuant to FACA, whenever 
practicable and subject to any applicable FOIA exemptions, those materials that we 
provide to advisory committee members in connection with that meeting must be made 
available for public inspection and copying before or at the time of the advisory 
committee meeting.  
 
Several FDA regulations (e.g., 21 CFR  20.61, 20.63, 171.1, 314.430, 514.12, 601.51, 
and 860.5) protect information that is exempt from public disclosure under FOIA.  We 
interpret our regulations to be consistent with FACA and intend to exercise our discretion 
under our regulations in a manner consistent with FACA and FOIA.  This guidance 
should help ensure that information that is exempt from disclosure under FOIA will not 
be made publicly available.   
 
B.  Advisory Committee Meetings  General Information 
III.      
We convene advisory committee meetings for a variety of different purposes.  Some 
meetings discuss particular matters such as the approval or testing of products.  Topics 
commonly discussed at this type of advisory committee meeting often involve marketing 
applications/submissions such as:  
  
  New drug applications and application supplements; 
  New animal drug applications and application supplements; 
  Biologics license applications and application supplements; 
  Premarket approval applications for medical devices and their supplements; 
  Premarket notifications for medical devices; and 
  Medical device classifications and reclassifications.  
 
5 Contains Nonbinding Recommendations 
 
 
We also convene advisory committee meetings to discuss general matters, such as 
guidance documents, issues pertaining to trial design, post-approval monitoring, citizens 
petitions, and policy issues related to FDA-regulated products.  
 
III.  MAKING BRIEFING MATERIALS AVAILABLE TO THE PUBLIC  
 
A.  Scope of Briefing Materials Subject to this Guidance 
 
This guidance uses the term briefing materials to describe the package of information 
that we provide to advisory committee members before a meeting.  The briefing materials 
usually contain information prepared by us and/or the sponsor (if the meeting involves an 
application or a particular product).  Although interested persons (i.e., individuals or 
organizations who are not sponsors) may submit information to an advisory committee 
pursuant to 21 C.F.R.  14.29 or 14.35(d), this guidance does not consider those 
submissions to be briefing materials.4  
 
B.  Timelines for Submitting and Making Briefing Materials Publicly 
Available 
 
For an open advisory committee meeting for which the briefing materials may contain 
information that, under certain circumstances, could be considered to be exempt from 
public disclosure under FOIA, we intend (as set forth in the Appendices) to post a 
publicly available version of the briefing materials on our Web site no later than two full 
business days5 before the day the advisory committee meeting (or the part of the meeting 
to which the materials pertain) is scheduled to occur.   
 
With respect to meetings for which the briefing materials do not contain information that, 
under certain circumstances, could be considered exempt from public disclosure under 
FOIA, we will try to make the briefing materials available on our Web site more than two 
full business days before the day the advisory committee meeting (or the part of the 
meeting to which the materials pertain) is scheduled to occur.  We anticipate that 
meetings subject to this timeline will normally address general matters such as guidance 
documents and policy issues related to FDA-regulated products. 
 
Even when a sponsor states that its briefing materials are fully releasable (as described in 
section IV.D.), we intend to post the briefing materials in accordance with the timelines 
in the Appendices if the briefing materials contain the type of information that, under 
certain circumstances, could be considered to be exempt from public disclosure under 
FOIA.  Please note that, as described in the Appendices, we intend to post both sponsor-
                                                 
4 Information submitted by interested persons is considered to be publicly disclosable and must conform to 
the requirements of 21 CFR  10.20.  Failure to comply with the requirements will result in rejection of the 
submission for filing or, if it is filed, in exclusion from consideration of any portion that fails to comply (21 
CFR  10.20(c)(6)). 
5 In this guidance, a business day is a day that we are officially open for business. 
 
6 Contains Nonbinding Recommendations 
 
prepared and agency-prepared briefing materials for a particular advisory committee 
meeting (or part of a meeting) at the same time.  
 
If an advisory committee meeting is scheduled to address more than one topic, separate 
briefing materials may be prepared for the different topics on the meeting agenda.  For 
meetings that last more than one day, we intend to post the publicly available version of 
the briefing materials on our Web site no later than two full business days before the 
topic to which the materials pertain will be discussed.  For example, assume that two 
drugs, A and B, will be discussed on days 1 and 2 respectively.  We would make the 
briefing materials on drug A available no later than two full business days before the 
scheduled day 1 of the advisory committee meeting and the briefing materials on drug B 
available no later than two full business days before the scheduled day 2 of the advisory 
committee meeting.  Please note that the timelines for sponsors to submit materials to us 
are linked to the first day of the meeting and not to the specific day on which a particular 
topic will be discussed.  Thus, in our example, the sponsor for drug B would have the 
same deadline for submitting materials to us as the sponsor for drug A, even though the 
discussions for their drugs (and the posting of their briefing materials) would occur on 
different days.   
 
The Appendices to this guidance provide timelines for preparing and submitting briefing 
materials to us.  Appendix A provides timelines for FDA-prepared briefing materials and 
sponsor-prepared briefing materials in those instances where the sponsor states that its 
materials are fully releasable to the public.  Appendix B provides timelines for briefing 
materials in instances where the sponsor asserts that its materials are not fully releasable.  
Please note that the timelines in the Appendices do not provide for formal predisclosure 
notification to sponsors pursuant to 21 CFR  20.61(e) and (f).  The predisclosure 
notification requirements in that regulation apply only where the disclosure is to be made 
in response to a specific request for our records.  The disclosures contemplated here are 
not made in response to a request for our records, but to comply with FACA.  
Nevertheless, the timelines in the Appendices are at least as generous as the timeframes 
for notification under 21 CFR  20.61. 
 
This guidance does, however, constitute public notice under 21 CFR 14.35(d)(2) that a 
sponsor should submit information to us within the timelines listed in the Appendices if 
the sponsor wants the advisory committee to consider that information before the 
meeting.  If we do not receive a sponsors briefing materials within the applicable 
timeline in the Appendices, we do not intend to provide the sponsors briefing materials 
to the members of the committee, and the committee will not consider the sponsors 
materials before the meeting. 
 
C.  Postponing the Public Release of Briefing Materials 
 
On occasion, the issue of whether certain information in the briefing materials should be 
made available to the public may need to be decided in court.  If a federal court directs us 
to not release information in briefing materials, we will not release that information and 
 
7 Contains Nonbinding Recommendations 
 
may postpone the advisory committee meeting where the information would have been 
discussed until the matter is resolved. 
 
IV.   PREPARING BRIEFING MATERIALS  
 
The contents of the briefing materials provided to advisory committee members for their 
review in advance of a meeting differ from meeting to meeting, and the type and amount 
of information included generally will depend on the type of product or issues to be 
discussed.  Additionally, as indicated in the Appendices, the times by which sponsors 
should submit briefing materials differ depending on whether the materials contain 
information that the sponsor claims is exempt from disclosure under FOIA.    
 
It is important to minimize the time we will need to spend reviewing briefing materials, 
consulting with sponsors, and redacting such materials.  The more time we need to 
complete this process, the earlier the sponsors may need to submit materials for an 
advisory committee meeting.  If the preparation of the materials occurs too far in advance 
of a meeting, the materials may not adequately address the issues that will be the subject 
of the meeting because those issues will not yet have been fully identified.  
 
A.  General Recommendations on Preparing Briefing Materials 
 
For open advisory committee meetings that involve sponsor-prepared briefing materials,   
approximately 55 business days before the meeting is scheduled to occur, FDA intends to 
notify a sponsor that an advisory committee will consider an issue that is directly relevant 
to the sponsor.  We will explain the meetings focus to the sponsor and also may advise 
the sponsor about the information it may wish to include in its briefing materials.  To 
facilitate the review and eventual posting of sponsor-prepared briefing materials, we 
strongly recommend that sponsors submit both paper and electronic versions of their 
materials.  Sponsors should consult the appropriate FDA component about compatible 
electronic formats and consult the Designated Federal Official6 for a given meeting to 
determine the appropriate number of paper copies.7    
 
We emphasize that a sponsors submissions should include only information related to 
the issue being discussed by the committee.  Statements or suggestions that could be 
viewed as misleading or promotional (e.g., statements that go beyond study conclusions 
or speculate about clinical or commercial implications not supported by the data) are 
inappropriate for inclusion in the briefing materials.  In addition, statements or language 
that are defamatory, irrelevant, or intemperate are inappropriate for inclusion in briefing 
materials and should be avoided. 
                                                 
6 The Designated Federal Official is a federal employee who is responsible for the overall administrative 
management of an advisory committee. 
7 If an advisory committee meeting involves advisory committees from different agency components (e.g., 
a joint meeting of a Center for Biologics Evaluation and Research advisory committee and a Center for 
Drug Evaluation and Research advisory committee), sponsors should consult the relevant Designated 
Federal Officials of the two committees as to the Designated Federal Official coordinating the briefing 
material process.  
 
 
8 Contains Nonbinding Recommendations 
 
 
B.  Information in Briefing Materials That Typically Will Be Disclosable 
Under FOIA 
 
We generally will consider the following information in advisory committee briefing 
materials to be disclosable without redaction, unless the sponsor demonstrates that 
disclosure of the information is likely to cause substantial competitive harm: 
 
  Summaries of clinical safety and effectiveness data; 
  Summaries of non-clinical safety and effectiveness data; 
  Summaries of adverse drug reaction data; 
  Written discussion or analysis of safety or effectiveness data relevant to the 
topic of the meeting; 
  A general description (such as that which would typically be included in 
product labeling) of product functions, mechanics, and/or engineering; 
  A general description of physical characteristics and performance parameters; 
  Clinical or preclinical protocols or summaries of protocols; 
  Statistical protocols and analyses; 
  Information that is proposed to be included in product labeling, such as 
indications and usage, dosage and administration, and safety information such 
as warnings and precautions;  
  Literature references;8 
  Any other information that has been previously publicly disclosed by the 
sponsor;  
  Copies of the sponsors slides to be presented at the advisory committee 
meeting, if included in the briefing materials; and 
  Guidance documents. 
 
The above list is neither exhaustive nor absolute.  
 
With regard to certain topics discussed at advisory committee meetings (for example, 
issues relating to the approval of a pending New Drug Application (NDA), Biologics 
Licensing Application (BLA), Premarket Approval Application (PMA), 510(k), New 
                                                 
8 FDA does not post copyrighted materials on its Web site.  If sponsors do wish to submit copyrighted 
materials, they should provide a bibliography of the copyrighted materials that can be posted. 
 
9 Contains Nonbinding Recommendations 
 
Animal Drug Application (NADA), or a supplement to any of these), some of the 
information listed above might be considered confidential commercial information at 
earlier stages of the product development process.  However, we believe it is appropriate 
to make this information available under 21 CFR  20.82, 314.430(d)(1), 514.11(d), 
601.51(d)(1), 814.9(d)(1), and/or 171.1(h)(2) (whichever is applicable) at the time of an 
advisory committee meeting if the information is germane to the issues to be discussed at 
the meeting.  These materials are often necessary to a committees consideration of the 
safety and effectiveness of a product being discussed and committees and sponsors 
routinely discuss such matters at open advisory committee meetings.  It is widely 
understood that, when advisory committees consider such products, the information 
contained in these materials will be the subject of open discussion.   
 
C.  Information in Briefing Materials That Will Typically Be Exempt from 
Disclosure  
 
We generally will consider the following types of information to be exempt from 
disclosure under FOIA:  
  Information about product functions, mechanics, engineering, and schematic 
drawings not in the proposed labeling and not within the scope of the agenda for 
the meeting; 
  Proprietary physical characteristics and performance parameters not in the 
proposed labeling and not within the scope of the agenda for the meeting; 
  Manufacturing process information; 
  Manufacturing quality control information; 
  Clinical raw data; 9 
  Non-clinical raw data;  
  Supplier names, customer lists, production costs, inventory information, failure 
rates of products, production quality control information;  
  Information for which the release would constitute an unwarranted invasion of 
personal privacy; and 
  Product formulation information not in the labeling. 
 
The above list is neither exhaustive nor absolute. 
 
The advisory committee members will receive complete copies of the briefing materials, 
including information that is exempt from disclosure under FOIA.  However, we will not 
include information that is exempt from disclosure under FOIA in the publicly available 
                                                 
9 For the purposes of this guidance, FDA considers "raw data" to be a complete data set of case report 
forms, case report tabulations, or line listings. Data that summarize individual or multiple subject outcomes 
or results are considered summaries. Summaries may include examples of specific findings.  
 
 
10 Contains Nonbinding Recommendations 
 
version of the briefing materials, and we will notify the committee members in writing 
that any such exempt information may not be discussed during any open portion of the 
advisory committee meeting. 
 
D.  Fully Releasable Sponsor Briefing Materials 
 
To shorten the process for complying with FACA's disclosure requirements, we strongly 
encourage sponsors to submit briefing materials that may be released to the public, in 
accordance with the timelines in Appendix A, in their entirety without redaction (i.e., that 
do not contain any information that the sponsor asserts is exempt from disclosure under 
FOIA).  Sponsors also benefit from preparing fully releasable briefing materials because 
such briefing materials eliminate the need for us to redact trade secret and/or confidential 
commercial information and, as a result, can be submitted to us closer in time to the 
advisory committee meeting than briefing materials containing information that the 
sponsor asserts is exempt from disclosure under FOIA.  As a result, sponsors may be able 
to devote more time to preparing their submissions before the advisory committee 
meeting occurs (see timelines in the Appendices).  
 
If a sponsor chooses to submit fully releasable briefing materials that it agrees can be 
posted in accordance with the timeline in Appendix A, it should mark the materials as:  
Advisory Committee Briefing Materials: Available for Public Release. 
 
When we receive briefing materials marked as fully releasable, we will review the 
materials for completeness.  We will assume that sponsors who mark their materials 
Available for Public Release have carefully reviewed the included materials to make 
sure that they all may be made available to the public without redaction.  Sponsors should 
not expect us to identify trade secret or confidential commercial information in briefing 
materials marked as Available for Public Release.  We will, however, review sponsor 
briefing materials for information that, if publicly released, would constitute a clearly 
unwarranted invasion of personal privacy, and we will redact such information.  This 
review time is reflected in the timeline in Appendix A.  Additionally, as stated in section 
III.B., and as set forth in Appendix A, FDA intends to post both the sponsor-prepared 
briefing materials and the agency-prepared briefing materials at the same time.  As 
discussed in section IV.F., and as set forth in Appendix A, the various activities relating 
to our briefing materials will not have been completed at the time the sponsor submits 
briefing materials that it indicates are fully releasable. 
 
E.  Sponsor Briefing Materials that Contain Information Claimed to be 
Exempt from Disclosure 
 
A sponsor may elect to prepare advisory committee briefing materials that contain 
information that it believes is exempt from disclosure under FOIA (see section IV.C. for 
a discussion of what types of information we generally will consider to be exempt from 
disclosure).  If the sponsor chooses to prepare such briefing materials, it should prepare 
two versions of its briefing materials at the same time.  One version should be complete, 
 
11 Contains Nonbinding Recommendations 
 
and should include the information that the sponsor believes should not be available for 
public release.  The second version should be a publicly releasable version.   
 
We recommend that, when preparing briefing materials that contain information the 
sponsor believes is exempt from disclosure, the sponsor should segregate the information 
it believes is exempt from disclosure from the releasable information (e.g., by placing it 
in a separate portion of the briefing materials) or clearly identify the specific information 
that it believes is exempt from disclosure.   
 
The complete version of the briefing materials (that is, the one that would not be 
available for public release because it includes the information the sponsor believes is 
exempt from disclosure under FOIA) should be clearly marked as:  Draft: Advisory 
Committee Briefing Materials: Not for Public Release: Contains Trade Secret and/or 
Confidential Commercial Information.  
 
For the version of the briefing materials that would be publicly releasable, the sponsor 
should prepare and submit a copy of the same materials as are included in the version that 
is not for public release, but this version should indicate what information the sponsor 
believes is exempt from disclosure under FOIA.  Sponsors should indicate the 
information they believe is exempt by providing a redacted copy.  We suggest that, when 
redacting information, sponsors should identify any proposed deletions and indicate 
exactly how much material should be redacted.  Sponsors can indicate the amount of 
information that has been removed in several ways.  For example, a sponsor could 
include a statement such as two paragraphs have been deleted, or five pages have been 
removed.  For each document or portion of a document that the sponsor believes is 
exempt from disclosure under FOIA, the sponsor should explain, in detail, why it 
believes that the information is exempt from disclosure under FOIA.  We caution that, to 
the extent that the sponsor intends to discuss specific information during the open portion 
of the meeting, it will be difficult for the sponsor to claim that the information is exempt 
from disclosure under FOIA. 
 
Sponsors should label the redacted copy prominently as: Draft: Advisory Committee      
Briefing Materials: Available for Public Release.  
 
After we receive the two versions of the briefing materials (the non-public and publicly 
releasable versions), we will review the briefing materials for completeness and 
determine if the sponsor appropriately identified exempt information.  If we disagree that 
any of the information the sponsor has redacted is exempt from disclosure under FOIA, 
we will discuss the matter with the sponsor.  When the discussions are concluded, we will 
notify the sponsor of our final decision.  Once we have notified the sponsor of our final 
decision, no new documents or information may be added to the briefing materials.  See 
the Appendices for details on the timing of this process. 
 
When the sponsor receives our final decision regarding what information, if any, we have 
determined to be exempt from disclosure under FOIA, the sponsor has four options: 
 
 
12 Contains Nonbinding Recommendations 
 
  Option 1:  The sponsor may remove from the briefing materials information 
that we have determined is not exempt from disclosure under FOIA and thus 
would not be redacted from the materials.  The sponsor may reformat the 
materials accordingly.   
 
  Option 2:  If the sponsor accepts our determination as to the releasability of 
the information in the briefing materials, and there is still information in the 
materials that we and the sponsor agree is exempt from disclosure, the sponsor 
should submit a final copy of both versions of the briefing materials.  The 
final documents should be prominently labeled:  Final: Advisory Committee 
Briefing Materials: Not for Public Release: Contains Trade Secret and/or 
Confidential Commercial Information and Final: Advisory Committee 
Briefing Materials: Available for Public Release.   
 
  Option 3: If we and the sponsor agree that no information in the materials is 
exempt from disclosure under FOIA, then the sponsor should submit a copy 
marked "Final: Advisory Committee Briefing Materials: Available for Public 
Release. 
 
  Option 4:  If the sponsor disagrees with our determination regarding the 
releasability of information in the briefing materials, the sponsor may seek 
judicial review in federal court to prevent us from releasing the information.   
If the sponsor chooses this option, we will not release the information that is 
in dispute and may postpone the advisory committee meeting where the 
information would be discussed until the matter is resolved.  
 
When this process is complete, we will send the final version of the sponsor-prepared 
briefing materials to the advisory committee members in preparation for the scheduled 
meeting.  We will identify for the advisory committee members any information in the 
materials that is exempt from disclosure under FOIA, and we will advise them that such 
exempt information may not be discussed during any open portion of the advisory 
committee meeting.  Additionally, if during this process the sponsor has asserted, and 
FDA has agreed, that certain information in the briefing materials is exempt from 
disclosure under FOIA, the sponsor should not in turn discuss that information at an open 
portion of the advisory committee meeting; such public discussion would be inconsistent 
with the sponsor's assertions regarding the nonpublic status of the information.  
 
F.  FDA-Prepared Advisory Committee Briefing Materials 
 
For most advisory committee meetings, we prepare our own briefing materials and send 
them to the advisory committee members.  When we have prepared our briefing 
materials, we will review them to determine if they contain information that, under 
certain circumstances, could be considered to be exempt from disclosure under FOIA 
(specifically, confidential commercial or trade secret information belonging to a sponsor).  
If the materials do not contain information that, under certain circumstances, could be 
considered to be confidential commercial or trade secret information belonging to a 
 
13 Contains Nonbinding Recommendations 
 
sponsor, the portions of the timelines (see Appendices) that pertain to sharing our briefing 
materials with sponsors will not apply.  As discussed in section III.B., under such 
circumstances we will try to post such briefing materials on our Web site more than two 
full business days before the day the advisory committee meeting (or the portion of it to 
which the briefing materials pertain) is scheduled to occur. 
 
If we determine that our briefing materials contain information that, under certain 
circumstances, could be considered to be confidential commercial or trade secret 
information belonging to a sponsor, the portions of timelines in the Appendices 
pertaining to sharing our briefing materials with sponsors will apply, and we will send 
our briefing materials to the sponsor as described in the timelines.  If the briefing 
materials include information pertaining to more than one sponsor, we will send only the 
relevant portion to each sponsor.  We will discuss with each sponsor any disagreements it 
may have about the disclosability of information in the materials.  We note that, in 
circumstances where the sponsor has submitted briefing materials that it has asserted are 
not fully releasable, we may already have had discussions with the sponsor regarding the 
releasability of certain information in the sponsor's briefing materials and have informed 
the sponsor of our final decision regarding the redaction of information from its briefing 
materials.  Thus, our discussion with the sponsor regarding our briefing materials should 
focus on new issues and information, and not on issues or information that were 
previously discussed with the sponsor in the context of the sponsor's briefing materials.   
 
When the discussions of our briefing materials are concluded, we will notify each 
sponsor of our final decision regarding the public availability of the information in our 
briefing materials.  If the sponsor disagrees with our determination regarding the 
releasability of information in our briefing materials, the sponsor may seek judicial 
review in federal court to prevent us from releasing the information.  If the sponsor 
chooses this option, we will not release the information that is in dispute and may 
postpone the advisory committee meeting where the information would be discussed until 
the matter is resolved. 
 
G. Posting Briefing Materials on FDAs Web Site 
 
We will post the briefing materials for an open advisory committee meeting subject to 
this guidance on our Web site at http://www.fda.gov/ohrms/dockets/ac/acwhatsnew.htm.  
The materials also will be available in hard copy at our Division of Dockets 
Managements Public Reading Room.10  We will post only the publicly available 
sponsor-prepared briefing materials and the publicly available FDA-prepared briefing 
materials on our Web site.  
 
To avoid any misunderstanding that we have endorsed the contents of a sponsors 
briefing materials by posting them on our Web site, we will display the following 
statement with the sponsors briefing materials placed on our Web site:  
 
                                                 
10 The Public Reading Room is open Monday through Friday, 9:00 a.m. to 4:00 p.m.  The Public Reading 
Room is located at 5630 Fishers Lane, Room 1061, Rockville, Maryland 20857. 
 
14 Contains Nonbinding Recommendations 
 
The statements contained in this document are those of 
the products sponsor.  FDA does not necessarily agree 
with the sponsors statements.  FDA has not made a final 
determination about the issues described in this 
document. 
 
We also may take appropriate action to address any information that may be promotional 
or misleading, including posting a correction on our Web site.  
 
Please note that if unforeseen difficulties prevent us from posting the briefing materials 
on our Web site before an advisory committee meeting, we will make hard copies 
available to the public at the time of the advisory committee meeting. 
 
If you have questions, please refer to the contact information listed below. 
 
  For briefing materials pertaining to the Center for Biologics Evaluation and 
Research: 
   
  Office of Communication, Training, and Manufacturers Assistance, HFM-40 
  Center for Biologics Evaluation and Research 
  1401 Rockville Pike, Suite 200N 
  Rockville, MD 20852 
  Phone: 301-827-1800 
 
  For briefing materials pertaining to the Center for Devices and Radiological 
Health: 
   
  Freedom of Information Officer, Joy Lazaroff 
  Office of Management Operations 
  Division of Ethics and Management Operations, HFZ-23 
  Center for Devices and Radiological Health 
  7520 Standish Place 
  Rockville, MD 20855 
  Phone: 301-827-7258 
 
  For briefing materials pertaining to the Center for Drug Evaluation and 
Research: 
   
  Advisors and Consultants Staff, HFD-21 
  Center for Drug Evaluation and Research 
  5630 Fishers Lane, Room 1093 
  Rockville, MD 20850 
  Phone: (301) 827-7001 
 
  For briefing materials pertaining to the Center for Food Safety and Applied 
Nutrition: 
 
15 Contains Nonbinding Recommendations 
 
   
  Freedom of Information Officer, Patricia Gee 
  Executive Operations Staff, HFS-22 
  Center for Food Safety and Applied Nutrition 
  5100 Paint Branch Parkway 
  College Park, MD   20740-3835 
  Phone: 301-436-2121 
 
  For briefing materials pertaining to the Center for Veterinary Medicine: 
   
  Freedom of Information Officer, Marilyn Broderick 
  Communications Staff, HFV-12 
  Center for Veterinary Medicine 
  7519 Standish Place 
  Rockville, MD 20855 
  Phone: 240-276-9107 
 
  For briefing materials pertaining to the National Center for Toxicological 
Research: 
 
  Rose Huber 
  Office of the Director, HFT-1 
  National Center for Toxicological Research 
  3900 NCTR Road 
  Jefferson, AR 72079 
  Phone: 870-543-7130 
 
  For briefing materials pertaining to the Office of the Commissioner: 
 
Carlos Pena, PhD, MS 
Office of Science and Health Coordination 
Office of the Commissioner 
5600 Fishers Lane, HF-33 
Rockville, MD 20857 
Phone : 301-827-3340 
 
 
 
 
16 Contains Nonbinding Recommendations 
 
Appendices 
 
APPENDIX A:  TIMELINE FOR OPEN FDA ADVISORY COMMITTEE MEETINGS 
INVOLVING FDA BRIEFING MATERIALS AND SPONSOR BRIEFING MATERIALS 
THAT THE SPONSOR STATES ARE FULLY RELEASABLE  
   
FDA Action  Business  Sponsor Action 
Days Before 
Meeting 
We intend to notify the sponsor that we are  55   
taking an issue directly relevant to the sponsor 
to an advisory committee.  
  54 through 23  If the sponsor plans to submit briefing 
materials to FDA that include any information 
that it believes is exempt from disclosure, the 
sponsor should follow the timeline in Appendix 
B, which calls for the submission of those 
materials on Day 42.  Otherwise, the sponsor 
should prepare its fully releasable briefing 
materials for submission to agency staff on day 
22. 
  22  The sponsor should submit its briefing 
materials to the appropriate agency staff. 
We will conduct the following activities:  21 through 14   
  We will review the sponsor-prepared 
briefing materials for completeness. 
  We will review both the sponsor and final 
agency briefing materials for disclosure. 
o  We will send the complete 
(unredacted) agency and sponsor 
briefing materials to the advisory 
committee members. 
o  We will send a copy of our briefing 
materials (or relevant portions 
thereof), as prepared for public 
release, to the sponsor to review. 
We will discuss with the sponsor any concerns  13 through 9  The sponsor should review our briefing 
it has raised regarding the disclosability of any  materials (or relevant portions thereof), as 
information in our briefing materials.  prepared for public release.  
  The sponsor may raise with appropriate center 
staff any concerns it has regarding the 
disclosability of any information in our briefing 
materials. 
The sponsor should inform us whether it 
 
17 Contains Nonbinding Recommendations 
 
FDA Action  Business  Sponsor Action 
Days Before 
Meeting 
disagrees with us regarding the disclosability of 
any information in our briefing materials. 
If the sponsor has raised concerns with us  7   
about the disclosability of information in our 
briefing materials, we will inform the sponsor 
of our final decision regarding the redaction, if 
any, of our briefing materials. 
We will submit both the sponsors and the 
agencys briefing materials (as prepared for 
public release) to our Division of Dockets 
Management for posting on our Web site. 
We will post on our Web site both the  No later than   
sponsors and the agency's publicly available  2 full business 
briefing materials.  days before 
the day on 
which the 
sponsors 
topic will be 
discussed 
 
 
18 Contains Nonbinding Recommendations 
 
APPENDIX B:  TIMELINE FOR OPEN FDA ADVISORY COMMITTEE MEETINGS 
INVOLVING FDA BRIEFING MATERIALS AND SPONSOR BRIEFING MATERIALS 
THAT THE SPONSOR ASSERTS ARE NOT FULLY RELEASABLE 
 
FDA Action  Business  Sponsor Action 
Days Before 
Meeting 
We intend to notify the sponsor that we are  55   
taking an issue directly relevant to the sponsor 
to an advisory committee. 
  42  The sponsor should submit two versions of its 
briefing materials: a complete (unredacted) 
version and a redacted version. 
We will send copies of both the complete  41   
(unredacted) and the redacted sponsors 
submissions to the appropriate disclosure staff 
and a copy of the complete sponsor submission 
to the appropriate review staff. 
We will inform the sponsor whether we agree  34   
with the sponsor's proposed redactions to the 
sponsors briefing materials. 
If we disagree with any of the sponsors  33 through  29  The sponsor may respond to any disagreements 
proposed redactions, we will discuss the  we have raised with regard to the sponsor's 
redaction of the sponsors briefing materials  proposed redactions to the sponsors briefing 
with the sponsor.  materials.   
We will inform the sponsor of our final  28  The sponsor should decide whether to remove 
decision regarding the redaction of information  any materials that we have determined will not 
from the sponsor's briefing materials.   be redacted and to reformat the materials 
accordingly.  No new documents or 
 
information may be added to the briefing  
materials at this time. 
  22  The sponsor should submit the final version or 
versions of its briefing materials to the 
appropriate agency staff. 
We will conduct the following activities:   21 through 14   
  We will send the complete (unredacted) 
agency and sponsor briefing materials to 
the advisory committee members. 
  We will send a copy of our briefing 
materials (or relevant portions thereof), as 
prepared for public release, to the sponsor 
to review. 
We will discuss with the sponsor any concerns  13 through 9  The sponsor should review our briefing 
the sponsor has raised regarding the  materials (or relevant portions thereof), as 
 
19 Contains Nonbinding Recommendations 
 
FDA Action  Business  Sponsor Action 
Days Before 
Meeting 
disclosability of any information in our  prepared for public release. 
briefing materials. 
The sponsor will discuss with appropriate 
  center staff any concerns it has regarding the 
disclosability of any information in our briefing 
materials.   
The sponsor should inform us whether it 
disagrees with us regarding the disclosability of 
any information in our briefing materials. 
If the sponsor has raised concerns with us  7   
about the disclosability of information in our 
briefing materials, we will inform the sponsor 
of our final decision regarding the redaction, if 
any, of our briefing materials. 
We will submit both the sponsors and the 
agencys briefing materials (as prepared for 
public release) to our Division of Dockets 
Management for posting on our Web site. 
We will post on our Web site both the  No later than   
sponsor's and the agencys publicly available  2 full business 
briefing materials.  days before 
the day on 
which the 
sponsors 
topic will be 
discussed 
 
 
 
20