Assessing User Fees 
Under the 
Over-the-Counter 
Monograph Drug User 
Fee Program 
 
 
Guidance for Industry 
 
 
DRAFT GUIDANCE 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research 
 
October 2022 
User Fees  
 
   
   
Assessing User Fees 
Under the 
Over-the-Counter 
Monograph Drug User 
Fee Program 
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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research 
 
October 2022 
User Fees 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS  
I.   INTRODUCTION............................................................................................................. 1  
II.   BACKGROUND ............................................................................................................... 2  
III.   DEFINITIONS .................................................................................................................. 2  
IV.   FACILITY FEES.............................................................................................................. 5  
A.   Facility Fee for an MDF ................................................................................................................ 6  
B.   Facility Fee for a CMO .................................................................................................................. 7  
C.   Facilities Not Eligible for Facility Fees Under OMUFA............................................................. 7  
D.   Exceptions to the Facility Fees...................................................................................................... 8  
E.   Fees for Multiple Locations or Relocations of the Same Entity ................................................. 9  
F.   Disputing an OMUFA Facility Fee ............................................................................................. 10  
G.   Waivers and Reductions to OMUFA Facility Fees ................................................................... 10  
V.   OTC MONOGRAPH ORDER REQUEST FEES ....................................................... 10  
A.   Tier 1 OMOR Fees ....................................................................................................................... 10  
B.   Tier 2 OMOR Fees ....................................................................................................................... 11  
C.   Exceptions to the OMOR Fees.................................................................................................... 11  
D.   OMOR Refused for Filing or Withdrawn ................................................................................. 12  
E.   OMOR Tier Recharacterization ................................................................................................. 12  
F.   Disputing an OMOR Fee ............................................................................................................. 12  
G.   Waivers and Reductions to OMOR Fees ................................................................................... 12  
VI.   FAILURE TO PAY FEES.............................................................................................. 13  
A.   Facility Fees .................................................................................................................................. 13  
B.   OMOR Fees .................................................................................................................................. 13  
VII.   PAYMENT INFORMATION AND PROCEDURES ................................................. 14  
A.   Payment Procedures for OMUFA Fees ..................................................................................... 14  
B.   Acceptable Forms of Payment  .................................................................................................... 14  
C.   Timely Payment of Fees............................................................................................................... 14  
D.   Nonpayment of OMUFA Fees ..................................................................................................... 15  
VIII.   REFUNDS, DISPUTES CONCERNING FEES, AND APPEAL PROCESS ........... 15  
A.   Refunds and Disputes Concerning Fees Request ...................................................................... 15  
B.   Reconsideration Request ............................................................................................................. 15  
C.   Appeal Request ............................................................................................................................ 16  
IX.   OTHER RESOURCES................................................................................................... 17  
  Contains Nonbinding Recommendations 
 
Assessing User Fees Under the Over-the-Counter Monograph Drug 
1 
User Fee Program Guidance for Industry1  
2 
3   
4   
5  This guidance represents the current thinking of the Food and Drug Administration (FDA or 
6  Agency) on this topic. It does not establish any rights for any person and is not binding on FDA 
7  or the public. You can use an alternative approach if it satisfies the requirements of the 
8  applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff 
9  responsible for this guidance as listed on the title page.   
10   
11   
12   
13  I.  INTRODUCTION  
14   
15  This guidance provides stakeholders with information regarding FDAs implementation of the 
16  Over-the-Counter Monograph Drug User Fee Program under sections 744L and 744M of the 
17  Federal Food, Drug, and Cosmetic Act (the FD&C Act), 2 as added by the Coronavirus Aid, 
18  Relief, and Economic Security Act (or the CARES Act), which authorize FDA to assess and 
19  collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs3  
20  and requestors4 of OTC Monograph Order Requests (OMORs)5, other than OMORs for certain 
21  safety changes. FDA refers to the OTC Monograph Drug user fee program as OMUFA 
22  throughout this document. 
23   
24  This guidance describes the types of OMUFA fees, the due dates for fee payment, and the 
25  exceptions to certain fees. In addition, this guidance describes the process for submitting fee 
26  payments to FDA, the consequences for failing to pay the required fees, and the process for 
27  submitting refund requests or disputing FDAs assessment of OMUFA fees.  This guidance does 
28  not address how FDA calculates OMUFA fee rates for each fiscal  year (FY), nor does it address 
29  FDAs implementation of other user fee programs administered by the Agency.6  Throughout 
30  this guidance, references to user  fees or user fee program are to over-the-counter monograph 
31  drug user fees authorized, assessed, and collected under sections 744L and 744M of the FD&C 
32  Act. 
33   
 
1 This  guidance has been  prepared by the Division of  User Fee Management, Office of  Management, in the Center 
for Drug Evaluation and Research at the FDA.  
2  21 U.S.C. 379j-71  and 21 U.S.C. 379j-72.  
3 See section  744L(5)  of the FD&C Act which  defines an  OTC monograph drug as a nonprescription drug  without 
an approved new drug application which is  governed by the provisions of section 505G  of the FD&C Act. (21 
U.S.C. 355h). 
4 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. 
5 Section 744L(7) of the FD&C Act defines an  OTC monograph  order request as a request submitted  under section  
505G(b)(5) of the FD&C Act. 
6 For example,  under the Prescription Drug  User Fee Act  (PDUFA), Biosimilar User Fee Act (BSUFA), or Generic 
Drug User Fee Amendments (GDUFA). 
  1  Contains Nonbinding Recommendations 
 
34  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
35  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
36  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
37  the word should in Agency guidances means that something is suggested or recommended, but 
38  not required. 
39   
40   
41  II.  BACKGROUND 
42   
43  The CARES Act was signed into law on March 27, 2020.  Division A of the CARES Act 
44  includes an important legislative initiative, detailed in subtitle F of title III, 7 that reforms and 
45  modernizes the way OTC monograph drugs are regulated in the United States.   
46   
47  Accompanying this OTC monograph reform legislation, the CARES Act also added8 FD&C Act 
48  provisions under which FDA is authorized to assess and collect user fees dedicated to OTC 
49  monograph drug activities9 for each of FYs 2021 through FY 2025. These fees are: (1) annual 
50  facility fees from qualifying manufacturers of OTC monograph drugs; and (2) fees from 
51  requestors of OMORs, except for OMORs that request certain safety-related changes.10   
52  OMUFA fees provide additional resources11 to help the Agency conduct important regulatory 
53  activities in a timely manner, as with other user fee programs administered by the Agency, and 
54  ultimately help provide the public with access to innovative OTC monograph drugs.  
55   
56  Development of recommendations to Congress for the reauthorization of OMUFA are expected 
57  to begin before FY 2025, the final fiscal year of OMUFA's current authorization. 
58   
59  III.  DEFINITIONS 
60   
61  For purposes of this guidance: 
62   
63     The term affiliate means a business entity that has a relationship with a second business 
64  entity if, directly or indirectly, (1) one business entity controls, or has the power to 
65  control, the other business entity; or (2) a third party controls, or has the power to control, 
66  both of the business entities.12  
67   
68     The term contract manufacturing organization facility (CMO) means an OTC 
69  monograph drug facility where neither the owner of such manufacturing facility nor any 
70  affiliate of such owner or facility sells the OTC monograph drug produced at such facility 
71  directly to wholesalers, retailers, or consumers in the United States.13  
72   
 
7 Part I of Subtitle F of title III, Division  A of the CARES Act. 
8 Part II of Subtitle F of title III, Division  A of the CARES Act. 
9 Section 744L(6) of the FD&C Act. 
10 Section 744M(a)(2)(C)  of the FD&C Act. 
11 User fees are available for obligation in accordance with appropriations Acts. 
12 Section 744L(1) of the FD&C Act. 
13 Section 744L(2) of the FD&C Act. 
  2  Contains Nonbinding Recommendations 
 
73     The term FDA establishment identifier (FEI) is the unique number automatically 
74  generated by FDAs Field Accomplishments and Compliance Tracking System (FACTS) 
75  (or any successor system).14  
76   
77     The term OTC monograph drug is a nonprescription, over-the-counter (or OTC) drug 
78  that may be marketed without an approved new drug application under section 505 of the 
79  FD&C Act if it meets the requirements of section 505G of the FD&C Act, as well as 
80  other applicable requirements.15    
81   
82     The term OTC monograph drug facility means a foreign or domestic business or other 
83  entity that:16  
84    is under one management, either direct or indirect; and 
85    is at one geographic location or address engaged in manufacturing or 
86  processing the finished dosage form17 of an OTC monograph drug; 
87    includes a finished dosage form manufacturer facility in a contractual 
88  relationship with the sponsor of one or more OTC monograph drugs to 
89  manufacture or process such drugs; and 
90    does not include a business or other entity whose only manufacturing or 
91  processing activities are one or more of the following: production of clinical 
92  research supplies; testing; or placement of outer packaging on packages 
93  containing multiple products, for such purposes as creating multipacks, when 
94  each monograph drug product contained within the overpackaging is already 
95  in a final packaged form prior to placement in the outer overpackaging.18  
96   
97  For purposes of this definition:      
98   
99  o   separate buildings or locations within close proximity are considered to be at one 
100  geographic location or address if the activities conducted in such buildings or 
101  locations are: 
102    closely related to the same business enterprise;  
103    under the supervision of the same local management; and 
104    under a single FEI and capable of being inspected by the FDA during a single 
105  inspection.19   
106   
107  If a business or other entity would be considered an OTC monograph drug facility, but 
108  for being under multiple management, the business or other entity is deemed to constitute 
109  multiple OTC monograph drug facilities, one per management entity.20  
110   
 
14 Section 744L(4) of the FD&C Act. 
15 Section 744L(5) of the FD&C Act. 
16 Section 744L(10)(A).   
17 See discussion of finished  dosage form in section IV, below.  
18 See discussion of  overpackaging in section IV, subsection C, below.  
19 Section 744L(10)(B) of the FD&C Act, 
20 Section 744L(10)(C) of the FD&C Act. 
  3  Contains Nonbinding Recommendations 
 
111     The term OTC monograph drug meeting means any meeting regarding the content of a 
112  proposed OTC monograph order request (OMOR).21  
113   
114     The term OTC monograph order request  (OMOR) refers to a request for an order 
115  submitted under section 505G(b)(5) of the FD&C Act.22   
116   
117     The term person includes an affiliate of a person.23  
118   
119     The term requestor is any person or group of persons marketing, manufacturing, 
120  processing, or developing a drug.24  
121   
122     The term sponsor is any person marketing, manufacturing, or processing a drug that is 
123  listed under section 510(j) and is or will be subject to an administrative order of the FDA 
124  under section 505G of the FD&C Act.25   
125     
126     The term Tier 1 OTC monograph order request means any OTC monograph order 
127  request not determined to be a Tier 2 OTC monograph order request.26   
128   
129     The term Tier 2 OTC monograph order request means an OTC monograph order request 
130  for: 
131    the reordering of existing information in the Drug Facts label of an OTC 
132  monograph drug; 
133    the addition of information to the "Other information" section of the Drug 
134  Facts label of an OTC monograph drug, as limited by section 201.66(c)(7) of 
135  title 21, Code of Federal Regulations (or any successor regulations); 
136    modification to the Directions for Use section of the Drug Facts label of an 
137  OTC monograph drug, if such changes conform to changes made pursuant to 
138  section 505G(c)(3)(A) of the FD&C Act; 
139    the standardization of the concentration or dose of a specific finalized 
140  ingredient within a particular finalized monograph; 
141    a change to ingredient nomenclature to align with nomenclature of a 
142  standards-setting organization; or 
143    addition of an interchangeable term in accordance with section 330.1 of title 
144  21, Code of Federal Regulations (or any successor regulations).27,28  
145   
146   
 
21 Section 744L(11) of the FD&C Act. 
22 Section 744L(7) of the FD&C Act. 
23 Section 744L(12) of the FD&C Act; see also section 201(e) of the FD&C Act. 
24 Section 505G(q)(3) of the FD&C Act. 
25 Section 505G(q)(2) of the FD&C Act. 
26 Section 744L(8) of the FD&C Act. 
27  Section 744L(9)(A) of  the FD&C Act.  
28 FDA may,  based on program implementation experience or  other factors  found appropriate by the Agency, 
characterize any OMOR as a Tier 2 OMOR  (including  recharacterizing an OMOR from Tier 1 to  Tier  2) and publish  
such  determination in a proposed order issued  pursuant to section 505G  of the FD&C Act.  See section 744L(9)(B)  
of  the FD&C Act. 
  4  Contains Nonbinding Recommendations 
 
147  IV.  FACILITY FEES  
148   
149  FDA is authorized to assess and collect annual facility fees from qualifying manufacturers of 
150  OTC monograph drugs.29  A full facility fee will be assessed to each qualifying person that owns 
151  a facility that is identified as an OTC monograph drug facility and does not meet the definition of  
152  a Contract Manufacturing Organization (CMO) facility.  OTC monograph drug facilities that are 
153  assessed the full facility fee are referred to by FDA as Monograph Drug Facilities (MDF).  The 
154  amount of the facility fee for a CMO is two-thirds of the full facility fee.30   
155   
156  For the first program year (FY 2021), facility fees were due 45 calendar days after publication of 
157  the FY 2021 fee rate notice in the Federal Register.31, 32  For each fiscal year after FY 2021, the 
158  facility fees are due on the later of: 1) the first business day of June of such year; or 2) the first 
159  business day after the enactment of an appropriations Act providing for the collection and 
160  obligation of fees.33     
161   
162  Under OMUFA, a facility (see section III) that is identified as an OTC monograph drug facility 
163  (i.e., MDF or CMO) on December 31 of the fiscal year or at any time during the preceding 12-
164  month period (e.g., for FY 2021, January 1, 2020, through December 31, 2020) is required to pay 
165  a facility fee for that fiscal year.34   
166   
167  As noted above in section III, an OTC monograph drug facility is a foreign or domestic business 
168  entity that (in addition to meeting other criteria) is engaged in manufacturing or processing the 
169  finished dosage form of an OTC monograph drug, i.e., the dosage form that the product will be 
170  in when marketed to the consumer.35  For example: 
171   
172     A facility engaged in the manufacture or processing of bulk finished tablets or capsules, 
173  for subsequent packaging and labeling by that facility (or another facility) as a marketed 
174  OTC monograph drug product, would generally be considered to be engaged in the 
175  manufacturing or processing of a finished dosage form of an OTC monograph drug.   
176   
177     If the dosage form of an OTC monograph drug to be marketed to the consumer is an  
178  active pharmaceutical ingredient (API) without any inactive ingredients, such as in the 
179  case of products consisting solely of glycerin, mineral oil, petroleum jelly, or saline eye 
180  wash, a facility engaged in the manufacture or processing of such products would 
181  generally be considered to be engaged in the manufacturing or processing of a finished 
182  dosage form of an OTC monograph drug. 
183   
 
29 Section 744M(a)(1)  of the FD&C Act. 
30 Section 744M(a)(1)(B)(ii)  of the FD&C Act.  
31  86  FR 16223 (March 26, 2021). 
32 Section 744M(a)(1)(D)(i)(II) of the FD&C Act. 
33 Section 744M(a)(1)(D)(ii)  of the FD&C Act.  
34 Section 744M(a)(1)(A) of the FD&C Act. 
35 See e.g., the description of finished  dosage  form in  21 CFR 210.3(b)(4), relating to Current  Good  Manufacturing 
Practice (CGMP) requirements: "a finished  dosage form, for  example, tablet, capsule, solution, etc., that contains an  
active ingredient, generally  but not necessarily, in association with inactive ingredients". 
  5  Contains Nonbinding Recommendations 
 
184     If a facility only manufactures an API that is intended to be included in subsequent 
185  manufacturing or processing (i.e., combining the API with inactive ingredients) of the 
186  dosage form produced by another registered facility and marketed to the consumer, then 
187  the facility manufacturing only the API would generally not be considered to be engaged 
188  in the manufacturing or processing of a finished dosage form of an OTC monograph 
189  drug. 
190   
191  Additionally, a facility that engages in the final steps of packaging or labeling of the finished 
192  dosage form (FDF) of the OTC monograph drug, such as placing the FDF drug products into a 
193  bottle or container or affixing the labels on the containers or packages containing the FDF, is 
194  also considered an OTC monograph drug facility subject to the OMUFA facility fee.36  
195  Section 510 of the FD&C Act requires firms that manufacture, prepare, propagate, compound, or 
196  process drugs in the United States or drugs that are imported or offered for import into the 
197  United States to register with the FDA.37  Facilities are required to review and update registration 
198  within the electronic Drug Registration and Listing System (eDRLS)38 and should use current 
199  Structured Product Labeling (SPL) Business Operation Qualifier codes each year.  Registering 
200  the facility using the appropriate SPL Business Operation Qualifier codes helps FDA in 
201  determining whether the facility is subject to an applicable OMUFA facility fee.    
202  Entities may refer to the eDRLS SPL webpage at FDA SPL Business Operation Qualifiers39 for 
203  the entirety of the SPL codes for further clarification and definition. 
204  A.   Facility Fee for an MDF 
205   
206  Under section 744M(a)(1) of the FD&C Act, Each person that owns a facility identified as an 
207  OTC monograph drug facility on December 31 of the fiscal year or at any time during the 
208  preceding 12-month period shall be assessed an annual fee for each such facility. For example, 
209  for purposes of FY 2022 facility fees, that time period is January 1, 2021, through December 31, 
210  2021. A full facility fee will be assessed to each person that owns a facility during the applicable 
211  time period that is identified as an OTC monograph drug facility and does not meet the definition 
212  of a CMO (see section 744M(a)(1) of the FD&C Act). A separate full facility fee will generally 
213  be assessed for each such facility owned by that person.40  
 
36  See section 744L(10)(A); see also section 744L(10)(A)(iii) of  the FD&C Act, excluding from  the definition of  
OTC monograph drug facility those facilities whose manufacturing  or processing  consists solely of a narrow range  
of specified activities (e.g., placement of outer overpackaging on products already in final packaged  form); cf  
section 744A(6)(A)(ii) of  the FD&C Act.  See also  21 CFR  207.1 (addressing drug establishment registration), 
stating that [m]anufacture means each step in the manufacture, preparation, propagation, compounding, or 
processing of a drug, and indicating that the term  manufacture, preparation, propagation, compounding,  or  
processing, as used in section 510 of the Federal  Food, Drug, and Cosmetic Act, includes relabeling, repackaging,  
and salvaging  activities. 
37 Sections  510(b) and 510(i)  of the FD&C  Act. For information and instructions on the electronic registration 
process,  please refer to FDA eDRLS Instruction webpage available at: https://www.fda.gov/drugs/drug-registration-
and-listing-system-drls-and-edrls/electronic-drug-registration-and-listing-instructions. 
38 Section 510(p)  of the FD&C  Act; 21 CFR   207.29 
39  https://www.fda.gov/industry/structured-product-labeling-resources/business-operation-qualifier. 
40 Section 744M(a)(1)(A) of the FD&C Act.  See also section  IV.E of  this draft guidance, which addresses situations 
involving multiple manufacturing or processing sites.  
  6  Contains Nonbinding Recommendations 
 
214   
215  B.   Facility Fee for a CMO 
216   
217  A CMO facility is an OTC monograph drug facility where neither the owner nor any affiliate of 
218  the owner or facility sells the OTC monograph drug produced at such facility directly to 
219  wholesalers, retailers, or consumers in the United States (see section 744L(2) of the FD&C Act).  
220  CMO facilities will be assessed two-thirds of the amount of the fee paid by an MDF. 
221   
222  If a facility pays the facility fee for a CMO when the facility does not meet the definition of a 
223  CMO (i.e., the facility is an MDF), FDA will assess the difference in fees to the facility (i.e., the 
224  difference in fee amounts between the MDF and the CMO facility fees). 
225   
226  C.   Facilities Not Eligible for Facility Fees Under OMUFA 
227  The FDA does not assess OMUFA facility fees for facilities that do not meet the statutory 
228  definition of an "OTC monograph drug facility" as described in section III.  Thus, no OMUFA 
229  facility fee will be assessed with respect to facilities that solely perform the following activities:  
230     manufacture or process human OTC drug products that are marketed under an application 
231  approved under section 505 of the FD&C Act or section 351 of the Public Health Service 
232  Act; 
233     manufacture or process human OTC drug products that are not governed by the 
234  provisions of section 505G of the FD&C Act (which addresses lawful marketing of 
235  certain nonprescription drugs absent an approved application);  
236     manufacture API ingredients that are intended to be included in subsequent 
237  manufacturing or processing.41  
238     manufacture or process the finished dosage form of an OTC monograph drug only for the 
239  production of clinical research supplies or testing;42     
240     engage in, as their only manufacturing or processing activity, the placement of outer 
241  packaging on packages containing multiple products, for such purposes as creating 
242  multipacks, when each monograph drug product contained within the overpackaging is 
243  already in a final packaged form prior to placement in the outer overpackaging.43  
244     For the purpose of this guidance, FDA considers overpackaging to be the enclosure of 
245  individual drug products that each bear full and complete labeling information required 
246  under the FD&C Act (e.g., Drug Facts Label44 and Principal Display Panel45) and that 
247  could each be legally marketed independently, if not overpackaged and marketed as a set 
248  of such products. 
249  o   For example, overpackaging may involve plastic shrink wrapping that encloses 
250  already packaged OTC monograph drug products that each bear complete labeling 
 
41 Section 744L(10)(A)(i)(II) of the FD&C Act. But see section  IV of this draft guidance which explains when the 
manufacturer of API may  be  subject to a facility fee.  
42 Section 744L(10)(A)(iii). 
43 Id.  
44 See 21 CFR 201.66. 
45 See 21 CFR 201.60. 
  7  Contains Nonbinding Recommendations 
 
251  information (including Drug Facts Label and Principal Display Panel), as a set of 
252  such products for convenience or for "multipack" purposes such as first aid kits.   
253   
254  Consistent with the Federal Register notices (FRN) published by the Department of Health and 
255  Human Services (HHS) on January 12, 2021,46 and by the FDA on March 26, 202147 and March 
256  16, 2022,48 FDA will not assess OMUFA facility fees upon those firms that first registered with 
257  FDA on or after the January 27, 2020, declaration of the COVID-19 Public Health Emergency 
258  (PHE),49  solely for purposes of manufacturing hand sanitizer products50 during the PHE.51,52    
259   
260  However, under the FD&C Act, whether an entity is subject to OMUFA fees has no bearing on 
261  whether the entity or the entitys products are subject to other requirements under the FD&C Act.  
262  FDA will continue to use its regulatory compliance and enforcement tools to protect consumers, 
263  including from potentially dangerous or subpotent hand sanitizers. 
264   
265  D.   Exceptions to the Facility Fees  
266   
267  A facility fee will not be assessed for an OTC monograph drug facility for a fiscal year if the 
268  facility: 
269     has ceased all activities related to OTC monograph drugs prior to December 31 of the 
270  year preceding the applicable fiscal year, and  
271     has updated its registration within eDRLS to reflect such changes under the requirements 
272  for the drug establishment registration set forth in section 510 of the FD&C Act.53   
273   
274  For example, for FY 2021 (which began October 1, 2020), if an OTC monograph drug facility 
275  had ceased all activities related to OTC monograph drugs and updated its registration (e.g., 
 
46  See  https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-
over-the-counter-drug-market-to-supply-hand-sanitizer-during (86 FR  2420). 
47  See https://www.federalregister.gov/documents/2021/03/26/2021-06361/fee-rates-under-the-over-the-counter-
monograph-drug-user-fee-program-for-fiscal-year-2021. 
48  See https://www.federalregister.gov/documents/2022/03/16/2022-05542/over-the-counter-monograph-drug-user-
fee-rates-for-fiscal-year-2022.   
49  See  https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.  
50 The term hand sanitizer commonly refers  to consumer antiseptic rubs.   However,  because the HHS Federal 
Register  notice referred to persons that entered the over-the-counter drug  market to supply hand sanitizer products  
in response to the COVID-19  Public Health Emergency  (86 FR 2420), FDA is using the same terminology--hand  
sanitizer products-- to refer to  OTC monograph drug products intended for  use (without water) as antiseptic hand  
rubs or antiseptic hand  wipes  by consumers or health care  personnel.   Use of the term hand sanitizer products to  
refer to antiseptic hand  rubs and antiseptic hand wipes intended for use by consumers or health care personnel  does 
not alter any existing regulatory distinctions between these products. 
51  See  86 FR 2420.  Facility fees would  be assessed to entities that manufacture, distribute, and  sell over-the-
counter drugs in addition to  hand sanitizer and entities that continue to  manufacture (as opposed to  hold, 
distribute, or sell existing inventories) hand  sanitizer products as of  December  31 of the  year immediately following  
the year  during which the COVID-19 Public Health  Emergency is terminated. 
52 For more information regarding hand sanitizers, please refer to FDAs COVID-19-Related Guidance  Documents 
for Industry, FDA Staff, and Other Stakeholders webpage  at https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-
stakeholders. 
53 Section 744M(a)(1)(B)(i) of  FD&C Act. 
  8  Contains Nonbinding Recommendations 
 
276  delisted its OTC monograph drug products and deregistered the facility) within FDAs eDRLS 
277  prior to December 31, 2019, the FY 2021 facility fee was not assessed. 
278   
279  E.   Fees for Multiple Locations or Relocations of the Same Entity  
280   
281  If an entity has multiple sites manufacturing or processing one or more OTC monograph drugs, 
282  and each site is in a different geographic location (including by relocation to a different 
283  geographic location during the relevant timeframe used for fee assessment),54 each site is 
284  generally assessed a separate annual facility fee for the fiscal year at issue.  However, separate 
285  buildings within close proximity are considered to be at one geographic location or address, for 
286  purposes of assessing a single facility fee, if:  
287   
288     the activities in them are closely related to the same business enterprise;  
289     they are under the supervision of the same local management; and  
290     they are under a single FDA FEI and are capable of being inspected by FDA during a 
291  single inspection.55  
292   
293  These are the same criteria used by FDAs Office of Regulatory Affairs to evaluate whether 
294  separate FEIs are necessary for multiple facilities.56  FDA utilizes its assignment of FEIs to help 
295  properly assess OMUFA facility fees in cases involving multiple locations of the same entity.  
296  FEI assignments are a designated data input when a person remits a facility payment through 
297  FDAs User Fee System.     
298   
299  If an entity believes that multiple FEIs have been  assigned in error or that its separate facilities 
300  qualify for a single FEI, the entity may request consolidation of the FEIs.  However, once a 
301  facility fee has been incurred for a fiscal year, the fee is not waived, reduced, or refunded if FDA 
302  subsequently agrees to consolidate FEI numbers for that fiscal year.  The consolidated FEI 
303  numbers will be reflected in the following fiscal year user fee assessments.  
304   
305  Domestic entities should submit the request to the appropriate FDA district office.  Contact 
306  information is available at 
307  http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123522.pdf. 
308   
309  The FEI Search Portal57 is available for facilities to look up an FEI number.  The FEI Portal 
310  FAQs58 provides additional information and resources on FEI.   
311   
 
54 Foreign  or domestically located.   
55  Section 744L(10)(B) of  the FD&C Act. Additionally, section 744L(10)(C)  of the FD&C  Act states that if a 
business or other entity would meet the definition of an OTC monograph drug  facility under section 744L(10)(A) 
but for being under multiple management, the business or entity  is deemed  to constitute multiple facilities, one per 
management entity. 
56 An FEI number is issued by  FDA to track inspections of the regulated establishment or facility.  FEI numbers are 
also used to  track OTC facility fee payments.  An FEI number is different  from a Central  File Number and Federal 
Tax Identification Number. 
57  https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=portal.login. 
58  https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq. 
  9  Contains Nonbinding Recommendations 
 
312   
313  F.   Disputing an OMUFA Facility Fee  
314   
315  To qualify for the return of a facility fee claimed to have been paid in error, a person must submit 
316  to FDA a written request with justification for the return within 180 calendar days after the date 
317  such fee was paid (see Section VII.C. below).59    
318   
319  See Section VIII.A. below on how to request a refund or file a dispute request contesting FDAs 
320  user fee assessment.  
321   
322  G.  Waivers and Reductions to OMUFA Facility Fees 
323   
324  Waivers and reductions to OMUFA facility fees are not authorized under the statute and thus not 
325  available. All companies pay the same applicable facility fee (i.e., MDF or CMO) regardless of 
326  size.  
327   
328  V.  OTC MONOGRAPH ORDER REQUEST FEES  
329   
330  Under section 744M(a)(2) of the FD&C Act, the Agency is authorized to assess and collect fees 
331  from each person that submits an OMOR,60 except for OMORs that request certain safety-related 
332  changes (as described in Section V.C).61    
333   
334  OMOR fees are due on the date of the submission of the OMOR (see Section VII.C. below).62    
335   
336  OMORs are separated into two categories: Tier 1 or Tier 2,63 for which different fees apply.64   
337   
338  A.   Tier 1 OMOR Fees 
339   
340  Tier 1 OMOR fees apply to any OMOR not determined to be a Tier 2 OMOR. Examples of Tier 
341  1 OMORs include, but are not limited to, the addition of a new:     
342   
343     ingredient to a monograph that already has one or more ingredients that have been 
344  found to be generally recognized as safe and effective (GRASE); 
345     indication to a monograph that already has one or more ingredients that have been 
346  found to be GRASE, and the new indication applies to one or more of the GRASE 
347  ingredients; 
348     fixed-dose combination of ingredients to a monograph that already has one or more 
349  ingredients that have been found to be GRASE;  
 
59 Section 744M(a)(3)(B)  of the FD&C Act. For the purposes of  OMUFA  fees, FDA considers the payment date to 
be the date on which the payment is received by FDA, not necessarily the  date  of payment submission. 
60 Section 744M(a)(2)(A) of the FD&C Act. 
61 Section 744M(a)(2)(C)  of the FD&C Act.  
62 Section 744M(a)(2)(B)  of the FD&C Act. 
63  A Tier 1 OMOR  is defined as any OMOR that is not a Tier 2 OMOR (see section 744L(8) of  the FD&C Act).  
Tier 2 OMORs are detailed in section 744L(9) of the FD&C Act. 
64 Section 744M(a)(2)(A) of the FD&C Act. 
  10   Contains Nonbinding Recommendations 
 
350     test method for a monograph that already has one or more ingredients that have been 
351  found to be GRASE, and the new test method applies to one or more of the GRASE 
352  ingredients; 
353     route of administration for a monograph that already has one or more ingredients that 
354  have been found to be GRASE, and the new route of administration applies to one or 
355  more of the GRASE ingredients;  
356     dose or concentration for a GRASE ingredient for a particular monograph; or 
357     monograph therapeutic category (each ingredient proposed for the new therapeutic 
358  category will be a separate OMOR).65  
359   
360  B.   Tier 2 OMOR Fees 
361   
362  Tier 2 OMOR fees apply to Tier 2 OMORs, which are OMORs for66: 
363   
364     reordering of existing information on the Drug Facts label;  
365     addition of information to the Other Information section of the Drug Facts label, as 
366  limited by 21 CFR 201.66(c)(7); 
367     modification to the Directions for Use section of the Drug Facts label, if such 
368  modification conforms to a final order under section 505G of the FD&C Act 
369  applicable to certain minor dosage form changes for the drug67; 
370     the standardization of the concentration or dose of a specific finalized ingredient  
371  within a particular finalized monograph; 
372     a change to the ingredient nomenclature to align with the nomenclature of a 
373  standards-setting organization; 
374     the addition of an interchangeable term in accordance with 21 CFR 330.1(i); or 
375     any OMOR determined by the FDA to be a Tier 2 OMOR and published as such in a 
376  proposed order issued pursuant to section 505G of the FD&C Act.   
377   
378  C.   Exceptions to the OMOR Fees 
379     
380  An OMOR fee will not be assessed if the OMOR seeks to make certain safety-related changes 
381  with respect to an OTC monograph drug. Specifically, no fee will be assessed if FDA finds that 
382  the OMOR seeks to change the Drug Facts labeling of an OTC monograph drug in a way that 
383  would add to or strengthen: 
384   
385     a contraindication, warning, or precaution;  
386     a statement about risk associated with misuse or abuse; or  
387     an instruction about dosage and administration that is intended to increase the safe 
388  use of the OTC monograph drug.68  
389   
 
65 See page 10  of the document titled Over-the-Counter  Monograph User Fee Program Performance Goals and  
Procedures - Fiscal Years 2018-2022 at https://www.fda.gov/media/106407/download. 
66 Section 744L(9) of the FD&C Act. 
67 See sections  744L(9)(A)(iii) and 505G(c)(3)(A) of the FD&C Act. 
68 Section 744M(a)(2)(C)  of the FD&C Act. 
  11   Contains Nonbinding Recommendations 
 
390  D.   OMOR Refused for Filing or Withdrawn 
391   
392  An OMOR fee is due and must be paid in full no later than the date of submission of the 
393  qualifying OMOR.  If the requestor withdraws the OMOR before FDA accepted or refused the 
394  OMOR for filing or FDA refuses to file the OMOR, FDA will refund 75 percent of the OMOR 
395  fee to the payor.69  A written refund request is not required. 
396   
397  If an OMOR is withdrawn after it is filed, FDA may refund the fee or a portion of the fee if no 
398  substantial work was performed on the OMOR. FDA has the sole discretion in determining 
399  whether to refund a fee or a portion of the fee to the requestor of the OMOR, including whether 
400  substantial work was performed on the filed OMOR.  FDA's determination concerning a refund 
401  in these circumstances is generally not reviewable.70  
402   
403  An OMOR that was submitted but was refused for filing or was withdrawn before being 
404  accepted or refused for filing is subject to the full fee if the OMOR is resubmitted or filed over 
405  protest.71   
406   
407  E.   OMOR Tier Recharacterization  
408   
409  If FDA determines that an OMOR initially characterized as Tier 1 shall be recharacterized as 
410  Tier 2, and the requestor has paid a Tier 1 fee, the difference between the Tier 1 and Tier 2 fees 
411  will be refunded.72  In addition, the appropriate OMOR fee shall be refunded if FDA 
412  characterizes the OMOR involved to be an OMOR seeking certain safety-related changes for 
413  which an OMOR fee does not apply.73  A written refund request is not required when the Agency 
414  recharacterizes an OMOR in either manner.  
415   
416  F.   Disputing an OMOR Fee 
417   
418  To qualify for the return of an OMOR fee claimed to have been paid in error, a person must 
419  submit to FDA a written request with justification for the return of the OMOR fee within 180 
420  calendar days after the date such fee was paid (see Section VII.C. below).74    
421   
422  See Section VIII.A. below on how to request a refund or file a dispute request contesting FDAs 
423  user fee assessment.  
424   
425   
426  G.  Waivers and Reductions to OMOR Fees  
427   
 
69 Section 744M(a)(2)(E)  of the FD&C Act. 
70 Section 744M(a)(2)(G) of the FD&C Act. 
71 Section 744M(a)(2)(F)  of the FD&C Act. 
72 Section 744M(a)(2)(D) of the FD&C Act. 
73 Section 744M(a)(2)(C)  of the FD&C Act. 
74 Section 744M(a)(3)(B)  of the FD&C Act. 
  12   Contains Nonbinding Recommendations 
 
428  Waivers and reductions to OMOR fees are not authorized under the statute and thus not 
429  available. 
430   
431  VI.  FAILURE TO PAY FEES  
432   
433  Failure to remit payment in full for user fees incurred pursuant to section 744M of the FD&C 
434  Act will result in certain penalties on an entity and/or its affiliates based on the type of fee, as 
435  described below. In addition, if payment of the fee is not received within 30 calendar days after 
436  the invoice is issued, such fee shall be treated as an obligation to the U.S. Government, and 
437  failure to pay fees may lead to collection activities by the Government pursuant to applicable 
438  laws.75   
439   
440  FDA is not required to notify requestors before refusing to receive an OMOR submission on the 
441  basis of unpaid fees.76  Requestors are in the best position to monitor their business affiliates for 
442  compliance with OMUFA fee obligations.  It is the requestors responsibility to ensure that its 
443  user fee obligations, as well as those of its affiliates, are satisfied before submitting an OMOR. 
444   
445  A.   Facility Fees 
446   
447  There are several consequences for failure to pay the facility fee: 
448   
449     If the annual fee for a facility is not paid within 20 calendar days of the due date, as 
450  specified in section 744M(e)(1)(A) of the FD&C Act, the Agency will place the facility 
451  on a publicly available arrears list,77,78 and all OTC monograph drug products produced at 
452  that facility or containing an ingredient manufactured at that facility are deemed 
453  misbranded under section 502(ff) of the FD&C Act;79    
454     If a person subject to a facility fee does not pay the facility fee, any OMOR submitted to 
455  FDA by such person is considered incomplete and will not be accepted for filing by FDA 
456  until all fees owed have been paid;80 and 
457     If a person subject to a facility fee does not pay the facility fee, that person is ineligible 
458  for OTC monograph drug meetings until all fees owed have been paid.81   
459   
460  If an entity believes that a facility's appearance on the arrears list is in error, the entity  should 
461  contact the Division of User Fee Management at CDERCollections@fda.hhs.gov and include 
462  supporting documentation as to why the entity believes the facility should not be included on the 
463  arrears list.  
464   
465  B.   OMOR Fees  
466   
 
75 Section 744M(g)  of the FD&C Act. 
76 Section 744M(e)(2)  of the FD&C Act. 
77 Section 744M(e)(1)(A)(i)  of  the FD&C Act. 
78 The publicly available arrears list is available within the User Fee Lists section of the OMUFA user fee website 
at: https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa   
79 Section 744M(e)(1)(A)(ii)  of the FD&C Act.  
80 Section 744M(e)(2)  of the FD&C Act. 
81 Section 744M(e)(3)  of the FD&C Act. 
  13   Contains Nonbinding Recommendations 
 
467  If a person fails to remit the appropriate payment when submitting an OMOR, or is currently in 
468  arrears when submitting an OMOR, that OMOR shall be considered incomplete and shall not be 
469  accepted for filing until all fees owed are paid.82  OTC monograph drug meeting requests from 
470  persons in arrears for OMOR fees will be denied or cancelled.83   
471   
472  VII.  PAYMENT  INFORMATION AND PROCEDURES  
473   
474  This section generally describes the process for payment of OMUFA fees.  More detailed 
475  instructions for paying the fees can be found in the FDA OMUFA user fee website.84  Additional 
476  instructions will be provided when the payor creates the OMUFA cover sheet using the FDA 
477  User Fee System.85    
478   
479  A.   Payment Procedures for OMUFA Fees 
480   
481     Those responsible for payment of fees enter the required information on FDAs User Fee 
482  System86 to generate an OMUFA cover sheet.   
483     The cover sheet is designed to provide the minimum necessary information to determine 
484  if a person has satisfied all relevant user fee obligations.   
485     The cover sheet is submitted to FDA electronically, generating a user fee identification  
486  (ID) number to assist in tracking payment. 
487   
488  One entity may pay OMUFA fees on behalf of another entity.  Those paying fees are responsible 
489  for determining all financial institution transaction fees that may be deducted from an entitys 
490  authorized amount for payment to FDA.  These include wire transfer and foreign exchange fees. 
491  Fee payors must ensure that the net amount paid to FDA is the full amount owed. 
492   
493  B.   Acceptable Forms of Payment  
494   
495  Payment must be made in U.S. currency using U.S. bank accounts as well as U.S. credit cards. 
496  Payment must be by electronic check or wire transfer, payable to the order of the Food and Drug 
497  Administration. The preferred payment method is online using electronic check (Automated 
498  Clearing House (ACH) also known as eCheck) or credit card for payments under $25,000 
499  (Discover, VISA, MasterCard, American Express).87  
500       
501  C.   Timely Payment of Fees 
502   
503  FDAs expectation is for a timely and full payment of all OMUFA fees.  For penalties associated 
504  with nonpayment by the fees due date, see Sections VI.A. and VI.B.  
505   
 
82 Section 744M(e)(2)  of the FD&C Act. 
83 Section 744M(e)(3)  of the FD&C Act. 
84  https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa   
85  https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp  
86  https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp  
87  https://www.federalregister.gov/documents/2022/03/16/2022-05542/over-the-counter-monograph-drug-user-fee-
rates-for-fiscal-year-2022   
  14   Contains Nonbinding Recommendations 
 
506  OMUFA fee payments should be made in a timely manner to meet the required facility fee 
507  payment due date or be paid upon submission of an OMOR. FDA records, as the receipt date of 
508  an OMOR submission, the later of the following:  
509   
510     the date the OMOR submission is received by FDA; or  
511     the date FDA receives payment for the submitted OMOR.  
512   
513  D.   Nonpayment of OMUFA Fees 
514   
515  Delinquent entities will receive an invoice from FDA detailing information on the user fee 
516  incurred, the due date, and the payment instructions. 
517   
518  If full payment is not received by the date specified on the invoice, interest will be charged at a 
519  rate set by the U.S. Department of Treasury. In addition, delinquent invoices will have a $20 
520  administrative fee assessed for each 30-day period that the invoice remains outstanding.  A 
521  penalty of 6 percent per year will be assessed on any invoice delinquent for more than 90 days in 
522  accordance with 45 CFR 30.18. 
523   
524  VIII.   REFUNDS, DISPUTES CONCERNING FEES, AND APPEAL PROCESS 
525   
526  A.   Refunds and Disputes Concerning Fees Request 
527   
528  A person may submit a written request to FDA requesting the return of the fees claimed to have  
529  been paid in error or otherwise disputing FDAs user fee assessment.88  The permissible grounds 
530  for a refund are discussed in more detail in section 744M(a)(3) of the FD&C Act.  The request 
531  justifying the return of the fee or disputing FDAs user fee assessment must be submitted within 
532  180 calendar days after the date such fee was paid.89  Note that if a written request is not made 
533  within 180 calendar days after the date such fee was paid, no return of fees is permitted.  A 
534  written request and a completed Form FDA 391390 are to be submitted to the Division of User 
535  Fee Management at CDERCollections@fda.hhs.gov. 
536   
537  B.   Reconsideration Request 
538   
539  If FDA fully or partially denies an entity's request for a refund or reduction91 of user fees, the 
540  entity may request reconsideration of that decision.  A request for reconsideration should be 
541  made within 30 calendar days of the issuance of FDAs decision to fully or partially deny a 
542  request for refund or reduction of user fees.  
543    
544  FDA recommends that requests for reconsideration state the entitys reasons for believing that 
545  FDAs decision is in error and include any additional information that is relevant to the entitys 
 
88 Section 744M(a)(3).  
89 Section 744M(a)(3)(B)  of the FD&C Act. 
90  http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM492188.pdf. 
91 A fee reduction may occur if the FDA reclassifies (a) an  OMOR from Tier  1 to Tier 2, (b) an  OMOR  from Tier 1 
or Tier 2 to an  OMOR which  requests certain safety-related changes such that the OMOR is fee-exempt, or (c) an  
MDF to a CMO.  
  15   Contains Nonbinding Recommendations 
 
546  position. The Agency will issue a response upon reviewing the reconsideration request, setting 
547  forth the basis for the decision. 
548   
549  All requests for reconsideration are to be submitted via email to CDERCollections@fda.hhs.gov   
550  and are to be addressed to the following:  
551   
552  Division of User Fee Management 
553  Attention: Division Director  
554  Center for Drug Evaluation and Research 
555   
556  In instances where an entity is unable to submit an electronic request, the entity can mail the 
557  request to FDA via the carrier of its choice.  For the most updated mailing address, visit the 
558  following FDA website: https://www.fda.gov/industry/fda-user-fee-programs/over-counter-
559  monograph-user-fee-program-omufa. 
560   
561  C.   Appeal Request 
562   
563  If a request is denied upon reconsideration, the entity may choose to appeal the denial.  A request 
564  for an appeal should be made within 30 calendar days of the issuance of FDAs decision to 
565  affirm its denial of a request for a refund or reduction of user fees. All of the following 
566  information should be included in the appeal: 
567   
568     the original request 
569     the denial of the original request 
570     the reconsideration request 
571     the denial of the reconsideration request 
572     a statement of the entitys reasons for believing that the prior conclusions were in 
573  error 
574   
575  No new information or new analyses are to be presented in the appeal request.  If new 
576  information or analyses are presented in the appeal request, the appeal will not be accepted, and 
577  the matter will be referred back to the original deciding authority to consider the new 
578  information or analyses.  
579   
580  All requests for appeals should be submitted to the Director of CDERs Office of Management 
581  via CDERCollections@fda.hhs.gov, and a copy should be submitted to the CDER Formal 
582  Dispute Resolution Project Manager. The contact information can be found on the CDER 
583  Formal Dispute Resolution web page.92  Alternatively, an entity can mail the request to FDA via 
584  the carrier of the entitys choice.  For the most updated mailing address, visit the following FDA 
585  website: https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-
586  program-omufa. 
587   
588  After FDA reviews the information submitted in the appeal request, the Director of CDERs 
589  Office of Management will issue a written decision on the entitys request.  
 
92  https://www.fda.gov/about-fda/cder-contact-information/cder-formal-dispute-resolution  
  16   Contains Nonbinding Recommendations 
 
590   
591  If the entitys appeal is denied at one management level, the entity can appeal the same matter to 
592  the next higher management level in the CDER chain of command.  A new request should be 
593  submitted for each appeal to the next management level and should follow the process provided 
594  in this guidance.  If the entity has exhausted CDERs management levels and remains unsatisfied 
595  with the decision, the entity may request review of the matter by the Commissioner of Food and 
596  Drugs (Commissioner) under 21 CFR 10.75(c).  Requests for review by the Commissioner 
597  should be submitted to FDAs Ombudsman, with copies provided to CDER.  Review of such 
598  matters by the Commissioner is discretionary.93  
599       
600  IX.  OTHER RESOURCES  
601   
602  The following documents may be helpful: 
603   
604     CDER, Office of New Drugs (OND), Office of New Drugs Clinical (ONDC), Office of 
605  Nonprescription Drug (ONPD) Webinar, Monograph reform is here! Learn what to 
606  expect and how to prepare (May 29, 2020), available at: 
607  https://www.fda.gov/drugs/news-events-human-drugs/webinar-monograph-reform-here-
608  learn-what-expect-and-how-prepare-05292020-05292020  
609     Federal Register notice, Fee Rates Under the Over-the-Counter Monograph Drug User 
610  Fee Program for Fiscal Year 2021 (March 26, 2021),  available at: 
611  https://www.federalregister.gov/documents/2021/03/26/2021-06361/fee-rates-under-the-
612  over-the-counter-monograph-drug-user-fee-program-for-fiscal-year-2021   
613     Over-the-Counter (OTC) Drug Monograph Process website, 
614  https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process   
615     Over-the-Counter Monograph User Fee Program Performance Goals and Procedures - 
616  Fiscal Years 2018-2022, https://www.fda.gov/media/106407/download  
617     Over-the-Counter Monograph User Fee Program Performance Goals and Procedures 
618  Table II.J.3: Summary of Dates of Specified Activities under OMUFA Fiscal Years 
619  2021-2025, https://www.fda.gov/media/146283/download    
620     Over-The-Counter Monograph User Fee Program (OMUFA) website,  
621  https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-
622  program-omufa   
623     User Fee Payment Refund Request, FDA Form 3913, 
624  https://www.fda.gov/media/96650/download  
625     User Fees Payment Portal, https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp  
 
93 See 40 FR 40682 at 40693  (September 3, 1975); see 21 CFR 10.75.  
  17