Description
This guidance provides stakeholders with information regarding FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program under sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Coronavirus Aid, Relief, and Economic Security Act (or the CARES Act), which authorize FDA to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and requestors of OTC Monograph Order Requests (OMORs), other than OMORs for certain safety changes. This guidance describes the types of OMUFA fees, the due dates for fee payment, and the exceptions to certain fees. In addition, this guidance describes the process for submitting fee payments to FDA, the consequences for failing to pay the required fees, and the process for submitting refund requests or disputing FDA’s assessment of OMUFA fees.
Scope & Applicability
Product Classes
2Nonprescription drugs marketed under section 505G of the FD&C Act; Drugs that meet applicable monograph conditions
Consumer antiseptic rubs or wipes subject to specific fee exemptions during the PHE
Stakeholders
5Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Final discretionary authority for reviewing user fee appeals.
Entity that controls or is controlled by the applicant; Business entities related to the applicant
Persons or organizations seeking designation of a method of manufacturing; Entity that has developed a technology and submitted an AMT designation request.
responsible for justifying omission of studies
Regulatory Context
Attributes
1Status of an OMOR if fees are not paid
Related CFR Sections (5)
- 21CFR10.75§ 10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →
- 21CFR201.66§ 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
(a) Scope. This section sets forth the content and format requirements for the labeling of all OTC drug products. Where an OTC drug product is the subject of an applicable monograph or regulation that contains content and format requirements that conflict with this section, the content and format reRead full regulation →
- 21CFR330.1§ 330.1 General conditions for general recognition as safe, effective and not misbranded.
An over-the-counter (OTC) drug listed in this subchapter is generally recognized as safe and effective and is not misbranded if it meets each of the conditions contained in this part and each of the conditions contained in any applicable monograph. Any product which fails to conform to each of the cRead full regulation →
- 21CFR210.3§ 210.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 , 225 , and 226 of this chapter .Read full regulation →
- 21CFR207.1§ 207.1 What definitions and interpretations of terms apply to this part?
The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:Read full regulation →
Related Warning Letters (10)
- 2022-04-26
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Guangzhou Zhongkebaishi Health Industry Co., Ltd.
- 2021-12-21
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Guangdong Kemei Pharmaceutical Technology Co. Ltd.
- 2021-10-12
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Notarika, S.A. de C.V.
- 2021-07-13
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Guangzhou Minghui Cosmetics Co., Ltd.
- 2021-05-11
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Ismar Soluciones Dinámicas S de RL de CV
- 2021-05-11
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
C&G Laboratorios SA de CV
- 2021-04-13
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
MYM Hidrominerales S.A. de C.V.
- 2021-03-30
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Distribuidora Lagunera del Norte S.A. de C.V.
- 2021-03-09
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Plasticos Las Palmas, S.A. de C.V
- 2021-01-26
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Ignacio Reyes Gonzalez
See Also (8)
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development (Status: Final)
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)
- Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (Status: Final)
- Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff (Status: Final)
- How to Write a Request for Designation (RFD): Guidance for Industry (Status: Final)
- Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (Status: Final)
- CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM (Status: Final)
- Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments: Guidance for Industry (Status: Final)