Requests for 
Reconsideration at the 
Division Level Under 
GDUFA 
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DRAFT GUIDANCE
 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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) Martha Nguyen at 240-695-3412. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
January 2024 
Generic Drugs 
 
Revision 1 
19503969dft.docx 
1/10/2024   
Requests for 
Reconsideration at the 
Division Level Under 
GDUFA 
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 (CDER) 
 
January 2024 
Generic Drugs 
 
Revision 1
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  CONSIDERATIONS FOR APPLICANTS BEFORE SUBMITTING A REQUEST 
FOR RECONSIDERATION ........................................................................................... 3 
A.  What Is an Appropriate Matter for a Request for Reconsideration? ....................................... 3 
B.  When Is a Matter Not Appropriate for a Request for Reconsideration? ................................. 4 
C.  Can the Applicant Submit New Information With a Request for Reconsideration? .............. 5 
IV.  TIMELINES AND PROCEDURES FOR SUBMITTING AND RESPONDING TO 
A REQUEST FOR RECONSIDERATION ................................................................... 5 
A.  Timelines for Responding to Requests for Reconsideration ...................................................... 5 
B.  How to Submit a Request for Reconsideration ........................................................................... 6 
C.  Content and Format of a Request for Reconsideration .............................................................. 7 
D.  FDAs Procedures for Reviewing and Responding to a Request for Reconsideration ............ 8 
V.  FORMAL DISPUTE RESOLUTION ............................................................................. 9 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Requests for Reconsideration  
2  at the Division Level Under GDUFA 
3  Guidance for Industry1 
4   
5   
6   
7  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
8  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
9  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
10  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
11  for this guidance as listed on the title page.   
12   
13   
14   
15  I.  INTRODUCTION 
16   
17  This guidance provides recommendations on the procedures for applicants of abbreviated new 
18  drug applications (ANDAs) that wish to pursue a request for reconsideration within the review 
19  discipline at the division level or original signatory authority. As described further below in 
20  section III, requests within the scope of this guidance document should concern certain actions 
21  that relate to an ANDA and have scientific significance.2 During the assessment of an ANDA, 
22  FDA considers important issues that are central to product evaluation.  Sometimes, an applicant 
23  may disagree with FDA, and because these disagreements often involve intricate matters, it is 
24  critical to have procedures in place to ensure open and prompt consideration of an applicants 
25  concern(s).  The procedures and policies described in this guidance are intended to formalize 
26  FDAs current and historical practices and to continue to promote rapid and fair resolution of 
27  eligible requests between an applicant and FDA.  
28   
29  This draft guidance revises the draft guidance of the same title issued in October 2017.  This 
30  revision is being issued to reflect the most recent reauthorization of the Generic Drug User Fee 
31  Amendments (GDUFA) in the Continuing Appropriations and Ukraine Supplemental 
32  Appropriations Act, 20233 and to clarify what matters are appropriate for requests for 
33  reconsideration. 
34   
35  This guidance does not describe the formal dispute resolution procedures for resolving eligible 
36  requests between FDA and sponsors or applicants that cannot be resolved through the request for 
 
1 This guidance has been prepared by the Office of Generic Drugs in the Center for Drug Evaluation and Research at 
the Food and Drug Administration. 
 
2 See section III. A of this guidance that discusses matters that are appropriate requests for reconsideration. See also 
the Generic Drug Use Fee Amendments (GDUFA) III commitment letter titled GDUFA Reauthorization 
Performance Goals and Program Enhancements Fiscal Years 20232027 available at 
https://www.fda.gov/media/153631/download (describing processes and goals for dispute resolution).  
 
3 See Title III of Division F (the FDA User Fee Reauthorization Act of 2022) of the Continuing Appropriations and 
Ukraine Supplemental Appropriations Act, 2023 (Public Law 117-180). 
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Draft  Not for Implementation 
37  reconsideration process at the division level.4  This guidance also does not describe the 
38  procedures for resolving administrative matters, such as disputes regarding user fee 
39  assessments.5  
40   
41  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
42  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
43  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
44  the word should in Agency guidances means that something is suggested or recommended, but 
45  not required.  
46   
47   
48  II.  BACKGROUND 
49   
50  The Generic Drug User Fee Amendments of 2012 (GDUFA I)6 amended the Federal Food, 
51  Drug, and Cosmetic Act to authorize FDA to assess and collect user fees to provide the Agency 
52  with resources to help ensure patients have access to quality, affordable, safe, and effective 
53  generic drugs.  GDUFA fee resources7 bring greater predictability and timeliness to the review 
54  of generic drug applications.  GDUFA has been reauthorized every 5 years to continue FDAs 
55  ability to assess and collect GDUFA fees, and this user fee program has been reauthorized two 
56  times since GDUFA I, most recently in the Continuing Appropriations and Ukraine 
57  Supplemental Appropriations Act, 2023 (for GDUFA III).8  As described in the GDUFA III 
58  commitment letter applicable to this latest reauthorization,9 FDA has agreed to performance 
59  goals and program enhancements regarding aspects of the generic drug assessment program that 
60  build on previous authorizations of GDUFA.  New enhancements to the program are designed to 
61  maximize the efficiency and utility of each assessment cycle, with the intent of reducing the 
62  number of assessment cycles for ANDAs and facilitating timely access to generic medicines for 
63  American patients.  
64   
65  As described in the GDUFA III commitment letter applicable to this latest reauthorization, an 
66  ANDA applicant may pursue a request for reconsideration within the assessment discipline at 
 
4 For information on the formal dispute resolution process, see the guidance for industry and review staff Formal 
Dispute Resolution:  Sponsor Appeals Above the Division Level (November 2017).  We update guidances 
periodically.  To make sure you have the most recent version of a guidance, check the FDA guidance web page at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents.    
 
5 For information about user fee assessments and the procedures to dispute such assessments, see the Generic Drug 
User Fee Amendments web page at https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-
amendments.  
 
6 Title III of the Food and Drug Administration Safety and Innovation Act, (Public Law 112-144) (21 U.S.C. 301). 
 
7 User fees are available for obligation in accordance with appropriations acts. 
 
8 See Title III of Division F (the FDA User Fee Reauthorization Act of 2022) of the Continuing Appropriations and 
Ukraine Supplemental Appropriations Act, 2023 (Public Law 117-180). 
 
9 See the GDUFA III commitment letter. 
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67  the Division level or original signatory authority, as needed.10  The GDUFA III commitment 
68  letter also states that the Office of Generic Drugs, Office of Regulatory Operations Associate 
69  Director will track each request for Division-level reconsideration through resolution.11  At the 
70  conclusion of a request for reconsideration, an applicant may pursue formal dispute resolution 
71  above the division level.12 
72   
73  This guidance provides information for applicants to consider before pursuing a request for 
74  reconsideration, procedures for submitting a request for reconsideration, and the Agencys 
75  process for responding to such a request. 
76   
77   
78  III.  CONSIDERATIONS FOR APPLICANTS BEFORE SUBMITTING A REQUEST 
79  FOR RECONSIDERATION 
80   
81  A.  What Is an Appropriate Matter for a Request for Reconsideration? 
82   
83  An FDA regulatory action that relates to an ANDA and has scientific significance is a matter that 
84  could be handled appropriately through a request for reconsideration.  Appropriate regulatory 
85  actions13 for a request for reconsideration include, but are not limited to the following: 
86   
87    Refuse-to-receive decision 
88   
89    Tentative approval letter 
90   
91    Complete response letter (CRL)14 
92   
 
10 Id. at section II.E.1.  For purposes of identifying the original signatory authority, any decision made on behalf of 
the division is deemed to be made by the Division Director of that division.  For example, if an acknowledgement 
letter is signed by a project manager in the Division of Project Management, then the original signatory authority is 
the Division Director of the Division of Project Management.   
 
11 Id. at section II.E.2. 
 
12 Id. at section II.E.3. 
 
13 FDA has determined that an applicant may pursue a request for reconsideration of an acknowledgement letter 
even though the Agency does not consider this to be a regulatory action. 
 
14 If FDA issues a CRL, the CRL will set forth the deficiencies that an applicant must satisfactorily address before 
the ANDA can be tentatively approved or approved (see 21 CFR 314.110; 21 CFR 314.3(b)).  See also 21 CFR 
314.102.  A CRL may contain additional or fewer deficiencies than were provided in previously issued discipline 
review letters (DRLs), depending on the final assessment of the ANDA.  If the Agency has communicated 
deficiencies to an applicant in a CRL, FDA will not rescind the CRL and instead communicate the deficiencies in an 
information request (IR) or DRL.  FDA does not consider IRs or DRLs to be CRLs because they do not represent a 
complete assessment of the entire application and therefore do not stop the assessment clock.  See the guidance for 
industry Information Requests and Discipline Review Letters Under GDUFA (October 2022) at 3. 
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Draft  Not for Implementation 
93    FDA determination that a supplement-changes being effected or a supplement-changes 
94  being effected in 30 days is a prior approval supplement (PAS) 
95   
96    Classification of a major amendment to an ANDA or PAS15 
97   
98    Classification of the standard assessment status of an ANDA, ANDA amendment, PAS, 
99  or PAS amendment 
100   
101    Denial of a reclassification of a facility-based major CRL amendment16 
102   
103    Denial of a pre-ANDA meeting  
104   
105  B.  When Is a Matter Not Appropriate for a Request for Reconsideration? 
106   
107  Advice communicated during meetings or teleconferences, in meeting minutes, and in other 
108  correspondence (e.g., information requests, discipline review letters) is not a regulatory action 
109  taken by FDA; therefore, such advice would not be an appropriate subject for a request for 
110  reconsideration by an applicant.17  Matters not appropriate for a request for reconsideration by an 
111  applicant include, but are not limited to, general advice letters and advice communicated during 
112  meetings or in meeting minutes to discuss generic drug development before ANDA submission 
113  (pre-ANDA meetings),18 including meetings for complex generic drug products as noted in the 
114  GDUFA III commitment letter.19  
115   
116  Under GDUFA III, an applicant may request a post-CRL clarification teleconference concerning 
117  deficiencies identified in a CRL.20  Additionally, applicants can request post-CRL scientific 
118  meetings for FDAs scientific advice on possible approaches to identified deficiencies in a CRL 
 
15 FDA agreed to certain assessment goals and procedures for requests for reclassification of a major amendment to 
an ANDA or a PAS as described in the GDUFA III commitment letter at section II.C.16.  These goals and 
procedures do not apply to a request for reclassification of a major amendment in response to a CRL that was 
deemed major only because of a facility deficiency, which is subject to the goals and procedures described in the 
GDUFA III commitment letter at section II.C.7.  
 
16 GDUFA III commitment letter at section II.C.7. 
 
17 See the guidance for industry and review staff Formal Dispute Resolution:  Sponsor Appeals Above the Division 
Level at 5.  
 
18 Ibid. 
 
19 See the guidance for industry Formal Meetings Between FDA and ANDA Applicants of Complex Products Under 
GDUFA (October 2022).  
 
20 GDUFA III commitment letter at section II.B.8.a.  See also the guidance for industry Post-Complete Response 
Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA (October 2022). 
 
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Draft  Not for Implementation 
119  related to establishing equivalence.21  FDA encourages applicants to request meetings under 
120  GDUFA III before submitting a request for reconsideration.  
121   
122  Agency communications, such as meeting minutes or other correspondence, typically include 
123  recommendations or advice that generally convey FDAs current thinking on a particular topic 
124  raised by the applicant.  However, applicants are not bound by such recommendations or advice.  
125  Applicants can follow the advice from meeting minutes or other correspondence, or they can use 
126  an alternative approach, if the approach satisfies the requirements of the applicable statutes and 
127  regulations.   
128   
129  In addition, to further ensure efficient use of Agency resources, the applicant submitting a 
130  request for reconsideration should not actively engage with other entities within FDA or pursue 
131  other regulatory or legal pathways on the same matter at the same time because this will at best 
132  lead to inefficiencies in Agency review and could impede FDAs consideration of a request for 
133  reconsideration.  Such engagement with other entities may also result in a determination that the 
134  applicant failed to exhaust administrative remedies.   
135   
136  C.  Can the Applicant Submit New Information With a Request for 
137  Reconsideration? 
138   
139  The applicant should not submit new information as part of a request for reconsideration because 
140  FDAs decision must be based on the same information that was used to make the original 
141  decision (i.e., information already in the ANDA file).22  If the applicant wants FDA to consider 
142  new information, the applicant should submit it as an amendment to the ANDA or PAS for 
143  review by the division and the original signatory authority.23  FDA considers new analyses of 
144  previously reviewed data submitted by the applicant to be new information, because the original 
145  signatory authority might have made a different decision if given the opportunity to review the 
146  new analyses.  
147   
148   
149  IV.  TIMELINES AND PROCEDURES FOR SUBMITTING AND RESPONDING TO 
150  A REQUEST FOR RECONSIDERATION 
151   
152  A.  Timelines for Responding to Requests for Reconsideration 
153   
154  As a general matter, FDA will review and respond to requests for reconsideration as 
155  expeditiously as possible.  However, as stated in the GDUFA III commitment letter, for requests 
156  to reclassify a Major Amendment or standard assessment status, FDA will schedule and conduct 
157  the teleconference and decide 90 percent of such reclassification requests within 30 days of the 
 
21 GDUFA III commitment letter at section II.B.8.c.  See also the guidance for industry Formal Meetings Between 
FDA and ANDA Applicants of Complex Products Under GDUFA. 
 
22 21 CFR 10.75(d). 
 
23 For a refuse-to-receive decision, the applicant should submit new information as part of the formal refuse-to-
receive response (ANDA resubmission) and remit any applicable user fees. 
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Draft  Not for Implementation 
158  date of FDAs receipt of the request for a teleconference.24  This 30-day goal only applies to a 
159  request for reconsideration when the applicant accepts the first scheduled teleconference date the 
160  FDA offers,25 and the applicant submits the request for reconsideration within 7 calendar days 
161  from the date of the regulatory action taken by FDA, as described below in section IV.B. 
162   
163  B.  How to Submit a Request for Reconsideration 
164   
165  The applicant should submit a request for reconsideration in the following manner: 
166   
167    For all requests for reconsideration, applicants should clearly identify on the cover letter 
168  or checklist that a request for reconsideration is included within the amendment 
169  submission; and a copy should be emailed to ANDAReconsideration@fda.hhs.gov.  
170   
171    For requests for reconsideration of the denial of a pre-ANDA meeting, the applicant 
172  should submit the request to the project manager identified in the communication for 
173  which the reconsideration is being requested, and a copy should be emailed to 
174  ANDAReconsideration@fda.hhs.gov.   
175   
176    For requests for reconsideration of a filing decision (e.g., refuse-to-receive decisions), the 
177  applicant should submit the request as a separate amendment to the ANDA;26 a copy 
178  should be emailed to ANDAReconsideration@fda.hhs.gov and the Division of Filing 
179  Review at DFRSupervisor@fda.hhs.gov.   
180   
181    For all other requests for reconsideration, the applicant should submit the request as a 
182  separate amendment to the ANDA; a copy should be emailed to 
183  ANDAReconsideration@fda.hhs.gov and to the project manager identified in the 
184  communication for which the reconsideration is being requested.   
185   
186   
187  The applicant should submit the request for reconsideration within 7 calendar days from the date 
188  of the regulatory action taken by FDA.27  For example: 
189   
190    If an applicant would like to submit a request for reconsideration of a CRL, the applicant 
191  should submit the request within 7 calendar days from FDAs issuance of the CRL.  
192   
 
24 GDUFA III commitment letter at section II.C.5.  
 
25 Ibid. 
 
26 For purposes of GDUFA III, a request for reconsideration will be received by the Agency when it is submitted to 
the ANDA (or to the project manager for denials of pre-ANDA meetings), Monday through Friday from 12:00 a.m. 
to 11:59 p.m. Eastern Standard Time/Eastern Daylight Savings Time, excluding Federal holidays and days when the 
FDA office reviewing the request is closed.  See the guidance for industry Providing Regulatory Submissions in 
Electronic Format  Receipt Dates (February 2014). 
 
27 The Agency believes that 7 calendar days provides an applicant sufficient time to review FDAs regulatory action 
and determine whether the applicant would like to pursue a request for reconsideration.   
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Draft  Not for Implementation 
193    If an applicant would like to submit a request for reconsideration of the assessment 
194  classification of a major amendment, the applicant should submit the request within 7 
195  calendar days from FDAs CRL to receive a GDUFA III goal date for the request for 
196  reconsideration.   
197   
198    If an applicant would like to submit a request for reconsideration of the assessment 
199  classification of a standard review status, the applicant should submit the request within 7 
200  calendar days from FDAs acknowledgement letter to receive a GDUFA III goal date for 
201  the request for reconsideration. 
202   
203  If the applicant does not submit the request for reconsideration of the CRL, assessment 
204  classification of a major amendment or standard review status within 7 calendar days, FDA will 
205  respond as expeditiously as possible, but the request for reconsideration will not receive a 
206  GDUFA III goal date.   
207   
208  C.  Content and Format of a Request for Reconsideration 
209   
210  To facilitate efficient review, any request for reconsideration should include adequate 
211  information to explain the nature of the eligible request and to allow the signatory authority to 
212  determine the appropriate steps to resolve the matter quickly and efficiently.  If FDA determines 
213  that the request does not contain the information specified in the bulleted list in this section, the 
214  request will not be considered to be received for purposes of GDUFA III.  The applicant should 
215  submit each request as a separate amendment to the ANDA and include the following: 
216   
217    Identification of the applicants submission as a request for reconsideration on the Form 
218  FDA 356h (Application to Market a New or Abbreviated New Drug or Biologic for 
219  Human Use) and cover letter 
220   
221    Application number for the ANDA and, if applicable, the supplement number 
222   
223    Established name of the drug product(s) 
224   
225    Brief, but comprehensive, statement of each matter to be resolved, including the 
226  following: 
227   
228    Description of the eligible request to be resolved 
229   
230    Summary of the relevant regulatory history 
231   
232    Statement of the applicants proposed possible solutions or outcomes 
233   
234    Statement identifying the Office of Generic Drugs or Office of Pharmaceutical Quality 
235  suboffice that issued the decision on the matter that is the subject of the request for 
236  reconsideration.  
237   
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238    Statement that the applicant is requesting discussion of the reclassification of a major 
239  amendment or standard assessment status via a teleconference with FDA, if applicable.28 
240   
241    If the applicant is requesting discussion via a teleconference, the request should also 
242  include a list of all individuals, with their titles and affiliations, who will participate in 
243  the requested teleconference from the applicants organization, including consults and 
244  interpreters, if applicable. 
245   
246    List of documents previously submitted to the ANDA that are deemed appropriate for 
247  resolution of the matter, with reference to submission dates so the documents may be 
248  readily located. 
249   
250    Statement that no new information has been submitted in support of the request for 
251  reconsideration.  
252   
253  D.  FDAs Procedures for Reviewing and Responding to a Request for 
254  Reconsideration   
255   
256  Depending on the eligible request that is the subject of the request for reconsideration, the 
257  Division of Filing Review or the project manager will conduct a preliminary review of the 
258  applicants request for reconsideration to evaluate whether the request satisfies the procedural 
259  factors (as described in section IV.C) and can be accepted.  If FDA accepts the applicants 
260  request for reconsideration, the Division of Filing Review or the project manager will forward 
261  the request to the signatory authority and send the applicant an acknowledgment letter 
262  identifying the signatory authority, the GDUFA III goal date for a response to the request for 
263  reconsideration (if applicable, as described in section IV.A.), and the date of any teleconference 
264  (if applicable, as described in section IV.C.).  If FDA does not accept a request for 
265  reconsideration, the Division of Filing Review or the project manager will inform the applicant 
266  on behalf of the signatory authority and state the reason(s) the request was not accepted.   
267   
268  The signatory authority or the signatory authoritys designee will send a written decision to an 
269  applicant that submits a request for reconsideration that is accepted for review.  The written 
270  decision will grant or deny the request for reconsideration.  If the signatory authority does not 
271  agree with the applicants proposal for the reconsideration request, the signatory authority should 
272  provide the reasons for not agreeing with the applicants proposal.    
273   
274   
 
28 If the applicant is requesting reconsideration of a matter other than the classification of a major amendment or 
standard review status and would like to request a teleconference, the applicant should include a statement 
requesting a teleconference.  FDA, at its discretion, will determine whether to grant the request for the 
teleconference.  Although the teleconference for a request for reconsideration is an opportunity for the applicant to 
explain their reasoning for the request, it is not an opportunity to seek a decision from FDA.  
 
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275  V.  FORMAL DISPUTE RESOLUTION 
276   
277  If the eligible request cannot be resolved through the request for reconsideration process at the 
278  division level or original signatory authority, the applicant may pursue formal dispute resolution 
279  above the division level (see the guidance for industry and review staff Formal Dispute 
280  Resolution: Sponsor Appeals Above the Division Level).   
  9