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Office of Orphan Products Development
Grants Program

Grant Application Receipt Dates:
For FY 2009 - 02/06/08
For FY 2010 - 02/04/09 


Updates may still be coming so please check back periodically and with the www.grants.gov page for more instructions.

To comply with the President’s Management Agenda, the Department of Health and Human Services is participating as a partner in the new government-wide Grants.gov Apply site.  Users of Grants.gov will be able to download a copy of the application package, complete it off-line, and then upload and submit the application via the Grants.gov site.  When you enter the Grants.gov site, you will find information about submitting an application electronically through the site. 

The Center for Orphan Program Development (OPD), Catalog of Federal Domestic Assistance (CFDA) number 93.103, is one of the programs included in the project.  The Food and Drug Administration (FDA) is accepting applications for this program electronically via Grants.gov.  Applicants are strongly encouraged to apply electronically by visiting the website http://www.grants.gov and follow the instructions under “APPLY.”  All application documents may be submitted electronically.  We strongly recommend that you do not wait until the application deadline date to begin the application process through Grants.gov.

To Use Grants.gov

Applicants must have a DUNS number and register with in the Central Contractor Registry (CCR) in order to submit an application.  Information about CCR is available at www.grants.gov/CCRRegister.  Applicants should allow a minimum of five (5) days to complete the CCR registration.

The applicant must also register with the Credential Provider for Grants.gov.  Information about this requirement is available at www.grants.gov/CredentialProvider

Electronic submission requires institutions to register with Grants.gov and NIH eRA Commons (Grants.gov registration; eRA Commons registration). The eRA Commons component is new for February 2008 submissions.  Principle Investigators (PIs) also will need to make sure they are registered with the eRA Commons (Creating PI Account).  Registration can take 2-4 weeks so start early.

Outline of Process for Electronic Application Submissions

FDA grant submission process for grants.gov is similar to the NIH process.  The following steps, as described on the NIH website, mirror our process and provide clarification.

1. Do your homework. Take the time to understand the process. Electronic submission involves two separate systems working together – Grants.gov and eRA Commons.  Review Helpful Hints below.

2.  Develop a submission plan. Institution administrators and principal investigators should work together to come up with a submission plan. Think about:

      Who will be responsible for completing the different forms within the application?
      When must the forms be completed in order to allow time for the actual submission?

3.  Prepare to submit. Electronic submission requires institutions to register with Grants.gov and NIH eRA Commons (Grants.gov registration; eRA Commons registration). Principle Investigators (PIs) also will need to make sure they are registered with the eRA Commons (Creating PI Account).
Registration can take 2-4 weeks – start early! The registration process can start immediately, so please do so.

4.  Verify successful submission. Your Authorized Organization Representatives submits your SF424 (R&R) application to Grants.gov. The FDA will retrieve your application and process it into our own electronic system, the eRA Commons.  Part of that process includes actually assembling the data and PDF attachments submitted into a cohesive application. You will be able to login to eRA Commons to see if any “errors” or “warning” were identified for your submission. An application must be error-free to complete the electronic submission process.

5.  See Check Submission Status for details. You are responsible for checking eRA Commons to ensure successful submission of your application. 

6.  View your assembled application. Once an error-free application is received, FDA holds that application for two days (Monday-Friday, excluding Federal holidays) to allow submitters and PIs a chance to view the final assembled application in eRA Commons. This is your first opportunity to see the application just as a reviewer will see it – take advantage of it.  See Check Assembled Application for details.

Other Information

FDA may request original signatures be provided at a later date.

If you experience technical difficulties with your online submission, you should contact either the grants.gov Customer Response Center http://www.grants.gov/contactus/contactus.jsp or Marc Pitts, Grants Management Specialist (Phone:  301-827-7162; E-Mail:  marc.pitts@fda.hhs.gov) as per the announcement for this program posted in the Federal Register.

Upon submitting an application, the applicant will receive an acknowledgement from Grants.gov which contains a Grants.gov tracking number.

You may not e-mail an electronic copy of a grant application to FDA. 

Please note that applicants may locate the downloadable application package for this program by the CFDA number or Grants.gov funding opportunity number, which can be found at Grants.gov under “FIND.”

Applicants will also need to download and install the PureEdge Viewer program. This small, free program will allow the applicant to access, complete, and submit applications electronically and securely.


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