ANDAs:  Pre-Submission of 
Facility Information Related to 
Prioritized Generic Drug 
Applications (Pre-Submission 
Facility Correspondence) 
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DRAFT GUIDANCE
 
 
  This guidance document is being distributed for comment purposes only.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 90 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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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 PFC-Inquiries@fda.hhs.gov.  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
November 2017 
Pharmaceutical Quality/CMC 
   
ANDAs:  Pre-Submission of 
Facility Information Related to 
Prioritized Generic Drug 
Applications (Pre-Submission 
Facility Correspondence)  
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  
http://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) 
 
November 2017 
Pharmaceutical Quality/CMC 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  SCOPE ............................................................................................................................... 3 
IV.  PRE-SUBMITTING FACILITY INFORMATION - CONTENTS............................. 4 
V.  ANDA SUBMISSION TIMING ...................................................................................... 7 
VI.  RECEIPT AND ASSESSMENT PROCESS FOR PRE-SUBMITTED FACILITY 
INFORMATION ............................................................................................................... 7 
A. Pre-Submitting Priority ANDA Sections Containing Facility Information through FDAs 
Electronic Submissions Gateway (ESG). ..................................................................................... 7 
B.  ANDA Submission .................................................................................................................... 8 
VII.  NOTIFICATIONS TO THE APPLICANT ................................................................... 9 
A. Pre-Submission Assessment:  Preliminary Assessment of ANDA Priority .......................... 9 
B. ANDA Review:  Determining Whether the ANDA Qualifies for the Priority 
Review Goal ................................................................................................................................... 10 
VIII.  QUESTIONS AND ANSWERS ..................................................................................... 10 
IX.  DEFINITIONS ................................................................................................................ 11 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  ANDAs:  Pre-Submission of Facility Information Related to 
2  Prioritized Generic Drug Applications (Pre-Submission Facility 
3  Correspondence) 
1,2
4  Guidance for Industry  
5   
6   
7  This revised 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  I.  INTRODUCTION   
15   
16  The Food and Drug Administration (FDA) is issuing this revised3 draft guidance to describe the 
17  process through which prospective generic drug applicants seeking a priority review goal4 
18  submit complete, accurate facility information in advance of submitting a priority original 
19  abbreviated new drug application (original ANDA), prior approval supplement (PAS), PAS 
20  amendment, or ANDA amendment (hereafter collectively referred to as ANDA).5 FDA is 
21  revising the draft guidance because, after issuance of the original draft guidance, section 
22  505(j)(11) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (U.S.C. 355(j)(11)) as 
23  added by section 801 of the FDA Reauthorization Act of 2017 (FDARA)6 resulted in changes to 
24  the pre-submission of facility information. Specifically, that provision requires the pre-
25  submission of relevant sections of the ANDA as determined by FDA.7 This permits FDA to 
26  utilize the existing process for submission of ANDAs (including electronic Common Technical 
                                                 
1 This guidance has been prepared by a multidisciplinary workgroup including members from the Office of 
Pharmaceutical Quality, the Office of Translational Sciences, the Office of Generic Drugs, and the Office of 
Business Informatics in the Center for Drug Evaluation and Research at the Food and Drug Administration, and in 
consultation with the Office of Regulatory Affairs, the Office of Combination Products, and the Center for Devices 
and Radiological Health. 
2 When final, this guidance will represent the FDAs current thinking on this topic. For the most recent version of a 
guidance, check the FDA Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.   
3 The first draft of this document, ANDAs: Pre-Submission Facility Correspondence Associated with Priority 
Submissions, was issued pursuant to 21 CFR 10.115 in June 2017. See Federal Register notice at 82 FR 28072. 
4 In this guidance, italicized text is used to denote terms that are defined in section IX, Definitions. 
5 In this guidance, the term "ANDA" collectively includes original ANDAs, PASs, PAS amendments, and ANDA 
amendments. The term "original ANDA" is used alone when referring exclusively to an original abbreviated new 
drug application. 
6 Public Law 115-52. 
7 Section 505(j)(11) also makes clear that the pre-submission of facility information is not the submission of an 
original ANDA under Section 505. That is important because the submission of an original ANDA is delayed by 
statute until 5 years after approval of the reference listed drug (or 4 years if there is a patent challenge) in certain 
circumstances, see Section 505(j)(5)(F)(ii), and the statute makes clear that the pre-submission can be submitted 
before the date that a full original ANDA can be submitted. 
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27  Document (eCTD) submission format) for the pre-submission of facility information and avoids 
28  the duplicative effort by applicants that would have been required if the relevant facility 
29  information had to be first submitted as identified in the original draft guidance and then 
30  resubmitted, in somewhat different form, in the ANDA itself. While this change will ultimately 
31  lead to greater efficiency for applicants and for FDA, it does require that FDA identify the 
32  relevant sections of the ANDA to be included in the pre-submission and clarify the process for 
33  submission of this information. FDA is doing so in this revised guidance. 
34   
35  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
36  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
37  as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
38  the word should in Agency guidances means that something is suggested or recommended, but 
39  not required.  
40   
41  II.  BACKGROUND   
42     
43  In 2016-2017, FDA, regulated industry, and public stakeholders conducted negotiations 
44  concerning reauthorization of the Generic Drug User Fee Amendments (GDUFA). A chief 
45  product of these congressionally-mandated discussions was the GDUFA Reauthorization 
46  Performance Goals and Program Enhancements, FYs 2018-2022 (GDUFA II Commitment 
47  Letter). 8 Together, the Generic Drug User Fee Amendments of 2017 and the GDUFA II 
48  Commitment Letter describe FDAs performance goals, as well as changes and improvements to 
49  the user fee program. The performance goals and program enhancements address aspects of the 
50  generic drug review program that are important for facilitating timely access to quality, 
51  affordable generic medicines. 
52   
53  On August 18, 2017, FDARA, which reauthorized GDUFA (Title III) and added other provisions 
54  related to generic drugs (Title VIII), was signed into law. In particular, section 801 of FDARA 
55  added section 505(j)(11) to the FD&C Act to address priority review of generic drugs.  
56    
57  One of the enhancements specified in both Title VIII, section 801 of FDARA and the GDUFA II 
58  Commitment Letter (hereafter collectively referred to as GDUFA II) is a mechanism to enable a 
59  shorter review goal (priority review goal) for certain priority original ANDAs, PASs, PAS 
60  amendments, and ANDA amendments, through the pre-submission of facility information, 
61  including sections of the ANDA determined to be relevant by FDA. Applicants submitting such 
62  priority ANDAs qualify for review with an 8-month goal date9 by pre-submitting complete, 
63  accurate information regarding facilities involved in manufacturing processes and testing of the 
                                                 
8 See GDUFA Reauthorization Performance Goals and Program Enhancements, FYs 2018-2022.  All public 
documents cited in this guidance may be found on the FDA web site (www.fda.gov).  
9 Section 801 of FDARA establishes an 8-month goal date for priority original ANDAs. However, the GDUFA II 
Commitment Letter includes a shorter review goal for priority ANDA amendments, PASs, and PAS amendments, 
when an inspection is not needed. See GDUFA Reauthorization Performance Goals and Program Enhancements, 
FYs 2018-2022 for further details. For the purposes of this guidance, priority review goal refers to all such goal 
dates. 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
64  drug that is the subject of the application,10 as outlined in this guidance, not later than 60 days 
65  prior to ANDA submission, giving FDA at least 60 days to determine whether inspection of a 
66  facility is necessary and, if so, begin inspection planning in advance of the ANDA receipt.11   
67   
68  FDA intends to consider an ANDA to be a priority ANDA if it meets the criteria listed in either 
69  section 505(j)(11)(A) of the FD&C Act, or the Center for Drug Evaluation and Researchs 
70  (CDERs) Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of 
71  Original ANDAs, Amendments, and Supplements (Prioritization MAPP).12  
72   
73  It is important to note that the pre-submitted facility information must be unchanged relative to 
74  the date of the ANDA submission to maintain eligibility for a priority review goal, with one 
75  exception:  Applicants may exclude a facility that was not used to generate data to meet any of 
76  the application requirements for the submission and that is not the only facility intended to 
77  conduct one or more unit operations in commercial production.13 This situation may occur when 
78  an applicant provides for the use of alternate manufacturing or testing facilities to perform 
79  redundant functions as compared to the primary facility. 
80   
81  Failure to follow the process for pre-submission of facility information described below will only 
82  impact whether an ANDA is eligible for the priority review goal. ANDAs that are not eligible 
83  for the priority review goal under GDUFA II may still be prioritized for review under the 
84  Prioritization MAPP, but the standard review goal14 will apply. Absent extraordinary 
85  circumstances, FDA does not expect to utilize its limited resources to review a second pre-
86  submission of facility information for an ANDA if the first pre-submission does not qualify the 
87  ANDA for priority designation.  
88   
89  III.  SCOPE 
90   
91  This guidance establishes FDAs expectations for the content, timing, and assessment of sections 
92  of the ANDA containing facility information submitted to the Agency not less than 60 days 
93  before the priority ANDA submission. Specifically, the guidance describes:   
                                                 
10 See section 505(j)(11)(B) of the FD&C Act, which states in part that ...the applicant shall provide complete, 
accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the 
subject of the application, including facilities in corresponding Type II active pharmaceutical ingredients drug 
master files referenced in an application and sites or organizations involved in bioequivalence and clinical studies 
used to support the application, to enable [FDA] to make a determination regarding whether an inspection of a 
facility is necessary.  
11 See section 505(j)(11) of the FD&C Act. 
12 Section 505(j)(11)(D) of the FD&C Act reaffirms FDAs authority to prioritize review of other applications as 
[FDA] deems appropriate. To make sure you have the most recent version of a MAPP, check the FDA/CDER 
MAPPs web page at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProc
edures/default.htm. 
13 See section 505(j)(11)(B) of the FD&C Act. 
14 For the purpose of this guidance, the standard review goal is the goal that otherwise will apply to a submission 
if it is not eligible for a priority review goal. 
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Draft  Not for Implementation 
94    The content and format of the facility information that should be submitted to enable 
95  FDAs assessment of facilities listed in the pre-submission. 
96    Timeframes for pre-submitting sections of the ANDA containing complete, accurate 
97  facility information, and the intersection of these timeframes with submission of the 
98  ANDA. 
99    The possible outcomes of the Agencys assessment of pre-submitted ANDA sections 
100  containing facility information. 
101    When and how the Agency notifies an applicant about the status of the pre-submitted 
102  ANDA sections containing facility information.   
103   
104  IV.       PRE-SUBMITTING FACILITY INFORMATION - CONTENTS 
105   
106  Pre-submitting sections of the ANDA containing facility information to the Agency ahead of 
107  ANDA submission provides the information FDA needs to conduct a meaningful assessment of 
108  the facilities involved in manufacturing processes and testing of the drug, including facilities in 
109  corresponding Type II active pharmaceutical ingredient drug master files referenced in the 
110  application, and sites or organizations involved in bioequivalence and clinical studies used to 
111  support the application to determine whether an inspection is necessary.15 Under GDUFA II, this 
112  complete, accurate facility information shall include the relevant (as determined by [FDA]) 
113  sections of the ANDA.16 These sections of the ANDA must be submitted in eCTD format.17 
114  The relevant sections as determined by FDA, along with the corresponding eCTD Module 
115  Number, are stated below18: 
116   
117   
118   
119   
120   
121   
122   
123   
124   
                                                 
15 See section 505(j)(11)(B) of the FD&C Act. 
16 See footnote 10. 
17 See the guidance for industry Providing Regulatory Submissions in Electronic Format  Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. See also the eCTD 
Technical Conformance Guide, at 
https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm5
35180.htm. 
18 Per normal submission practices, information for eCTD module 3.2.S may be incorporated through reference to a 
type II DMF, where a letter of authorization (LOA) has been submitted to the DMF by the DMF holder, and a copy 
of that LOA is included in eCTD module 1.4.2 of the ANDA. 
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eCTD 
Section  Description 
Number 
Form FDA 356h  the Form FDA 356h should be submitted with 
the pre-submission of facility information. Submitting the Form 
FDA 356h will enable the Agency to expedite processing of the 
pre-submission. Consider the following when submitting a Form 
FDA 356h associated with a pre-submission: 
  Field 21 Submission  this field accommodates selection of 
1.1   all of the choices that apply. For a Pre-Submission of facility 
information related to a priority ANDA, select Product 
Correspondence and Other. In the Other field, specify that 
this is a Pre-Submission of Facility Information Related to a 
Priority ANDA. 
  Field 22 Submission Sub-Type  for this field, select Pre-
submission. 
Cover Letter  the Cover Letter accompanying the pre-submission 
of facility information should include: 
  Statement of justification for expedited review request under 
1.2  the Prioritization MAPP19  
  Statement of inspection readiness 
  Statement identifying the Reference Listed Drug 
  Anticipated date of ANDA submission  
1.3.1.2  U.S. Agent Appointment Letter (if applicable) 
Statement of Right of Reference  this includes the DMF Right of 
1.4.2 
Reference Letter, if applicable 
Summary of Biopharmaceutic Studies and Associated Analytical 
2.7.1 
Methods (Tables 2 and 10)20 
3.2.S.1.1  Nomenclature  
3.2.S.1.2  Structure  
3.2.S.1.3  General Properties  
3.2.S.2.1  Manufacturer(s)  
3.2.S.2.2  Drug Substance Manufacturing Process Description 
3.2.S.2.3  Control of Materials 
3.2.S.2.4  Control of Critical Steps and Intermediates 
3.2.S.2.5  Process Validation / Evaluation 
3.2.S.2.6  Manufacturing Process Development 
3.2.S.4.1  Specification  
3.2.S.4.4  Batch Analyses 
                                                 
19 Applicants should include a statement in the cover letter describing the basis for their expedited review request 
under 505(j)(11)(A) or the Prioritization MAPP. For example, if the ANDA drug product is on FDAs drug shortage 
list, the applicant should include that information in the cover letter accompanying the submission. 
20 See Model Bioequivalence Data Summary Tables: Technical Specifications Document, at 
https://www.fda.gov/downloads/drugs/ucm120957.pdf.  
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eCTD 
Section  Description 
Number 
3.2.P.1  Description and Composition of the Drug Product 
Pharmaceutical Development - Manufacturing Process 
3.2.P.2.3 
Development  
3.2.P.3.1  Manufacturer(s)  
3.2.P.3.2  Batch Formula  
3.2.P.3.3  Description of Manufacturing Process and Process Controls  
Control of Critical Steps, and Intermediates  this section also 
3.2.P.3.4 
includes control of materials. 
Process Validation and/or Evaluation - any available process 
3.2.P.3.5  validation information at the time of the pre-submission of facility 
information.   
3.2.P.4.1  Specifications 
3.2.P.5.4  Batch Analyses 
Comparative Bioavailability and Bioequivalence Study Reports and 
related information.  Specifically: 
  Study Report (ICH E3, Section 1, Section 3 to 15)21 
  Protocol and Amendments (ICH E3 16.1.1) 
  List and Description of Investigators (ICH E3 16.1.4) 
5.3.1.2 
  Randomization Schemes (ICH E3 16.1.7) 
  Discontinued Subjects (ICH E3 16.2.1) 
  Protocol Deviations (ICH E3 16.2.2) 
  Subjects excluded from the statistical analysis (for example, 
adverse effects and serious adverse effects)  (ICH E3 16.2.3) 
In-Vitro  In-Vivo Correlation Study Reports and Related 
5.3.1.3 
Information 
Reports of Bioanalytical and Analytical Methods for all 
5.3.1.4 
bioequivalence studies 
125   
126  NOTE  For PASs and ANDA amendments, only the modules applicable to these types of 
127  submissions need to be submitted. 
128   
129  NOTE regarding combination products and non-drug constituent parts  If the product that is the 
130  subject of an ANDA is a combination product (as defined at 21 CFR 3.2),22 then facility 
131  information related to the manufacturing and testing of the non-drug constituent parts23 generally 
                                                 
21 The ICH guidance for industry E3 Structure and Content of Clinical Study Reports. 
22 As set forth in 21 CFR 3.2(e), a combination product is a product composed of any combination of a drug, device, 
or biological product with one another. 
23 See the guidance for industry Current Good Manufacturing Practice Requirements for Combination Products, 
section 2.C Overview of the Final Rule. This guidance explains how to demonstrate compliance with CGMP 
requirements for drug-device combination products as described in 21 CFR part 4. The rule allows manufacturers of 
drug-device combination products to implement a streamlined approach by demonstrating compliance with either 
the drug CGMPs (21 CFR parts 210 and 211) or the device Quality System (QS) regulation (21 CFR part 820), and 
 
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132  should be located in the same eCTD sections that would include information for the drug 
133  constituent part alone.24  
134   
135  V.  ANDA SUBMISSION TIMING 
136   
137  Under GDUFA II, in order for the ANDA to be eligible to receive the priority review goal, the 
138  facility information sections of a qualifying priority ANDA, described in section IV above, shall 
139  be submitted not later than 60 days prior to the submission of the ANDA itself. This timing 
140  allows the Agency to begin assessing the facility information before receiving the ANDA. To 
141  minimize the possibility of changes to facility information between the pre-submission of facility 
142  information and the ANDA (and consequently loss of the priority review goal), FDA encourages 
143  applicants to pre-submit the facility information no more than 90 days before submission of the 
144  ANDA.     
145   
146  VI.  RECEIPT AND ASSESSMENT PROCESS FOR PRE-SUBMITTED FACILITY 
147  INFORMATION 
148   
149  The following section describes the process for the receipt and assessment of the pre-submission 
150  of facility information related to a priority ANDA.   
151   
152  A.  Pre-Submitting Priority ANDA Sections Containing Facility Information 
153  through FDAs Electronic Submissions Gateway (ESG)   
154   
155  1.  Obtaining a Pre-Assigned ANDA Number (if applicable) 
156   
157  For original ANDAs, the applicant should request a pre-assigned ANDA 
158  number before pre-submitting the facility information. For PASs, PAS 
159  amendments, and original ANDA amendments, the applicant should use 
160  the relevant ANDA application number on the Form FDA 356h. 
161   
162  2.   Transmitting the Facility Information Pre-Submission through FDAs 
163  ESG 
164   
165  The pre-submission of ANDA sections containing facility information 
166  must be submitted electronically in eCTD format25 through the FDA ESG 
                                                                                                                                                             
also demonstrating compliance with specified provisions from the other of these two sets of CGMP requirements. If 
your non-drug constituent is a medical device, to inform FDAs facility assessment you should include in your 
submission summaries of basic Quality System procedures, including management review procedures (21 CFR 
820.20), design controls (21 CFR 820.30), purchasing controls (21 CFR 820.50), and corrective and preventive 
action procedures (21 CFR 820.100).  As applicable to the combination product, you also should include summary 
information on compliance with installation (21 CFR 820.170) and servicing (21 CFR 820.200) requirements.   
24 For additional information on how to incorporate information regarding non-drug constituent parts into the eCTD 
Sequence, please refer to the eCTD Technical Conformance Guide at 
https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm5
35180.htm. 
25 See footnote 17. 
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167  following the Agencys instructions.26 When transmitting the pre-
168  submission through the ESG, choose CDER when selecting the 
169  appropriate Center, and choose eCTD when selecting the submission 
170  type.   
171   
172  Following the pre-submission of the ANDA sections containing facility 
173  information, the applicant should submit the priority ANDA consistent 
174  with the ANDA Submission Timing described above in section V. If the 
175  applicant decides not to submit the ANDA, FDA should be notified in 
176  writing.  The notice of decision not to submit the ANDA should reference 
177  the submission number, and be submitted to eCTD Module 1.2.   
178     
179  3.  FDAs Assessment of the Pre-Submission 
180   
181  After receiving the pre-submitted sections of the ANDA containing 
182  facility information, the Agency will preliminarily assess whether the 
183  ANDA meets the priority designation criteria under section 505(j)(11)(A) 
184  of the FD&C Act or the Prioritization MAPP.27 FDA will communicate 
185  with the applicant as described in Section VII.A below. Note that this 
186  assessment of priority is preliminary. FDA will assess and make the 
187  official priority designation under section 505(j)(11)(A) of the FD&C Act 
188  and the Prioritization MAPP after the ANDA is submitted.   
189   
190  If upon assessment of the pre-submission, the ANDA preliminarily 
191  appears to meet the priority designation criteria, FDA will use the pre-
192  submitted facility information to begin the facility assessment process with 
193  the expectation that the ANDA will be submitted following the ANDA 
194  Submission Timing, described above in section V. 
195   
196  B.  ANDA Submission  
197   
198  In order for an ANDA to be eligible for a priority review goal, it must 1) be 
199  designated a priority as described in 505(j)(11)(A) of the FD&C Act or in the 
200  Prioritization MAPP; 2) be submitted no less than 60 days after the corresponding 
201  pre-submission; 3) have been the subject of a pre-submission of complete, 
202  accurate facility information; and 4) not contain any changes to the pre-submitted 
203  facility information.28   
204   
                                                 
26 See the Electronic Submissions Gateway web page at 
https://www.fda.gov/forIndustry/ElectronicSubmissionsGateway/default.htm for technical details related to 
submitting documents through FDAs Electronic Submission Gateway. 
27 Prioritization of review is determined per the criteria established in CDERs MAPP 5240.3, entitled Prioritization 
of the Review of Original ANDAs, Amendments, and Supplements. 
28 See footnote 1311.  
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205  The applicant should submit a signed certification statement (in eCTD Module 
206  1.2) stating either that the applicant has made no changes to the pre-submitted 
207  facility information, or that the only change made was to exclude a facility as 
208  described in 505(j)(11)(B) of the FD&C Act.29      
209   
210  Changes other than those permitted under 505(j)(11)(B) generally will result in 
211  assignment of the standard review goal. Such changes should be made by 
212  including the changed information in the appropriate eCTD module with the 
213  ANDA submission. Such changes should be identified in the cover letter. 
214   
215  FDAs review of the ANDA, which will include an official assessment and 
216  determination of whether the ANDA meets the priority designation criteria, will 
217  be performed in accordance with its established statutes, regulations, policies and 
218  procedures for ANDA reviews. The Agency will notify the applicant of the 
219  standard or priority designation and the assigned goal date in the ANDA 
220  acknowledgment letter.   
221   
222  VII.  NOTIFICATIONS TO THE APPLICANT 
223   
224  A.  Pre-Submission Assessment:  Preliminary Assessment of ANDA Priority  
225   
226  As part of its preliminary assessment of priority, as stated in section VI.A.3 above, if 
227  FDA determines that the drug product to be submitted for review in the ANDA is 
228  likely to meet the priority designation criteria in 505(j)(11)(A) of the FD&C Act or 
229  the Prioritization MAPP, the Agency will send a letter to: 
230   
231    Indicate that the ANDA appears, upon preliminary review, to meet the 
232  priority designation criteria and the pre-submitted facility information is 
233  eligible for further assessment;  
234    Inform the submitter that a goal date incorporating any priority designation 
235  determination will be provided after submission and receipt for review of the 
236  ANDA; and 
237    Remind the submitter that they must submit their ANDA no sooner than 60 
238  days after the date of submission of the pre-submitted facility information date 
239  in order to be eligible for the priority review goal. 
240   
241  If FDA preliminarily determines that the ANDA will not meet the priority 
242  designation criteria, the Agency will send a letter stating this. The letter will also 
243  state that the pre-submission is not eligible for further assessment.  
244   
                                                 
29 Section 505(j)(11)(B) of the FD&C Act states that the pre-submitted information shall be unchanged relative to 
the date of [ANDA submission], except to the extent that a change is made to such information to exclude a facility 
that was not used to generate data to meet any application requirements for such submission and that is not the only 
facility intended to conduct one or more unit operations in commercial production. 
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245  B.  ANDA Review:  Determining Whether the ANDA Qualifies for the Priority 
246  Review Goal 
247   
248  After receiving the ANDA, FDA will determine the applicable goal date for the 
249  submission. Establishing the applicable goal date for the ANDA is based on the 
250  Agencys priority designation determination at the time of ANDA submission, and 
251  assessment of whether the applicant submitted complete, accurate facility information 
252  that did not change relative to the date of ANDA submission.30 The Agency will 
253  convey the outcomes of this assessment and the resulting goal date in the ANDA 
254  acknowledgement letter or paragraph IV acknowledgement letter. Upon receiving the 
255  ANDA, if the Agency determines that the application does not meet FDAs priority 
256  designation criteria as defined in GDUFA II or the Prioritization MAPP, or if the pre-
257  submitted facility information is not found to be complete, accurate, and unchanged 
258  relative to the ANDA submission date, the ANDA will receive a standard goal date.    
259   
260  During the course of review of an ANDA granted a priority designation, if FDA 
261  determines that the applicant made changes to the pre-submitted facility information, 
262  the review goal will be converted to the standard review goal. The Agency will notify 
263  the applicant through FDA's current process for communicating goal date 
264  modifications.31 
265   
266  VIII.  QUESTIONS AND ANSWERS 
267   
268  A.  What types of submissions are addressed by this guidance? 
269   
270  This guidance applies to priority original ANDAs, PASs, PAS amendments, and 
271  original ANDA amendments.  
272   
273  B.  What is the purpose of the certification statement to which section VI refers? 
274     
275  The certification statement is the applicant's signed statement that the pre-submitted 
276  sections of the ANDA are unchanged as of the date of ANDA submission, or that the 
277  only change made was to exclude a facility as described in 505(j)(11)(B) of the 
278  FD&C Act, as is required by GDUFA II for priority review goal eligibility.32   
279   
280  Applicants including changes to the pre-submitted facility information in the ANDA 
281  other than changes permitted under 505(j)(11)(B) of the FD&C Act should omit the 
282  certification statement and identify such changes in the cover letter. 33 Such changes 
283  will generally result in assignment of the standard review goal.   
284   
                                                 
30 See footnote 13. 
31 See guidance for industry ANDA Submissions  Amendments and Easily Correctable Deficiencies under GDUFA. 
32 See footnote 13. 
33 FDA will determine whether a change made since the pre-submitted facility information (other than those allowed 
by section 505(j)(11)(B) of the FD&C Act) constitutes a change that impacts FDAs facility assessment. 
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285  C.  When the ANDA is submitted, should it include the facility information that was 
286  originally provided in the pre-submitted facility information? 
287   
288  No. The applicant should not re-submit the sections of the ANDA that were pre-
289  submitted as recommended in section IV of this guidance. However, if the pre-
290  submitted facility information has changed, the new information must be included in 
291  the ANDA34 and should be identified in the cover letter.   
292   
293  D.  Can an applicant pre-submit more of its ANDA than is recommended in this 
294  guidance? 
295   
296  No. The applicant should not pre-submit sections of their ANDA unless they are 
297  listed in Section IV of this guidance.  
298   
299  E.  Do the facilities need to be ready for inspection at the time of the pre-
300  submission?  
301   
302  Yes. Under the terms of the GDUFA II Commitment Letter, if a facility is not ready 
303  for inspection at the time of pre-submission, the ANDA may not receive the priority 
304  review goal. 
305   
306  F.  Is there a user fee payment required when pre-submitting facility information? 
307   
308  No. There are no user fees associated with the pre-submission of facility information.  
309  Application fees are paid at the time of the ANDA submission.35 
310   
311  IX.  DEFINITIONS 
312   
313  A.  Complete, Accurate Facility Information 
314  GDUFA II establishes that applicant shall provide complete, accurate information 
315  regarding facilities involved in manufacturing processes and testing of the drug that is 
316  the subject of the application, including facilities in corresponding Type II active 
317  pharmaceutical ingredients drug master files referenced in an application and sites or 
318  organizations involved in bioequivalence and clinical studies used to support the 
319  application.... Such information shall include the relevant (as determined by [FDA]) 
320  sections of such application. (Section 505(j)(11)(B) of the FD&C Act.)   
321   
322  B.  Facility 
323  For the purposes of this guidance, the term facility(ies) means manufacturing site 
324  and bioequivalence site.   
325   
326  Manufacturing site means all facilities involved in manufacturing processes, 
                                                 
34 21 CFR 314.50 and 21 CFR 314.94. 
35 See www.fda.gov - Generic Drug User Fee Cover Sheet and Payment Information. 
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327  packaging, and testing for the ANDA and corresponding Type II API DMF.36 For the 
328  purpose of this guidance, this term refers to any manufacturing, packaging or testing 
329  site associated with a planned ANDA that conducts an operation to support 
330  manufacturing or testing of the drug substance and/or product. This includes sites 
331  listed in Type II DMFs and sites that manufacture non-drug constituent parts of a 
332  combination product.  
333   
334  Bioequivalence site means all sites or organizations involved in bioequivalence and 
335  clinical [endpoint bioequivalence] studies used to support the ANDA submission.37   
336  For the purposes of this guidance, this term also captures sites that conduct analytical 
337  testing in support of the planned ANDA. 
338   
339  C.  Priority  
340  The term priority refers to ANDAs that meet the relevant criteria listed in section 
341  505(j)(11)(A) of the FD&C Act or submissions affirmatively identified as eligible for 
342  expedited review pursuant to CDERs Manual of Policy and Procedures (MAPP) 
343  5240.3, Prioritization of the Review of Original ANDAs, Amendments and 
344  Supplements, as revised (Prioritization MAPP).38   
345   
346  D.  Priority Review Goal  
347  The term priority review goal refers to the accelerated goal dates identified in 
348  GDUFA II for ANDAs that are designated priority by FDA and have submitted 
349  within the proper timeframe complete, accurate information regarding facilities that 
350  is unchanged relative to the date of subsequent ANDA submission.39 
351   
                                                 
36 21 CFR 314.50(d)(1)(i) and (iii). 
37 21 CFR 314.94(a)(7). See also 21 CFR 320.24(b). 
38 See footnote 27. 
39 Section 505(j)(11)(B) of the FD&C Act and Submission Review Performance Goals, GDUFA Reauthorization 
Performance Goals and Program Enhancements, FYs 2018-2022, section I.  
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