Providing Submissions in Electronic 
Format  Postmarketing Safety 
Reports for Vaccines 
 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional copies of this guidance are available from the Office of Communication, Outreach 
and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, 
MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, or 
from the Internet at 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida
nces/default.htm. 
 
For questions on the content of this guidance, contact OCOD at the phone numbers or email 
address listed above. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
August 2015 Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  GENERAL INFORMATION ABOUT VACCCINE ICSR SUBMISSIONS ............. 3 
A.  Parts of an ICSR Submission ............................................................................... 4 
B.  Options for Electronic Submission of an ICSR and ICSR Attachments into 
VAERS ................................................................................................................... 4 
C.  Technical Specifications for Electronic Submission of ICSRs for Vaccine 
Products ................................................................................................................. 4 
D.  Unique Case Identification Numbers for Initial and Follow-up ICSRs .......... 5 
E.  Sending in Submissions ........................................................................................ 5 
F.  Notification of Receipt of Submissions by the FDA ........................................... 5 
G.  Contingencies If the ESG Is Temporarily Unavailable ..................................... 6 
IV.  POSTMARKETING SAFETY REPORTS OTHER THAN ICSRS ........................... 7 
V.  WAIVER REQUESTS ..................................................................................................... 8 
A.  Content of Waiver Requests ................................................................................ 8 
B.  Where to Submit Waiver Requests ..................................................................... 8 
C.  FDA Response to Waiver Requests ..................................................................... 9 
 
 
 
 
 
The technical specification associated with this guidance is provided in a separate 
document and is updated periodically.  To ensure that you have the most recent version of 
the technical specifications document, check the CBER ICSR Specifications Web page at:  
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm174963.htm 
i  Contains Nonbinding Recommendations 
 
Providing Submissions in Electronic Format  Postmarketing 
Safety Reports for Vaccines 
__________________________________________________________ 
 
Guidance for Industry 
 
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 staff 
responsible for this guidance as listed on the title page. 
 
I.  INTRODUCTION 
 
This is one in a series of guidance documents intended to assist you, an applicant, in making 
postmarket regulatory submissions in electronic format to the Center for Biologics Evaluation 
and Research (CBER) at FDA.  The guidance provides information and recommendations 
pertaining to the electronic submission of postmarketing safety reports involving vaccine 
products, including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR 
attachments),1 into the Vaccine Adverse Event Reporting System (VAERS).  VAERS is a 
national vaccine safety surveillance program established in response to the National Childhood 
Vaccine Injury Act2 of 1986, which requires health professionals and vaccine manufacturers to 
report specific adverse events that occur after the administration of routinely recommended 
vaccines.  VAERS is co-sponsored by the Centers for Disease Control and Prevention (CDC) 
and FDA.  The guidance is applicable to vaccine products marketed for human use with 
approved biologics license applications (BLAs) for which CBER has regulatory responsibility.3  
The guidance does not apply to any other biologic product.   
 
This guidance finalizes the draft guidance of the same title, dated July 2014, and supersedes the 
FDA guidance entitled Guidance for Industry:  How to Complete the Vaccine Adverse Event 
Reporting System Form (VAERS-1), dated September 1998.   
 
Postmarketing ICSRs and ICSR attachments for biological products, which are not addressed by 
this guidance, are processed into the FDA Adverse Event Reporting System (FAERS) database.4  
                                                 
1 See section III of this document for a description of ICSRs and ICSR attachments. 
2 The National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) created the National Vaccine Injury 
Compensation Program (VICP).  The VICP was established to ensure an adequate supply of vaccines, stabilize 
vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by 
certain vaccines.   
3 If an applicant is not sure where to file, the applicant should contact CBERs OCOD for information. 
4 In September 2012, the FAERS database replaced the previously used Adverse Event Reporting System (AERS) 
database.  The transition to the FAERS database has been an important step in improving FDAs postmarketing 
surveillance capabilities.  Information regarding the FAERS database is available on FDAs Web site at: 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.ht
m.  
  1  Contains Nonbinding Recommendations 
 
For general information pertaining to electronic submission of postmarketing safety reports, 
including ICSRs and ICSR attachments for these other products, please refer to the FDA draft 
guidance entitled, Providing Submissions in Electronic Format  Postmarketing Safety Reports 
dated June 2014.5  Agency guidance on electronic submissions will be updated as necessary to 
reflect the evolving nature of the technology and the experience of those using this technology. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the FDAs 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 FDAs guidances means that something is suggested or 
recommended, but not required. 
 
 
II.  BACKGROUND 
 
In the Federal Register of June 10, 2014 (79 FR 33072), FDA published a final rule entitled 
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission 
Requirements.  This final rule requires, among other things, that certain postmarketing safety 
reports required under 21 CFR 310.305, 314.80, 314.98, and 600.80 ( 310.305, 314.80, 
314.98, and 600.80) and section 760 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 379aa) be submitted to FDA in an electronic format that the Agency can process, 
review, and archive.  This final rule also adds 21 CFR 329.100 ( 329.100) to address electronic 
submission of safety reports required by section 760 of the FD&C Act.  These requirements 
became effective as of June 10, 2015.6   
 
                                                 
5 The draft guidance is available at: 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072369.pdf.  
When finalized, this guidance will represent FDAs current thinking on this topic.  Further information regarding 
regulations and guidances related to postmarketing safety reporting can be found on the FDA Web site, 
Postmarketing Safety Reporting Requirements for Drug and Biologic Products, at: 
http://www.fda.gov/Drugs/DrugSafety/ucm299833.htm. 
6 Section 745A(a) of the FD&C Act (21 U.S.C. 379k-1), added by section 1136 of the Food and Drug 
Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), provides that submissions under section 
505(b), (i), or (j) of the FD&C Act or section 351(a) or (k) of the Public Health Service Act (42 U.S.C. 262(a) or 
(k)) shall be submitted in such electronic format as specified by FDA in guidance.  In section 745A(a), Congress 
granted explicit statutory authority to FDA to implement the electronic format for submissions requirement by 
guidance.  This grant of authority, however, does not preclude FDA from implementing such requirements by notice 
and comment rulemaking (5 U.S.C. 553).  Accordingly, at this time, even though FDA has concluded that certain 
submissions that are addressed in the final rule are also within the scope of section 745A(a), FDA has determined 
that it is appropriate to amend the regulations on the submission of postmarketing safety reports to remove 
references to paper submissions and to specify that such reports be submitted in an electronic format that FDA can 
process, review, and archive.  FDA may consider, at a future date, whether to include information pertaining to 
submission of postmarketing safety reports in electronic format in guidance pursuant to section 745A(a) of the 
FD&C Act. 
  2  Contains Nonbinding Recommendations 
 
III.  GENERAL INFORMATION ABOUT VACCCINE ICSR SUBMISSIONS  
 
For purposes of this guidance, an ICSR is a description of an adverse experience related to an 
individual patient or subject that is associated with the use of a vaccine product.  More 
specifically, an ICSR is made up of data elements, such as the date and time of the adverse 
experience, the name of the suspect vaccine and the name of the manufacturer of a vaccine 
administered in the 4 weeks prior to the vaccination at issue.  These data elements include those 
listed in the relevant regulations at  600.80, most notably  600.80(g), as well as VAERS form 
data elements used for reports collected from healthcare providers and patients.  You should 
submit ICSRs electronically in XML7 format in accordance with  the International Conference 
on Harmonisations (ICH) E2B(R3) specification8.  See section III.C of this guidance document 
for more information about this specification. 
 
ICSR attachments include supporting information for ICSRs, such as relevant hospital discharge 
summaries and autopsy reports or death certificates.  ICSR attachments also include published 
articles for ICSRs based on scientific literature ( 600.80(d)).  Please refer to the draft guidance 
entitled Postmarketing Safety Reporting for Human Drug and Biological Products Including 
Vaccines, dated March 2001 (2001 draft guidance)9 for more information concerning ICSR 
attachments.  Technical specifications related to the submission of ICSR attachments are 
published on the CBER ICSR Implementation webpage at:   
http://www.fda.gov/forindustry/electronicsubmissionsgateway/ucm387293.htm for more 
information about sending ICSR attachments. 
 
Follow-up ICSRs should provide a complete picture of the current understanding of an adverse 
experience, rather than providing only the changes and/or updates to an ICSR.  Accordingly, 
follow-up ICSRs should include information about an adverse experience that has been 
previously reported as an initial ICSR along with any new information, including any new ICSR 
attachments.  However, any ICSR attachments submitted with an initial ICSR (e.g., literature 
articles, hospital discharge summaries) should not be resubmitted with a follow-up ICSR.  See 
section III.D of this guidance document for information on using unique case identification 
numbers for the initial ICSR and follow-up ICSRs to help ensure linkage between the two.  
  
Information obtained from VAERS through CDCs website (i.e., public use dataset) or other 
sources should not be resubmitted to FDA.  Because VAERS is co-sponsored by FDA and CDC, 
applicants are not required to resubmit ICSRs for adverse event reports obtained from the 
VAERS database (i.e., adverse events reports obtained from VAERS data publically available on 
CDCs website or from publications based on VAERS data, or that were forwarded to the  
                                                 
7 For purposes of this guidance, the term XML refers to Extensible Markup Language. 
8 The ICH E2B(R3) ICSR specification and related files are available for download at:  
http://estri.ich.org/e2br3/index.htm. 
9 See the 2001 draft guidance, including section V.A.2: Supporting Documentation, section C.1: Content of Follow-
up Reports, section VI.A: Scientific Literature Reports, and Appendix B:  Report Checklist, Question A.7: Have 
you included all relevant attachments and eliminated unnecessary attachments?  The guidance is available at:  
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Va
ccines/ucm092257.pdf.  When finalized, this guidance will represent FDAs current thinking on this topic.   
  3  Contains Nonbinding Recommendations 
 
applicant by FDA or CDC), unless the applicant obtains additional follow-up information or 
corrections.  Please refer to the regional technical specifications document posted on the CBER 
ICSR Specifications Web page for more information about the resubmission of VAERS reports. 
 
The following sections provide general information related to the electronic submission of initial 
and follow-up ICSRs and ICSR attachments.  Note that regardless of the type of submission (i.e., 
those submitted as 15-day Alert reports or reports of adverse experiences that are both serious 
and expected or nonserious), the electronic submission procedure is the same. 
 
A.  Parts of an ICSR Submission 
 
For purposes of this discussion of electronic submissions, an initial or a follow-up ICSR 
submission is considered to have two parts: 
 
1.  The ICSR itself; and  
2.  The ICSR attachments, if applicable. 
 
B.  Options for Electronic Submission of an ICSR and ICSR Attachments into 
VAERS 
 
FDA provides two options for electronic submission of ICSRs and ICSR attachments 
involving vaccine products for processing into VAERS:  the direct database-to-database 
submission method and the eSubmitter tool method.  The direct database-to-database 
submission method is described on FDAs Electronic Submissions Gateway (ESG) Web 
page.10  Electronic submission of ICSRs for vaccine products using the FDA eSubmitter 
tool (data entry tool used to create ICSR files) is described on the CBER eSubmitter Web 
page.11  Both options involve use of XML files that are submitted to the FDA ESG.  The 
ESG is the central transmission point for sending information electronically to FDA.  
Once received through the ESG, the submitted reports are processed into the VAERS 
database. 
 
C.  Technical Specifications for Electronic Submission of ICSRs for Vaccine 
Products  
 
ICSRs and ICSR attachments must be submitted to FDA in an electronic format that we 
can process, review, and archive  600.80(h)(1).  For this purpose, CBER will provide 
associated technical specification documents that will give more information concerning 
how to create and submit FDA-compliant ICSRs on CBERs ICSR Specifications Web 
page. 
 
                                                 
10The FDA ESG Web page is available at: 
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm 
11 FDA eSubmitter Web page is available at: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm317156.htm. 
  4  Contains Nonbinding Recommendations 
 
D.  Unique Case Identification Numbers for Initial and Follow-up ICSRs 
 
Postmarketing safety reporting often involves submitting a series of reports consisting of 
the initial ICSR and follow-up ICSRs, along with any associated attachments, over the 
life cycle of an individual case.  It is important to note that the unique case identification 
number must be the same in the initial report and any subsequent follow-up report(s)  
( 600.80(g)(7)(viii)).12  Using a unique case identification number allows FDA to link 
the initial ICSR with any follow-up reports in the VAERS database, regardless of the 
time or method of transmission of an individual report.  For further information, see the 
section on identification numbers for initial and follow-up ICSRs in the ICH E2B(R3) 
technical specifications document on CBERs ICSR Specifications Web page.   
 
E.  Sending in Submissions 
 
Electronic ICSRs and ICSR attachments should be submitted to FDA through FDAs 
ESG, which is open 24 hours a day, 7 days a week.  ICSR attachments should be 
submitted to FDA at the same time that the associated ICSR file is submitted or as an 
attachment to a follow-up report.  Once received through the ESG, the ICSRs and ICSR 
attachments will be processed into VAERS. 
 
Before submitting an ICSR in electronic format to FDA for the first time, you should 
submit your request to CBER via email at CBERICSRSUBMISSIONS@fda.hhs.gov.  
The eVAERS Coordinator will assist you with submission of a test file.  For subsequent 
submissions in electronic format, it is not necessary to contact the VAERS Coordinator 
before submitting the ICSR.  For additional information on providing submissions using 
the ESG, refer to FDAs ESG Web page at: http://www.fda.gov/esg. 
 
F.  Notification of Receipt of Submissions by the FDA 
 
Once a submission (one or more ICSRs and ICSR attachments) reaches the ESG and is 
successfully recognized and decrypted, an ESG message delivery notice (MDN) will be 
sent to the sender.  The date of this ESG MDN will serve as the official FDA receipt date 
of each successfully transmitted ICSR and ICSR attachment in the submission.  See 
FDAs ESG Web page for further information about receipt of submissions through the 
ESG. 
 
After receipt of the submission, CBER will process the ICSRs and ICSR attachments and 
a second automated acknowledgement message (CBER receipt acknowledgment) will be 
sent to the sender via the ESG.  The CBER receipt acknowledgement will serve to inform 
the sender that the ICSR submission(s) have successfully reached CBER.  We expect that 
you will receive your ESG MDN and CBER receipt acknowledgement within 24 hours 
after you have submitted an ICSR, including any associated ICSR attachments to the 
ESG.  A third automated acknowledgment message (VAERS file validation and load 
acknowledgment) will be sent to the sender to provide file validation and load status for 
                                                 
12 Note that the unique case identification number replaces the Manufacturer Report Number on Form FDA 
3500A and the VAERS form.   
  5  Contains Nonbinding Recommendations 
 
each ICSR submission.  For additional information about VAERS acknowledgement 
message files and format, refer to the FDA regional technical specifications for ICH 
E2B(R3) implementation at CBERs ICSR Specifications Web page.    
 
ICSRs and associated ICSR attachments must be submitted to the Agency within the time 
periods specified in  600.80(c).  Please plan your submissions accordingly. 
 
Additional information on the receipt date of submissions is available in the FDA 
guidance entitled Guidance for Industry:  Providing Regulatory Submissions in 
Electronic Format  Receipt Dates dated February 2014.13   
 
G.  Contingencies If the ESG Is Temporarily Unavailable 
 
As stated previously, we expect that you will receive your ESG MDN and CBER receipt 
acknowledgement within 24 hours after you have submitted an ICSR or ICSR 
attachment(s) to the ESG.  If you do not receive these messages within 24 hours, we 
recommend that you first check the FDA ESG Web page to determine whether we are 
experiencing any problems with the ESG.  
 
  If the ESG is functional, and you have not received the CBER receipt 
acknowledgement within 24 hours after the end of the transmission, contact 
ESGHelpDesk@fda.hhs.gov for assistance.  Please be prepared to provide the 
Core ID, which is the ID assigned by the FDA ESG for submission tracking, as 
well as the company name on the account and the date and time the submission 
was sent. 
 
  If the ESG is not functional for more than 24 hours, FDA will post a notice on 
the FDA ESG Web page to provide further guidance concerning alternative 
submission methods.  If the ESG is not functional for more than 48 hours, the 
FDA ESG email distribution list (listserv) will be used to communicate 
procedures on how to proceed with your submission.  If you follow these 
procedures, it is important that you do not resubmit the ICSRs or ICSR 
attachment(s) to FDA using the ESG when it becomes functional.  Note that when 
you follow the alternate submission method, the official FDA receipt date of the 
ICSRs or ICSR attachment(s) will be the date when the submission is received by 
the CBER Document Control Room (DCC) or VAERS program (for example, if 
the submission is faxed, the receipt date will be the date on the timestamp of the 
successful fax). 
 
If you submit ICSRs or ICSR attachment(s) that we are unable to load into the VAERS 
database because you did not use the correct data elements or an electronic transport 
format that CBER supports, the third automated VAERS acknowledgement message will 
indicate that we could not load these ICSRs (or ICSR attachment(s)) into VAERS.  The 
acknowledgement also will indicate which, if any, ICSRs or ICSR attachment(s) that you 
                                                 
13 The guidance is available at: 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072385.pdf.   
  6  Contains Nonbinding Recommendations 
 
sent to the ESG at the same time were processed into VAERS.  You should resubmit to 
us only those ICSRs or ICSR attachment(s) that were not processed into VAERS.  Your 
resubmission should be given a different file name (batch identifier) than the original 
submission and should take place within the required reporting timeframe.  The date of 
the ESG MDN acknowledgement for the resubmission will serve as the official FDA 
receipt date of the ICSR or ICSR attachment(s). 
 
 
IV.  POSTMARKETING SAFETY REPORTS OTHER THAN ICSRs 
 
Under  600.80(c)(2), you must submit postmarketing periodic safety reports at prescribed 
intervals.  Among other things, each periodic safety report must contain a descriptive portion and 
the ICSRs for all adverse experiences other than those submitted as 15-day Alert reports or 
follow-up reports to 15-day Alert reports for the reporting period (i.e., reports of adverse 
experiences that are both serious and expected or nonserious).14  The descriptive portion can be 
submitted as a periodic adverse experience report,15 a periodic safety update report,16 or a 
periodic benefitrisk evaluation report.17   
 
For purposes of this discussion of electronic submissions, a postmarketing periodic safety report 
( 600.80(c)(2)) is considered to have three parts: 
 
1.  Descriptive information; 
2.  ICSR(s); and 
3.  ICSR attachment(s), if applicable. 
 
Submission of ICSR(s) and ICSR attachment(s) are addressed in section III of this guidance 
document.  The descriptive information portion of the periodic safety report required under  
600.80(c)(2)(ii)(A) should be submitted separately as a portable document file (PDF) to section 
5.3.6 of the Electronic Common Technical Document (eCTD).18  Firms should not submit non-
expedited ICSRs to the eCTD in a PDF format together with the descriptive portion of the 
periodic safety report.   
 
                                                 
14 As described in  600.80(c)(2)(ii)(B).  Non-expedited ICSRs were previously referred to as periodic ICSRs.   
15 As described in  600.80.  
16 FDA allows firms with approved waivers (see  600.90) to use the ICH E2C Periodic Safety Update Report 
format when submitting the descriptive portion of periodic safety reports.  See the 2001 draft guidance, including 
section XI concerning waiver requests.  When finalized, this guidance will represent FDAs current thinking on this 
topic. 
17 FDA allows firms with approved waivers (see  600.90) to use the ICH E2C(R2) Periodic Benefit-Risk 
Evaluation Report format when submitting the descriptive portion of periodic safety reports.  See the guidance 
document entitled Guidance for Industry:  Providing Submissions in Electronic Format  Postmarket Non-
Expedited ICSRs Technical Questions and Answers dated July 2013.  The guidance is available at: 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM362174.pdf. 
18 Information regarding the eCTD is available at: 
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ 
ucm153574.htm.  
  7  Contains Nonbinding Recommendations 
 
V.  WAIVER REQUESTS 
 
Under  600.90, an applicant required to submit a postmarketing safety report under  600.80 
may ask FDA to waive temporarily the requirement that the safety report be submitted in 
electronic format.  We anticipate that temporary waivers for licensed vaccine products regulated 
by CBER will be needed only in rare circumstances.  Companies experiencing technical 
difficulties with transmission of their electronic submissions to FDA should consult FDA for 
technical assistance rather than submitting a waiver request.  Companies that normally use the 
direct database-to-database method to submit reports to FDA could use the eSubmitter tool we 
have made available as a backup method during short-term, temporary outages.    
 
A.  Content of Waiver Requests 
 
An applicants request to waive the electronic format requirement must include one of the 
following as supporting documentation:  An explanation why the applicants compliance 
with the requirement is unnecessary or cannot be achieved (e.g., acts of nature, 
widespread internet outages, temporary issues with the applicants adverse event 
database(s)); a description of an alternative submission that satisfies the purpose of the 
requirement; or other information justifying a waiver ( 600.90(a)). 
 
We recommend that this request be submitted to FDA in writing by mail.  The request 
should reference all vaccines that are to be covered by the waiver.  If not already 
provided as justification for the waiver for purposes of meeting the requirements under  
600.90(a), we recommend that the waiver request include the reason for the request (i.e., 
information justifying the waiver).  Reasons could include, for example, acts of nature, 
widespread internet outages, and temporary issues with an applicants adverse event 
database(s).  The waiver request also should include a proposed end date for the waiver 
and steps being taken to meet the reporting requirements, such as additional training or 
system testing, and a company contact.  The waiver request also should include a 
proposed end date for the waiver and a description of any proposed alternative reporting 
method, as relevant to the circumstances.  Potential alternative reporting methods could 
include (but are not limited to) physical media and fax.  The waiver request should be 
clearly titled WAIVER REQUEST  POSTMARKETING SAFETY 
REQUIREMENTS in bold capital letters at the top of the first page of the submission..   
 
B.  Where to Submit Waiver Requests 
 
For licensed vaccine products regulated by CBER, waiver requests should be addressed 
to: 
U.S. Food and Drug Administration 
Center for Biologics Evaluation and Research  
Office of Biostatistics and Epidemiology  
Document Control Center 
10903 New Hampshire Avenue 
Bldg. 71, Rm. G112 
Silver Spring, MD 20993-0002. 
  8  Contains Nonbinding Recommendations 
 
 
C.  FDA Response to Waiver Requests 
 
FDA reviews waiver requests on a case-by-case basis.  FDA intends to respond in writing 
to the requestor,19 stating whether or not the waiver is granted.  If the waiver is granted, 
FDA intends to also include in its response letter a description of the acceptable alternate 
format(s) for the safety report.  Waivers of the requirement to submit reports in 
electronic format, if granted, will be temporary. 
 
 
                                                 
19 To follow up with the company, FDA intends to contact the individual who submitted the waiver request unless 
an alternate contact person is provided. 
  9