Formal Dispute Resolution and 
Administrative Hearings of 
Final Administrative Orders 
Under Section 505G of the 
Food, Drug, and Cosmetic Act 
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DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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) Jung Lee at (301) 796-3599. 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
June 2023 
Procedural 
 
39539225dft.docx 
6/13/2023   
Formal Dispute Resolution and 
Administrative Hearings of 
Final Administrative Orders 
Under Section 505G of the 
Food, Drug, and Cosmetic Act 
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) 
 
June 2023 
Procedural 
   
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
A.  Regulatory Framework ................................................................................................................. 2 
B.  Over-the-Counter Monograph User Fee Program Performance Goals and Procedures ........ 3 
III.  FORMAL DISPUTE RESOLUTION ............................................................................. 4 
A.  Considerations Before Submitting a Request for FDR .............................................................. 4 
1. Who Is Eligible to Request FDR? .................................................................................................... 4 
2. What Is an Appropriate Matter for FDR? ....................................................................................... 4 
3. What Is Not Appropriate for FDR? ................................................................................................. 4 
4. Is There a Specific Timeline to Request FDR? ................................................................................ 5 
5. May New Information or New Analyses of Previously Reviewed Data Be Included in a Request 
for FDR? .......................................................................................................................................... 5 
6. Is FDR and the Information Submitted to FDA in Connection with FDR Confidential? ................ 6 
B.  Procedures for Submitting a Request for FDR ........................................................................... 7 
1. How to Request FDR ....................................................................................................................... 7 
2. Content and Format of a Request for FDR ...................................................................................... 7 
C.  FDA Action ..................................................................................................................................... 8 
1. Letter Accepting or Not Accepting a Request for FDR .................................................................... 8 
2. Responses to an Accepted Request for FDR .................................................................................... 9 
3. Timelines for Reviewing an Accepted Request for FDR .................................................................. 9 
D.  Repeat Requests for FDR ............................................................................................................ 10 
IV.  ADMINISTRATIVE HEARING .................................................................................. 10 
A.  Considerations Before Submitting a Request for a Hearing .................................................... 11 
1. Who Is Eligible to Request a Hearing? .......................................................................................... 11 
2. Who Is Not Eligible to Request a Hearing? ................................................................................... 11 
3. When Will FDA Not Provide Notice and an Opportunity for a Hearing? ..................................... 11 
4. Is There a Specific Timeline to Request a Hearing? ...................................................................... 11 
5. Is There a Specific Timeline for When a Hearing Must Be Complete? ......................................... 12 
6. May New Information or New Analyses of Previously Reviewed Data Be Included in a Hearing 
Request? ......................................................................................................................................... 12 
7. Is a Hearing and the Information Submitted in Connection with a Hearing Confidential? .......... 12 
B.  Procedures for Submitting a Request for a Hearing ................................................................ 12 
1. How Does An Eligible Requestor or Sponsor Request a Hearing? ............................................... 12 
2. What Is the Content and Format of a Request for a Hearing? ...................................................... 13 
C.  FDA Action in Response to Request for Hearing ...................................................................... 14 
D.  Hearing Procedure ....................................................................................................................... 14 
1. Public Hearing ............................................................................................................................... 14 
2. Presiding Officer ............................................................................................................................ 15 
3. Rights of Parties to Hearing .......................................................................................................... 15 
4. Final Decision ................................................................................................................................ 15 
V.  CONSOLIDATED PROCEEDINGS ............................................................................ 15   
A.  Consolidation of Proceedings by FDA ....................................................................................... 15 
1. Proceedings FDA May Consolidate .............................................................................................. 15 
2. Notice of Consolidation ................................................................................................................. 16 
B.  Consolidation of Proceedings by Eligible Parties ...................................................................... 16 
1. Joint Request for FDR or a Hearing .............................................................................................. 16 
2. Content and Format of Joint Request for FDR or a Hearing ........................................................ 16 
C. Voluntary Termination of FDR and Hearing Process by Eligible Requestor or Sponsor in a 
Consolidated Proceeding ................................................................................................................. 16  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Formal Dispute Resolution and Administrative Hearings of Final 
2  Administrative Orders Under Section 505G of the Food, Drug, and 
3  Cosmetic Act 
4  Guidance for Industry 
5   
6   
7   
8  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
9  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
10  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
11  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
12  for this guidance as listed on the title page.   
13   
14   
15   
16  I.  INTRODUCTION  
17   
18  This guidance provides recommendations for industry and review staff on the formal dispute 
19  resolution and administrative hearings procedures for resolving scientific and/or medical disputes 
20  between the Center for Drug Evaluation and Research (CDER) and requestors1 and sponsors2 of 
21  drugs that will be subject to a final administrative order (final order) under section 505G of the 
22  Food, Drug, and Cosmetic Act (FD&C Act)(21 U.S.C. 355h). The drugs that this guidance 
23  covers are nonprescription drugs without approved new drug applications, which are governed 
24  by the provisions of section 505G (hereafter referred to as over-the-counter (OTC) monograph 
25  drugs3).4 Specifically, this guidance describes the CDER formal dispute resolution (FDR) 
26  procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical 
27  issue related to a final order. This guidance also outlines the procedures for an administrative 
28  hearing (hearing) related to a final order. Finally, this guidance describes the procedures for 
29  consolidated proceedings for FDR and hearings to resolve scientific and/or medical disputes 
30  related to final orders.  
31   
32  In general, FDAs guidance documents do not establish legally enforceable responsibilities. Instead, 
33  guidances describe the Agencys current thinking on a topic and should be viewed only as 
34  recommendations, unless specific regulatory or statutory requirements are cited. The use of the word 
35  should in Agency guidances means that something is suggested or recommended, but not required.  
 
1 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. 
 
2 Sponsor is defined in section 505G(q)(2) of the FD&C Act as any person marketing, manufacturing, or processing 
a drug that is listed pursuant to section 510(j) of the FD&C Act and is or will be subject to an administrative order 
under section 505G of the FD&C Act. 
 
3 See section 744L(5) of the FD&C Act.  
 
4 This guidance does not apply to internal disputes involving FDA staff. 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
36   
37   
38  II.  BACKGROUND 
39   
40  A.  Regulatory Framework 
41   
42  On March 27, 2020, the president signed into law the Coronavirus Aid, Relief, and Economic 
43  Security Act (CARES Act). The CARES Act added section 505G to the FD&C Act. Section 
44  505G reforms and modernizes the framework for the regulation of OTC monograph drugs. OTC 
45  monograph drugs may be marketed without an approved drug application under section 505 of 
46  the FD&C Act if they meet the requirements of section 505G of the FD&C Act, as well as all 
47  other applicable requirements.  
48   
49  The CARES Act also added section 744M to the FD&C Act authorizing FDA to assess and 
50  collect user fees dedicated to OTC monograph drug activities. 
51   
52  Under the process set forth in section 505G(b) of the FD&C Act, FDA has the authority to 
53  issue orders (proposed and final) that add, remove, or change generally recognized as safe and 
54  effective (GRASE) conditions for OTC drug monographs.5 Either FDA or a requestor can 
55  initiate the order process.6 A requestor can initiate the order process by submitting an OTC 
56  monograph order request (OMOR)7 with respect to certain drugs, classes of drugs, or 
57  combinations of drugs.8  
58   
59  After FDA issues a final order in accordance with section 505G(b)(2) of the FD&C Act, FDA 
60  must afford requestors of drugs that will be subject to such an order the opportunity for FDR up 
61  to the level of the Director of CDER.9 FDR begins at the management level in the CDER chain 
62  of command above the level where the decision was made. Similarly, after FDA issues a final 
63  order in an expedited procedure under section 505G(b)(4) of the FD&C Act, FDA must afford 
64  sponsors of drugs that will be subject to such an order the opportunity for FDR up to the level of 
65  the Director of CDER.10  
66   
 
5 See section 505G(b) of the FD&C Act. 
 
6 See section 505G(b)(1)(A) of the FD&C Act. 
 
7 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. 
 
8 See section 505G(b)(5) of the FD&C Act. 
 
9 See section 505G(b)(2)(A)(iv)(III) of the FD&C Act. 
 
10 See section 505G(b)(4)(D)(iii) of the FD&C Act. 
 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
67  If an eligible requestor or sponsor has participated in each stage of FDR up to the level of the 
68  Director of CDER and remains unsatisfied with CDERs decision, the eligible requestor or 
69  sponsor may request a hearing.11 
70   
71  If more than one request for FDR or a hearing is submitted with respect to the same final order, 
72  FDA may consolidate the requests and direct that a single proceeding be conducted for FDR and 
73  the hearing.12 Section 505G(l)(4) of the FD&C Act requires FDA to issue guidance on 
74  consolidated proceedings for appeal and the procedures for such proceedings.  This guidance, 
75  including section V., fulfills this requirement.    
76   
77  B.  Over-the-Counter Monograph User Fee Program Performance Goals and 
78  Procedures  
79   
80  The Over-the-Counter Monograph User Fee Program Performance Goals and Procedures 
81  document, commonly referred to as the OMUFA commitment letter, specifies FDA and industry 
82  mutually agreed-upon timelines for FDR, as described in this guidance.13 The OMUFA 
83  commitment letter does not specify timelines for hearings.  
84   
85  The OMUFA commitment letter specifies that FDA will revise the guidance for industry and 
86  review staff Formal Dispute Resolution: Sponsor Appeals Above the Division Level (November 
87  2017)14 (2017 FDR guidance) to include circumstances and procedures under which FDR may 
88  be used with respect to final orders under section 505G of the FD&C Act. In addition, consistent 
89  with the statutory requirement under 505G(l)(4), the OMUFA commitment letter explains that 
90  FDA will issue guidance on its views regarding best practices for consolidated proceedings for 
91  appeals.   
92   
93  For administrative efficiency, rather than amend the existing FDR guidance to include FDR 
94  procedures for final orders and issue a separate guidance for consolidated proceedings for appeal, 
95  FDA is issuing this single guidance. This guidance addresses the process for resolving scientific 
96  and/or medical disputes between CDER and requestors and sponsors of drugs that will be subject 
97  to final orders, including FDRs, hearings, and consolidated proceedings.15 FDA has incorporated 
98  recommendations from the existing FDR guidance as appropriate.  
 
11 See section 505G(b)(3) of the FD&C Act.  
 
12 See section 505G(b)(3)(C)(ii) and section 505G(l)(4) of the FD&C Act. 
 
13Available at 
https://www.fda.gov/media/106407/download. Per the statutory authority for OMUFA fees enacted under the 
CARES Act, FDA updated the OMUFA goal dates to reflect that FY 2021 is OMUFAs first program year. The 
updated goal dates are available at https://www.fda.gov/media/146283/download. 
 
14 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. 
 
15 This guidance does not address judicial review. 
 
 
 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
99  III.  FORMAL DISPUTE RESOLUTION OF FINAL ORDERS 
100   
101  A.  Considerations Before Submitting a Request for FDR 
102   
103  1.  Who Is Eligible to Request FDR? 
104   
105  Requestors of OTC monograph drugs that will be subject to the final order issued in accordance 
106  with section 505G(b)(2)(A)(iv)(I) of the FD&C Act (hereafter referred to as eligible requestors) 
107  are eligible to request FDR under section 505G(b)(2)(A)(iv)(III).  
108   
109  Sponsors of OTC monograph drugs that will be subject to a final order issued in an expedited 
110  procedure in accordance with section 505G(b)(4)(D)(i) of the FD&C Act (hereafter referred to as 
111  eligible sponsors) are eligible to request FDR under section 505G(b)(4)(D)(iii).  
112   
113  2.  What Is an Appropriate Matter for FDR? 
114   
115  After FDA issues a final order, FDA is required to afford eligible requestors or sponsors the 
116  opportunity for FDR up to the level of the Director of CDER.16,17 As set forth in the 2017 FDR 
117  guidance, FDA has provided formal dispute resolution to address scientific and/or medical 
118  disputes between a sponsor and CDER or [the Center for Biologics Evaluation and Research] as 
119  such disputes relate to the sponsors application for a product covered by user fee goals (user fee 
120  products).18 Accordingly, FDA believes that FDR pursuant to section 505G(b)(2)(A)(iv)(III) is 
121  appropriate for scientific and/or medical disputes related to a determination in a final order 
122  whether there are conditions under which a specific drug, a class of drugs, or a combination of 
123  drugs is determined to be (1) not subject to section 503(b)(1) of the FD&C Act, which requires 
124  certain drugs to be dispensed by prescription only, and (2) generally recognized as safe and 
125  effective under section 201(p)(1) of the FD&C Act, which provides, with certain exceptions, that 
126  a drug is a new drug if it is not generally recognized, among experts qualified by scientific 
127  training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for 
128  use under the conditions prescribed, recommended, or suggested in the labeling thereof.19  
129   
130  3.  What Is Not Appropriate for FDR? 
131   
132  The issuance of a proposed order20 or an interim final order21 is not a final order and therefore 
133  would not be appropriate for FDR.  
 
16 See section 505G(b)(2)(A)(iv)(III) and section 505G(b)(4)(D)(iii) of the FD&C Act. 
 
17 FDR begins at the next management level in the CDER chain of command above the level at which the decision 
being appealed was made and proceeds up to the level of the Director of CDER. 
 
18 See section II. A., Regulatory Framework, of the 2017 FDR guidance. 
 
19 See section 505G(b)(2)(A)(ii)(I) of the FD&C Act. 
 
20 See section 505G(b)(2)(A)(ii)(I) of the FD&C Act. 
 
21 See section 505G(b)(4)(A)(i)(I) and section 505G(b)(4)(B)(i)(II) of the FD&C Act. 
 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
134   
135  Meeting minutes and other correspondences that communicate advice are not final orders and 
136  therefore would not be appropriate subjects for a request for FDR by an eligible requestor or 
137  sponsor. FDA communications, such as meeting minutes or other correspondences (e.g., general 
138  advice letters), typically include recommendations and/or advice made to a requestor or sponsor 
139  that generally conveys CDERs current thinking on a particular topic raised by the requestor or 
140  sponsor. Requestors and sponsors are not bound by such recommendations and/or advice. 
141  Requestors and sponsors can follow the advice in meeting minutes or other correspondences, or 
142  they can use an alternative approach if the approach satisfies the requirements of the applicable 
143  statutes and regulations.  
144   
145  To ensure efficient use of FDA resources, the eligible requestor or sponsor submitting a request 
146  for FDR should not actively engage with other entities within FDA or pursue other regulatory or 
147  legal pathways on the same matter at the same time. 
148   
149  4.  Is There a Specific Timeline to Request FDR? 
150   
151  For FDR with respect to a final order issued in accordance with 505G(b)(2) of the FD&C Act, an 
152  eligible requestor must submit the request for FDR within 45 calendar days of the issuance of the 
153  final order. For subsequent levels of appeal, an eligible requestor must submit the request for 
154  FDR within 30 calendar days of the prior decision.22  
155   
156  For FDR with respect to a final order under section 505G(b)(4) of the FD&C Act, an eligible 
157  sponsor must submit the request for FDR within 45 calendar days of the issuance of the final 
158  order. For subsequent levels of appeal, an eligible sponsor must submit the request for FDR 
159  within 30 calendar days of the prior decision.23 FDA must complete any hearings for the final 
160  order issued in an expedited procedure under section 505G(b)(4) of the FD&C Act not later than 
161  12 months after the date on which the final order is issued.24 Therefore, FDA must specify in an 
162  interim final order issued under section 505G(b)(4) if shorter periods for requesting FDR are 
163  necessary to meet the 12-month timeline for completing a hearing.25 
164   
165  5.  May New Information or New Analyses of Previously Reviewed Data Be Included 
166  in a Request for FDR? 
167   
168  Because internal FDA review of a decision that has been appealed by an eligible requestor or 
169  sponsor should be based on the same information as was relied on to make the original decision 
170  (i.e., information already in the relevant administrative file, including public comments 
171  submitted during the public comment period for the proposed order), no new information 
 
22 See section 505G(b)(2)(A)(iv)(III) of the FD&C Act. 
 
23 See section 505G(b)(4)(D)(iii) of the FD&C Act. 
 
24 See section 505G(b)(4)(F)(i)(II) of the FD&C Act. 
 
25 See section 505G(b)(4)(F)(ii) of the FD&C Act. 
 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
172  should be submitted as part of a request for FDR.26 CDER regards new or updated analyses of 
173  previously reviewed data to be new information because the original deciding official might 
174  have made a different decision had he or she had the opportunity to review the new analyses. 
175   
176  6.  Is FDR and the Information Submitted to FDA in Connection with FDR 
177  Confidential? 
178   
179  Section 505G(d) of the FD&C Act addresses the confidentiality of information submitted to 
180  FDA in connection with proceedings on an order, including FDR under section 505G(b).27 The 
181  OTC monograph order processes under section 505G(b) of the FD&C Act are generally public 
182  processes.28 Except to the extent public disclosure of information submitted to FDA is 
183  prohibited, the Agency generally intends to make information submitted to FDA in the context of 
184  FDR, which may include a request for FDR or information submitted to FDA in support thereof, 
185  available to the public upon submission.29 
186   
187  Under section 505G(d)(2)(B), information submitted in connection with FDR will remain 
188  confidential if (1) the information pertains to pharmaceutical quality information, unless such 
189  information is necessary to establish standards under which a drug is GRASE, or (2) the 
190  information is of the type contained in raw datasets.30 
191   
 
26 If an eligible requestor or sponsor wants CDER to consider new information, including safety information, the 
new information should be submitted outside FDR. For example, new important safety information may be 
submitted as part of a Type X meeting submission, or new safety or efficacy data in support of a condition that FDA 
previously determined through a final order was non-GRASE may be submitted under an OMOR.   
 
27 Section 505G(d) consists of (1) a prohibition on FDA disclosure of certain information under section 505G(d)(1) 
without the requestors consent, subject to (2) requirements that FDA make certain information publicly available 
under section 505G(d)(2)(A)(i) and (ii), subject to (3) limitations on FDA disclosing certain such information as 
described in section 505G(d)(2)(B)(i)-(iv). 
 
28 In general, section 505G(b) of the FD&C Act describes processes to determine whether there are conditions under 
which a drug, in relevant part, is generally recognized as safe and effective under section 201(p)(1).  See section 
505G(b)(1). Under section 201(p)(1), a new drug, in relevant part, is a drug the composition of which is such that 
such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the 
safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or 
suggested in the labeling thereof. It is well-settled that general recogni[tion] of safety and effectiveness under 
section 201(p)(1) requires, among other things, the information demonstrating that a drug is safe and effective for its 
intended use to be published so that such information is generally available to qualified experts. See, for example, 
Weinberger v. Bentex Pharm., Inc., 412 U.S. 645, 652 (1973); Tri-Bio Labs., Inc. v. United States, 836 F.2d 135, 
142 (3d Cir. 1987); United States v. Articles of Drug . . . Promise Toothpaste, 826 F.2d 564, 572-73 (7th Cir. 1987) 
(citing United States v. An Article of Drug . . . 4,680 Pails, 725 F.2d 976, 987 (5th Cir. 1984)); United States v. 
Undetermined Quantities of . . . Equidantin Nitrofurantoin, 675 F.2d 994, 1000-01 (8th Cir. 1982); Premo Pharm. 
Labs., Inc. v. United States, 629 F.2d 795, 802-03 (2d Cir. 1980); United States v. An Article of Drug . . . Entrol-C 
Medicated, 513 F.2d 1127, 1128 (9th Cir. 1975); United States v. Hakim, 462 F. Supp. 3d 418, 431 (S.D.N.Y. 2020); 
United States v. Innovative BioDefense, Inc., 2019 WL 7195332 at *4 (C.D. Cal. Nov. 15, 2019). 
 
29 See section 505G(d)(2)(A)(i) and (ii).  
 
30 See section 505G(d)(2)(B)(i), (iv) of FD&C Act. 
 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
192  In addition, although certain information submitted in connection with FDR is to be made 
193  available to the public in accordance with section 505G(d) of the FD&C Act, any meeting held 
194  during FDR is not open to the public to attend, and only the eligible requestor or sponsor may be 
195  present at the meeting with FDA.31 
196   
197  B.  Procedures for Submitting a Request for FDR 
198   
199  1.  How to Request FDR 
200   
201  An eligible requestor or sponsor should submit a request for FDR as described in this section and 
202  section III. B .2., Content and Format of a Request for FDR. Before an eligible requestor or 
203  sponsor submits a request, FDA strongly encourages the eligible requestor or sponsor to contact 
204  CDER and provide advance notice of the intent to submit a request for FDR to ensure prompt 
205  handling and, if applicable, consolidation of FDR requests (see section V., Consolidated 
206  Proceedings).   
207   
208  The request for FDR should be submitted to FDA via the CDER NextGen Portal.32 An electronic 
209  copy of the request should also be submitted to the CDER Formal Dispute Resolution Project 
210  Manager (FDRPM).33 CDER encourages eligible requestors and sponsors to contact the FDRPM 
211  before submitting the request. 
212   
213  2.  Content and Format of a Request for FDR 
214   
215  A request for FDR should include information adequate to explain the nature of the scientific 
216  and/or medical dispute and to allow the deciding official to determine the necessary steps needed 
217  to resolve the matter. Each request should include the following: 
218   
219    Identification of the submission as FORMAL DISPUTE RESOLUTION REQUEST 
220  in bold, uppercase letters 
221   
222    The order identification (ID) number 
223   
224    The OTC monograph ID number and OTC monograph title, if applicable  
225   
226    The determination(s) in the final order that are the subject(s) of dispute, including the 
227  identification of specific OTC monograph provisions, if any, that are implicated 
 
31 21 CFR 10.65(c). 
 
32 CDERs NextGen Portal is available at 
https://edm.fda.gov/EDMIDPLogin/welcome?response_type=code&client_id=0oa1as7rb2poiYTch297&scope=ope
nid%20profile&state=876592757_1614020952133&redirect_uri=https%3A%2F%2Fedm.fda.gov%2Foidcclient%2
Fedmrp. 
 
33 The contact information can be found on the CDER Formal Dispute Resolution web page, available at 
https://www.fda.gov/about-fda/cder-contact-information/cder-formal-dispute-
resolution#:~:text=Formal%20Dispute%20Resolution%20(FDR)%20is,resolved%20at%20the%20division%20level
.  
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
228   
229    A brief but comprehensive statement of each issue to be resolved, including the 
230  following: 
231   
232    A description of the scientific and/or medical dispute to be resolved 
233   
234    A summary of relevant regulatory history, including any prior stage of FDR related to 
235  the same scientific and/or medical dispute, if applicable 
236   
237    A statement of the eligible requestors or sponsors proposed possible solutions 
238  and/or outcomes 
239   
240    A statement identifying the division and/or office that issued the final order and, if 
241  applicable, the deciding official on any prior stage of FDR related to the same scientific 
242  and/or medical dispute 
243   
244    A list of documents previously submitted as part of the eligible requestors or sponsors 
245  OMOR or public comments (including information and data) submitted during the public 
246  comment period for the proposed order that are deemed necessary for resolution of the 
247  matter, with reference to submission dates so the documents can be readily located 
248   
249    A statement that no new information has been submitted in support of the request for 
250  FDR and, if applicable, that the last deciding official received and had the opportunity to 
251  review all of the material now being relied upon for FDR 
252   
253    The name, title, and contact information (i.e., mailing address, email address, telephone 
254  number, fax number) for the eligible requestors or sponsors contact for the FDR 
255   
256  C.  FDA Action  
257   
258  The FDRPM functions as the administrative contact for all issues related to a request for FDR. 
259  The FDRPM is responsible for communicating and explaining to an eligible requestor or sponsor 
260  all regulatory processes related to FDR. FDA will conduct a preliminary review of the request to 
261  determine if it is timely and if the requestor or sponsor is eligible to request FDR. 
262   
263  1.  Letter Accepting or Not Accepting a Request for FDR  
264   
265  If the eligible requestors or sponsors request for FDR is accepted, the FDRPM will forward the 
266  appeal to the appropriate CDER management level, as established under the CDER chain of 
267  command. The FDRPM will also send the eligible requestor or sponsor an acknowledgment 
268  letter identifying the deciding official, the due date for response, and the date of any meeting, if 
269  applicable.  
270   
271  If a request for FDR is not accepted, the FDRPM will send the eligible requestor or sponsor a 
272  letter on behalf of the deciding official identifying the reasons the request was not accepted.  
273   
  8  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
274  2.  Responses to an Accepted Request for FDR  
275   
276  In general, the deciding official will send a written decision to an eligible requestor or sponsor 
277  that submits a request for FDR that is accepted for review. The written decision will grant or 
278  deny the appeal. If the deciding official does not agree with the eligible requestors or sponsors 
279  proposed outcome, he or she should provide the reasons for not agreeing with the eligible 
280  requestors or sponsors proposal and possibly suggest other options to achieve resolution and 
281  identify any actions that could be taken to address the concerns articulated by the deciding 
282  official. Before issuing a final decision, the deciding official may also provide an interim 
283  response (e.g., a request to clarify information in the request for FDR or a request for a meeting 
284  with the eligible requestor or sponsor) before making a decision on the appeal. The interim 
285  response should explain why an interim response is being issued instead of a final decision on 
286  the appeal. 
287   
288  3.  Timelines for Reviewing an Accepted Request for FDR 
289   
290  Consistent with the relevant timelines from the 2017 FDR guidance, the deciding official should 
291  complete his or her review and provide the eligible requestor or sponsor an interim response or a 
292  decision on the appeal within 30 calendar days from receipt of a request for FDR that has been 
293  accepted. The deciding official should respond to the eligible requestor or sponsor within the 30-
294  day window in writing or by telephone (i.e., 30-day response). If the response is by telephone, 
295  the deciding official should follow up with a written confirmation within 14 calendar days of the 
296  verbal response.  
297   
298  For the deciding official to reach a decision, there may be instances when he or she needs 
299  additional clarifying information34 or input from other persons knowledgeable about the 
300  specific matter in dispute or about the issue or area more generally. In such situations, the 
301  deciding official should issue the eligible requestor or sponsor an interim response identifying 
302  the additional information or input needed. The interim response should be made within 30 
303  calendar days of receipt of the appeal. 
304   
305    In instances when the deciding official needs clarifying information from the eligible 
306  requestor or sponsor, the deciding official should send the eligible requestor or 
307  sponsor a request for this information within 30 calendar days from receipt of the 
308  request for FDR. The deciding official should provide an interim response or a 
309  decision on the request within 30 calendar days from receipt of the clarifying 
310  information submitted by the eligible requestor or sponsor. 
311   
312    In instances when the deciding official decides a meeting with the eligible requestor or 
313  sponsor is needed before an interim response or decision can be issued, the deciding 
314  official should send the eligible requestor or sponsor a request for a meeting within 30 
 
34 Clarifying information does not include new information or reanalysis of data that have not been reviewed by the 
division and/or office. As stated previously, FDA considers new analyses of previously reviewed data to be new 
information because the original deciding official might have made a different decision had he or she had the 
opportunity to review the new analyses. 
 
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315  calendar days from receipt of the eligible requestors or sponsors request for FDR. 
316  CDER should schedule any meetings as quickly as the eligible requestor or sponsor and 
317  CDER are able to agree on a mutually acceptable date and time. After the meeting is 
318  held, the deciding official should provide an interim response or a decision on the request 
319  to the eligible requestor or sponsor within 30 calendar days from the meeting date. 
320   
321    In instances when the deciding official needs to discuss the request for FDR with 
322  internal or external experts, CDER should inform the eligible requestor or sponsor 
323  within 30 calendar days from receipt of the eligible requestors or sponsors request for 
324  FDR that the deciding official is seeking this additional input. CDER should schedule 
325  such discussions with internal or external experts as quickly as possible. After this 
326  discussion takes place, the deciding official should provide an interim response or a 
327  decision on the FDR to the eligible requestor or sponsor within 30 calendar days from 
328  the date of the discussion. 
329   
330  If the deciding official is unable to complete the review and provide either an interim response 
331  or a decision to the eligible requestor or sponsor within 30 calendar days, CDER should notify 
332  the eligible requestor or sponsor, explain the reasons for the delay, and provide the anticipated 
333  timeline for completing the review. In these cases, the performance goals outlined in the 
334  OMUFA commitment letter for the dispute response would not be met. 
335   
336  D.  Repeat Requests for FDR 
337   
338  If an eligible requestors or sponsors request for FDR is denied at one management level, the 
339  eligible requestor or sponsor can appeal the same matter to the next higher management level in 
340  the CDER chain of command up to the level of the Director of CDER.35 For each appeal, a new 
341  request for FDR should be submitted to the next management level and should follow the 
342  process and timelines provided in this guidance.  
343   
344   
345  IV.  ADMINISTRATIVE HEARING  
346   
347  Pursuant to section 505G of the FD&C Act, the hearing on a final order is held before a 
348  presiding officer designated by FDA.   
349   
350  Upon completion of FDR up to the Director of CDER, FDA will inform the eligible requestors 
351  and sponsors that participated in each stage of FDR of their right to request a hearing.36  
352   
 
35 See section 505G(b)(2)(A)(iv)(III) and section 505G(b)(4)(D)(iii) of the FD&C Act. 
 
36 See section 505G(b)(2)(A)(iv)(IV) of the FD&C Act. 
 
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353  A.  Considerations Before Submitting a Request for a Hearing 
354   
355  1.  Who Is Eligible to Request a Hearing? 
356   
357  Upon completion of FDR up to the level of the Director of CDER, an eligible requestor or 
358  sponsor that participated in each stage of FDR may request a hearing concerning a final order 
359  unless the final order relates to certain drugs as specified in section 505G(b)(3)(B) of the FD&C 
360  Act. 37,38 
361   
362  2.  Who Is Not Eligible to Request a Hearing? 
363   
364  A requestor or sponsor that did not participate in each stage of FDR may not request a hearing on 
365  a final order. 
366   
367  3.  When Will FDA Not Provide Notice and an Opportunity for a Hearing? 
368   
369  FDA will not provide notice and an opportunity for a hearing if (1) the final order involved 
370  relates to a drug that is described in section 505G(a)(3)(A) of the FD&C Act,39 which applies to 
371  certain drugs that are classified in category III for safety or effectiveness in the preamble of a 
372  proposed rule establishing a tentative final monograph that is the most recently applicable 
373  proposal or determination for such drug issued under 21 CFR part 330, and (2) no human or non-
374  human data studies40 relevant to the safety or effectiveness of such a drug have been submitted to 
375  the administrative record since the issuance of the most recent tentative final monograph relating 
376  to such a drug.41 
377   
378  4.  Is There a Specific Timeline to Request a Hearing? 
379   
380  The eligible requestor or sponsor must submit the request for a hearing not later than 30 calendar 
381  days after receiving notice of the final decision of the FDR procedure.42  
382   
 
37 See section 505G(b)(3)(A) of the FD&C Act. 
 
38 See section 505G(b)(4)(E) of the FD&C Act. 
 
39 See section 505G(b)(3)(B)(i)(I) of the FD&C Act. 
 
40 The term human data studies means clinical trials of safety or effectiveness (including actual use studies), 
pharmacokinetics studies, or bioavailability studies. See section 505G(b)(3)(B)(ii)(I) of FD&C Act. The term non-
human data means data from testing other than with human subjects which provides information concerning safety 
or effectiveness. See section 505G(b)(3)(B)(ii)(II) of the FD&C Act. 
 
41 See section 505G(b)(3)(B)(i)(II) of the FD&C Act. 
 
42 See section 505G(b)(3)(A) and section 505G(b)(3)(A) of the FD&C Act. 
 
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383  5.  Is There a Specific Timeline for When a Hearing Must Be Complete? 
384   
385  FDA must complete any hearings for a final order issued in an expedited procedure under section 
386  505G(b)(4)(F) of the FD&C Act not later than 12 months after the date on which the final order 
387  is issued.  
388   
389  6.  May New Information or New Analyses of Previously Reviewed Data Be Included 
390  in a Hearing Request? 
391   
392  The eligible requestor or sponsor must submit a request for a hearing that is based solely on 
393  information in the administrative record.43 Therefore, FDA will not consider new information or 
394  new analyses of previously reviewed data as evidence in a hearing. 
395   
396  7.  Is a Hearing and the Information Submitted in Connection with a Hearing 
397  Confidential? 
398   
399  Section 505G(d) of the FD&C Act addresses the confidentiality of information submitted to 
400  FDA in connection with proceedings on an order, including hearings under section 505G(b).44 
401  As noted above, the OTC monograph order processes under section 505G(b) of the FD&C Act 
402  are generally public processes.45 Except to the extent public disclosure of information submitted 
403  to FDA is prohibited, the Agency generally intends to make information submitted to FDA in the 
404  context of a hearing, which may include a request for a hearing or information submitted to FDA 
405  in support thereof, available to the public upon submission.46 
406   
407  Under section 505G(d)(2)(B), information submitted in connection with a hearing will remain 
408  confidential if (1) the information pertains to pharmaceutical quality information, unless such 
409  information is necessary to establish standards under which a drug is GRASE, or (2) the 
410  information is of the type contained in raw datasets.47 
411   
412  B.  Procedures for Submitting a Request for a Hearing 
413   
414  1.  How Does An Eligible Requestor or Sponsor Request a Hearing? 
415   
416  After FDA informs an eligible requestor or sponsor of their right to request a hearing, the eligible 
417  requestor or sponsor can submit a request for a hearing as described below. Before the eligible 
418  requestor or sponsor submits a request for a hearing, FDA strongly encourages the eligible 
419  requestor or sponsor to contact FDA and provide advance notice of the intent to submit a request 
 
43 See section 505G(b)(3)(A) of the FD&C Act. 
 
44 See supra note 27. 
 
45 See supra note 28. 
 
46 See section 505G(d)(2)(A)(i), (ii) of the FD&C Act. 
 
47 See section 505G(d)(2)(B)(i), (iv) of the FD&C Act. 
 
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420  for a hearing to ensure prompt handling and, if applicable, consolidation of the hearing (see 
421  section V., Consolidated Proceedings).   
422   
423  The request for a hearing should be submitted to the FDA via the CDER NextGen Portal. FDA 
424  encourages the eligible requestor or sponsor to contact the Office of New Drugs in CDER before 
425  submitting the request for a hearing. 
426   
427  2.  What Is the Content and Format of a Request for a Hearing? 
428   
429  The request for a hearing must be based solely on information in the administrative record.48   
430   
431  The request for a hearing should include the following: 
432   
433    Identification of the submission as OTC MONOGRAPH FINAL ORDER 
434  ADMINISTRATIVE HEARING REQUEST in bold, uppercase letters 
435   
436    The order ID number  
437   
438    The OTC monograph ID number and OTC monograph title, if applicable  
439   
440    The determination(s) in the final order that that are the subject(s) of dispute, including the 
441  identification of specific OTC monograph provisions, if any, that are implicated 
442   
443    A brief but comprehensive statement of each issue to be resolved, including the 
444  following: 
445   
446    A description of what the requestor or sponsor contends is a genuine and substantial 

447  question of material fact justifying a hearing 
448   
449    A list of references to information in the administrative record that supports the 

450  hearing request, including submission dates, so the documents can be readily located 
451   
452    A statement that no new information has been submitted in support of the request for a 
453  hearing  
454   
455    The name, title, and contact information (i.e., mailing address, email address, telephone 
456  number, fax number) for the eligible requestors or sponsors contact for the request for a 
457  hearing 
458   
 
48 See section 505G(b)(3)(A) of the FD&C Act. 
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459  C.  FDA Action in Response to Request for Hearing 
460   
461  FDA will conduct a preliminary review of a request for a hearing to determine if it is timely and 
462  if the requestor or sponsor is eligible to request a hearing.49 If the requestor or sponsor is eligible 
463  and the request is timely, then the request for a hearing will be accepted and the Office of 
464  Scientific Integrity (OSI) within the Office of the Chief Scientist will send the eligible requestor 
465  or sponsor an acknowledgment letter. If the request for a hearing is not accepted, OSI will send a 
466  letter identifying the reasons the request for a hearing was not accepted. 
467   
468  If the eligible requestors or sponsors request for a hearing is accepted, FDA will decide 
469  whether to grant or deny it. 
470   
471  FDA may deny a request for a hearing if the request does not identify the existence of a genuine 
472  and substantial question of material fact. In making such a determination, FDA may consider 
473  only information and data that are based on relevant and reliable scientific principles and 
474  methodologies.50 
475   
476  D.  Hearing Procedure 
477   
478  Section 505G of the FD&C Act provides further detail on the hearing procedures as described in 
479  this section. 
480   
481  A hearing for a final order under section 505G of the FD&C Act is not a formal evidentiary 
482  hearing.51 
483   
484  1.  Public Hearing 
485   
486  A hearing for a final order is generally public. 
487   
488  FDA expects rarely to close all or part of a hearing because the OTC monograph order processes 
489  under section 505G(b) of the FD&C Act are generally public processes and hearings are based 
490  solely on information in the administrative record. However, FDA may close all or part of the 
491  hearing to prevent the disclosure of information that FDA has held as confidential in the 
492  administrative record. 
493   
 
49 Ibid. 
 
50 See section 505G(b)(3)(C)(i) of the FD&C Act.  
 
51 See section 505G(p) of the FD&C Act (providing that the requirements of subchapter II of the Administrative 
Procedure Act, which include requirements relating to formal hearings, shall not apply with respect to orders issued 
under section 505G of the FD&C Act).  
 
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494  2.  Presiding Officer 
495   
496  If FDA grants a request for a hearing, a presiding officer will be appointed to conduct the 
497  hearing.52 The presiding officer will not be an employee of CDER or have been previously 
498  involved in the development of the administrative order at issue or proceedings relating to that 
499  administrative order.53 
500   
501  3.  Rights of Parties to Hearing 
502   
503  The parties to a hearing have the right to present testimony, including testimony of expert 
504  witnesses, and to cross-examine witnesses presented by other parties. When appropriate, the 
505  presiding officer may require that cross-examination by parties representing substantially the 
506  same interests be consolidated to promote efficiency and avoid duplication (see section V., 
507  Consolidated Proceedings).54 
508   
509  4.  Final Decision 
510   
511  At the conclusion of the hearing, the presiding officer for the hearing will issue a decision 
512  containing findings of fact and conclusions of law.55 The decision of the presiding officer will be 
513  final.56 
514   
515   
516  V.  CONSOLIDATED PROCEEDINGS 
517   
518  A.  Consolidation of Proceedings by FDA  
519   
520  1.  Proceedings FDA May Consolidate 
521   
522  If more than one request for FDR or a hearing is submitted with respect to the same final order, 
523  FDA may consolidate the requests and direct that a single proceeding be conducted for FDR or a 
524  hearing, as applicable.57  
525   
526  To promote efficiency and avoid duplication, generally, FDA expects that multiple requests for 
527  FDR or hearings with respect to the same final order and, especially, with respect to the same 
528  issue (e.g., a specific monograph condition) if multiple issues are being addressed under the 
529  same order, will be consolidated into a single proceeding.  
 
52 See section 505G(b)(3)(C)(iii) of the FD&C Act.  
 
53 See section 505G(b)(3)(C)(iii) of the FD&C Act. 
 
54 See section 505G(b)(3)(C)(iv) of the FD&C Act. 
 
55 See section 505G(b)(3)(C)(v)(I) of the FD&C Act. 
 
56 Ibid. 
 
57 See section 505G(b)(3)(C)(ii) and section 505G(l)(4) of the FD&C Act. 
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530   
531  Although all consolidated parties may participate in the FDR or hearing, the number of 
532  individuals from each party able to attend the consolidated proceedings in person may be limited 
533  because of facility and space limitations. FDA will determine the total number of individuals 
534  who can attend the consolidated proceedings in person. 
535   
536  2.  Notice of Consolidation 
537   
538  FDA will provide written notification to all eligible requestors or sponsors detailing (1) that the 
539  FDR or hearing will be consolidated into a single proceeding in which all parties may participate 
540  and (2) a listing of the consolidated eligible requestors or sponsors. 
541   
542  B.  Consolidation of Proceedings by Eligible Parties  
543   
544  1.  Joint Request for FDR or a Hearing 
545   
546  Eligible requestors or sponsors with respect to the same final order may submit a joint request for 
547  FDR or a hearing.  
548   
549  2.  Content and Format of Joint Request for FDR or a Hearing 
550   
551  In addition to the information that is to be submitted in a request for FDR (see section III. B. 2., 
552  Content and Format of a Request for FDR) or a hearing (see section IV. B. 3, What Is the 
553  Content and Format of a Request for a Hearing?), a joint request for FDR or a hearing should 
554  include the following information: 
555   
556    Identification of the submission as CONSOLIDATED OTC MONOGRAPH FINAL 
557  ORDER FORMAL DISPUTE RESOLUTION REQUEST or CONSOLIDATED 
558  OTC MONOGRAPH FINAL ORDER HEARING REQUEST in bold, uppercase 
559  letters 
560   
561    List of eligible sponsors or requestors submitting the joint request  
562   
563    The name of the point of contact as designated by the eligible requestors or sponsors 
564  submitting the joint request and appropriate documentation designating the point of 
565  contact 
566   
567  C.  Voluntary Termination of FDR and Hearing Process by Eligible Requestor 
568  or Sponsor in a Consolidated Proceeding 
569   
570  If an eligible requestor or sponsor participating in a consolidated proceeding no longer wants to 
571  continue with the FDR or hearing process, the eligible requestor or sponsor must submit notice to 
572  FDA to terminate their participation in the consolidated proceeding. Termination precludes the 
573  eligible requestor or sponsor from continuing in the FDR or hearing process; however, the FDR 
574  or hearing process may proceed with the other eligible requestors or sponsors.  
  16