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NIH

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Title: NIH


1
NIH
  • Electronic Submissions

2
HOW 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

3
Searching for the Funding Opportunity Announcement
First click On Find Grant Opportunities
Then, click on Search Grant Opportunities
4
Click on Basic Search to search by Keyword, FOA
, and CFDA
If you know the FOA , you type it here.
5
Click 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.
6
Click 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.
7
Enters 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).
8
PI must open and complete all forms indicated
under Mandatory Documents. For Optional
Document guidance, refer to Program
Instructions.
9
HSC 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.

10
What 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
11
PreAward 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.

12
After 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.

13
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14
Internal 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
15
After 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.

16
When 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.

17
Avoiding 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).

18
Avoiding 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.

19
How to Find Your Errors in Commons
First, log into eRA Commons.
Then, click on the Status tab.
20
Click 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.
21
eRA Commons Errors
22
Complete Submission
23
Preparation 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.

24
E-Commons Fill in all Personal Info After
Registered
Step through and fill out
25
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26
Completing 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.

27
SF424 (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

28
SF424 (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

29
SF424 (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

30
SF424 (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

31
SF424 (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
32
SF424 (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)
33
Component 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

34
Project/Performance Site Location(s)
35
Component 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)
36
Other Project Information
37
Component 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

38
Data 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

39
Senior/Key Person Profile
Enter PI eRA Commons User Name
40
Component 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!

41
Note New Page
42
Component 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)

43
Component 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

44
RR Budget Sections A B
45
Component 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

46
RR Budget Sections C E
47
Component 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.

48
RR 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

49
CUMULATIVE 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
50
Component 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

51
If 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.
52
Agency-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

53
Component 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

54
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55
Component 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

56
PHS 398 Cover Page Supplement Page 1
57
PHS 398 Cover Page Supplement Page 2
58
PHS 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)

59
MODULAR CUMULATIVE BUDGET
Cumulative Budget is system-generated Budget
Justification PDF text attachments for
Personnel, Consortium and Other
60
Component 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

61
Component 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.)

62
PHS 398 Research Plan
Note Leadership Plan Attachment Required For
Multi-PI Projects
63
Component 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

64
PHS 398 Checklist Page 1
65
PHS 398 Checklist Page 2
66
What 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

67
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68
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69
Cross Terminology
70
Advice 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

71
Advice 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

72
Business 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

73
Other 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

74
Finding 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!
75
THANK YOU
  • Call Your Contract Grant Administrator in
    PreAward for Help 272-6264
  • QUESTIONS???
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