Formal Meetings 
Between FDA and 
Sponsors or Requestors 
of Over-the-Counter 
Monograph Drugs 
Guidance for Industry 
 
 
 
 
DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 30 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit electronic comments to https://www.regulations.gov.  Submit written 
comments to the Dockets Management Staff (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 publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) Trang Tran at 240-402-7945 or by 
email at Trang.Tran@fda.hhs.gov. 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
February 2022 
Procedural
39537786dft.docx 
01/27/22  Formal Meetings 
Between FDA and 
Sponsors or Requestors 
of Over-the-Counter 
Monograph Drugs 
Guidance for Industry 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD  20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
February 2022 
Procedural  TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  MEETING TYPES ........................................................................................................... 3 
A.  Type X Meeting .............................................................................................................................. 4 
B.  Type Y Meeting .............................................................................................................................. 4 
C.  Type Z Meeting .............................................................................................................................. 5 
IV.  MEETING FORMATS .................................................................................................... 5 
V.  MEETING REQUESTS ................................................................................................... 6 
VI.  ASSESSING AND RESPONDING TO MEETING REQUESTS ................................ 8 
A.  Meeting Granted ............................................................................................................................ 8 
B.  Meeting Denied .............................................................................................................................. 9 
VII.  MEETING PACKAGE .................................................................................................. 10 
A.  Timing of Meeting Package Submission .................................................................................... 10 
B.  Where and How Many Copies of Meetings Packages to Send ................................................. 11 
C.  Meeting Package Content ............................................................................................................ 11 
VIII.  PRELIMINARY RESPONSES ..................................................................................... 13 
IX.  RESCHEDULING MEETINGS.................................................................................... 13 
X.  CANCELING MEETINGS ........................................................................................... 14 
XI.  MEETING CONDUCT .................................................................................................. 15 
XII.  MEETING MINUTES.................................................................................................... 16 
XIII.  FORMAL MEETINGS WITH MULTIPLE MEETING REQUESTERS (JOINT 
MEETINGS) .................................................................................................................... 17 
A.  General Information About Joint Meetings .............................................................................. 17 
B.  Formation of an OTC Monograph Industry Working Group................................................. 17 
C.  Procedures for Joint Meetings .................................................................................................... 18 
1. Meeting Request ............................................................................................................................. 18 
2. Meeting Package ............................................................................................................................ 19 
3. Meeting Conduct ............................................................................................................................ 19 
XIV.  CONFIDENTIALITY OF INFORMATION SUBMITTED TO FDA IN 
CONNECTION WITH FORMAL MEETINGS ......................................................... 19  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Formal Meetings Between FDA and Sponsors or Requestors of 
2  Over-the-Counter Monograph Drugs 
3  Guidance for Industry1 
4   
5   
6   
7  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
8  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
9  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
10  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
11  for this guidance as listed on the title page.   
12   
13   
14   
15  I.  INTRODUCTION 
16   
17  This guidance provides recommendations to industry on formal meetings between the Food and 
18  Drug Administration (FDA) and sponsors2 or requestors3 of  nonprescription drugs without 
19  approved new drug applications that are governed by section 505G of the Federal Food, Drug, 
20  and Cosmetic Act (FD&C Act) (21 U.S.C. 355h) (hereafter referred to as OTC (over-the-
21  counter) monograph drugs4).5  This guidance specifies the procedures and principles for formal 
22  meetings between FDA and sponsors or requestors for an OTC monograph drug (hereafter 
23  referred to collectively as meeting requesters).6  In doing so, it describes procedures under which 
24  meeting requesters can meet with appropriate FDA officials to obtain advice on the studies and 
25  other information necessary to support submissions under section 505G of the FD&C Act, to 
26  obtain advice on other matters relevant to the regulation of nonprescription drugs, and to obtain 
27  advice on the development of new OTC monograph drugs.7  This guidance also specifies 
 
1 This guidance has been prepared by the Office of Nonprescription Drugs in the Center for Drug Evaluation and 
Research at the Food and Drug Administration. 
 
2 Sponsor is defined in section 505G(q)(2) of the FD&C Act as any person marketing, manufacturing, or processing 
a drug that is listed pursuant to FD&C Act 510(j) and is or will be subject to an administrative order under section 
505G of the FD& Act.  When this guidance uses a different definition of sponsor, an explanatory footnote is 
provided. 
 
3 Requestor is defined in section 505G(q)(3) of the FD&C Act as any person or group of persons marketing, 
manufacturing, processing, or developing a drug. 
 
4 For purposes of this guidance, the term OTC monograph drug is consistent with the definition at section 744L(5) 
established for user fee purposes. 
 
5 Section 505G of the FD&C Act was added by the Coronavirus Aid, Relief, and Economic Security Act (CARES 
Act), Public Law 116-136, which was enacted on March 27, 2020. 
 
6 See section 505G(l) of the FD&C Act. 
 
7 See section 505G(h) of the FD&C Act. 
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28  procedures to facilitate efficient participation in joint meetings by multiple meeting requesters 
29  and/or organizations nominated by them to represent their interests.8 
30   
31  For the purposes of this guidance, a formal meeting includes a meeting that is requested by a 
32  meeting requester following the procedures provided in this guidance and includes meetings 
33  conducted in any format (i.e., face to face, teleconference/videoconference, or written response 
34  only (WRO)). 
35   
36  This guidance discusses the principles of good meeting management practices and describes 
37  standardized procedures for requesting, preparing, scheduling, conducting, and documenting 
38  such formal meetings. 
39   
40  This guidance does not apply to meetings for the development of nonprescription drug products 
41  intended for submission in new drug applications or abbreviated new drug applications under 
42  section 505 of the FD&C Act.  This guidance does not apply to meetings between FDA and pre-
43  investigational new drug or investigational new drug sponsors.9,10 
44   
45  The contents of this document do not have the force and effect of law and are not meant to bind 
46  the public in any way, unless specifically incorporated into a contract.  This document is 
47  intended only to provide clarity to the public regarding existing requirements under the law.  
48  FDA guidance documents, including this guidance, should be viewed only as recommendations, 
49  unless specific regulatory or statutory requirements are cited.  The use of the word should in 
50  Agency guidances means that something is suggested or recommended, but not required. 
51   
52   
53  II.  BACKGROUND 
54   
55  On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic 
56  Security Act (CARES Act).  The CARES Act added section 505G to the FD&C Act.  Section 
57  505G reforms and modernizes the framework for the regulation of OTC monograph drugs.  OTC 
58  monograph drugs may be marketed without new drug applications approved under section 505 of 
59  the FD&C Act if they meet the requirements of section 505G of the FD&C Act, as well as all 
60  other applicable requirements.  
61   
62  The CARES Act also added section 744M to the FD&C Act authorizing FDA to assess and 
63  collect user fees dedicated to OTC monograph drug activities.  
64   
65  Section 505G(h) of the FD&C Act requires that FDA establish procedures under which meeting 
66  requesters can meet with appropriate FDA officials to obtain advice on the studies and other 
 
8 See section 505G(i) of the FD&C Act. 
 
9 Sponsor, in the context of investigational new drug applications, is defined in 21 CFR 312.3. 
 
10 See the guidance for industry and review staff Best Practices for Communication Between IND Sponsors and 
FDA During Drug Development (December 2017).  We update guidances periodically.  For the most recent version 
of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents. 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
67  information necessary to support submissions under section 505G of the FD&C Act, other 
68  matters relevant to the regulation of nonprescription drugs, and the development of new 
69  nonprescription drugs under section 505G of the FD&C Act.11  In addition, section 505G(i) of 
70  the FD&C Act requires FDA to, among other things, establish procedures to facilitate efficient 
71  participation in joint meetings by multiple meeting requesters and/or organizations nominated by 
72  them to represent their interests.12  Finally, section 505G(l)(1) requires FDA to issue guidance 
73  that specifies the procedures and principles for formal meetings between FDA and meeting 
74  requesters for OTC monograph drugs.13  This guidance fulfills all three of these requirements 
75  with respect to meetings. 
76   
77  We expect that each year FDA review staff will participate in meetings with meeting requesters 
78  who seek advice relating to the development and regulation of OTC monograph drugs.  Because 
79  these meetings can represent critical points in the regulatory and development process, it is 
80  important that there are efficient, consistent procedures for the timely and effective conduct of 
81  such meetings.  The good meeting management practices described in this guidance are intended 
82  to provide consistent procedures that will promote well-managed meetings and to ensure that 
83  such meetings are scheduled within a reasonable time, conducted efficiently, and documented 
84  appropriately.  
85   
86  The Over-the-Counter Monograph User Fee Program Performance Goals and Procedures 
87  document,14 commonly referred to as the OMUFA commitment letter, specifies FDA and 
88  industry mutually agreed-upon timelines for various OTC monograph drug activities.  FDA has 
89  committed to specific performance goals that include meeting management goals for formal 
90  meetings that occur between FDA and meeting requesters.  These and other agreed-upon 
91  performance goals are described individually throughout this guidance.   
92   
93   
94  III.  MEETING TYPES 
95   
96  There are three types of formal meetings that may occur between meeting requesters and FDA 
97  staff to obtain advice on the studies and other information necessary to support OTC monograph 
98  order submissions, to obtain advice on other matters relevant to OTC monograph drug 
99  regulation, or to obtain advice on OTC monograph drug development: Type X, Type Y, and 
100  Type Z.   
101   
 
11 See section 505G(h) of the FD&C Act. 
 
12 See section 505G(i) of the FD&C Act. 
 
13 See section 505G(l)(1) of the FD&C Act. 
 
14 The meeting types and goal dates are described in the Over-the-Counter Monograph User Fee Program 
Performance Goals and Procedures document and apply to formal meetings between FDA staff and meeting 
requesters.  The document can be accessed at https://www.fda.gov/media/106407/download.  Based on passage of 
the CARES Act, FDA updated goal dates for fiscal years 20212025.  That document can be accessed at 
https://www.fda.gov/media/146283/download. 
 
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102  A.  Type X Meeting 
103   
104  Type X meetings are as follows: 
105   
106    A meeting that is necessary for an otherwise stalled OTC monograph order development 
107  program to proceed.  For example, a meeting that is requested by a meeting requester 
108  within 3 months of FDAs issuing a refuse-to-file letter for an OTC monograph order 
109  request (OMOR)15 submitted by that meeting requester. 
110   
111    A meeting that is necessary to address an important safety issue that needs immediate 
112  action when the meeting requester learns about a safety issue related to an OTC 
113  monograph drug that is marketed or being developed. 
114   
115  Before submitting a request for a Type X meeting, meeting requesters should contact FDA to 
116  discuss the appropriateness of the request.   
117   
118  B.  Type Y Meeting 
119   
120  A Type Y meeting is a meeting intended for milestone discussions during the course of a 
121  meeting requesters OTC monograph order development program. Type Y meetings are as 
122  follows: 
123   
124    Overall Data Recommendations Meetings 
125   
126  A meeting requester may request a meeting to discuss the overall data recommended to 
127  support the following:  
128   
129    A positive general recognition of safety and effectiveness (GRASE) determination for 

130  an OTC monograph drug containing a particular active ingredient or subject to some 
131  other condition of use after FDA has stated its intent to make that final GRASE 
132  determination 
133   
134    An OMOR submission when a meeting requester has an interest in initiating an 

135  OMOR (i.e., meeting requester has not yet begun an OTC monograph order 
136  development program) 
137   
138    Pre-OMOR Submission Meeting 
139   
140  When nearing completion of its development program for an OMOR, a meeting 
141  requester should request a pre-OMOR submission meeting to present a summary of the 
142  data supporting the OMOR and take the following steps: 
143   
 
15 OTC monograph order request (OMOR) is defined for user fee purposes in section 744L(7) of the FD&C Act and 
refers to a request for FDA to issue an administrative order under section 505G(b)(5) of the FD&C Act.  This term 
has the same meaning when used in this guidance document. 
 
  4  Contains Nonbinding Recommendations 
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144    Discuss the proposed format for the OMOR 

145   
146    Obtain FDA feedback on the adequacy of the proposal for the OMOR submission,16 

147  such as the format and content of the anticipated OMOR, including presentation of 
148  data, structure of dataset, acceptability of data for submission, as well as the projected 
149  submission date of the OMOR 
150   
151    Discuss the appropriate categorization of an OMOR (e.g., Tier 1 or Tier 217) 

152   
153  The meeting should be held sufficiently in advance of the planned submission of the 
154  OMOR to allow for meaningful response to FDA feedback and should generally occur 
155  not less than 3 months before the planned submission of the OMOR. 
156   
157  C.  Type Z Meeting 
158   
159  A Type Z meeting is any meeting that is not a Type X or Type Y meeting.  
160   
161   
162  IV.  MEETING FORMATS 
163   
164  There are three meeting formats:  face to face, teleconference/videoconference, and WRO as 
165  follows:  
166   
167    Face to face  Traditional face-to-face meetings are those in which the majority of 
168  attendees participate in person at FDA.  
169   
170    Teleconference/videoconference  Teleconferences/videoconferences are meetings in 
171  which the attendees participate from various remote locations via an audio (e.g., 
172  telephone) and/or video connection.  
173   
174    WRO  WRO responses are sent to meeting requesters in lieu of meetings conducted in 
175  one of the other two formats described above. 
176   
177   
 
16 See generally section 505G(b)(5)-(6) of the FD&C Act. 
 
17 The FD&C Act establishes two types of OMORs for user fee purposes:  Tier 1 and Tier 2.  As described in section 
744L(8) of the FD&C Act, a Tier 1 OMOR is any OMOR not determined to be a Tier 2 OMOR.  As described in 
section 744L(9)(A) of the FD&C Act, a Tier 2 OMOR is a request for reordering of existing information in the drug 
facts label of an OTC monograph drug; addition of information to the Other Information section of the drug facts 
label of an OTC monograph drug (subject to certain limitations); modification to the Directions for Use section of 
the drug facts label of an OTC monograph drug, consistent with a minor dosage form change made pursuant to 
section 505G(c)(3)(A); standardization of the concentration or dose of a specific finalized ingredient within a 
particular finalized monograph; change to ingredient nomenclature to align with nomenclature of a standards-setting 
organization; or addition of an interchangeable term in accordance with 21 CFR 330.1 (or any successor 
regulations).  FDA may also characterize any OMOR as a Tier 2 OMOR as described at section 744L(9)(B). 
 
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178  V.  MEETING REQUESTS 
179   
180  To make the most efficient use of FDA resources, meeting requesters should consult the 
181  information publicly available from FDA before seeking a meeting.  To disseminate a broad 
182  range of information in a manner that can be easily and rapidly accessed by interested parties, 
183  FDA develops and maintains web pages, portals, and databases and participates in interactive 
184  media as a means of providing advice on scientific and regulatory issues that fall outside of 
185  established guidance, policy, and procedures. 
186   
187  To promote efficient meeting management, meeting requesters should try to anticipate future 
188  needs and, to the extent practical, combine related OTC monograph order development program 
189  issues into the fewest possible meetings. 
190   
191  To request a meeting, meeting requesters must submit a written request to FDA electronically.18 
192   
193  The meeting request should include adequate information for FDA to assess the potential utility 
194  of the meeting and to identify FDA staff necessary to discuss proposed agenda items.   
195   
196  The meeting request should include the following information: 
197   
198  1.  The OMOR number, if applicable. 
199   
200  2.  The product name, if applicable.  
201   
202  3.  The relevant OTC monograph, or if an OTC monograph has not yet been established, the 
203  proposed therapeutic category. 
204   
205  4.  The chemical name, established name, and/or structure.  
206   
207  5.  Indications or proposed indications (uses). 
208   
209  6.  The meeting type being requested (i.e., Type X, Type Y, or Type Z) and the rationale for 
210  requesting the meeting type. 
211   
212  7.  Suggested dates and times (e.g., morning or afternoon) for the meeting that are within or 
213  beyond the appropriate scheduling time frame of the meeting type being requested (see 
214  Table 2 in section VI.A, Meeting Granted).  Dates and times when the meeting requester 
215  is not available should also be included. 
216   
217  8.  A list of questions, grouped by FDA discipline.  For each question there should be a brief 
218  explanation of the context and purpose of the question.   
219   
 
18 See section 505G(j) of the FD&C Act. 
 
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220  The meeting request must include the following information to qualify for OMUFA performance 
221  goals:19 
222   
223  1.  A brief statement of the purpose of the meeting.  This statement should include a brief 
224  background of the issues underlying the agenda.  It can also include a brief summary of 
225  data that the meeting requester intends to discuss at the meeting, the general nature of the 
226  critical questions to be asked, and where the meeting fits in the overall OTC monograph 
227  order development program.  Although the statement should not provide the details of 
228  studies and clinical trials, it should provide enough information to facilitate 
229  understanding the issues, such as a small table that summarizes major results. 
230   
231  2.  The proposed format of the meeting (i.e., face to face, teleconference/videoconference, or 
232  WRO). 
233   
234  3.  A listing of the specific objectives or outcomes the meeting requester expects from the 
235  meeting. 
236   
237  4.  A proposed agenda, including estimated times needed for discussion of each agenda item. 
238   
239  5.  A statement of whether the meeting requester intends to discuss information exempt from 
240  disclosure under section 505G(d) of the FD&C Act or other laws at the meeting. 
241   
242  6.  A list of planned attendees from the meeting requesters organization, which should 
243  include their names and titles.  The list should also include the names, titles, and 
244  affiliations of consultants and interpreters, if applicable. 
245   
246  7.  A list of requested attendees and/or discipline representatives from the Center for Drug 
247  Evaluation and Research (CDER) with an explanation for the request as appropriate.  
248  Requests for attendance by FDA staff who are not otherwise essential to the meeting 
249  discussion may affect the ability to hold the meeting within the specified time frame of 
250  the meeting type being requested.  Therefore, when attendance by nonessential FDA staff 
251  is requested, the meeting request should provide a justification for such attendees and 
252  state whether a later meeting date is acceptable to the meeting requester to accommodate 
253  the nonessential FDA attendees. 
254   
255  8.  The date that the meeting package will be sent to FDA by the meeting requester (see 
256  section VII.A., Timing of Meeting Package Submission).  Meeting packages should be 
257  included with the meeting request for all Type X meetings. 
258   
259  When submitting a meeting request, the meeting requester should define the specific areas of 
260  input needed by FDA.  A well-written meeting request that includes the above components can 
261  help FDA understand and assess the utility and timing of the meeting.  The list of meeting 
 
19 The meeting types and goal dates are described in the Over-the-Counter Monograph User Fee Program 
Performance Goals and Procedures document and apply to formal meetings between FDA staff and requesters of 
OTC monograph meetings.  The document can be accessed at https://www.fda.gov/media/106407/download. 
 
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262  requester attendees and the list of requested FDA attendees can be useful in providing or 
263  preparing for the input needed at the meeting.  However, during the time between request and 
264  meeting, the planned attendees can change.  If there are changes, an updated list of attendees 
265  with their titles and affiliations should be provided to the appropriate FDA contact before the 
266  meeting. 
267   
268  The objectives and agenda provide overall context for the meeting topics, but it is the list of 
269  questions that is the most critical to understanding the kind of information or input needed by the 
270  meeting requester and to focus the discussion should the meeting be granted.  Each question 
271  should be precise and include a brief explanation of the context and purpose of the question.  The 
272  questions submitted within a single meeting request should be limited to those that can be 
273  reasonably answered within the allotted meeting time, taking into consideration the complexity 
274  of the questions submitted.  Similar considerations regarding the complexity of the questions 
275  submitted within a WRO should be applied.   
276   
277   
278  VI.  ASSESSING AND RESPONDING TO MEETING REQUESTS 
279   
280  The meeting requester can request a specific meeting type and format.  For any type of meeting, 
281  the meeting requester may request a WRO rather than a face-to-face meeting or teleconference.  
282  FDA assesses each meeting request, including WRO requests, and determines whether the 
283  request should be granted, the appropriate meeting type, and the appropriate meeting format.  
284  FDA may determine that a WRO is the most appropriate means for providing feedback and 
285  advice for the meeting.  When it is determined that the meeting request can be appropriately 
286  addressed through a WRO, FDA will notify the meeting requester in FDAs response to the 
287  meeting request, as described in section VI.A., Meeting Granted.  
288   
289  Requests for Type Y meetings will be honored except in unusual circumstances.  Generally, 
290  FDA will not grant a meeting requester more than one Type Y meeting to discuss a particular 
291  OTC monograph order development program or conditions of use for a particular OTC 
292  monograph. 
293   
294  A.  Meeting Granted 
295   
296  If a meeting request is granted, FDA will notify the meeting requester in writing according to the 
297  timelines described in Table 1.  For face-to-face and teleconference/videoconference meetings, 
298  the notification will include the date, time, conferencing arrangements and/or location of the 
299  meeting, and expected FDA participants.  For WRO meetings, the notification will include the 
300  date FDA intends to send the written response.  WRO response timelines are the same as those 
301  for scheduling face-to-face and teleconference/videoconference meetings. 
302   
303  For face-to-face and teleconference/videoconference meetings, FDA will schedule the meeting 
304  on the next available date at which all expected FDA staff are available to attend; however, the 
305  meeting should be scheduled consistent with the type of meeting requested (see Table 2 for FDA 
306  meeting scheduling time frames).  If the requested date for any meeting type is later than the 
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307  specified FDA meeting schedule time frame, the meeting date should be within 14 calendar days 
308  of the requested date. 
309   
310   
Table 1: Meeting Request Response Time Goals 
Meeting Type  FDAs Response Time  
(calendar days from receipt of 
meeting request/WRO request) 
X  14 
Y  14 
Z  21 
311   
312   
313   
Table 2: Meeting Scheduling or WRO Times 
Meeting Type  Meeting Scheduling or WRO Time 
(calendar days from receipt of request) 
X  30 calendar days from receipt of meeting request 
Y  70 calendar days from receipt of meeting request 
Z  75 calendar days from receipt of meeting request 
314   
315  B.  Meeting Denied 
316   
317  If a meeting request is denied, FDA will notify the meeting requester in writing according to the 
318  timelines described in Table 1.  The notification will include an explanation of the reason for the 
319  denial.  Denials will be based on a substantive reason, not merely on the absence of a minor 
320  element of the meeting request or minor element of the meeting package.  For example, a 
321  meeting request may be denied because it is clearly unnecessary; the meeting package does not 
322  provide an adequate basis for the meeting discussion; in situations when FDA recommends 
323  submission of a meeting package at the time of the request, the meeting package is either not 
324  included in the original request or does not provide an adequate basis for the meeting discussion 
325  (e.g., Type X meeting requests); or the meeting would be duplicative of a prior meeting. 
326   
327  FDA may also deny requests for meetings that do not have the substantive information related to 
328  the elements described in section V., Meeting Requests.  A subsequent request to schedule the 
329  meeting will be considered as a new request (i.e., a request that is assigned a new set of timelines 
330  described in section VI.A., Meeting Granted).  
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331   
332  FDA will deny a meeting request for an OTC monograph drug meeting20 from a person subject 
333  to fees under section 744M of the FD&C Act, including an OTC monograph drug meeting 
334  request from an affiliate, until all such fees owed by such person have been paid.21 
335   
336   
337  VII.  MEETING PACKAGE 
338   
339  Premeeting preparation is critical for achieving a productive discussion or exchange of 
340  information.  Preparing the meeting package should help the meeting requester focus on 
341  describing its principal areas of interest.  The meeting package should provide information 
342  relevant to the discussion topics and enable FDA to prepare adequately for the meeting.  In 
343  addition, the timely submission of the meeting package is important for ensuring that there is 
344  enough time for meeting preparation, accommodation of adjustments to the meeting agenda, and 
345  accommodation of appropriate preliminary responses to meeting questions. 
346   
347  A.  Timing of Meeting Package Submission 
348   
349  The meeting requester should submit the meeting package to FDA for each meeting type 
350  (including WRO) no later than the date specified in Table 3.  
351   
Table 3: Meeting Requester Meeting Package Timelines 
Meeting Type  FDA Receipt of Background Package 
(calendar days) 
X  At the time of the meeting request 
Y  No later than 50 calendar days before the date of the 
meeting or expected written response time 
Z  No later than 47 calendar days before the date of the 
meeting or expected written response time 
 
20 An OTC monograph drug meeting is defined in section 744L(11) of the FD&C Act for user fee purposes as any 
meeting regarding the content of a proposed OMOR. 
 
21 See section 744M(e) FD&C Act. 
 
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352  B.  Where and How Many Copies of Meetings Packages to Send 
353   
354  The meeting package must be submitted electronically to FDA.22   
355   
356  To facilitate the meeting process, an FDA regulatory project manager (RPM) may request that 
357  copies of meeting packages provided in electronic format also be provided in paper (desk copies) 
358  and sent to the FDA RPM at the mailing address provided in the letter granting the meeting. 
359   
360  C.  Meeting Package Content 
361   
362  The meeting package should identify the subject of the meeting and the date and time of the 
363  meeting, if known.  The meeting package should provide summary information relevant to the 
364  OTC monograph order development program or the regulation of the OTC monograph drug and 
365  any supplementary information needed to develop responses to issues raised by the meeting 
366  requester or the review division.  It is critical that the entire meeting package content support the 
367  intended meeting objectives.  The meeting package content will vary depending on the type and 
368  subject of the meeting.  FDA and ICH guidances identify and address many issues related to 
369  drug development and should be considered when planning, developing, and providing 
370  information needed to support a meeting with FDA.  If an OTC monograph order development 
371  program deviates from current guidances, or from current practices, the deviation should be 
372  recognized and explained.  Known difficult design and evidence issues should be raised for 
373  discussion.  
374    
375  To facilitate FDA review, the meeting package content should be organized according to the 
376  proposed agenda.  The meeting package should be a sequentially paginated document with a 
377  table of contents, appropriate indices, appendices, and cross references.  It should be tabbed or 
378  bookmarked to enhance reviewers navigation across different sections within the package, both 
379  in preparation for and during the meeting.  Meeting packages generally should include the 
380  following information, preferably in the order listed below:  
381   
382  1.  The OMOR number, if previously assigned.  
383   
384  2.  The product name, if applicable. 
385   
386  3.  The relevant OTC monograph, or if a relevant OTC monograph has not yet been 
387  established, the relevant therapeutic category. 
388   
389  4.  Chemical name, established name, and/or structure. 
390   
391  5.  United States Pharmacopeia active ingredient monograph, if applicable. 
392   
393  6.  The indications or proposed indications (uses) or context of OTC monograph order 
394  development program.  
395   
 
22 See section 505G(j) of the FD&C Act. 
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396  7.  The proposed tier of the OMOR (Tier 1 or Tier 2),23 if applicable. 
397   
398  8.  Dosage form, route of administration, and dosing regimen (strength, frequency, and 
399  duration), if applicable.  
400   
401  9.  A list of all individuals, with their titles and affiliations, who will attend the requested 
402  meeting from the meeting requesters organization, including consultants and 
403  interpreters. FDA, in general, expects non-FDA attendees will be limited to those listed in 
404  the meeting package and expects to be notified in advance of any changes to the list of 
405  attendees.   
406   
407  10. A background section that includes the following: 
408   
409  a.  A brief history and information about the issues to be discussed at the meeting about 
410  the OTC monograph order development program, regulation of the OTC monograph 
411  drug, or OTC monograph drug development, including substantive changes in 
412  development plans and current status of development, and relevant communications 
413  with FDA before the meeting. 
414   
415  b.  If applicable, a list of completed, ongoing, and planned studies. 
416   
417  11. A brief statement summarizing the purpose of the meeting. 
418   
419  12. A proposed agenda, including estimated times needed for discussion of each agenda item. 
420   
421  13. A list of the final questions for discussion grouped by discipline and with a brief 
422  summary for each question to explain the need or context for each question.  In general, 
423  there should be no more than 10 questions listed consecutively regardless of discipline.  
424  For example, if Question 1 has three parts, the numbering should be 1, 2, and 3 rather 
425  than numbering them 1a, 1b, and 1c.  If there are three clinical questions and three 
426  nonclinical questions, for a total of six questions, each question should have its own 
427  number (i.e., 1, 2, 3, 4, 5, 6, not Clinical 1, 2, 3 and then Nonclinical 1, 2, 3).  The 
428  numbering of each question in the meeting request (see section VI, Assessing and 
429  Responding to Meeting Requests) should be identical to the numbering of each question 
430  in the meeting package.  FDA requests that meeting requesters not submit subquestions. 
431   
432  14. Data to support discussion, organized by FDA discipline and question.  The level of 
433  detail of the data should be appropriate to the meeting type requested.  Protocols, full 
434  study and trial reports, or detailed data generally are not appropriate for meeting 
435  packages; the summarized material should describe the results of relevant studies and 
436  clinical trials with some degree of quantification and any decision about clinical trials 
437  that resulted.  If applicable, the trial endpoints should be stated, as should whether 
438  endpoints were altered or analyses changed during the trial. 
439   
440   
 
23 See section 744L(8) and (9) of the FD&C Act. 
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441  VIII.  PRELIMINARY RESPONSES 
442   
443  Communications before the meeting between meeting requesters and FDA, including 
444  preliminary responses, can serve as a foundation for discussion or as the meetings final 
445  responses.  Nevertheless, preliminary responses should not be construed as final unless there is 
446  agreement between the meeting requester and FDA that additional discussion is not necessary for 
447  any question (i.e., when the meeting is canceled because the meeting requester is satisfied with 
448  the FDAs preliminary responses) or a particular question is considered resolved allowing extra 
449  time for discussion of the other questions during the meeting.  Preliminary responses 
450  communicated by FDA are not intended to generate the submission of new information or new 
451  questions.  If a meeting requester nonetheless provides new data or a revised or new proposal, 
452  FDA may not be able to provide comments on the new information, and the meeting requester 
453  may need to submit a new meeting request for FDA to provide feedback on the new information.   
454   
455  FDA holds internal meetings to discuss the content of meeting packages and to compose and 
456  gain internal alignment on the preliminary responses.  FDA will send the meeting requester its 
457  preliminary responses to the questions in the meeting package no later than 5 calendar days 
458  before the meeting date for Type Y and Type Z meetings.  FDA will generally not send 
459  preliminary responses for Type X meetings.  For Type Y and Type Z meetings, the meeting 
460  requester should notify FDA no later than 3 calendar days following receipt of FDAs 
461  preliminary responses regarding whether the meeting is still needed.  If the meeting requester 
462  believes the meeting is still needed after receipt of FDAs preliminary responses, the meeting 
463  requester should send FDA a revised meeting agenda indicating which questions the meeting 
464  requester considers resolved and which questions the meeting requester will want to further 
465  discuss.   
466   
467   
468  IX.  RESCHEDULING MEETINGS 
469   
470  Occasionally, circumstances arise that necessitate the rescheduling of a meeting.  If a meeting 
471  needs to be rescheduled, it should be rescheduled as soon as possible after the original date.  A 
472  new meeting request should not be submitted.  Meeting requesters and FDA should take 
473  reasonable steps to avoid rescheduling meetings.  For example, if an attendee becomes 
474  unavailable, a substitute can be identified, or comments on the topic that the attendee would have 
475  addressed can be forwarded to the requester following the meeting.  It will be at the discretion of 
476  the review division whether the meeting should be rescheduled depending on the specific 
477  circumstances.  
478   
479  The following situations are examples of when a meeting may be rescheduled by FDA.  This list 
480  includes representative examples and is not intended to be an exhaustive list. 
481   
482    The meeting requester experiences a minor delay in submitting the meeting package.  The 
483  requester should contact FDA to explain why the timelines for submission will be missed 
484  and when the meeting package will be submitted. 
485   
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486    The review team determines that the meeting package is inadequate or additional 
487  information is needed to address the meeting requesters questions or other important 
488  issues for discussion and it is possible to identify the additional information needed and 
489  arrange for its timely submission. 
490   
491    There is insufficient time to review the material because the meeting package is 
492  voluminous (see section VII.C., Meeting Package Content) despite submission within the 
493  specified timelines and the appropriateness of the content. 
494   
495    After the meeting package is submitted, the meeting requester sends FDA additional 
496  questions or data that are intended for discussion at the meeting and require additional 
497  review time.  
498   
499    The meeting package contains additional questions or significant changes to questions 
500  from those submitted with the meeting request. 
501   
502    It is determined that attendance by additional FDA personnel not originally anticipated or 
503  requested are critical and their unavailability precludes holding the meeting on the 
504  original date. 
505   
506    Essential attendees are no longer available for the scheduled date and time because of an 
507  unexpected or unavoidable conflict or an emergency situation. 
508   
509   
510  X.  CANCELING MEETINGS 
511   
512  Failure to pay required fees will result in FDA canceling a previously scheduled meeting.24  If 
513  the meeting requester pays the required fee or fees after the meeting has been canceled because 
514  of nonpayment, FDA will consider a subsequent request to schedule a meeting to be a new 
515  request and the goal timeline for FDAs response will be calculated from the date of the 
516  subsequent request. 
517   
518  Occasionally, other circumstances arise that necessitate the cancellation of a meeting.   
519   
520  The following situations are examples of when a meeting can be canceled.  This list includes 
521  representative examples and is not intended to be an exhaustive list. 
522   
523    The meeting package is not received by FDA within the specified timelines (section 
524  VII.A., Timing of Meeting Package Submission). 
525   
526    FDA determines that the meeting package is inadequate.  Meetings are scheduled on the 
527  assumption that the meeting requester has submitted appropriate information to support 
528  the discussion.  Adequate planning by the meeting requester should avoid this problem. 
529   
 
24 See section 744M(e)(3) of the FD&C Act. 
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530    The meeting package and questions are substantively different from the original request 
531  and no longer meet the criteria for the meeting granted (see section VI., Assessing and 
532  Responding to Meeting Requests). 
533   
534    The meeting requester determines that preliminary responses to its questions are 
535  sufficient for its needs and additional discussion is not necessary (see section VIII., 
536  Preliminary Responses).  In this case, the meeting requester should contact the FDA 
537  RPM to request cancellation of the meeting.  FDA will consider whether it agrees that the 
538  meeting should be canceled.  Some meetings can be valuable because of the discussion 
539  they generate and the opportunity for the division to ask about relevant matters, even if 
540  the preliminary responses seem sufficient to answer the meeting requesters questions.  If 
541  FDA agrees that the meeting can be canceled, the reason for cancellation will be 
542  documented and the preliminary responses will represent the final responses and the 
543  official record. 
544   
545  If a circumstance arises that necessitate the cancellation of a meeting, FDA will consider a 
546  subsequent request to schedule a meeting to be a new request and the goal timeline for FDAs 
547  response will be calculated from the date of the subsequent request.  Meeting requesters and 
548  FDA should take reasonable steps to avoid canceling meetings (unless the meeting is no longer 
549  necessary).  Cancellation will be at the discretion of the review division and will depend on the 
550  specific circumstances. 
551   
552   
553  XI.  MEETING CONDUCT 
554   
555  Meetings will be chaired by an FDA staff member and begin with introductions and an overview 
556  of the agenda.  Attendees should not make audio or visual recordings of discussions at meetings 
557  described in this guidance.  All parties to a meeting are expected to behave in a professional 
558  manner.  If attendees are not behaving professionally during the meeting, FDA reserves the right 
559  to end the meeting immediately.  
560   
561  Presentations by meeting requesters generally are not needed because the information necessary 
562  for review and discussion should be part of the meeting package.  If a meeting requester plans to 
563  make a presentation, the presentation should be discussed ahead of time with the FDA RPM to 
564  determine if a presentation is warranted and ensure that FDA has the presentation materials 
565  ahead of the meeting, if possible.  All presentations should be kept brief to maximize the time 
566  available for discussion.  The length of the meeting will not be increased to accommodate a 
567  presentation.  If a presentation contains more than a small amount of content distinct from 
568  clarifications or explanations of previous data and the content was not included in the original 
569  meeting package submitted to FDA for review, FDA staff may not be able to provide 
570  commentary. 
571   
572  Either a representative of FDA or the meeting requester should summarize the important 
573  discussion points, agreements, clarifications, and action items.  Summation can be done at the 
574  end of the meeting or after the discussion of each question.  Generally, the meeting requester will 
575  be asked to present the summary to ensure that there is mutual understanding of meeting 
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576  outcomes and action items.  FDA staff can add or further clarify any important points not 
577  covered in the summary, and these items can be added to the meeting minutes.     
578   
579   
580  XII.  MEETING MINUTES 
581   
582  Because FDAs minutes are the official records of meetings, FDAs documentation of meeting 
583  outcomes, agreements, disagreements, and action items is critical to ensuring that this 
584  information is preserved for meeting attendees and future reference.  FDA intends to issue the 
585  official, finalized minutes to the meeting requester within 30 calendar days after the meeting.  
586  Meeting minutes will not be taken if FDA transmits a WRO for any meeting type. 
587   
588  The following are general considerations regarding meeting minutes: 
589   
590    FDA minutes will outline the important agreements, disagreements, issues for further 
591  discussion, and action items from the meeting in bulleted format.  This information need 
592  only be sufficient in detail to ensure clarity on the discussion and action items from the 
593  meeting.  The minutes are not intended to represent a transcript of the meeting. 
594   
595    FDA RPMs will use established templates to ensure that all important meeting 
596  information is captured. 
597   
598    FDA may communicate additional information in the final minutes that was not explicitly 
599  communicated during the meeting or that provides further explanation of discussion 
600  topics.  FDAs final minutes will distinguish this additional information from the 
601  discussion that occurred during the meeting. 
602   
603  The following steps should be taken when there is a difference of understanding regarding the 
604  minutes: 
605   
606    The meeting requester should contact the FDA RPM if there is a significant difference in 
607  their understanding and FDAs understanding of the content of the final meeting minutes 
608  issued to the meeting requesters. 
609   
610    If after contacting the FDA RPM there are still significant differences in the meeting 
611  requesters understanding and FDAs understanding of the content of the official meeting 
612  minutes, the meeting requester should submit a description of the specific disagreements 
613  in a letter to the division director, with a copy to the FDA RPM.   
614   
615    The review division and the office director, if the office director was present at the 
616  meeting, will take the meeting requesters concerns under consideration.  
617   
618    If the minutes are deemed to reflect the meeting discussion accurately and 

619  sufficiently, the FDA RPM will convey this decision to the meeting requester and the 
620  minutes will stand as the official documentation of the meeting.  
621    
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622    If FDA deems it necessary, changes will be documented in an addendum to the 

623  official minutes.   
624   
625  For input on additional issues that were not addressed at the meeting, the meeting requester 
626  should submit a new meeting request. 
627   
628   
629  XIII.  FORMAL MEETINGS WITH MULTIPLE MEETING REQUESTERS (JOINT 
630  MEETINGS) 
631   
632  A.  General Information About Joint Meetings 
633   
634  Multiple meeting requesters may want to join together and have a formal meeting with FDA to 
635  discuss studies and other information necessary to support OTC monograph order submissions, 
636  matters relevant to the regulation of OTC monograph drugs, or OTC monograph drug 
637  development that the multiple meeting requesters have a common interest in.  These formal 
638  meetings with multiple meeting requesters are known as joint meetings. 
639   
640  A joint meeting may be requested for Type X, Type Y, and Type Z meetings. 
641   
642  For example, joint meeting requests may be appropriate for the following: 
643   
644    A Type Y meeting to discuss overall data requested to support a positive GRASE 
645  determination after FDA has stated its intent to make a final GRASE determination for a 
646  particular monograph ingredient or other monograph condition of use   
647   
648    A Type X meeting to discuss safety concerns with a marketed OTC monograph drug  
649   
650  Because of facility and space limitations for face-to-face meetings, the number of individuals 
651  able to attend the joint meeting in person may be limited.  The FDA RPM will inform the 
652  meeting requesters of the total number of individuals who can attend in person when the meeting 
653  is granted. 
654   
655  To the extent that information submitted to FDA for discussion at the meeting could be protected 
656  from disclosure under section 505G(d) of the FD&C Act or other laws (see section XIV, 
657  Confidentiality of Information Submitted to FDA for Formal Meetings), the meeting request 
658  should include authorizations from each of the multiple meeting requesters for FDA to discuss 
659  that information with the other meeting requesters participating in the meeting.  
660   
661  B.  Formation of an OTC Monograph Industry Working Group 
662   
663  To facilitate efficient participation by multiple meeting requesters, meeting requesters may 
664  consider forming an OTC monograph industry working group (OTC IWG) to collaborate on 
665  issues of common interest.  The OTC IWG may consist of multiple meeting requesters and 
666  organizations nominated by meeting requesters to represent their interests.  Each member of the 
667  OTC IWG should be a meeting requester eligible for formal meetings with FDA or be an 
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Draft  Not for Implementation 
668  organization nominated by a meeting requester to represent their interests.  Members of the OTC 
669  IWG who are subject to fees under section 744M of the FD&C Act, including their affiliates, 
670  must not have any unpaid user fees to participate in an OTC monograph drug meeting25  
671   
672  The OTC IWG should consider creating agreements among its members on matters such as 
673  confidentiality, governance, and any other issues that may come up during the collaboration.  
674  FDA does not advise on the business arrangements between members of an OTC IWG nor 
675  mediate between parties within an OTC IWG. 
676   
677  If an OTC IWG is formed, the OTC IWG should designate a single point of contact (POC) to 
678  represent the OTC IWG in communications with FDA.  The POC should facilitate all 
679  communication between FDA and the OTC IWG about the joint meeting.  FDA will 
680  communicate only with the POC about the joint meeting.  The POC should be responsible for all 
681  submissions related to the joint meeting and should be the only individual who submits 
682  information to FDA for the joint meeting.  FDA should be notified with appropriate 
683  documentation if a new POC is designated at any time during the joint meeting process.    
684   
685  FDA will not meet individually with any meeting requester who is a member of an OTC IWG to 
686  discuss an issue that is the subject of a joint meeting for which the meeting requester attended or 
687  is scheduled to participate in unless the OTC IWG nominates such meeting requester to meet 
688  individually with FDA. 
689   
690  C.  Procedures for Joint Meetings 
691   
692  1.  Meeting Request 
693   
694  The POC can request a joint meeting on behalf of the OTC IWG consistent with section V., 
695  Meeting Requests.  In addition to the information that should be submitted in the meeting request 
696  (see section V., Meeting Requests), the meeting request should include the following 
697  information: 
698   
699    The meeting being requested is a joint meeting 
700   
701    Appropriate documentation of the formation of the OTC IWG and a list of its members, 
702  including organizations nominated by meeting requesters to represent their interests 
703   
704    The name of the POC as designated by the OTC IWG and appropriate documentation 
705  from OTC IWG designating the POC  
706   
707    Appropriate documentation from a member or members of the OTC IWG nominating an 
708  organization to represent its interests, if applicable 
709   
 
25 An OTC monograph drug meeting is defined in section 744L(11) of the FD&C Act for user fee purposes as any 
meeting regarding the content of a proposed OMOR. 
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710    To the extent that information submitted to FDA for discussion at the meeting could be 
711  protected from disclosure under section 505G(d) of the FD&C Act, authorization from 
712  each member of the OTC IWG that FDA may disclose that information to the other 
713  meeting requesters participating in the meeting  
714   
715  2.  Meeting Package 
716   
717  In addition to the information that should be submitted in the meeting package (see section VII. 
718  C., Meeting Package Content), the meeting package should include the following information:  
719   
720    Any specific topics of discussion that should not be discussed because the OTC IWG has 
721  not agreed to share information protected from disclosure under section 505G(d) of the 
722  FD&C Act or other laws 
723   
724  3.  Meeting Conduct 
725   
726  The OTC IWG POC is responsible for ensuring that discussion during the joint meeting is 
727  consistent with OTC IWG agreements on confidentiality. 
728   
729   
730  XIV.  CONFIDENTIALITY OF INFORMATION SUBMITTED TO FDA IN 
731  CONNECTION WITH FORMAL MEETINGS 
732   
733  The OTC monograph order process is generally a public process.  Under this order process, 
734  section 505G(d) of the FD&C Act limits the information that can be confidentially submitted to 
735  FDA in connection with proceedings on an order, including an OMOR.  This limitation on 
736  confidentiality extends to formal meeting requests and information submitted to FDA in 
737  connection with a formal meeting.  Such information in the context of formal meetings may 
738  include the meeting package, meeting minutes, and other meeting correspondence. 
739   
740  In general, until disclosure is triggered under section 505G(d)(2) of the FD&C Act, any 
741  information, including reports of testing conducted on the drug or drugs involved, that is 
742  submitted by a requestor in connection with proceedings on an order under section 505G and is a 
743  trade secret or confidential information subject to section 552(b)(4) of title 5 of U.S.C. or section 
744  1905 of title 18 of U.S.C. will not be disclosed to the public unless the requestor consents to that 
745  disclosure.26   However, FDA must make any information submitted by a requestor in support of 
746  an OMOR (e.g., meeting requests and meeting packages submitted by an OMOR requestor) 
747  available to the public not later than the date on which the proposed order is issued.27 
748  Additionally, FDA must make any information submitted by any other person with respect to an 
749  order requested (or initiated by FDA) available to the public upon such submission.28  
 
26 See section 505G(d)(1) of FD&C Act. 
 
27 See section 505G(d)(2)(A)(i) of FD&C Act. 
 
28 See section 505G(d)(2)(A)(ii) of FD&C Act. 
 
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750  Nonetheless, in both circumstances, the information will remain confidential if (1) the 
751  information pertains to pharmaceutical quality information, unless such information is necessary 
752  to establish standards under which a drug is GRASE; (2) the information is of the type contained 
753  in raw datasets; (3) the information is submitted in a requestor-initiated request, but the requestor 
754  withdraws the request in accordance with withdrawal procedures established by FDA before 
755  FDA issues the proposed order; or (4) FDA requests and obtains the information  under 505G(c) 
756  and the information is not submitted in relation to an order under 505G(b).29 
757   
758  In addition, although certain information in connection with a formal meeting may be publicly 
759  disclosed or otherwise publicly available in accordance with section 505G(d) of the FD&C Act, 
760  a formal meeting is not open to the public to attend and only the meeting requester or, for joint 
761  meetings, the group of meeting requesters and/or their representatives may be present at the 
762  meeting with FDA.30 
763   
 
29 See section 505G(d)(2)(B) of FD&C Act. 
 
30 21 CFR 10.65(c). 
  20