Providing Over-the-Counter 
Monograph Submissions in 
Electronic Format 
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DRAFT GUIDANCE
 
 
  This guidance document is being distributed for comment purposes only.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 60 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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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.  
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
September 2022 
Electronic Submissions 
39539029dft.docx 
09/13/22   
Providing Over-the-Counter 
Monograph Submissions in 
Electronic Format 
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) 
 
September 2022 
Electronic Submissions 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 1 
III.  SUBMITTING ELECTRONIC OTC MONOGRAPH SUBMISSIONS .................... 3 
A.  CDER NextGen Portal .................................................................................................................. 3 
1. Presubmission Considerations for CDER NextGen Portal ............................................................. 3 
2. Transmitting Electronic Submissions in CDER NextGen Portal ..................................................... 4 
3. Receipt Date for CDER NextGen Portal Submissions ..................................................................... 4 
4. Contact Information ......................................................................................................................... 4 
B.  OTC Monographs@FDA Portal ................................................................................................... 4 
C.  Electronic Drug Registration and Listing System ...................................................................... 5 
IV.  SUBMITTING CONFIDENTIAL INFORMATION IN AN OTC MONOGRAPH 
SUBMISSION ................................................................................................................... 5 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Providing Over-the-Counter Monograph 
2  Submissions in Electronic Format 
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 information on providing electronic submissions to FDA under section 
18  505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h) (hereafter 
19  referred to as over-the-counter (OTC) monograph submissions). This guidance is intended to 
20  assist submitters by describing the electronic OTC monograph submissions requirement in section 
21  505G(j) of the FD&C Act and providing recommendations and other information on how to send 
22  such OTC monograph submissions to FDA in electronic format.  
23   
24  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
25  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
26  as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
27  the word should in Agency guidances means that something is suggested or recommended, but 
28  not required.  
29    
30   
31  II.  BACKGROUND 
32   
33  On March 27, 2020, the president signed into law the Coronavirus Aid, Relief, and Economic 
34  Security Act (CARES Act). The CARES Act added section 505G to the FD&C Act. Section 
35  505G reforms and modernizes the framework for the regulation of OTC monograph drugs. OTC 
36  monograph drugs may be marketed without new drug applications approved under section 505 of 
37  the FD&C Act if they meet the requirements of section 505G of the FD&C Act, as well as all 
38  other applicable requirements.  
39   
40  The CARES Act also added section 744M to the FD&C Act authorizing FDA to assess and 
41  collect user fees dedicated to OTC monograph drug activities. 
 
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.   
 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
42   
43  Section 505G(j) of the FD&C Act requires that all submissions under section 505G (also referred 
44  to herein as OTC monograph submissions) must be in electronic format. Examples of OTC 
45  monograph submissions include, but are not limited to, the following: 
46   
47    OTC monograph order requests (OMORs)2  
48   
49    Public comments to a proposed administrative order (issued either on FDAs initiative3 or 
50  at the request of one or more requestors4) or interim final administrative order5 
51   
52    Formal meeting requests and meeting packages6 
53   
54    Formal dispute resolution requests related to a final administrative order7  
55   
56    Administrative hearing requests related to a final administrative order8 
57   
58    Responses to record requests by FDA relating to minor changes9 
59   
60    Updates to drug listing information for the drug in accordance with section 510(j) of the 
61  FD&C Act when a change is made to a drug subject to section 505G.10    
62   
63  Section 505G(l)(3) of the FD&C Act requires FDA to issue guidance that specifies the format of 
64  electronic submissions under section 505G.11 This guidance is being issued to fulfill this 
65  requirement.   
66   
 
2 See section 744L(7) of the FD&C Act, which defines an OTC monograph order request as a request submitted 
under section 505G(b)(5) of the FD&C Act. 
 
3 See section 505G(b)(1) and (2) of the FD&C Act. 
 
4 See section 505G(b)(1) and (5) of the FD&C Act. 
 
5 See section 505G(b)(4) of the FD&C Act. 
 
6 See section 505G(h), (l)(1) of the FD&C Act.  See also the draft guidance for industry Formal Meetings Between 
FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs (February 2022). When final, this 
guidance will represent the FDAs current thinking on this topic. 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. 
 
7 See, for example, section 505G(b)(2)(A)(iv)(III) of the FD&C Act. 
 
8 See, for example, section 505G(b)(3) of the FD&C Act. 
 
9 See section 505G(c)(2)(A) of the FD&C Act. 
 
10 See section 505G(e) of the FD&C Act.  
 
11 See section 505G(l)(3) of the FD&C Act. 
 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
67   
68  III.  SUBMITTING ELECTRONIC OTC MONOGRAPH SUBMISSIONS  
69   
70  OTC monograph submissions must be submitted electronically,12 and, depending on the type of 
71  submission, should be submitted to FDA through the CDER NextGen Portal13 or as specified by 
72  instructions in the OTC Monographs@FDA portal.14,15  
73   
74  OMORs, formal meeting requests and meeting packages, formal dispute resolution requests 
75  related to a final administrative order, administrative hearing requests related to a final 
76  administrative order, and responses to record requests by FDA relating to minor changes should 
77  be electronically submitted through the CDER NextGen Portal.   
78   
79  Data, information, and public comments to a proposed order or interim final order should be 
80  electronically submitted as specified by instructions in the OTC Monographs@FDA portal.  
81   
82  Submissions related to updating drug listing information should be electronically submitted 
83  consistent with the Electronic Drug Registration and Listing System (eDRLS) process and 
84  instructions.16 
85   
86  A.  CDER NextGen Portal 
87   
88  1.  Presubmission Considerations for CDER NextGen Portal  
89   
90  FDAs CDER NextGen Portal is a website for users to report information to the FDA, including 
91  certain OTC monograph submissions. Submitters need to have a CDER NextGen Portal account 
92  to submit OTC monograph submissions in electronic format through the CDER NextGen Portal. 
93  For information on how to set up an account and other related questions, visit CDER NextGen 
94  Portal website and click the FAQs link.17     
 
12 See section 505G(j) of the FD&C Act. 
 
13 CDER NextGen Portal is accessible at https://edm.fda.gov. 
 
14 OTC Monographs@FDA portal is accessible at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm. 
 
15 For OTC monograph submissions not explicitly described in this guidance, interested parties should check the 
OTC Monographs@FDA portal to see whether FDA has provided instructions on how they should be submitted 
electronically. If FDA has not provided instructions on how an OTC monograph submission not explicitly described 
in this guidance should be submitted, contact FDA at druginfo@fda.hhs.gov. 
 
16 Electronic Drug Registration and Listing System web page is accessible at https://www.fda.gov/drugs/electronic-
drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions). 
 
17 CDER NextGen Portal is accessible at https://edm.fda.gov. 
 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
95   
96  2.  Transmitting Electronic Submissions in CDER NextGen Portal  
97   
98  CDERs NextGen Portal provides for the secure submission of OTC monograph submissions. 
99  CDER NextGen Portal does not provide a means to edit OTC monograph submissions once 
100  they have been submitted. 
101   
102  For information related to file size limitations for OTC monograph submissions, contact CDER 
103  at EDMSupport@fda.hhs.gov.  
104   
105  3.  Receipt Date for CDER NextGen Portal Submissions 
106   
107  The receipt date for an electronic OTC monograph submission is determined only after the files 
108  in the submission have been validated (e.g., following successful file size verification and virus 
109  scan) in CDER NextGen Portal.18 After an OTC monograph submission has been successfully 
110  submitted, a confirmation will appear in the portal. Submitters will also receive an email 
111  notification from the portal confirming the submission is successful and establishing the 
112  submissions receipt date. The receipt date for an OTC monograph submission is the date on 
113  which the request is deemed to have arrived at FDA. The receipt date should not be confused 
114  with the date of FDAs subsequent decision to file a request. Additional information on receipt 
115  dates for electronic submissions is available in the guidance for industry Providing Regulatory 
116  Submissions in Electronic Format  Receipt Dates (February 2014).19  
117   
118  4.  Contact Information 
119   
120  For questions related to providing electronic submissions in CDER NextGen Portal according to 
121  the recommendations in this guidance, contact CDER electronic submission coordinator at 
122  EDMSupport@fda.hhs.gov. 
123   
124  B.  OTC Monographs@FDA Portal 
125   
126  FDAs OTC Monographs@FDA portal is a website that provides a resource for the public to 
127  view proposed, final, and interim final orders for OTC monograph drugs. This portal also 
128  facilitates the submission of comments and data from the public for proposed and interim final 
129  administrative orders. 
130   
131  Data and information submissions in response to an FDA data request and public comments to a 
132  proposed order or interim order should be electronically submitted as specified by the 
133  instructions in the OTC Monographs@FDA portal.   
134   
 
18 CDER NextGen Portal is similar to the Electronic Submissions Gateway. Therefore, the receipt date policy for 
submissions submitted via CDER NextGen Portal is identical to the policy for receipt of electronic submissions via 
the Electronic Submissions Gateway.  
 
19 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. 
 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
135  Instructions on how to submit data and information submissions will be found in the FDA data 
136  request posted in the OTC Monographs@FDA portal. 
137   
138  Instructions on how to submit public comments to a proposed order or interim final order are 
139  contained in the proposed order or interim final order posted in the OTC Monographs@ FDA 
140  portal. 
141   
142  C.  Electronic Drug Registration and Listing System 
143   
144  Sponsors electronically submitting updates to drug listing information for a drug subject to 
145  section 505G in accordance with section 510(j) of the FD&C Act based on changes they have 
146  made to the drug should follow the general process for providing updated listing information and 
147  instructions that be can be found on FDAs Electronic Drug Registration and Listing System 
148  (eDRLS) web page.20     
149   
150   
151  IV.  SUBMITTING CONFIDENTIAL INFORMATION IN AN OTC MONOGRAPH 
152  SUBMISSION 
153   
154  The OTC monograph order process is generally a public process. Under this order process, 
155  section 505G(d) of the FD&C Act limits the information that can be confidentially submitted to 
156  FDA in connection with proceedings on an order. 
157   
158  The CDER NextGen Portal provides instructions for identifying confidential information 
159  included in OTC monograph submissions and submitted electronically to the CDER NextGen 
160  Portal. Proposed orders or interim final orders posted in OTC Monographs@FDA portal provide 
161  instructions for how to submit public comments, on proposed orders or interim final orders, that 
162  include confidential information. 
 
20 Available at https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-
registration-and-listing-instructions. See also 21 U.S.C. 360 and 21 CFR part 207. 
 
  5