Facility Readiness:  
Goal Date Decisions 
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DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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) Karen Takahashi at 301-796-3191 
or Karen.takahashi@fda.hhs.gov. 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
October 2022 
Generic Drugs 
48745147_FacilityReadiness.docx 
09/30/22  Facility Readiness:  
Goal Date Decisions 
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/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 2022 
Generic Drugs 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  FACILITY READINESS:  ASSESSMENT AND REPORTING ................................ 3 
A.  Applicant Assessment of Facility Readiness ................................................................................ 3 
B.  Reporting Facility Readiness on Form FDA 356h ...................................................................... 4 
IV.  GOAL DATE ASSIGNMENT ......................................................................................... 5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Facility Readiness:  Goal Date Decisions Under GDUFA 
2  Guidance for Industry1 
3   
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   
16  I.  INTRODUCTION  
17   
18  This guidance provides information to applicants on how FDA intends to assign a goal date 
19  based on a facilitys readiness for inspection as certified on Form FDA 356h2,3 submitted as part 
20  of an original abbreviated new drug application (ANDA)4 under section 505(j) of the Federal 
21  Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).  This guidance explains how 
22  FDA incorporates a program enhancement agreed upon by the Agency and industry as part of the 
23  negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA), as 
24  described in GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal 
25  Years 2023-2027 (GDUFA III commitment letter).5 
26   
27  Under the commitment letter related to the GDUFA authorization for fiscal years 2018 through 
28  2022 (under the Generic Drug User Fee Amendments of 2017),6 a goal date was assigned 
29  without regard to facility readiness.  In the GDUFA III commitment letter, FDA agreed to 
30  incorporate facility readiness into goal date assignment, such that FDA generally assigns a 
31  15-month goal date and defers substantive assessment if a facility is not ready for an inspection 
32  at the time of application submission.7,8  FDA may not be able to complete substantive 
33  assessment of an application unless all facilities are ready for inspection.  Therefore, this change 
 
1 This guidance has been prepared by the Office of Pharmaceutical Quality (OPQ) and the Office of Generic Drugs 
(OGD) in the Center for Drug Evaluation and Research at the Food and Drug Administration.  
2 Form FDA 356h, titled Application to Market a New or Abbreviated New Drug or Biologic for Human Use, is 
available at https://www.fda.gov/media/72649/download. 
3 Form FDA 356h fulfills the 21 CFR 314.94(a)(1) application form requirement.   
4 For the purposes of this guidance, the term original ANDA refers exclusively to the application assessed during the 
first review cycle, including an application resubmitted after a refuse-to-receive action. 
5 The GDUFA III commitment letter is available at https://www.fda.gov/media/153631/download. 
6 Title III of the FDA Reauthorization Act of 2017, Public Law 115-52. 
7 See section I.A.3. of the GDUFA III commitment letter. 
8 OPQ and OGD generally use the terms assessment and review interchangeably.  In this guidance, assessment 
means the process of both evaluating and analyzing submitted data and information to determine whether the 
application meets the requirements for approval and documenting that determination. 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
34  helps FDA to focus resources on substantially complete9 applications that contain facilities ready 
35  for inspection.  
36   
37  This guidance does not apply to: 
38   
39    Facilities involved in bioequivalence and clinical studies used to support an application 
40    Amendments submitted after a complete response or tentative approval letter 
41    Supplements or amendments to a supplement 
42   
43  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
44  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
45  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
46  the word should in Agency guidances means that something is suggested or recommended, but 
47  not required. 
48   
49   
50  II.  BACKGROUND 
51   
52  The Generic Drug User Fee Amendments of 2012 (GDUFA I)10 amended the FD&C Act to 
53  authorize FDA to assess and collect user fees to provide FDA with resources11 to help ensure 
54  patients have access to quality, affordable, safe, and effective generic drugs.  GDUFA fee 
55  resources bring greater predictability and timeliness to the review of generic drug applications.  
56  GDUFA has been reauthorized every 5 years to continue FDAs ability to assess and collect 
57  GDUFA fees, and this user fee program has been reauthorized two times since GDUFA I, most 
58  recently in the Generic Drug User Fee Amendments of 2022.12  As described in the GDUFA III 
59  commitment letter applicable to this latest reauthorization, FDA has agreed to performance goals 
60  and program enhancements regarding aspects of the generic drug assessment program that build 
61  on previous authorizations of GDUFA.  New enhancements to the program are designed to 
62  maximize the efficiency and utility of each assessment cycle, with the intent of reducing the 
63  number of assessment cycles for ANDAs and facilitating timely access to generic medicines for 
64  American patients.  
65   
 
9 An applications substantial completeness is evaluated consistent with 21 CFR 314.101; information on FDAs 
policies and procedures for conducting a filing review to determine if an ANDA is substantially complete is 
available in the Manual of Policies and Procedures (MAPP) 5200.14 Filing Review of Abbreviated New Drug 
Applications (available at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-
policies-procedures-mapp). 
10 Title III of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144. 
11 User fees are available for obligation in accordance with appropriations acts. 
12 Enacted as Title III of Division F (the FDA User Fee Reauthorization Act of 2022) of the Continuing 
Appropriations and Ukraine Supplemental Appropriations Act, 2023. 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
66  A number of GDUFA III commitments are intended to reduce first assessment cycle facility-
67  related delays that could delay application approval.  The commitment outlined in this guidance 
68  sets the goal date to 15 months for an original ANDA containing a certification that a facility on 
69  Form FDA 356h is not ready for inspection.  An applicant can amend its original ANDA to reset 
70  the 15-month goal date to a standard or priority assessment goal, as applicable,13 once all 
71  facilities become ready for inspection.  However, the commitment letter also explains that for an 
72  application that continues to include a facility not ready for inspection 30 days before the 15-
73  month goal date expiration, FDA will reset the goal date for an additional 15 months (i.e., 30 
74  months from the date of original ANDA submission).  FDA agreed to assess and act on 90 
75  percent of such ANDAs within 30 months of the date of the original submission as applicable.14  
76  Through the implementation of this commitment, FDA and industry aim to incentivize the 
77  submission of applications that include facilities ready for inspection to facilitate their timely 
78  assessment.  
79   
80   
81  III.  FACILITY READINESS:  ASSESSMENT AND REPORTING 
82   
83  Under the GDUFA III commitment letter, FDA uses a facilitys readiness for inspection 
84  designation in the Establishment Information section of Form FDA 356h to assign an 
85  applications goal date.  Applicants should examine the accuracy of the facility information they 
86  submit on Form FDA 356h. 
87   
88  A.  Applicant Assessment of Facility Readiness 
89   
90  Applicants should assess whether each facility is ready for inspection before checking the 
91  appropriate box on Form FDA 356h.  FDA considers a facility that is ready for inspection to be 
92  one that complies with current good manufacturing practice (CGMP) requirements15 and meets 
93  the following criteria related to the application product: 
94   
95    Facility operations, methods, and product formulation are the same as those described in 
96  the application  
97   
 
13 FDA considers an ANDA to be a priority ANDA if it meets the criteria listed in either section 505(j)(11) of the 
FD&C Act (which governs for ANDAs subject to that provision) or MAPP 5240.3 Rev. 5 Prioritization of the 
Review of Original ANDAs, Amendments, and Supplements.  Section 505(j)(11)(D) of the FD&C Act reaffirms 
FDAs authority to prioritiz[e] the review of other applications as [FDA] determines appropriate.  
14 GDUFA III commitment letter, section I.A.3.b., page 5 
15 For the purposes of this guidance, CGMP refers to the requirements in section 501(a)(2)(B) of the FD&C Act and 
21 CFR parts 4, 210, and 211, as applicable. 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
98    Data at the facility are complete and accurate, and are consistent with data in the 
99  application16  
100   
101    The facility is ready for commercial manufacturing17  
102   
103  To assess these criteria during an inspection, FDA uses Compliance Program (CP) 7346.832 
104  Preapproval Inspections.18  Applicants may also find the considerations in CP 7346.832 (Part 
105  III, section 1, NDA/ANDA Inspectional/Audit Coverage, Objectives, and Techniques) useful 
106  when assessing facility readiness.19  FDA provides additional facility readiness 
107  recommendations in the guidance for industry Good ANDA Submission Practices (January 
108  2022), section V.D., Facilities.   
109   
110  FDA has experienced cases where facilities were not aware they were listed on Form FDA 
111  356h.20  This often results in a greater likelihood that a facility will be unprepared for an 
112  inspection.  FDA recommends that applicants notify each facility that the facility is listed on the 
113  applicants Form FDA 356h and inform the facility whether the applicant has checked the yes 
114  or no box in the Establishment Information Field 28 of Form FDA 356h to identify the 
115  inspection readiness of each manufacturing or testing facility listed. 
116   
117  When signing Form FDA 356h, an applicant certifies that the information in the application is 
118  complete and accurate.  Inaccurate representation of facility readiness may cause a delay in or 
119  refusal to approve an application.21  
120   
121  B.  Reporting Facility Readiness on Form FDA 356h 
122   
123  Form FDA 356h should be used to convey application-related facility information for 
124  manufacturing, packaging, and control sites for drug substance and drug product facilities.22  
125  Applicants should check the yes or no box in the Is the site ready for inspection? section 
126  of Field 28 (Establishment Information) on Form FDA 356h to identify the inspection readiness 
127  for each manufacturing or testing facility listed, including any reference to a manufacturing or 
128  testing facility associated with a drug master file. 
 
16 See the guidance for industry Data Integrity and Compliance With Drug CGMP; Questions and Answers 
(December 2018).  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. 
17 FDA considers ready for commercial manufacturing to mean that the establishment has a quality system that is 
designed to achieve sufficient control over the facility and commercial manufacturing operations for the product, 
among other elements further described in FDA Compliance Program 7346.832 Preapproval Inspections. 
18 Drug Compliance Programs are available at https://www.fda.gov/drugs/guidance-compliance-regulatory-
information/drug-compliance-programs.  
19 FDA considers it a best practice for all manufacturing facilities listed in an application to be ready for inspection 
at the time of submission.  These considerations are useful when assessing facility readiness for a preapproval 
inspection. 
20 If a facility identified in an ANDA believes it was included in error and seeks to be removed from that ANDA, the 
facility should work with the ANDA applicant to be removed from the application.   
21 See section 505(j)(4)(A) and (K) of the FD&C Act; 21 CFR 314.127.   
22 For more information regarding which facilities should be listed on Form FDA 356h, see the guidance for industry 
Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER, Questions and 
Answers (October 2019). 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
129   
130  The Is the site ready for inspection section of Field 28 also includes an N/A box, but this box 
131  should not be checked for original ANDA submissions.  Applicants should check the N/A box 
132  when they withdraw a facility from the application.  FDA will not consider an applicants 
133  estimated date of readiness (noted in Field 28) when assigning a goal date.  
134   
135  If the boxes in Field 28 are blank or incorrectly marked N/A, both of which prevent a 
136  determination of facility readiness, FDA will seek clarification by issuing the applicant an 
137  information request (IR) letter.  FDA will assign the application a 15-month goal date by default 
138  if the applicant does not respond within the time frame prescribed in the IR letter.23 
139   
140   
141  IV.  GOAL DATE ASSIGNMENT 
142   
143  When an original ANDA is submitted with a completed Form FDA 356h, FDA reviews the 
144  submission for facility readiness information, receives the application if substantially complete,24 
145  assigns the appropriate goal date,25 and issues an acknowledgement letter.26   
146   
147  To implement the GDUFA III commitment,27 FDA modified its procedures to incorporate 
148  facility readiness in goal date assignment.  In cases when one or more facilities are not ready for 
149  inspection, FDA generally assigns a 15-month goal date and defers substantive assessment of the 
150  original ANDA and any unsolicited amendments until receipt of an amendment with an updated 
151  Form FDA 356h stating all facilities are ready for inspection.  
152   
153  Upon receipt of an amendment with Form FDA 356h certifying that all facilities are ready for 
154  inspection, FDA will reassign the appropriate standard or priority goal date (as applicable) 
155  calculated from the amendment receipt date.  To facilitate goal date reassignment, FDA 
 
23 The GDUFA III commitment letter provides for FDA to communicate minor technical deficiencies (e.g., 
document legibility) and deficiencies potentially resolved with information in the ANDA at original submission 
within 10 days of original ANDA submission.  If the applicant resolves those deficiencies within 10 days of such 
communication from FDA, those deficiencies will not be a basis for a refuse-to-receive decision under the terms of 
the commitment letter.  See GDUFA III commitment letter, section II.A.2., at page 12 
(https://www.fda.gov/media/153631/download). 
24 See 21 CFR 314.101(b)(2).  See also the guidance for industry Providing Regulatory Submissions in Electronic 
Format  Receipt Dates (February 2014).  These submissions are deemed to be submitted to FDA on the day when 
transmission to the Electronic Submissions Gateway (ESG) is completed, except when the submission arrives on a 
weekend, Federal holiday, or a day when the FDA office that will assess the submission is otherwise not open for 
business.  In that case, the submission is deemed to be submitted on the next day when that office is open for 
business.  Additional information concerning the FDA ESG is available at https://www.fda.gov/industry/electronic-
submissions-gateway. 
25 GDUFA III commitment letter, section I.A. 
26 See 21 CFR 314.101(b)(2).  FDA sends an ANDA acknowledgement letter when it has determined that the 
ANDA can be received for assessment. 
27 GDUFA III commitment letter, section I.A.3., page 5.   
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
156  recommends the applicant state in the cover letter Facility Ready For Inspection along with 
157  the ANDA number.28,29   
158   
159  If the applicant does not submit an amendment with Form FDA 356h certifying all facilities are 
160  ready for inspection by 30 days before the goal date, FDA resets the goal date for an additional 
161  15 months (i.e., 30 months from the date of original ANDA submission) and commences 
162  substantive assessment.  FDA agreed to assess and act on 90 percent of such ANDAs within 30 
163  months of the date of the original submission as applicable.30 
 
28 See the guidance for industry ANDA Submissions  Amendments to Abbreviated New Drug Applications Under 
GDUFA (July 2018) for additional recommendations on information to be included on the first page of the 
submission.  See also the draft guidance for industry Cover Letter Attachments for Controlled Correspondences and 
ANDA Submissions (December 2021) (when final, this guidance will represent the FDAs current thinking on this 
topic). 
29 The application goal date is reset based on the calendar day after FDA receives the amendment certifying that all 
facilities are ready for inspection.  
30 GDUFA III commitment letter, section I.A.3.b., page 5. 
  6