Disclosure I do not have any relationship(s) with commercial interests

04/21/23 LSUHSC-NO ORS Training Series1

LSU School of Medicine-New Orleans (LSUSOM-NO) is the provider of Continuing Medical Education for this activity. The planning and presentation of all LSUSOM-NO activities ensure balance, independence, objectivity and scientific rigor.

The LSU School of Medicine-New Orleans designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credit(s) ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.


Disclosure

I do not have any relationship(s) with commercial interests.

A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.

Grants.gov:

Submitting anNIH Grant

Application


Welcome

– Presenter:• Nicole G. Hammill, MBA, CRA• Coordinator of Grants and Development• Office of Research Services

– [email protected]– (504) 568-4970 tel– (504) 568-8808 fax

– http: http://www.lsuhsc.edu/administration/academic/ors/grants_contracts_processing.aspx

http://www.lsuhsc.edu/administration/academic/ors/grants_contracts_processing.aspx

http://www.lsuhsc.edu/administration/academic/ors/grants_contracts_processing.aspx

Agenda

• Overview• What is Grants.gov?• What is eRA Commons?• Preparing to Apply• Creating an Application• Submitting an Application• Checking an Assembled Application• Lessons Learned• Overview (Review)• Questions and Answers


Helpful Administrative Information

• Most of the numbers, dates, names, and titles commonly needed for administrative purposes can be found here:

http://www.lsuhsc.edu/administration/academic/ors/docs/Helpful_Administrative_Information.pdf







Overview


Overview


What is Grants.gov?

– Federal government’s single online portal to find and apply for federal grant funding

– Used by all federal grant-making agencies– LSUHSC-NO is already registered

• Individual investigators do not register in Grants.gov

04/21/23 LSUHSC-NO ORS Training Series1 0

What is eRA Commons?

– NIH electronic research administration system that allows applicants/grantees to electronically receive and transmit application and award information

– Used by NIH and other HHS components (CDC, AHRQ)

– LSUHSC-NO is already registered• Individual investigators do need a Commons

account!• Commons accounts are established by Office of

Research Services personnel


Preparing to Apply

– Arrange for establishment of Commons account

• Contact Office of Research Services• Investigators have one account that follows

them throughout their careers; the same account may be “affiliated” with multiple organizations

– Office of Research Services can “affiliate” existing account with LSUHSC-NO

• Vital that information in investigator’s Commons profile is current and accurate

• Allow 4-5 business days for Commons account to be established (usually happens very quickly)


Preparing to Apply

– Procure software• Grants.gov offers free Adobe software:

http://www.grants.gov/help/download_software.jsp• Most LSUHSC-NO departments have latest version of

Adobe software• Investigators are responsible for ensuring the version of

Adobe used is compatible with Grants.gov. Check here: http://www.grants.gov/help/download_software.jsp#adobe811

• In most cases, a pop-up warns users if they are using the wrong version of Adobe. Using the wrong version can corrupt an application.

http://www.grants.gov/help/download_software.jsp

http://www.grants.gov/help/download_software.jsp#adobe811

http://www.grants.gov/help/download_software.jsp#adobe811


Preparing to Apply

– Select a Funding Opportunity Announcement (FOA)

• Since all applications must be submitted in response to an FOA, the NIH has created “parent” FOAs for Investigator-Initiated Research

– Apply using the “parent” electronic application package for your chosen award mechanism/activity code (R01, R03, etc.)

– NIH parent announcement page is here: http://grants.nih.gov/grants/guide/parent_announcements.htm

• FOAs are also issued for non-investigator-initiated projects

http://grants.nih.gov/grants/guide/parent_announcements.htm

http://grants.nih.gov/grants/guide/parent_announcements.htm


Search for specific(non-investigator-initiated) FOAs

here

Find “Parent” FOAs here


Select the FOA number to open the announcement


Preparing to Apply– Download FOA application package and

instructions• Once appropriate FOA has been selected, click the “Apply for

Grant Electronically” button• This will take you directly to Grants.gov so you may download

both the application package and its accompanying instructions– Be sure to fill out box to receive e-mails if changes to FOA occur

• Note that you cannot submit the application until the “opening date” shown on the FOA

• Note that any instructions in the FOA take precedence over the general instructions found in the Grants.gov application guide.

• The applicant must complete the application using the package attached to that particular FOA. Information from the specific FOA is used in the forms.

• Applicants cannot use any sample form packages or form packages from other FOAs.

• The applicant will complete data entry in all necessary components and upload appropriate attachments.


Note: you cannot apply until the “open date”

shown in the FOA

Important: the instructions in the FOA

take precedence over the Grants.gov application

guide.

Within the FOA, click the “Apply for Grant Electronically”

button.


Imperative that correct, most recent version of

FOA is used; use of older versions will not be accepted. Look for

“FORMS-C”


Important tip: Sign up to receive notification of changes to the FOA!

Download the application form and its instructions from this

location.


Select “save” to save the application to your local

hard drive, network drive, etc.


Preparing to Apply– Route materials through Office of

Research Services• For all grant applications (paper and electronic)• All "special conditions" noted in Funding Opportunity Announcements (FOAs), such

as limitations on the number of proposals accepted from a single institution, must be presented and discussed with the Office of Research Services prior to application submission.

• At least 10 working days in advance of an application deadline, PIs should provide to the Office of Research Services:

• A double-sided yellow routing sheet completely filled out and signed by the PI, Business Manager, and Department Head

– Routing sheets must be printed on yellow paper.– Routing sheets without keywords will be returned without review.– Routing sheets must contain information on regulatory (IRB / IACUC/ IBC,

etc.) approvals (if applicable).– If a particular signer is unavailable, signing authority to another party can

only be delegated in writing.

http://www.lsuhsc.edu/administration/academic/ors/docs/Routing_Sheet_updated_09_09_2014.pdf

http://www.lsuhsc.edu/administration/academic/ors/docs/Keywords.pdf

http://www.lsuhsc.edu/administration/academic/ors/irb.aspx

http://www.lsuhsc.edu/administration/academic/ors/iacuc.aspx

http://www.lsuhsc.edu/administration/academic/ors/ibc.aspx

Preparing to Apply

• Project Abstract – A draft is acceptable, but the abstract should reflect

the entire proposed scope of work.• A face page (including a signature line for institutional

official)• A budget.

– Budgets should include information on how F&A (“indirect”) costs were calculated.

• A budget justification


http://www.lsuhsc.edu/administration/academic/ors/docs/080814.xlsx

Preparing to Apply

• Sponsor's official written policy on F&A costs (if sponsor will not pay current federally-negotiated rate) – A letter or e-mail from the sponsor merely saying that they will

not pay full F&A is not sufficient to request a waiver of F&A cost recovery.

– If the sponsor does not have an official written policy on F&A costs, and is not willing to pay the current federally-negotiated rate, include a letter to the Authorized Institutional Official requesting that F&A costs be waived (be aware that the request may or may not be granted).

– Please see Permanent Memorandum 10 (http://www.lsuhsc.edu/administration/pm/pm-10.pdf) for more information on Indirect Cost Allowances on Grants and Contracts.


Preparing to Apply

• Letters of Intent to Establish a Consortium Agreement – These letters are required if a prime/subawardee relationship is

proposed (the subawardee should sign first).– If LSUHSC-NO is the proposed subawardee, investigators are

not authorized to release information to prime applicants until materials are reviewed and approved.

• SBIR/STTR letter(s) (if applicable)• All documents necessary to comply with CM-35 (Conflict of Interest

Attestation and Significant Financial Interests forms). – In lieu of COI and SFI forms, institutions wishing to serve as a

subawardee to LSUHSC-NO may visit this web site: http://nrc59.nas.edu/pub/fcoi_list.cfm and provide a printout as evidence of compliance with the NIH FCOI policy.



Creating an Application

– Complete application package• Application components include specific data fields as

well as multiple attachments• Most attachments are text• NIH requires .pdf text attachments

– Other sponsors who use Grants.gov may not require .pdf attachments; nevertheless, get into the habit of converting all attachments to .pdf

– Create attachments using any word processing software but convert to .pdf before attaching to the application form

– Do not include headers or footers in the text pages

• Details on creating an application will be provided in a separate session, entitled “NIH Application Forms”


Submitting an Application– Transmit the application to the Office of

Research Services after receiving word that paperwork has been signed

– Only the institution’s “Signing Official” (aka “SO” or “AOR”) is authorized to click the “submit” button

• Nicole Hammill and Dr. Kenneth Kratz are authorized to act on behalf of the Signing Official

– It is the investigator’s responsibility to transmit the completed application package to the Office of Research Services well in advance (at least 5 working days) of the deadline.

– Acceptable means of transmission include:• E-mail (by far the most popular method)• CD/DVD• Flash Drive

– Requests for submission should include a notation that the budget, abstract, etc. have already been approved in writing


Submitting an Application

– Confer with Office of Research Services personnel about required corrections and modifications to application package

– Correct/modify the application package, and re-transmit to the Office of Research Services for submission via Grants.gov.

• The Office of Research Services cannot and will not make modifications to an investigator’s application package.


Submitting an Application– Await series of e-mail notifications from

both Grants.gov and eRA Commons• These will be forwarded to the investigator from the Office of

Research Services

– Do not leave the country or otherwise become unavailable until all e-mail notifications have been received!

– E-mail notifications will be sent to all principal investigators and to the “department contact” named on the yellow routing sheet (generally the departmental business manager and/or grants coordinator).

– Expected system response times:• Grants.gov: generally within hours, up to 2 weekdays

– In rare instances, Grants.gov can take longer to respond. Example: submission of “Recovery Act” applications

• Commons: generally within hours, up to 1 weekday• Note that “weekdays” include holidays


Submitting an Application– Grants.gov performs “validations” to ensure that:

• All mandatory fields have been completed• All mandatory documents have been completed and moved to

the Completed Documents box• The DUNS number is correct• The date formats and e-mail formats are correct• No viruses are present

– E-mail notifications from Grants.gov are:• Submission Receipt – application received and is being

validated• Rejection Notice – application is not validated because of

Grants.gov errors• Submission Validation Receipt – application has been validated• Grantor Agency Retrieval Receipt – application has been

received by the agency/sponsor• Agency Tracking Number – application has been assigned a

tracking number by the grantor agency/sponsor


Submitting an Application– eRA Commons performs “validations” to ensure that:

• Instructions in Grants.gov application guide have been followed• Instructions in the specific FOA have been followed• Institutional information provided in the application matches

institutional information on file• A detailed list of Commons validations is available here:

http://grants.nih.gov/grants/electronicreceipt/files/SF424RR_Validation.pdf.

– E-mail notifications from Commons are:• Validations Complete/Check Assembled Application: Commons

has completed its validation process and the assembled application is ready for viewing

• Action Required: Commons has attempted to validate the application, but errors were encountered that must be addressed

• SO has refused electronic application: Commons has received a request from the institution’s signing official to halt processing of an application



– View errors and/or warnings• Errors must be addressed before the application

can move on to NIH receipt & referral • Warnings may be fixed at the applicant’s

discretion, but do not require action for the application to move on

– In most cases, warnings can be ignored


Click the “status” tab in Commonsto view application status

Follow “Show All Prior Errors” link to viewboth warnings and errors

<Obscured to protect PI privacy>


Sample WarningRemember, warnings can generally be ignored


Sample ErrorErrors must be corrected!


Submitting an Application– To correct errors:

• Log into Commons and locate your application.• Review error conditions that were identified during validation.• Within your application (the same file that you sent to the Office

of Research Services for submission), make whatever corrections are necessary, wherever appropriate.

• Check the “Changed/Corrected Application” box in block 1 of the SF424 (R&R) Cover component.

» When you check the Changed/Corrected Application box, Item 4C, “Previous Grants.gov Tracking ID” becomes a required field.

» In Item 4C, enter the Grants.gov tracking number for the previous application that you are correcting.

» Do not use the Changed/Corrected Application box to denote a submission of a revised or amended application. That will be indicated in item 8, Type of Application.



– Transmit the corrected application package back to the Office of Research Services for another attempt.

– The application will only be assigned for scientific review once errors are resolved.

– Important: if corrections are submitted after the due date/time, include an explanation about why the application is late in the Cover Letter Component.• The NIH is never under any obligation to accept

a late application – submit a late application only at your peril! See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-035.html.



– To address warnings:• In most cases, warnings can be ignored and no

action should be taken• The Office of Research Services will advise you

as to whether or not your particular warnings should be addressed.

• If warnings are corrected, process is identical to process for correcting errors


Checking an Assembled Application

– Review entire application– Assuming no errors were detected, the eRA

Commons system will:• Assemble the grant image• Generate a table of contents• Include headers (PI name) and footers (section name,

page numbers) on all pages• Imprint the Grants.gov tracking number, FOA number,

and date/time on each page

– Application not considered received by NIH until you see the application image in Commons

• If you can’t see it, the NIH can’t see it either


<Obscured to protect PI privacy>

View the application image by clickingon the Application ID


Then, click on the e-Application link to view the image


Be sure to review entire application carefully; your application is not

considered received by the NIH until you see this image in Commons


Checking an Assembled Application

– If errors in the “translation” between Grants.gov and Commons are discovered, it is possible to request that SO “reject” the application

• SO has a 2 weekday viewing window to reject an application that has system formatting errors

– Note that the NIH has indicated that this “window” will soon disappear;– Even though the “window” exists for now, if the application is submitted after the deadline,

IT IS STILL CONSIDERED LATE.

• If the application is not rejected within the 2 weekdays it will automatically proceed to Receipt & Referral

• Weekdays include holidays

• The option to ask the SO to “reject” the application should be used cautiously, and only to correct system formatting problems. It should not be used as an opportunity for PI to make additional changes to application.

– As the NIH states, “the AOR/institution is expected to enforce that application changes made within the window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.”

• Once rejected, follow the steps for correcting errors described previously


Lessons Learned– Work closely with:

• Your Departmental Administration: Be sure you’re aware of departmental policies, procedures, and deadlines.

• The Office of Research Services to ensure a streamlined internal process flow (review, approval, document sharing, etc.)

– Register now to be prepared• All PIs, fellows, postdocs, sponsors on fellowship grants,

and graduate students need to be registered in eRA Commons – and everyone should be registered

– Read and follow all instructions in the FOA and in the Application Guide:

• http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf


Lessons Learned– Beware of the most common mistakes:

• All attachments must be in .pdf format• File names should:

– Contain no more than 50 characters– Include no “special characters”, such as dashes or the “&”

symbol

• The .pdf files should not be write-protected• Each attached .pdf, as well as the overall application file,

should be virus-checked• Include the PI’s “credential” in the personnel section.

This is his or her Commons ID.• A comprehensive list of frequently-seen errors and

warnings is available here: http://www.lsuhsc.edu/administration/academic/ors/docs/common_errors_and_warnings.pdf


Overview (Review)


Overview (Review)


Coping with Time Constraints

We recognize that time constraints play a major role in investigators’ ability to successfully submit grant applications.

Our experience and conversations with successful investigators tell us that the key is breaking down each task into smaller bites.

To assist you, we’ve prepared the following sample six-month, week-by-week breakdown of what needs to happen to submit an NIH grant application via Grants.gov.

If your application is due June 5…

• January 1: make sure you are registered in eRA Commons.

• January 8: Create outline for your specific aims, significance, innovation, and approach sections.

• January 15: Verify compatibility of Adobe software.

• January 22: Write “Specific Aims” section



• January 29: Locate FOA and download instructions/application package.

• February 5: Write “Significance” section

• February 12: Create “shell” application, with at least administrative fields completed.

• February 19: Write “Innovation” section



• February 26: Request budget information, letters of intent to establish consortium agreement, biosketches, etc. from subcontractors, if any.

• March 5: Draft “Approach” section.

• March 12: Develop biosketch and request biosketches from other key personnel.

• March 19: Write “Human Subjects” sections, if applicable.



• March 26: Write “Animal Subjects” section, if applicable.

• April 2: Write “Select Agent Research”, “Multiple PD/PI Leadership Plan”, and “Resource Sharing Plan(s) section(s), if applicable.

• April 9: Develop budget and justification.

• April 16: Write 3-sentence “Public Health Relevance/Project Narrative” Section.



• April 23: Finalize project title.

• April 30: Write “Abstract” section.

• May 7: Write “Resources” and “Equipment” sections.

• May 14: Request and receive letters of support.

• May 21: Complete application “shell” to include budgets and biosketches but not scientific portions.



• May 25: Route paper materials through ORS for approval.

• May 26: Write cover letter.

• May 27: Finalize all scientific sections, including “Approach”.

• May 28: Finalize “Bibliography & References Cited” section.

• May 29: Finalize application file by inserting scientific section documents.



• June 1: E-mail completed electronic application file to ORS personnel for submission via Grants.gov.

• June 2: Work with ORS to address any corrections requested by ORS.

• June 3: Receive several submission confirmation e-mails from Grants.gov and eRA Commons.



• June 4: Working with ORS, address any errors or warnings generated by submission.

• June 5: Celebrate successful submission.


Questions and Answers

Thank You!