CARES Act Amount Information Reporting:

Reference Guide

Entering Data Manually

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Table of Contents

Introduction

CDER NextGen Portal Homepage

CARES Act Amount Information Report 

Submitter Information

Submission

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 NextGenPortal tomanually enter datato createandsubmit a 

CARES Act AmountInformationreport to the FDA. It is an expanded version of the original CARES Act 

Amount Information Reporting guide posted on the Coronavirus Aid, Relief, and Economic Security Act 

(CARES Act) Drug Shortage Mitigation Efforts webpage (https://www.fda.gov/drugs/drugshortages/coronavirus-aid-relief-and-economic-security-act-cares-act-drug-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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C

ARESActAmountInformationReporting

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Submission

Step8. IntheSubmissionscreen,select

theyear(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 to

submit productdata Manually. 

Step 11. In the confirmation screen, 

click Continue.
CARES Act Amount Information Reporting

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Step 12. To begin to 

submit product data

manually, select Add

Establishment to enter

a DUNSNumber.

Submission
C

ARESActAmountInformationReporting

Step 13.On the next 

screen, enter the 9-digit DUNS 

Number and click Search. If 

necessary, add leading zeroes.

If the search for a DUNS 

number succeeds, the name 

and address of the matching 

establishment is displayed. 

If this is the correct 

establishment, click in the radio 

button on the left and thenclick

Select.

If a different establishment is 

displayed, check that the DUNS 

number was correctly entered.

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Submission
CARES Act Amount Information Reporting

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Step 14.If the searchfor a 

DUNS number fails, an error 

message and an+Add

Manually button will appear. 

Click the button to enter 

establishment information.

Submission
CARES Act Amount Information Reporting

Step 15.When +Add

Manually is clicked, a screen 

for manually entering 

establishment information 

appears.

Enter the requested

information and then click

Save.

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Submission
C

ARESActAmountInformationReporting

Step 16. After a DUNS

number is selected, the 

Submission screen opens. Click the arrownext to the DUNS number or click on the 

DUNS number to expand its 

entry. Establishment 

information will be displayed.

Then, click onAddNew

BusinessOperation.

To enter data for another 

DUNS number, click on Add 

Establishment and repeat 

the process of adding a 

DUNS number.

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Submission
St

ep17. Selectanoption

fromthedrop-downmenu of 

Business Operations. Each 

Business Operation can be 

selected only once, and in 

any order. Each DUNS can 

have one Business Operation 

or multiple Business 

Operations. There is a 

Remove button next to each 

DUNS number and Business 

Operation, if needed.

Step18. Click+AddProduct

to add a product. Each 

Business Operation can have 

one product or multiple 

products. CARES

ActAmountInformationReporting

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Submission
St

ep19. Clicking on +Add 

Product opens a screen to 

enter an NDC. Enterthe

NDC of the product and 

thenclickSearch.

If the NDC appearson the 

right,checktheboxnext

to it and then clickSelect,

which will return you to 

the Submission screen.

If the searchfails,andyou

knowthe NDCnumberto

becorrect,click+Add

Manually.

CARESActAmountInformationReporting

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Submission
CARES Act Amount Information Reporting

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Step 20. After clicking on 

+Add Manually, enter the

NDC number and then click

Add Product, which will 

return you to the 

Submission screen.

Submission
Step 21. In the Submission screen, enter the requestedamountinformation of theproduct and click each 

pencilto enter the packagetypes. If a product has single-level packaging, use only the “Outermost Package” 

fields. Click +Add Productand/or Remove Product as needed. Select the checkbox under Market Unknown,if 

applicable. 

Scrollto the right and click the arrow to expand the record so that data can be entered by month.

CARES Act Amount Information Reporting

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Submission
St

ep 22. For each month, enter 

the amounts released or 

distributed. Use only whole 

numbers, no decimals or 

fractions.

Fields can be left blank for 

months during which the 

product was not released or 

distributed. 

The top row, which contains the 

NDC number, also contains fields 

for annual totals. The annual 

total fields will automatically 

update when a monthly field is 

updated. Also, annual totals can 

be entered directly into the top 

row.

CARESActAmountInformationReporting

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Submission
CARES Act Amount Information Reporting

Submission

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Step 23. Data will be 

validated before a report 

can be submitted.

When all data has been 

entered, click Save. The 

system requires saving the 

report at least once before 

validation.

Step 24. In the confirmation 

window, click Save to stay on the 

Submission page or click Save & 

Close to go to the landing page. 

On the landing page, select the 

newly created and saved 

report to return to it. 

The “Validated Successfully!” message 

means that validation occurred, not 

that all the data was found to be valid.
St

ep25. Click the Validate button at the 

bottom of the page. 

Step 26. If the data has been validated, 

Submitwill be active. After validation, the 

report can be saved or submitted. To submit 

the report, checkthebox in the 

Certifications section to affirm thatthe information you provided in this submissio

n is correct and then click Submit. 

ClickSave tokeep the report for later or

clickDelete toremovethe submission.

Step 27. In the confirmation screen,click 

Submittosend thereport. Click Cancel to 

return to the Submission section.

CARESActAmountInformationReporting

Submission

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CARES Act Amount Information Reporting

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Submission

Step 28. After clicking on 

Submit, there will be a 

confirmationscreen to confirm 

yourreport wassubmittedto 

the FDA.

Click ReturnHome to log out 

or New Reportto submit a

new report.
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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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