March 29, 2022

OTC Monograph Reform: 

Overview of Draft Guidance for Industry: Formal 

Meetings Between FDA and Sponsors or Requestors of 

Over-the-Counter Monograph Drugs

Trang Tran 

Commander, US Public Health Service

Division of Nonprescription Drugs 1

CDER | US FDA

Elizabeth Thompson

Commander, US Public Health Service

Division of Nonprescription Drugs 2

CDER | US FDA
www.fda.gov 2

Objectives

Draft Guidance for Industry: Formal Meetings Between FDA and 

Sponsors or Requestors of Over-the-Counter Monograph Drugs

• Provide overview of draft guidance

• Explain OMUFA timelines for meetings
3

OTC Monograph Reform

• On March 27, 2020, the “Coronavirus Aid, Relief, and 

Economic Security Act” (CARES Act) was enacted

• Includes important statutory provisions that reform

and modernize the way OTC monograph drugs are 

regulated in the United States

– Replaces the rulemaking process with an 

administrative order process to establish, revise, or 

amend OTC monographs

• Grants FDA the authority to assess and collect fees 

from regulated industry
4

Overview of Draft Guidance for Industry:

Formal Meetings Between FDA and Sponsors or 

Requestors of Over-the-Counter Monograph Drugs
5

Overview of Draft Guidance

FDA issued this guidance to:

–Specify procedures and principles for formal meetings with FDA and sponsors or 

requestors of OTC monograph drugs (“meeting requesters”).

–Describe procedures under which meeting requesters can meet with 

appropriate FDA officials to obtain advice on:

• Studies or other information necessary to support a submission under section 

505G of the FD&C Act

• Matters relevant to the regulation of OTC monograph drugs

• Development of new OTC monograph drugs

–Specify procedures to facilitate efficient participation by multiple sponsors or 

requestors and/or organizations nominated by them to represent their interests
6

Draft Guidance Performance Goals

Over-the-Counter Monograph User Fee Program Performance Goals

and Procedures (commonly referred to as OMUFA commitment 

letter)

– FDA agreed to meeting management goals for formal meetings 

(OMUFA performance goals)

– FDA also committed to issuing this guidance under specific 

timelines
7

Who Can Request a Formal Meeting?

Formal meetings are between FDA and sponsors and requestors of 

OTC monograph drugs (referred to collectively as meeting 

requesters) 

– Sponsor: any person marketing, manufacturing, or processing a drug 

that is listed pursuant to section 510(j) of the FD&C Act and is or will be 

subject to an administrative order under 505G

– Requestor: any person or group of persons marketing, manufacturing, 

processing, or developing a drug

www.fda.gov
8

Meeting Types Overview

www.fda.gov

Type X Type Y Type Z

• Necessary for an otherwise

stalled OTC monograph 

order development 

program to proceed

• Important safety issue that 

needs immediate action

• Overall data 

recommendations

• Pre-OTC 

monograph Order 

Request (OMOR) 

submission

Any meeting 

that is not a 

Type X or Type Y

meeting
9

Meeting Types

www.fda.gov

Type X

• Necessary for an otherwise stalled OTC monograph 

order development program to proceed

‒ For example, a meeting within 3 months of FDA 

issuing a refuse-to-file letter for an OMOR

• Important safety issue that needs immediate action 

when the meeting requester learns about a safety issue 

related to an OTC monograph drug that is marketed or 

being developed
10

Meeting Types (cont’d)

www.fda.gov

Type Y

Milestone discussions during the course of the meeting 

requester’s OTC monograph order development program

• Overall data recommendations to support the following:

‒ A positive general recognition of safety and effectiveness 

(GRASE) determination for an OTC monograph drug 

containing a particular active ingredient or subject to some 

other condition of use after FDA has stated its intent to make 

that final GRASE determination

‒ An OMOR submission when a meeting requester has an 

interest in initiating an OMOR (i.e., meeting requester has not 

yet begun an OTC monograph order development program)
11

Meeting Types (cont’d)

www.fda.gov

Type Y (cont’d)

• Pre-OMOR Submission:

‒ May request when nearing completion of the 

development program for an OMOR to:

o Present a summary of the data supporting the OMOR 

o Discuss the proposed format for the OMOR

o Obtain FDA feedback on the adequacy of the 

proposal for the OMOR submission

o Discuss the appropriate categorization of an OMOR 

(e.g., Tier 1 or Tier 2)
12

Meeting Types (cont’d)

www.fda.gov

Type Z

• Any meeting that is not a Type X or Type Y meeting
13

Meeting Formats

www.fda.gov

Face-to-Face Teleconference or 

Videoconference

Written Response 

Only (WRO)
14

Meeting Request: Submission

• A meeting request must be submitted to FDA electronically

• Guidance on how to submit OTC monograph submissions 

electronically is forthcoming

• Prior to publication of that guidance, email meeting requests to: 

Monograph-Meeting-Requests@fda.hhs.gov

www.fda.gov
15

Meeting Request: Content

A meeting request should include adequate information for FDA to 

assess the potential utility of the meeting and to identify FDA staff 

necessary to discuss proposed agenda items

– Draft guidance specifies information that should be included 

in the request

– Draft guidance specifies information that must be included 

qualify for OMUFA performance goals

www.fda.gov
16

Meeting Request: Content (cont’d)

To qualify for OMUFA performance goals, a written meeting request 

must include:

– Brief statement of the purpose of the meeting

– Proposed format of the meeting

– List of specific objectives or outcomes 

– Proposed agenda, including estimated time needed for discussion of each agenda

item

– Statement of whether the meeting requester intends to discuss information exempt 

from disclosure under section 505G(d) of the FD&C Act or other laws at the meeting

– List of meeting requester’s planned attendees, including their names and titles

– List of requested CDER attendees and/or disciplines, including an explanation for the 

request as appropriate 

– Date that the meeting package will be sent to FDA

www.fda.gov
17

Assessing Meeting Request

FDA assesses each meeting request and determines:

– whether the request should be granted or denied

– the appropriate meeting type

– the appropriate meeting format

www.fda.gov
18

Meeting Granted

FDA will provide written notification

– For face-to-face or teleconference meetings, the notification 

includes:

• Date/time

• Conference arrangements or location

• Expected FDA participants

– For WRO, the notification includes the date FDA intends to send the 

written response

www.fda.gov
19

Meeting Request Response Time Goals

Meeting Type FDA’s Response Time 

(calendar days from receipt of request)

X 14

Y 14

Z 21

www.fda.gov
20

Meeting Scheduling or WRO Times

Meeting Type Meeting Scheduling or WRO Time

(calendar days from receipt of request)

X 30

Y 70

Z 75

www.fda.gov
21

Meeting Denied

• FDA will provide written notification with explanation of the 

reason for the denial

• Reasons for denials include:

– A substantive reason (not merely the absence of a minor element of 

the meeting request or meeting package items)

– Failure to pay fees

• A subsequent request to schedule the meeting will be 

considered a new request

www.fda.gov
22

Meeting Package

• Should provide information relevant to the discussion 

topics

• Should enable FDA to prepare adequately for the meeting

• Must submit electronically to FDA

• ell organized and include the information s

www.fda.gov
23

Timing of Meeting Package

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

www.fda.gov
24

Preliminary Responses

• Communication from FDA prior to the meeting that serves as a foundation

for discussion

• Not a final response unless there is agreement between meeting requester 

and FDA that:

– additional discussion is not necessary for any question

– a particular question is considered resolved allowing extra time for 

discussion of the other questions during the meeting

• Not intended to generate submission of new information or questions

www.fda.gov
25

Preliminary Responses (cont’d)

Meeting Type

Preliminary Responses 

(NOT later than X days before meeting)

X N/A

Y 5 days

Z 5 days

www.fda.gov

Meeting requester should follow up with FDA notifying whether meeting

still needed or revised agenda
26

Rescheduling Meetings

• FDA has the discretion to reschedule meetings

• A new meeting request should not be submitted

• Examples of situations when a meeting may be rescheduled:

• Minor delays in submitting meeting package

• Meeting package inadequate or more information needed

• Meeting package contains additional questions or significant 

changes to questions from those submitted in the meeting 

request

www.fda.gov
27

Canceling Meetings

• FDA has the discretion to cancel meetings

• Examples of circumstances that necessitate the cancellation of a meeting 

– Failure to pay required fees 

– Other situations

• Meeting package not received within specified timeframe

• Meeting package inadequate 

• Meeting package and questions are different from the original 

request and no longer meet criteria for meeting granted

• Meeting requester determines preliminary responses are sufficient

www.fda.gov
28

Meeting Conduct

• Meetings will be chaired by an FDA staff member

• Attendees should not make audio or visual recordings of meeting 

discussions

• Presentations by meeting requesters are generally not needed

• Generally, the meeting requester will be asked to summarize the

meeting

www.fda.gov
29

Meeting Minutes

• Official record of the meeting

–Documents meeting outcomes, agreements, disagreements, 

and action items

– May communicate additional information not explicitly 

communicated during meeting or that provides further 

explanation of discussion topics

• Generally issued within 30 calendar days after the meeting 

(except WRO)

www.fda.gov
30

JOINT MEETINGS

www.fda.gov
31

Joint Meetings

• Formal meetings with multiple meeting requesters 

• All meeting types (X, Y, and Z)

www.fda.gov
32

OTC Monograph Industry Working Group (OTC IWG)

• Meeting requesters may consider forming OTC IWG to collaborate on issues of 

common interest

• Members

– Should be meeting requesters eligible for formal meetings or an organization nominated by a 

meeting requester to represent their interests

– must not have unpaid user fees in order to participate in an OTC monograph drug meeting as

defined at FD&C Act s. 744L(11)

• Agreements

– Consider creating agreements among OTC IWG members on matters such as confidentiality, 

governance, and any other issues

• Point of contact (POC)

– Should designate a POC to communicate with FDA

– FDA will not discuss an issue that is the subject of a joint meeting with an individual requester

www.fda.gov
33

Joint Meetings: Meeting Requests

A meeting request for a joint meeting should include:

– All information that should be included for a meeting request by a single meeting requester

– Meeting is a joint meeting

– Documentation of the formation of the OTC IWG and a list of its members

– Name of the POC and appropriate documentation from the OTC IWG designating the POC

– Appropriate documentation from a member or members of the OTC IWG nominating an 

organization to represent its interests

– Request submitted by the POC on behalf of the OTC IWG 

– To the extent that information submitted to FDA for discussion at the meeting could be 

protected from disclosure under s. 505G(d), authorization from each of the multiple meeting 

requesters for FDA to discuss that information with the other meeting requesters participating

in the meeting

www.fda.gov
34

Joint Meetings: Meeting Package

Joint meeting package should include:

– All information recommended for meeting package by a single 

meeting requester

– Any specific discussion topics that should not be discussed 

because OTC IWG has not agreed to share information 

protected from disclosure

www.fda.gov
35

Joint Meetings: Meeting Conduct

• POC is responsible for ensuring that discussion during the joint 

meeting is consistent with OTC IWG agreements on confidentiality

• Because of facility and space limitations for face-to-face meetings, 

the number of individuals able to attend the joint meeting in 

person may be limited 

www.fda.gov
36

CONFIDENTIALITY

www.fda.gov
37

Confidentiality

• OTC monograph order process is generally a public process

• Section 505G(d) limits information that can be confidentially 

submitted to FDA in connection with proceedings on an order, 

including formal meeting requests and information submitted to 

FDA in connection with a formal meeting

• Although certain information in connection with a formal meeting 

may be disclosed or otherwise publicly available in accordance 

with 505G(d) of the FD&C Act, a formal meeting is not open to the 

public to attend

www.fda.gov
38

Public Comment

• FDA posted the draft guidance on February 1, 2022

• Notice of Availability (NOA) was published in the Federal Register 

on February 7, 2022 (87 FR 6877)

–NOA provides instructions for submitting comments

• To ensure FDA considers your comment before it begins work on 

the final guidance, submit by April 8, 2022

www.fda.gov
39

Resources

• OTC Monograph Reform in the CARES Act

https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monographreform-cares-act#omor

• OTC Monograph Database

https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm

• Over-the-Counter OTC/Nonprescription Drugs

https://www.fda.gov/drugs/how-drugs-are-developed-and-approved/over-counter-otc-nonprescription-drugs

• Draft Meeting Guidance

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-food-and-drugadministration-and-sponsors-or-requestors-over-counter

www.fda.gov
40

Contact Us

• For questions on the Formal Meetings Between FDA and Sponsors 

or Requestors of Over-the-Counter Monograph Drugs draft

guidance, email FDA at druginfo@fda.hhs.gov

• Additional Questions:

– OTC Monograph Reform druginfo@fda.hhs.gov

– User fees (OMUFA) CDERCollections@fda.hhs.gov

– Meeting requests monograph-meeting-requests@fda.hhs.gov

– Small business and industry assistance cdersbia@fda.hhs.gov
Questions?

Trang Tran 

Commander, US Public Health Service

Division of Nonprescription Drugs 1

CDER | US FDA

Elizabeth Thompson

Commander, US Public Health Service

Division of Nonprescription Drugs 2

CDER | US FDA