Requests for Reconsideration at the Division Level Under GDUFA

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Requests for
Reconsideration at the
Division Level Under
GDUFA
Guidance for Industry
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
October 2024
Generic Drugs

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., 4 th 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)
October 2024
Generic Drugs

Contains Nonbinding Recommendations
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. 	What are FDA’s Timelines for Responding to Requests for Reconsideration? ....................... 5
B. 	How Does an Applicant Submit a Request for Reconsideration? ............................................. 6
C. 	What is the Content and Format of a Request for Reconsideration? ....................................... 7
D. 	What are FDA’s Procedures for Reviewing and Responding to a Request for
Reconsideration? ............................................................................................................................ 8
V. 	FORMAL DISPUTE RESOLUTION ............................................................................. 9

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Requests for Reconsideration
at the Division Level Under GDUFA
Guidance for Industry1
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on
this topic. It does not establish any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the
title page.
I. 	INTRODUCTION
This guidance provides recommendations on the procedures for applicants of abbreviated new
drug applications (ANDAs) that wish to pursue a request for reconsideration within the review
discipline at the division level or original signatory authority. As described further below in
section III, requests within the scope of this guidance should concern certain actions that relate to
an ANDA and have scientific significance.2 During the assessment of an ANDA, FDA considers
important issues that are central to product evaluation. Sometimes, an applicant may disagree
with FDA, and because these disagreements often involve intricate matters, it is critical to have
procedures in place to ensure open and prompt consideration of an applicant’s concern(s). The
procedures and policies described in this guidance are intended to formalize FDA’s current and
historical practices and to continue to promote rapid and fair resolution of eligible requests
between an applicant and FDA.
This guidance is being issued to reflect the second reauthorization of the Generic Drug User Fee
Amendments (GDUFA III)3 and to clarify what matters are appropriate for requests for
reconsideration.
This guidance does not describe the formal dispute resolution procedures for resolving eligible
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 2023–2027” 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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reconsideration process at the division level.4 This guidance also does not describe the
procedures for resolving administrative matters, such as disputes regarding user fee
assessments.5
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II. 	BACKGROUND
The Generic Drug User Fee Amendments of 2012 (GDUFA I)6 amended the Federal Food,
Drug, and Cosmetic Act to authorize FDA to assess and collect user fees to provide the Agency
with resources to help ensure patients have access to quality, affordable, safe, and effective
generic drugs. GDUFA fee resources7 bring greater predictability and timeliness to the review
of generic drug applications. GDUFA has been reauthorized every 5 years to continue FDA’s
ability to assess and collect GDUFA fees, and this user fee program has been reauthorized two
times since GDUFA I, most recently in the Continuing Appropriations and Ukraine
Supplemental Appropriations Act, 2023 (for GDUFA III).8 As described in the GDUFA III
commitment letter applicable to this latest reauthorization,9 FDA has agreed to performance
goals and program enhancements regarding aspects of the generic drug assessment program that
build on previous authorizations of GDUFA. New enhancements to the program are designed to
maximize the efficiency and utility of each assessment cycle, with the intent of reducing the
number of assessment cycles for ANDAs and facilitating timely access to generic medicines for
American patients.
As described in the GDUFA III commitment letter applicable to this latest reauthorization, an
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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the Division level or original signatory authority, as needed.”10 The GDUFA III commitment
letter also states that the “Office of Generic Drugs, Office of Regulatory Operations Associate
Director will track each request for Division-level reconsideration through resolution.”11 At the
conclusion of a request for reconsideration, an applicant may pursue formal dispute resolution
above the division level.12
This guidance provides information for applicants to consider before pursuing a request for
reconsideration, on procedures for submitting a request for reconsideration, and on the Agency’s
process for responding to such a request.
III. 	CONSIDERATIONS FOR APPLICANTS BEFORE SUBMITTING A REQUEST
FOR RECONSIDERATION
A. 	What Is an Appropriate Matter for a Request for Reconsideration?
An FDA regulatory action that relates to an ANDA and has scientific significance is a matter that
could be handled appropriately through a request for reconsideration. Appropriate regulatory
actions13 for a request for reconsideration include, but are not limited to, the following:
• 	Refuse-to-receive decision
• 	Tentative approval letter
• 	Complete response letter (CRL)14
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 and 21 CFR 314.3(b)). See also 21 CFR
314.102. A CRL may contain additional or fewer deficiencies than FDA 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 communicate those 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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• 	FDA determination that a supplement-changes being effected or a supplement-changes
being effected in 30 days is a prior approval supplement (PAS)
• 	Classification of a major amendment to an ANDA or PAS15
• 	Classification of the standard assessment status of an ANDA, ANDA amendment, PAS,
or PAS amendment
• 	Denial of a reclassification of a facility-based major CRL amendment16
• 	Denial of a pre-ANDA meeting
B. 	When Is a Matter Not Appropriate for a Request for Reconsideration?
Advice communicated during meetings or teleconferences, in meeting minutes, and in other
correspondence (e.g., information requests, discipline review letters) is not a regulatory action
taken by FDA; therefore, such advice would not be an appropriate subject for a request for
reconsideration by an applicant.17 Matters not appropriate for a request for reconsideration by an
applicant include, but are not limited to, general advice letters and advice communicated during
meetings or in meeting minutes to discuss generic drug development before ANDA submission
(pre-ANDA meetings),18 including meetings for complex generic drug products as noted in the
GDUFA III commitment letter.19
Under GDUFA III, an applicant may request a post-CRL clarification teleconference concerning
deficiencies identified in a CRL.20 Additionally, applicants can request post-CRL scientific
meetings for FDA’s 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.1 through 6. 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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related to establishing equivalence.21 FDA encourages applicants to request meetings under
GDUFA III before submitting a request for reconsideration.
Agency communications, such as meeting minutes or other correspondence, typically include
recommendations or advice that generally convey FDA’s current thinking on a particular topic
raised by the applicant. However, applicants are not bound by such recommendations or advice.
Applicants can follow the advice from meeting minutes or other correspondence, or they can use
an alternative approach, if the approach satisfies the requirements of the applicable statutes and
regulations.
In addition, to further ensure efficient use of Agency resources, the applicant submitting a
request for reconsideration should not actively engage with other entities within FDA or pursue
other regulatory or legal pathways on the same matter at the same time because this will at best
lead to inefficiencies in Agency review and could impede FDA’s consideration of a request for
reconsideration. Such engagement with other entities may also result in a determination that the
applicant failed to exhaust administrative remedies.
C. 	Can the Applicant Submit New Information With a Request for
Reconsideration?
The applicant should not submit new information as part of a request for reconsideration because
FDA’s decision must be based on the same information that was used to make the original
decision (i.e., information already in the ANDA file).22 If the applicant wants FDA to consider
new information, the applicant should submit it as an amendment to the ANDA or PAS for
review by the division and the original signatory authority.23 FDA considers new analyses of
previously reviewed data submitted by the applicant to be new information, because the original
signatory authority might have made a different decision if given the opportunity to review the
new analyses.
IV. 	TIMELINES AND PROCEDURES FOR SUBMITTING AND RESPONDING TO
A REQUEST FOR RECONSIDERATION
A. 	What are FDA’s Timelines for Responding to Requests for Reconsideration?
As a general matter, FDA will review and respond to requests for reconsideration as
expeditiously as possible. However, as stated in the GDUFA III commitment letter, for requests
to “reclassify a Major Amendment or standard assessment status, FDA will schedule and conduct
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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date of FDA’s receipt of the request for a teleconference.”24 This 30-day goal only applies to a
request for reconsideration when the applicant accepts the first scheduled teleconference date
FDA offers,25 and the applicant submits the request for reconsideration within 7 calendar days
from the date of the regulatory action taken by FDA, as described below in section IV.B.
B. 	How Does an Applicant Submit a Request for Reconsideration?
The applicant should submit a request for reconsideration in the following manner:
• 	For requests for reconsideration of the denial of a pre-ANDA meeting, the applicant
should submit the request to the project manager identified in the communication for
which the reconsideration is being requested, and the applicant should email a copy to
ANDAReconsideration@fda.hhs.gov.
• 	For requests for reconsideration of a determination made by the Division of Filing
Review (e.g., refuse-to-receive decisions), the applicant should submit the request as a
separate amendment to the ANDA and clearly identify on the cover letter or checklist that
a request for reconsideration is included within the amendment submission,26 and the
applicant should email a copy to ANDAReconsideration@fda.hhs.gov and the Division
of Filing Review at DFRSupervisor@fda.hhs.gov.
• 	For all other requests for reconsideration, the applicant should submit the request as a
separate amendment to the ANDA and clearly identify on the cover letter or checklist that
a request for reconsideration is included within the amendment submission, and the
applicant should email a copy to ANDAReconsideration@fda.hhs.gov and to the project
manager identified in the communication for which the reconsideration is being
requested.
The applicant should submit the request for reconsideration within 7 calendar days from the date
of the regulatory action taken by FDA.27 For example:
• 	If an applicant would like to submit a request for reconsideration of a CRL, the applicant
should submit the request within 7 calendar days from FDA’s issuance of the CRL.
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 FDA’s regulatory action
and determine whether the applicant would like to pursue a request for reconsideration.

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• 	If an applicant would like to submit a request for reconsideration of the classification of
the deficiencies in the CRL as major, the applicant should submit the request within 7
calendar days from FDA’s CRL to receive a GDUFA III goal date for the request for
reconsideration.
• 	If an applicant would like to submit a request for reconsideration of the assessment
classification of a major amendment, the applicant should submit the request within 7
calendar days from FDA’s acknowledgment letter to receive a GDUFA III goal date for
the request for reconsideration.
• 	If an applicant would like to submit a request for reconsideration of the assessment
classification of a standard assessment status, the applicant should submit the request
within 7 calendar days from FDA’s acknowledgement letter to receive a GDUFA III goal
date for the request for reconsideration.
If the applicant does not submit the request for reconsideration of the assessment classification of
a major amendment or standard assessment status within 7 calendar days, FDA will respond as
expeditiously as possible, but the request for reconsideration will not receive a GDUFA III goal
date.
C. 	What is the Content and Format of a Request for Reconsideration?
To facilitate efficient review, any request for reconsideration should include adequate
information to explain the nature of the eligible request and to allow the signatory authority to
determine the appropriate steps to resolve the matter quickly and efficiently. If FDA determines
that the request does not contain the information specified in the bulleted list in this section, FDA
will not consider the request to be received for purposes of GDUFA III. The applicant should
submit each request as a separate amendment to the ANDA and include the following:
• 	Identification of the applicant’s submission as a request for reconsideration on Form FDA
356h (Application to Market a New or Abbreviated New Drug or Biologic for Human
Use) and on the cover letter
• 	Application number for the ANDA and, if applicable, the supplement number
• 	Established name of the drug product(s)
• 	Brief, but comprehensive, statement of each matter to be resolved, including the
following:
 Description of the eligible request to be resolved
 Summary of the relevant regulatory history
 Statement of the applicant’s proposed possible solutions or outcomes

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• 	Statement identifying the Office of Generic Drugs or Office of Pharmaceutical Quality
suboffice that issued the decision on the matter that is the subject of the request for
reconsideration
• 	Statement that the applicant is requesting discussion of the reclassification of a major
amendment or standard assessment status via a teleconference with FDA, if applicable28
 If the applicant is requesting discussion via a teleconference, the request should also
include a list of all individuals, with their titles and affiliations, who will participate in
the requested teleconference from the applicant’s organization, including consultants
and interpreters, if applicable.
• 	List of documents previously submitted to the ANDA that are deemed appropriate for
resolution of the matter, with reference to submission dates so the documents can be
readily located
• 	Statement that no new information has been submitted in support of the request for
reconsideration
D. 	What are FDA’s Procedures for Reviewing and Responding to a Request for
Reconsideration?
Depending on the eligible request that is the subject of the request for reconsideration, the
Division of Filing Review or the project manager will conduct a preliminary review of the
applicant’s request for reconsideration to evaluate whether the request satisfies the procedural
factors (as described in section IV.C) and can be accepted. If FDA accepts the applicant’s
request for reconsideration, the Division of Filing Review or the project manager will forward
the request to the signatory authority and send the applicant an acknowledgment letter
identifying the signatory authority, the GDUFA III goal date for a response to the request for
reconsideration (if applicable, as described in section IV.A), and the date of any teleconference
(if applicable, as described in section IV.C). If FDA does not accept a request for
reconsideration, the Division of Filing Review or the project manager will inform the applicant
on behalf of the signatory authority and state the reason(s) the request was not accepted.
The signatory authority or the signatory authority’s designee will send a written decision to an
applicant that submits a request for reconsideration that is accepted for review. The written
decision will grant or deny the request for reconsideration. If the signatory authority does not
agree with the applicant’s proposal for the reconsideration request, the signatory authority should
provide the reasons for not agreeing with the applicant’s proposal.
28 If the applicant is requesting reconsideration of a matter other than the classification of a major amendment or
standard assessment 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 its reasoning for the request, the teleconference is not an opportunity to seek a decision from FDA.

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V. 	FORMAL DISPUTE RESOLUTION
If the eligible request cannot be resolved through the request for reconsideration process at the
division level or original signatory authority, the applicant may pursue formal dispute resolution
above the division level (see the guidance for industry and review staff Formal Dispute
Resolution: Sponsor Appeals Above the Division Level).29
29 GDUFA III commitment letter at section II.E.3.