Title: NIH
1NIH
2HOW DOES IT WORK?
- PI downloads the Pure Edge Software from
Grants.gov. - PI prints Grants.gov SF424 (RR) Application
Guide (Version 1 or 2) - PI finds FOA (Funding Opportunity Announcement)
through Grants.gov and downloads the application
package (SF424/RR), which provides program
specific application requirements. - These FOAs will typically be available 30 days
before the deadline
3Searching for the Funding Opportunity Announcement
First click On Find Grant Opportunities
Then, click on Search Grant Opportunities
4Click on Basic Search to search by Keyword, FOA
, and CFDA
If you know the FOA , you type it here.
5Click on the Opportunity Title This opens the
synopsis of the FOA.
Click on How to Apply to download the
instructions and PureEdge Package. You will also
want to click on the Full Announcement link for
the full FOA.
6Click on Download
The Application Instructions indicated here, is
only a resource. You need to open the Full
Announcement on the prior screens for specific
instructions.
Click on Download Application Package to
download the PureEdge Software.
7Enters Application Filing Name and saves to safe
directory on computer. Note A shortened version
of the projects descriptive title is
recommended, as this title is how the project
will be identified in Commons (30-40 characters
max).
8PI must open and complete all forms indicated
under Mandatory Documents. For Optional
Document guidance, refer to Program
Instructions.
9HSC Deadline Policy for NIH Electronic
Submissions ONLY
5-Day
10-Day
- PI emails PreAward FINAL proposal in PureEdge to
the HSC general mailbox. -
- If errors or questions, PI and/or contact point
on PDS are e-mailed (or telephoned) with
concerns. - If no questions or concerns, PreAward submits
application through Grants.gov. - Between 2 hours 2 days, Grants.gov formats the
application and sends an e-mail indicating there
are errors or that processing has occurred. - If errors found at NIH, PI corrects and e-mails
back to PreAward process begins again.
- PI submits required PDS, COI and other forms as
necessary. PI must print technical file and FOA
and include in paper package to PreAward. Submit
DRAFT PureEdge file via email to
HSC-PreAward_at_salud.unm.edu. All Institutional
information, budgets and budget justification
must be final this includes your subawardee
budget information as well. - PreAward logs project into PreAward database for
tracking and reviews as normal. - PreAward makes comments to PI/contact point
person if questions or errors detected.
10What Happens When Documents are Complete?
- The PI will e-mail the Pure Edge Software package
to - HSC-Preaward_at_salud.unm.edu
- 10 business days prior to submit date when
everything is complete (except technical portion
can still be in draft). Moving items over to
Mandatory Complete Documents for Submission is
an organizing tool to be used to indicate when
all information has been completed in each form.
(Forms can still be opened on this side or moved
back.)
Email to HSC-Preaward_at_salud.unm.edu Subject
CGA Name-NIH Electronic Submission
11PreAward Personnel Receives Package
- The Pure Edge package is one large unit with many
subcomponents. - PreAward Person will open and review every
Mandatory Form completed by the PI. If something
is missing or incorrect, the PreAward person will
notify the PI to make the correction and Re-email
corrected package again. - PreAward will focus on the correct institutional
information, such as correct DUNS Number and
Credentials (eRA Commons Username). This
information is critical in relating the
application to this institution, as well as,
applying it to the correct PI.
12After PreAward Review
- PI will email FINAL package to PreAward with all
their forms moved over to Mandatory Documents
Completed 5 business days prior to submit date. -
- PreAward will then Check the Page for Errors
and press the Submit Button if everything is a
go.
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14Internal Submission Process
Submit signed internal forms (PDS, COI)
Send completed PureEdge file 10 business days
prior to deadline.
Initiate eRA Commons Registration
Send FINAL PureEdge file 5 business days prior to
NIH deadline
Correct errors in Application if necessary
Preaward submits Application to Grants.gov
if errors
Submission Complete
Status in Check Submission Commons
View the Application Image
15After SubmissionWhat Next?
- PreAward receives four e-mail confirmations from
Grants. Gov. (up to 48 hours to complete) - The eRA Commons software checks the applications
against NIH Business Rules list of validation
checks in detail at http//era.nih.gov/ElectronicR
eceipt/prepare_app.htm5. - NIH notifies Signing Official (PreAward) via
email to check the eRA Commons for results of NIH
rule checking. - The final confirmation from Grants.gov tells us
that the application has been received by NIH.
16When Application is Received by NIH
- There will be an e-mail notification to PI that
will indicate whether any errors or warnings
resulted during validation process. - PI and PreAward log in to eRA Commons and review
assembled application and list of
warnings/errors. - 2 Business days to review if acceptable, no
action needed, if unacceptable CGA rejects
application. - If rejected, PI corrects errors and submission
process starts again.
17Avoiding Common Causes for Rejected Applications
- File and/or attachments are not in PureEdge or
PDF format - Other formats may be allowed through
Grants.gov but are not accepted by NIH. - Special characters in file namesFor instance,
brackets such as "" and "" are not accepted. - Signature not turned off
- When using Adobe Acrobat (and possibly
other tools), the signature has to be off when
you create the originals. Go to the security
options menu selection in Adobe to ensure the
signature is off. If you do not have the
originals, copy the content of the signed
documents and create a new document. Save this
document without signing it
- Submitting protected PDF documents
- Make sure security settings are not marked.
Check Document Security tab under Document
Properties (directly from the tab) and set the
security parameters to ensure open access so NIH
can process the content. Do not password protect
or mark Content Extraction or Copying Document
Assembly, etc. as Not Allowed. - NOTE If you are having trouble fixing the
PDF settings, simply cut and paste from the PDF
document into a Microsoft Word document and then
reconvert (in some cases it may be better to use
another PDF converter).
18Avoiding Common Causes for Rejected Applications
- PDF documents saved with editable fields
- Do not save PDF files with fields that can
be changed. If for example, you are using Adobe,
use your PDF printer tool (Go to File and click
on Print and select the output device for
printing to Adobe PDF) to create an Adobe PDF
print version file. Send the Adobe PDF print
version file, not the original editable version.
If you do not have a PDF print tool, click on the
link below to see a recommended list of tools
http//www.grants.gov/assets/PDFConversion.pdf
- Missing Commons User ID
- The application did not include the PIs
Commons User ID in the field called Credential,
e.g. agency login. This field is not marked as
required on the government-wide form but is
required by NIH. - See full list of most common errors in NIH
Handout. - NOTE Applicants have to read the agency
specific instruction in the application guide to
know what to include in this field.
19How to Find Your Errors in Commons
First, log into eRA Commons.
Then, click on the Status tab.
20Click on eApplications
Make sure Show Prior eSubmission Errors button
is checked. Everything else stays the way it is.
Make sure there are no dates in the date fields.
21eRA Commons Errors
22Complete Submission
23Preparation Checklist
- Ensure PI has NIH E-Common user ID, remembers
password has filled in all personal info. - Ensure PI has downloaded PureEdge software
(free). - Ensure PI has PDF Software and is trained in use.
(Recommend Adobe 7.0 Technical - 40 at CIRT) - Ensure PI is using the correct DUNS number for
UNM 868853094. - Ensure PI Always Reads Application
- Ensure PI attends HSC training or reads
- http//era.nih.gov/ElectronicReceipt/training.
htm and practices the demo application. - Ensure HSC timelines are followed.
24E-Commons Fill in all Personal Info After
Registered
Step through and fill out
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26Completing the SF424 (RR)
- Consolidates forms used by Federal grant making
agencies so applicants can use familiar forms
regardless of the program or agency. - FOA will indicate which components are required,
and which are optional. - Not all components will be used for FOA.
- You have to complete a new SF424 for each
project, and you may not use ANY sample form
package.
27SF424 (RR) Components
- Application Package Header
- SF424 (RR)An application cover component
- Research Related Project/Performance Site
Location(s) - Research Related Other Project Information
- Research Related Senior/Key Person Profile
(Expanded in 2a Version) - Research Related Budget
- RR Subaward Budget Attachment Form
28SF424 (RR) - Cover Component Avoiding Errors -
A Few Data Issues
Non-Competing Continuations are processed through
eRA Commons
- Item 8, Type of Application--New Terminology
- New A new application is expected to be
substantially different in content and scope with
more significant differences than are seen in a
resubmitted application - Resubmission is equivalent to a Revision (a
revised or amended application). Only two
resubmissions are allowed. A 3rd Resubmission
will NOT be considered, however, there is no
longer a 2 year limit for resubmissions. - Renewal is equivalent to a Competing Continuation
- Continuation is for non-competing continuations
for only select agencies. It is equivalent to a
Progress Report, so for the purposes of NIH and
other PHS agencies, the box for Continuation will
not be used and should not be checked. - Revision is equivalent to a Competing Supplement
(after initial award its used to request
additional support for current period) - Preapplication Do not use unless specifically
instructed - Terminology cross-walk provided in instructions
29SF424 (RR) - Cover ComponentAvoiding Errors
More Data Issues
- Item 5, Organizational DUNS Must match DUNS in
eRA Commons profile for Applicant Institution - Item 14, Congressional District Should be listed
in Alpha-numeric form with 2-letter State
designation, a dash, and 3-digit district number
i.e. NM-001, or NM-003, or NM-all - Use Organizational DUNS (not any DUNS for a
specific individual) - If Organization has multiple DUNS numbers, pick a
single one for grants
30SF424 (RR) - A Cover ComponentAvoiding Errors
Final Data Issues
- Item 10, CFDA Number Title
- CFDA Catalog of Federal Domestic Assistance
- Fields are pre-filled based on the specific
announcement - Fields may be blank for applications in response
to an FOA that includes multiple CFDAs - When multiple CFDAs are listed in an
announcement, a CFDA will be assigned by the eRA
system once a specific Institute assignment is
made
31SF424 (RR) Cover Component Page 1
- Similar to PHS 398 Face Page
- Provides general information about the applicant
organization and contact information for the
PD/PI and AO (PreAward) - Provides application- specific information
- Federal Identifier in field 4 is only for
renewals or submissions that have had previously
assigned grant numbers. (8 character limit i.e.
CA123456) - Note Field 11 (descriptive title) has 80
character limit
For Multi-PI Projects, Contact PI Goes Here
32SF424 (RR) Cover Component Page 2 Note In the
Position/Title field for your Authorized
Representative, use an ampersand in place of the
word and to remain within character
limitations i.e. Contract Grant
Administrator. Also Do not use the Plus-4
suffix on our zip code (exceeds character limit)
33Component Research and Related
Project/Performance Site Locations
- Equivalent to the PHS 398 Form Page 2 Performance
Site section - Collects individual data for up to 8 locations
- gt8 locations information is provided in an
attachment (not structured data, just text) and
uploaded in the Additional Locations field - Format for the gt8 attachment available on SF424
(RR) Forms Page http//grants.nih.gov/grants/fun
ding/424/index.htm
34Project/Performance Site Location(s)
35Component Research and Related Other Project
Information
- Includes information on involvement of Human
Subjects, Vertebrate Animals, Environmental
Impact, Foreign Involvement - Caution Human Subjects number is alpha-numeric
and has a ten character limit. Do not leave a
space between letters and numbers or you may
exceed the character limit for this field. - Includes separate PDF attachments for
- Project Summary/Abstract (Description)
- Project Narrative
- More detail about contribution to Public Health.
NIH will use this upload for the Relevance
section of the Abstract - Separate component developed for Research Plan
- Bibliography References (previously section G.
Literature cited in Research Plan) - Facilities Other Resources
- Equipment Resources
Equivalent to PHS 398 Resources Format Page (Used
to be 1 document)
36Other Project Information
37Component Research and Related Senior/Key Person
- Captures personal profile information on the
PD/PI, Key Personnel, and Other Significant
Contributors - Alphabetical order is recommended but not
required - Captures structured data for 8 individuals (PI
and 7 others) - Version 2A has second page for expanded Senior
Key Personnel (such as for multiple PI
applications) - gt8 information is provided in an attachment (not
structured data, just text) - Format for the gt8 attachment available on SF424
Version 2A (RR) Forms Page http//grants.nih.gov
/grants/funding/424/index.htm
38Data Issues Research and Related Senior/Key
Person
- Credential Must enter the eRA Commons User Name
- for the PD/PI, this is a mandatory field for
NIH submissions. (1 Validation Error to date) - Biosketch is attached for each person
- Same data requirements exist however, page
limits slightly change to just 4 pages and it
must be converted to a PDF file - Eliminated the 2-page limit for subsections
- Note, Attachment for Current Pending Support
(a.k.a. Other Support) will not be used at time
of submission unless specified in FOA. For most
applications, this will continue to be a
Just-In-Time submission
39Senior/Key Person Profile
Enter PI eRA Commons User Name
40Component Senior Key Personnel
Expanded
- The new Expanded form allows for the collection
of up to 40 Senior Key Persons in structured data
fields. - For more than 8 Senior Key Persons you will be
instructed to open the supplementary form-in-form
for each additional 8 Senior Key Persons up to 40 - The form-in-form model is similar to how the RR
Subaward Budget form works you will attach
PureEdge forms within the PureEdge form - Do NOT convert the supplemental forms to PDF
before attaching (these are PureEdge forms) - Beware Grants.gov will still allow you to attach
additional Senior Key persons in 1 PDF
attachment, but NIH will not!
41Note New Page
42Component Research and Related Budget, Sections
A B
- Personnel separated into 2 sections
- A. Senior/Key Personnel
- Allows 8 as named individuals structured data
- gt8 information is provided in an attachment (not
structured data, just text) - Info for PD/PI must be entered, even if 0
- Note NIH Salary cap increase to 186,600
- B. Other Personnel
- Postdocs, Grad Students, Undergrads captures
only - NIH will request more detail in Budget
Justification - (See specific application instructions)
43Component Research and Related Budget, Sections
A B
- Business Process Change from Percent Effort to
Person Months - Must enter in Calendar months, either Academic
and/or Summer for all Senior/Key Persons - Incorporated this business process change
throughout--See 4/2006 Interim change to PHS 398
PHS2590 Progress Report, including Budget
Pages, Other Support documentation, Key Personnel
Reports, etc. Announced 4/7/2006 in NIH Guide
Notices. - FAQs and a Calculator available at
http//grants.nih.gov/grants/policy/person_months_
faqs.htm
44RR Budget Sections A B
45Component Research and Related Budget, Sections
C E
- C. Equipment
- Allows itemization of up to 10
- gt10 equipment items details provided in an
attachment total funds requested in attachment
are entered in Line 11 - D. Travel
- RR separates out Domestic Foreign
- This will not change any NIH policy/practice. We
will continue to award as a single category. - E. Participant/Trainee Support Costs
- Will not be used by NIH unless specifically noted
in an announcement - Tuition Remission will continue to be included in
Section - F. Other Direct Costs
46RR Budget Sections C E
47Component Research and Related Budget, Sections
F - K
- F. Other Direct Costs
- Itemizes Supplies, Publication Costs,
Consultants, ADP/Computer Services, Consortium
Costs, Equipment or Facility Rental/User Fees,
Alterations Renovations - This section may also be used to account for
patient care costs tuition remission (refer to
agency-specific instructions) - G. Total Direct Costs (A F)
- H. Indirect Costs
- I. Total Costs (GH)
- J. Fee
- K. Budget Justification a PDF text attachment
- Next Period Button At the top of the last
budget page. All required data fields in this
component must be entered before this button is
available. This includes the Budget Justification.
48RR Budget Sections F - K
- Section F Other Direct Costs
- Item 5 should show grand total of Subaward
dollars - Patient Care Fees and Tuition Remission can be
listed in Items 8 and 9 - All budget figures should be in whole numbers
49CUMULATIVE BUDGET
Applicant prepares a detailed budget for every
budget period There is no summary budget page
like the PHS 398 Form Page 5 The detailed
Cumulative budget is system-generated
50Component RR Subaward Budget Attachment Form
- Use for detailed budget from any consortium
grantee only when the prime is submitting
detailed budget - Do not use if prime is submitting Modular Budget
- Consortium grantee(s) must have PureEdge
installed - Allows up to 10 separate budget attachmentsone
for each consortium grantee (over 10 add to
Budget Just.) - Applicant sends the RR budget component to the
consortium grantee for completion it is returned
to the applicant applicant attaches it in this
component - Applicant still needs to include the total costs
for all consortiums in their own detailed budget,
Section F.5
51If more than 10 Subawardees add in Budget
Justification
Note Remind your Subawardees that the
designation of PI should only be used if the main
project is a multi-PI project.
52Agency-specific Components (a.k.a. PHS 398
Components)
- PHS 398 Cover Letter File
- PSH 398 Cover Page Supplement (supplements the
RR Cover) - PHS 398 Modular Budget
- PHS 398 Research Plan
- PHS 398 Checklist
53Component PHS 398 Cover Letter
- Provides a text attachment for a cover letter
- Should not be scanned in. Create as Word
Processing file then convert to PDF so that NIH
can data mine if needed - Instructions to applicant remain the same as in
the PHS 398 - Is stored separately in the eRA Grant Folder, not
as a part of the main application grant image - Is seen only by appropriate NIH staff not peer
reviewers - Required when submitting a Changed/Corrected
Application after submission date - If revising the cover letter for a
Changed/Corrected application, include all
previous submitted letter text
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55Component PHS 398 Cover Page Supplement
- Companion form to the (RR) Cover Component
- For the PI, includes New Investigator Code
Degree fields (Note, PD/PI info at the top is
pre-filled. Provided here for reference only.) - Includes Clinical Trial Phase-III defined
clinical trial indicators - For the Business Official Contact, includes
complete contact information (title mailing
address missing from section 5 of the RR Cover) - Includes Human Embryonic Stem Cells section
56PHS 398 Cover Page Supplement Page 1
57PHS 398 Cover Page Supplement Page 2
58PHS 398 Modular Budget
- Provides data entry for each budget period for
- Direct Costs (less Consortium FA)
Consortium FA Total Direct Costs - B. Indirect Costs
- Calculation section
- C. Total Costs
- (A B)
59MODULAR CUMULATIVE BUDGET
Cumulative Budget is system-generated Budget
Justification PDF text attachments for
Personnel, Consortium and Other
60Component PHS 398 Research Plan
- Separate PDF attachments for each section
(designed to maximize benefits of system
validations to accommodate bookmarking of the
image) - Same formatting requirements in the PHS 398
continue here margins, page limits, etc. - Appendix Material
- Allows up to 10 separate attachments
- Will be stored separately in the eRA Grant
Folder, not as a part of the main application
grant image - Will be accessible to appropriate NIH staff and
peer reviewers - Use links to on-line journals for publication
references when available. See Guide Notice
http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-06-051.html
61Component PHS 398 Research Plan Helpful Hints
- Create as a single document using any word
processing software. Separate only at the end
before uploading. - Do not include headers or footers
- Do include a section heading as part of the text
i.e., Specific Aims, Background Significance - Avoid 2-column format for text (difficult for
reviewers to read electronically) - Avoid scanning when text has been generated using
a word processing tool (Specific Aims, etc.)
62PHS 398 Research Plan
Note Leadership Plan Attachment Required For
Multi-PI Projects
63Component PHS 398 Checklist
- Captures additional information currently in the
PHS 398 Checklist - Change of PI
- Change of Grantee Institution
- Inventions Patents
- Program Income
- PDF text upload for an Assurances/Certifications
explanation
64PHS 398 Checklist Page 1
65PHS 398 Checklist Page 2
66What Will a Completed Application Look Like?
- After submission, the eRA system will
- Assemble the grant image
- Generate a Table of Contents
- Include headers (PI name) footers (page
numbers) on all pages - Sample Document eRA Assembly of the SF424 (RR)
Application - Includes a sample Table of Contents, and
- a chart cross-referencing the location in the
forms components for each piece of the grant
image. - http//grants.nih.gov/grants/funding/424/index.ht
m -
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69Cross Terminology
70Advice From Experience Important Document
Creation Recap
- Tips for creating PDF files
- Use no special characters in file names
- Do not add headers and footers/NIH will generate
- Do not write-protect the PDF file disable all
security features in the PDF document - Avoid scanning text attachments (particularly
abstract specific aims). Generate using word
processing package and then convert to PDF. - For more information see Avoiding Common Errors
- http//era.nih.gov/ElectronicReceipt/avoiding_erro
rs.htm
71Advice From Experience
- Register in eRA Commons now to be prepared
- Allow time for corrections
- Take time to review the image
- When calling the Help Desk, be prepared to
provide identifying information for your
application and organization - Only the AOR/SO (PreAward) is allowed to submit
72Business Process Change Option to
Review
- PI strongly recommended to view grant image
within 2 weekdays of availability in the NIH
Commons - Only AOR/SO (PreAward) has authority to Reject
the image if there are errors - If no rejection within 2 weekdays of image
availability, application automatically proceeds
to next step in NIH processing - http//grants.nih.gov/grants/guide/notice-fil
es/NOT-OD-06-055.html
73Other Tools
- UNMHSC PreAward Web-site http//hsc.unm.edu/co
ntroller/preaward/ - Frequently Asked Questions http//era.nih.gov/Elec
tronicReceipt/faq.htm - Electronic Submission Timeline http//era.nih.gov/
ElectronicReceipt/strategy_timeline.htm - Avoiding Common Errors http//era.nih.gov/Electron
icReceipt/avoiding_errors.htm - Communications and Outreach Resources (brochures,
presentations, drop-in newsletter articles)
http//era.nih.gov/ElectronicReceipt/communication
.htm
74Finding Help eRA Commons/Grants.gov
- If help is needed with the eRA Commons
registration or review process in the eRA Commons
after submission through Grants.gov - Check the resources available on the Grants.gov
website first (http//grants.gov/ ) - Grants.gov help is also provided by the following
office - Grants.gov Customer Support
- Contact Center Phone 1-800-518-4726
- Business Hours M-F 7 a.m.-9 p.m. EST
- Email support_at_grants.gov
- Check the resources available on the eRA Commons
website - https//commons.era.nih.gov/commons/index.jsp
- eRA Commons Help DeskPhone 301-402-7469
- Toll Free 866-504-9552 TTY
301-451-5939 - Business hours M-F, 7am-8pm EST
Email commons_at_od.nih.gov - Web support http//ithelpdesk.nih.gov/eRA/
New Enter your own help ticket!
75THANK YOU
- Call Your Contract Grant Administrator in
PreAward for Help 272-6264 - QUESTIONS???