CARES Act Amount Information Reporting:

Reference Guide

Uploading Data From a CSV File

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Table of Contents

Introduction

CDER NextGen Portal Homepage

CARES Act Amount Information Report

Submitter Information

Submission

Submission Errors 

CDER NextGen Portal Support & Resources

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4

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Introduction

CARES Act AmountInformationReporting systemisintended to provide a portalsolutionfor all registrantsor

their authorized agentsto submit reportson the amount of each listed drug that was manufactured,

prepared, propagated,compounded,or processed for commercialdistributionin compliance with section

3112(e) of the CoronavirusAid, Relief, and EconomicSecurityAct.

This guide describes how to use the CDER NextGenPortalto upload data from a comma-separated values 

(CSV) file to createand submit a CARES ActAmount Informationreportto the FDA. It is an expanded 

version of the original reference guide (CARES Act Amount Information Reporting) posted on the 

Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts webpage 

(https://www.fda.gov/drugs/drug-shortages/coronavirus-aid-relief-and-economic-security-act-cares-actdrug-shortage-mitigation-efforts).

Fortechnicalassistance, please email theEDM Support Team (EDMSupport@fda.hhs.gov).

For questions on how to enter or upload data, please email the Drug Amount Reporting Team

(DrugAmountReporting@fda.hhs.gov). 

CARES Act Amount Information Reporting

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CDER NextGen PortalHomepage

Step 1. First, sign in on the CDER

NextGenPortal homepage.

CARES Act Amount Information Reporting

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CARES Act Amount Information Reporting

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CDER NextGen PortalHomepage

Step 2. From the main menu,

click CARESAct Amount

InformationReporting.
CARES Act Amount Information Report

CARES Act Amount Information Reporting

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Step 3. The next screen is the 

landing page. Draft reports 

and submitted reports 

appear here. Click + New 

Report at the top right of the 

screen.
CARES Act Amount Information Reporting

CARES Act Amount Information Report

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Step 4. On the Introduction

screen, review theGetting

Startedinformationfor

submittinga CARES Act

Amount InformationReport. 

Section descriptions of the 

submission process are 

displayed.

Step 5. Click Next.
Step 6. On the Submitter 

Information screen, select if you

are submitting as a Registrantor

Authorized Agent.

Step 7. Review the prepopulated 

informationin the Profile 

Informationsection, and then 

click Next. Contact technical 

support if any fields need to be 

updated.

CARES Act Amount Information Reporting

Submitter Information

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S

tep8. IntheSubmissionsection,

selecttheyear(calendar year) 

that the report will cover. Step 9. If you are submitting a 

replacement report to a previous 

submission, check Yes. Then, 

select the report ID of the 

previous submission from the 

drop-down menu.

Step 10. Selectthatyouwould

like tosubmit productdata via 

CSV File. 

Step 11. In the confirmation 

screen, click Continue. CARES Act Amoun

tInformationReporting

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Submission
C

ARESActAmountInformationReporting

Submission

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Note:The templatewill download with an .xlsx extension. Prior to

uploading, savethe

document with a.csv

extension.

If a file contains multiple 

tabs, save each tab as a 

separate CSV file.

Each file should contain 

fewer than 200,000 lines.

Step 12. Clickand

download the template. 

There are also 

instructions that can be 

downloaded. 
Step 13. Enterthe requested

information in the CSV templateor

construct your own CSV file to

matchthis template. Then,save 

the documentto your computer as 

a CSV file.

The portal requires that each 

DUNS–Business Operation–NDC 

combination have 13 lines, one for 

each month and one for the 

annual total.

CARES Act Amount Information Reporting

Submission

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Note: There is a separate document that describes how to 

enter data into a CSV file: “CARES Act Amount Information 

Reporting CSV Template Instructions.”
C

ARESActAmountInformationReporting

Submission

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Step 14. Once all data has been 

entered into the CSV file, uploadthe

datafromthe documentintothe

portal by 

(1)clickingUpload Files and 

selecting the CSV file, or

(2) dragging and dropping the CSV 

file onto Or drop files.

Step 15. When the status bar 

indicates that the data has finished 

uploading, clickDone. 

Step 16. Your file is now being 

processed. You will receive an email 

once processing is complete. Exit the 

Submission page by clicking Save 

and Save & Close. 
CARES Act Amount Information Reporting

Submission

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Step 17. Once you receive an 

email confirming the processing 

of your CSV file, return to the 

landing page and click on the 

report ID. 

Note: If you need to update 

your CSV file, please click on 

the X next to the old filename 

to remove it and then upload 

the updated CSV file.
CARES Act Amount Information Reporting

Submission

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Step 18. After validation, the report can be saved or 

submitted. To submit the report, check the box in the 

Certifications section to affirm thatthe information 

you provided in this submissionis correct and then 

click Submit. 

Click Save to keep the report for later or click Delete

toremove the submission.

Step 19. In the confirmation screen,click Submitto

send the report. Click Cancel to return to the Submission 

section.
CARES Act Amount Information Reporting

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Submission 

Step 20. After clicking on 

Submit, there will be a 

confirmationscreen to confirm 

yourreport wassubmittedto 

the FDA.

Click ReturnHome to return to 

the landing page or log out or 

click NewReportto submit a

new report.
C

ARESActAmountInformationReporting

Submission Errors 

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The email sent after processing is 

completed will either state that 

there were no errors or specify 

one of three different types of 

errors. Return to the landing page 

and click on the draft submission 

to review the error messages and 

submitted data.

On the Submission page, click 

View Results to view messages 

about the error(s). Depending on 

the error type, you can either 

(1) proceed with the submission 

or 

(2) remove the CSV file and 

upload a corrected CSV file. 

To review common error 

types and resolutions, 

please review the CSV 

Instructions document.
C

ARESActAmountInformationReporting

Submission Errors 

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The three error types are called 

Validation, Hierarchy, and 

Parsing.

Validation error: At least one 

DUNS, NDC, and/or source 

NDC was found to not match 

values in the drug listings 

database. Data may still be 

submitted without updating. 

Hierarchy error: One or more 

required values are missing.

Parsing error: At least one 

value could not be processed, 

such as having an incorrect 

format or being the wrong 

data type.
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Technical Support and Resources

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The CDER NextGen Portalhasmany resourcesforsupport.

CDERNextGen PortalVideoTutorial

The “VideoTutorial” contains1-

4 minute video clipson how to 

completesubmissionsfor events 

on the portal.

CDERNextGen PortalAnnouncements

Your portal home page 

containsportal 

announcementsso users

are alwaysin the know.

Learn More Information

Everything relatedto the 

portal events canbe found 

on the “LearnMore” link.

On the event home page, 

users canfind the “Learn 

More” link to Reference 

Guidesand FAQs.

Technical Support

For all technicalsupport,

contact CDERPlatform 

Support Team at 

EDMSupport@fda.hhs.gov.

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CDER NextGen Portal Support & Resources

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