ANDA Submissions  
Prior Approval 
Supplements Under 
GDUFA 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
October 2022 
Generic Drugs 
 
Revision 2
   
ANDA Submissions  
Prior Approval 
Supplements 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 
and/or 
 
Office of Communication, Outreach, and Development 
Center for Biologics Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128  
Silver Spring, MD 20993-0002 
Phone:  800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-
guidances 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
October 2022 
Generic Drugs 
 Revision 2
      Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  IMPACT OF GDUFA PERFORMANCE GOALS ON PAS SUBMISSIONS ........... 2 
A.  Changes to an Approved Application .......................................................................................... 3 
B.  GDUFA Performance Goals for PAS Submissions ..................................................................... 4 
C.  Inspections for PAS Submissions ................................................................................................. 7 
D.  Submission of Supplements ........................................................................................................... 7 
E.  Other Matters ................................................................................................................................. 8 
1. Grouped Supplements ...................................................................................................................... 8 
2. Incorrect Reporting Category .......................................................................................................... 8 
3. Reconsideration of Incorrect Reporting Category Determination .................................................. 8 
APPENDIX A  SUPPLEMENTS FLOW CHART ................................................................ 10 
i  Contains Nonbinding Recommendations 
 
ANDA Submissions  Prior Approval Supplements  
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 is intended to assist applicants preparing to submit to FDA prior approval 
supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) 
under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
355(j)).  The guidance explains how the Generic Drug User Fee Amendments (GDUFA) relates 
to PAS submissions.  The guidance revises the guidance of the same title issued in October 2017. 
This revision is being issued to incorporate the performance goals currently outlined in the 
GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years [Fiscal 
Years [FYs]] 2023-2027 (GDUFA III commitment letter) that FDA has agreed to meet,2 and 
clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the 
performance goals in the GDUFA III commitment letter.   
 
Specifically, this guidance describes how the GDUFA performance goals apply to: 
  A PAS subject to the refuse-to-receive (RTR) standards 
  A PAS that requires an inspection3 
  A PAS for which an inspection is not required 
  An amendment to a PAS 
  Other PAS-related matters 
 
 
1 This guidance has been prepared by the Division of Policy Development in the Office of Generic Drug Policy in 
the Center for Drug Evaluation and Research at the Food and Drug Administration.  You may submit comments on 
this guidance at any time.  Submit comments to Docket No. FDA-2014-D-0901 (available at 
https://www.regulations.gov/docket/FDA-2014-D-0901).   
2 The performance goals were proposed jointly by FDA and representatives of the generic drug industry.  See the 
GDUFA I commitment letter, available at https://www.fda.gov/media/82022/download, the GDUFA II commitment 
letter, available at https://www.fda.gov/media/101052/download, and the GDUFA III commitment letter, available 
at https://www.fda.gov/media/153631/download. 
3 Section 704 of the FD&C Act (21 U.S.C. 374) authorizes FDA to conduct inspections. 
  1  Contains Nonbinding Recommendations 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys 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 guidance means that something is suggested or recommended, but 
not required.  
 
II.  BACKGROUND 
 
The Generic Drug User Fee Amendments of 2012 (GDUFA I)4 amended the FD&C Act to 
authorize FDA to assess and collect user fees to provide the Agency with resources5 to help 
ensure patients have access to quality, affordable, safe, and effective generic drugs.  GDUFA fee 
resources bring greater predictability and timeliness to the review of generic drug applications.     
GDUFA has been reauthorized every 5 years to continue FDAs ability to assess and collect 
GDUFA fees, and this user fee program has been reauthorized two times since GDUFA I, most 
recently in the FDA User Fee Reauthorization Act of 2022.  As described in the GDUFA III 
commitment letter applicable to this latest reauthorization 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. 
 
In the GDUFA III commitment letter, FDA committed to assess and act on a certain percentage 
of PASs within a specified period from the date of submission in FY 2023-2027.  The applicable 
assessment goal depends on whether assessment of a PAS requires an inspection. As reflected in 
the GDUFA III commitment letter, FDA also agreed to certain performance goals that are carried 
over from the GDUFA II commitment letter. 
 
GDUFA I established application fees (for ANDAs, PASs to ANDAs, and certain drug master 
files (DMFs)), annual facility fees, and a one-time fee for ANDAs that were pending on October 
1, 2012 (referred to as backlog applications).  As explained in the GDUFA II commitment 
letter, however, the Agency and industry agreed to the elimination of PAS fees.  As of October 1, 
2017, ANDA applicants are no longer required to pay application fees when they submit a PAS.  
Please note that Type II active pharmaceutical ingredient (API) DMF holders are still subject to a 
DMF fee the first time an initial letter of authorization references that DMF in an ANDA or 
PAS.6   
  
 
III.  IMPACT OF GDUFA PERFORMANCE GOALS ON PAS SUBMISSIONS      
 
FDA regulations lay out requirements for making and reporting changes to approved ANDAs 
(see 21 CFR 314.70).  Under the GDUFA III commitment letter, the generic drug industry and 
FDA have agreed to certain performance goals, including those applicable to PASs.  This section 
 
4 Title III of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144. 
5 User fees are available for obligation in accordance with appropriations acts. 
6 Procedures for ANDA and PAS submissions are set forth in FDAs regulations in part 314 (21 CFR part 314).  
  2  Contains Nonbinding Recommendations 
 
describes the specific performance goals that apply to PASs and amendments to PASs submitted 
to ANDAs.  
 
The GDUFA performance goals do not apply to new drug applications (NDAs) or biologics 
license applications (BLAs).  Nor do they apply to supplements filed for NDAs or BLAs, 
changes-being-effected (CBE) supplements and amendments to CBEs for ANDAs, or annual 
report filings to NDAs, BLAs, or ANDAs.  In this guidance, any reference to a PAS refers only 
to a PAS filed for an ANDA, unless clearly indicated otherwise. 
 
A.  Changes to an Approved Application 
 
Section 506A of the FD&C Act (which was added by section 116 of the Food and Drug 
Administration Modernization Act of 1997) provides requirements for making and reporting 
manufacturing changes to an approved application and for distributing a drug product made with 
such changes.7  The following sections of FDAs regulations set forth the requirements for 
supplements and other changes to approved applications under section 506A: 
   
   314.70 describes the different reporting categories for changes to an approved 
application.   
   314.71 outlines the procedures for submitting a supplement to an approved application.   
   314.97 provides that supplements and other changes to an approved ANDA must 
comply with the requirements of  314.70 and 314.71.      
 
Specifically, section 506A of the FD&C Act and  314.70 of FDA regulations provide for the 
following reporting categories of changes to an approved application: 
  
1.  Major Change:  a change that has a substantial potential to have an adverse effect on the 
identity, strength, quality, purity, or potency of a drug product as these factors may relate 
to the safety or effectiveness of the drug product.  A major change requires the 
submission of a PAS and approval by FDA before distribution of the drug product made 
using the change.8  
 
2.  Moderate Change:  a change that has a moderate potential to have an adverse effect on 
the identity, strength, quality, purity, or potency of a drug product as these factors may 
relate to the safety or effectiveness of the drug product.  Depending on the nature of the 
change, one of the following two types of supplements must be submitted to FDA for a 
moderate change: 
 
a.  Supplement  Changes Being Effected in 30 Days (CBE-30 supplement):  A 
CBE-30 supplement involves certain moderate changes that require the 
 
7 21 U.S.C. 356a.  
8  314.70(b). 
  3  Contains Nonbinding Recommendations 
 
submission of the supplement to FDA at least 30 days before the distribution of 
the drug product made using the change.9  
b.  Supplement  Changes Being Effected (CBE-0 supplement):  A CBE-0 
supplement involves certain moderate changes that allow distribution to occur as 
soon as FDA receives the supplement.10   
 
3.  Minor Change:  a change that has minimal potential to have an adverse effect on the 
identity, strength, quality, purity, or potency of a drug product as these factors may relate 
to the safety or effectiveness of the drug product.  The applicant must describe minor 
changes in its next annual report.11  
 
The criteria for submitting information as a PAS, as a CBE, or in an annual report were not 
changed by GDUFA.12  This guidance does not discuss the various criteria that apply in 
determining the respective reporting categories for these supplements.  For additional 
information on these reporting categories, refer to  314.70, as well as related guidances, 
including but not limited to the Scale-Up and Post-approval Changes (SUPAC) guidances and 
the Changes to an Approved NDA or ANDA guidance.  
 
Additionally, a comparability protocol submitted in a PAS to an ANDA for a specific drug 
product, once approved, may justify a reduced reporting category for the same change in 
subsequent supplements to that ANDA.  For further information on a comparability protocol 
submitted in a PAS, see the draft guidance for industry Comparability Protocols:  Chemistry, 
Manufacturing, and Controls Information.13  
 
 
B.  GDUFA Performance Goals for PAS Submissions 
 
 
The GDUFA II commitment letter outlined the performance goals FDA agreed to for assessing 
and acting on PASs submitted in FY 2018 through FY 202214 and delineated between standard 
and priority PASs for performance purposes.15  It further revised FDAs GDUFA performance 
 
9  314.70(c)(3). 
10  314.70(c)(6). 
11  314.70(d). 
12 In regard to submissions for modifications and revisions to approved risk evaluation and mitigation strategies 
(REMS), refer to the guidance for industry Risk Evaluation and Mitigation Strategies: Modifications and Revisions 
(June 2020).  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. 
13 When final, this guidance will represent the current thinking of FDA.    
14 The performance goals related to PASs and PAS Amendments appear on pages 66686-8 of the GDUFA II 
commitment letter. 
15 The GDUFA II and GDUFA III commitment letter define priority as submissions affirmatively identified as 
eligible for expedited review pursuant to CDERs Manual of Policy and Procedures (MAPP) 5240.3, Prioritization 
 
  4  Contains Nonbinding Recommendations 
 
goals for amendments, eliminating the Tier system.16  The performance goals for assessing and 
acting on PASs have not changed from the GDUFA II commitment letter to the GDUFA III 
commitment letter  Specifically, under the GDUFA III commitment letter, FDA agreed to the 
goals outlined as follows: 
 
Submission Type  Goal 
Standard PASs  90% assessed and acted on within 6 months of submission date if 
preapproval inspection not required. 
90% assessed and acted on within 10 months of submission date if 
preapproval inspection required. 
Priority PASs  90% assessed and acted on within 4 months of submission date if 
preapproval inspection not required. 
90% assessed and acted on within 8 months of submission date if 
preapproval inspection required and applicant meets requirements 
under section I(B)(2)(b) relating to submission of Pre-Submission 
Facility Correspondence (PFC).17 
90% within 10 months of submission date if preapproval inspection 
is required and applicant meets any limitations as described under 
section I(B)(2)(c) relating to submission of a PFC.18 
 
Submission Type  Goal 
Standard PAS Major  90% assessed and acted on within 6 months of submission date if 
Amendments  preapproval inspection not required. 
90% assessed and acted on within 10 months of submission date if 
preapproval inspection required. 
Priority PAS Major  90% assessed and acted on within 4 months of submission date if 
Amendments   preapproval inspection not required. 
90% assessed and acted on within 8 months of submission date if 
preapproval inspection required and applicant meets requirements 
under section I(B)(4)(b) relating to submission of a PFC. 
 
of the Review of Original ANDAs, Amendments and Supplements, as revised.  See page 27 of the GDUFA II 
commitment letter and page 47 of the GDUFA III commitment letter. 
16 For more detail on how FDA intends to classify major and minor amendments to original ANDAs and PASs 
under GDUFA, see the guidance for industry ANDA Submissions  Amendments to Abbreviated New Drug 
Applications Under GDUFA (July 2018).   
17 Under the GDUFA III commitment letter, the 8-month goal date is available to priority PASs requiring an 
inspection when the applicant submits a complete and accurate Pre-Submission Facility Correspondence (PFC) no 
later than 60 days prior to the date of the PAS submission and the PFC is found to be complete, accurate, and remain 
unchanged at the time of the PAS submission.  See page 8 of the GDUFA III commitment letter. 
18 Under the GDUFA III commitment letter, the 10-month goal date is available to priority PASs requiring an 
inspection when the applicant submits a PFC later than 60 days prior to the date of the PAS submission or does not 
submit a PFC, or when the PFC is found to be incomplete or inaccurate or the information submitted in the PFC 
differs significantly from the PAS submission.  See page 8 of the GDUFA III commitment letter. 
  5  Contains Nonbinding Recommendations 
 
90% within 10 months of submission date if preapproval inspection 
is required and applicant meets any limitations as described under 
section I(B)(4)(c) relating to submission of a PFC. 
Standard and Priority  90% within 3 months of submission date. 
Minor PAS 
Amendments 
 
GDUFA defines the date of submission as the date a generic drug submission (such as an 
ANDA, ANDA amendment, or ANDA prior approval supplement) or Type II API DMF arrives 
in the Electronics Submissions Gateway (ESG) of FDA.19  If a submission arrives in physical 
media form in eCTD format, it is deemed to be submitted on the day it arrives at FDAs 
appropriate designated document room.20  As described in the GDUFA III commitment letter, 
FDA will calculate the goal date from the day after a submission.21   
 
Filing an unsolicited amendment22 to a PAS may revise the existing goal date associated with 
that PAS.   FDA will assess and act on unsolicited PAS amendments submitted during the 
assessment cycle by the later of the goal date for the original PAS submission/solicited 
amendment or the goal date assigned in accordance with the above goals for standard and 
priority PAS amendments  FDA will assess and act on unsolicited PAS amendments submitted 
between assessment cycles during the next assessment cycle by the later of the goal date for the 
subsequent solicited amendments or the goal date assigned in accordance with the above goals 
for standard or priority PAS amendments.   
 
With limited exceptions, FDA strongly recommends that, at the time of submission, a 
supplement should be complete and ready for a comprehensive assessment.  Modifications to the 
supplement, in the form of an amendment, should be made only to clarify part of the already 
submitted supplement or to answer specific questions raised by the FDA assessment team.  FDA 
 
19 See 21 U.S.C. 379j-42(a)(6)(A);) 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 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 
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. 
20 21 USC 379j-42(a)(66)(B); see also guidance for industry Providing Regulatory Submissions in Electronic 
Format  Receipt Dates,  
21 GDUFA III commitment letter at 4. 
22 A solicited amendment is an amendment submitted in response to a complete response (CR) letter.  A CR letter 
refers to a written communication to an applicant or DMF holder from FDA, usually describing all the deficiencies 
the agency has identified in an ANDA (including pending amendments) or a DMF that must be satisfactorily 
addressed before the ANDA can be approved.  CR letters reflect a complete assessment and require a complete 
response from industry to restart the clock.  See the GDUFA III commitment letter at 45; see also  314.110.  An 
unsolicited amendment is an amendment with information not requested by the FDA except for those unsolicited 
amendments considered routine or administrative in nature that do not require scientific assessment.  GDUFA III 
commitment letter at 48. 
  6  Contains Nonbinding Recommendations 
 
does not recommend that modifications expand or broaden the scope of the already submitted 
supplement unless the Agency requested a modification to the PAS.23   
 
C.  Inspections for PAS Submissions 
 
As outlined above, the GDUFA goal date for a PAS depends on whether the PAS requires an 
inspection.  If a PAS does not require an inspection, the goal date is either 4 or 6 months from 
the date of submission; but if a PAS requires an inspection, the goal date is either 8 or 10 months 
from the date of submission.24 Establishments that are required to be registered under section 
510 of the FD&C Act (21 U.S.C. 360) and  207.20 of the FDA regulations (21 CFR 207.20) are 
subject to inspection to ensure they comply with current good manufacturing practice (CGMP) 
regulations.25  Determining whether an inspection is required for a PAS is within the discretion 
of FDA and depends on the nature of the supplement.  
 
Generally, we expect that any submitted PAS that requires an assessment of the need for an 
inspection, including, for example, a PAS involving a facility not approved in the original 
ANDA or involving a fundamental change in the manufacturing process or technology, will be 
treated initially as a PAS requiring an inspection and will be assigned an 8 or 10-month GDUFA 
goal date; however, the GDUFA goal date can be revised to 4 or 6 months if it is later 
determined that an actual inspection is not required for that PAS.26  Conversely, an initial goal 
date of 6 months occasionally may change to a 10-month goal date if, during the assessment, 
FDA determines an inspection is necessary.   
 
D.  Submission of Supplements27 
 
Any PAS to an approved ANDA should identify on the first page of the submission that it is a 
PAS.  To facilitate processing, FDA recommends that the applicant provide the following 
information on the first page of the submission: 
 
1.  A statement indicating whether the PAS is for a new-strength product 
2.  A statement indicating whether the PAS is for a request for proprietary name 
assessment 
3.  A statement indicating whether the PAS is for a Risk Evaluation and 
Mitigation Strategy (REMS) or a REMS modification 
 
23 See guidance for industry ANDA Submissions  Amendments to Abbreviated New Drug Applications Under 
GDUFA (July 2018) for more detail on how submission of amendments may affect an applications assessment goal 
dates.   
24 As explained in section III.B of this guidance, filing an amendment to a PAS may revise the goal date associated 
with that PAS. 
25 See section 510(h) of the FD&C Act; 21 CFR parts 210-216.  
26 Under the GDUFA III commitment letter, the 8-month goal date is available to priority PASs requiring an 
inspection when the applicant submits a complete and accurate Pre-Submission Facility Correspondence (PFC) no 
later than 60 days prior to the date of the PAS submission and the PFC is found to be complete, accurate, and remain 
unchanged at the time of the PAS submission.  See pages 7-8 of the GDUFA III commitment letter.  
27 See also FDAs draft guidance for industry, Cover Letter Attachments for Controlled Correspondences and ANDA 
Submissions (Dec. 2021).  When final, this guidance will represent the current thinking of FDA. 
  7  Contains Nonbinding Recommendations 
 
4.  A statement indicating whether the submission is an amendment to a PAS, 
and if so, whether it is a major or minor amendment 
5.  A statement indicating whether the PAS contains any manufacturing or 
facilities changes 
6.  A list of the specific assessment disciplines to assess the PAS (Chemistry, 
Biopharmaceutics, Labeling, DMF, Bioequivalence, Microbiology, or 
Clinical) 
7.  If expedited assessment is requested, the label Expedited Review Request 
should be placed prominently at the top of the submission.  The submission 
should include a basis for the expedited assessment request 
8.  If the submission is part of a grouped supplement (see section III.E.1 below), 
a statement identifying the additional submissions for the same/identical 
proposed change(s) should be added.  This request would greatly facilitate 
OPQs identification of grouped supplements). 
 
E.  Other Matters 
 
1.  Grouped Supplements 
  
Grouped supplements are multiple supplements submitted to ANDAs by a single applicant for 
the same chemistry, manufacturing, and controls (CMC) change to each application.  For further 
information on grouped supplements, refer to the Manual of Policies and Procedures 5015.6, 
Rev. 1, Review of Grouped Product Quality Supplements, or its latest revision.     
 
In addition to grouped supplements, there are alternative ways of submitting multiple PASs for 
the same change.  For example, for some changes (e.g., widening of an approved specification or 
introduction of a new API supplier), once a PAS is submitted and approved for the lead ANDA, 
subsequent supplements for the same change to other ANDAs may be classified as CBE-30s.  
The Agency recommends that applicants contact the appropriate assessment division beforehand 
to ensure the change is appropriate for a PAS followed by a CBE-30, or if there are specific 
questions regarding this alternative.  
 
2.  Incorrect Reporting Category 
 
If FDA finds that a supplement submitted as a CBE supplement should have been submitted as a 
PAS, it will notify the applicant.  The applicant is not required to withdraw the CBE supplement 
because when FDA sends a letter explaining that the applicants submission is not accepted as a 
CBE supplement, FDA administratively closes the CBE supplement, and it is considered 
withdrawn.  The applicant may resubmit the supplement as a PAS and the GDUFA performance 
goals will apply to that PAS.   
   
3.  Reconsideration of Incorrect Reporting Category Determination 
 
  8  Contains Nonbinding Recommendations 
 
An applicant may request reconsideration of FDAs supplement reporting category 
determination.28 If an applicant disagrees with the outcome of the reconsideration, the applicant 
may initiate a formal appeal.29  Any applicant seeking an appeal above the division level should 
first seek reconsideration at the division level (21 CFR 314.103).   
 
28 See FDAs draft guidance for industry, Requests for Reconsideration at the Division Level Under GDUFA (Oct. 
2017).  When final, this guidance will represent the current thinking of FDA. 
29 The process for appeals above the division level is outlined in the guidance for industry and assessment staff 
Formal Dispute Resolution: Sponsor Appeals Above the Division Level (November 2017).   
  9  Contains Nonbinding Recommendations 
 
APPENDIX A  SUPPLEMENTS FLOW CHART 
 
 
 
* Under the GDUFA III commitment letter, the 8-month goal is available to priority PASs and priority PAS major 
amendments when the applicant submits a complete and accurate PFC no later than 60 days prior to the date of the 
PAS or PAS major amendment submission and the PFC is found to be complete, accurate and remains unchanged 
at the time of the PAS or PAS major amendment submission.  Please see the draft guidance for industry ANDAs: 
Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission 
Facility Correspondence) (October 2022) for further information on PFC. 
 
If an amendment is filed to the supplement, it may change the goal date.  Please see the guidance 
for industry ANDA Submissions  Amendments to Abbreviated New Drug Applications Under 
GDUFA for further information.  In addition, the 10-month and 8-month goal dates can change 
to 6-month and 4-month goal dates, respectively, if an inspection is deemed unnecessary.  
  10  Contains Nonbinding Recommendations 
 
Similarly, 4-month and 6-month goal dates can change to 8-month and 10-month goal dates, 
respectively, if during the review, an inspection is ultimately deemed necessary.     
 
  11