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Updates from MUSC's Offices of Research Administration


NIH Notice NOT-OD-17-062

Notice NOT-OD-17-062 announced a transition from the current NIH grant application forms (“FORMS-D”) to the next iteration of forms (“FORMS-E”) for due dates on or after January 25, 2018.

Highlights of the new FORMS-E will include:

  • Consolidation of human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms
  • Expansion and use of discrete form fields for clinical trial information to
    • provide the level of information needed for peer review;
    • lead applicants through clinical trial information collection requirements;
    • present key information to reviewers and agency staff in a consistent format; and
    • align with ClinicalTrials.gov (where possible) and position us for future data exchange with ClinicalTrials.gov
  • Incorporation of recent Grants.gov changes to R&R Budget and SBIR/STTR Information forms

Application guides for FORMS-E application packages will be posted to the How to Apply - Application Guide page no later than October 25, 2017.

  • New FOAs posted before October 25, 2017 with initial due dates on or after January 25, 2018 will be posted without application forms. Application packages will be added to these FOAs by November 10, 2017.

All NIH "parent" announcements that use standard due dates will be expired and reissued with new FOA numbers, FORMS-E application packages and instructions. The FORMS-E parent announcements will be posted no later than 60 days before their standard due date. For a transition period, both FORMS-D and FORMS-E parent announcements will be active. Applicants must choose the announcement with the appropriate application package for their due date (see table below).

All active FOAs with due dates both before and after January 25, 2018 will be updated to add FORMS-E application packages between October 25, 2017 and November 25, 2017. For a transition period, both FORMS-D and FORMS-E application packages will be active. Applicants must choose the appropriate application package for their due date when presented with both FORMS-D and FORMS-E application packages on the same FOA (see table below).

If your due date is…

You must use…

On or before January 24, 2018, including:

  • Applications submitted for due dates on or before January 24, 2018
  • Applications submitted under NIH Late Policy 2-week window of consideration for intended due dates on or before January 24, 2018
  • Applications submitted by February 7, 2018 under NIH Continuous Submission Policy for January 7, 2018 AIDS intended due date

FORMS-D application package

On or after January 25, 2018, including:

  • Applications submitted for due dates on or after January 25, 2018
  • All application types (New, Resubmission, Renewal, Revision)
  • Applications submitted early for intended dues dates on or after January 25, 2018

FORMS-E application package

Additional guide notices for individual FOAs with unique due date considerations will be issued as needed and referenced in the Related Notices section of each FOA.

Form Update Timing for Administrative Supplement, Successor-in-Interest (Type 6) and Change of Institution (Type 7) Parent Announcements

Parent announcements for administrative supplements and post award administrative actions (successor-in-interest and change of institution applications) do not have set due dates and, consequently, will follow a different timeline than other parent announcements.

The FOAs in the table below will be reissued with new FOA numbers, FORMS-E application packages and instructions on January 25, 2018. Applications started on or after January 25, 2018 must use the new FOAs and FORMS-E application packages.

These FOAs will expire on February 25, 2018 giving applicants one month to complete their initiated FORMS-D applications.

 FOA#

FOA Title

 PA-16-285

 Change of Grantee Organization (Type 7 Parent)

 PA-16-286

 Successor-in-Interest (Type 6 Parent)

 PA-16-287

 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Admin Supp)

 PA-16-288 

 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)

 PA-16-289

 Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp)

 

Applications Proposing Clinical Trials

As previously announced, all applications involving clinical trials must be submitted to FOAs specifically designed for clinical trials beginning with due dates on or after January 25, 2018 (NOT-OD-16-147, NOT-OD-17-043).

NIH will take the following steps to accommodate this new policy:

  • Issue new clinical trial FOAs with clinical trial-specific review criteria, FORMS-E application packages, and FORMS-E instructions for due dates on or after January 25, 2018
  • Add a new "Clinical Trials" item to the table in Section II of all FOAs (just below "Application Types Allowed") which will include one of the following statements:
    • Only accepting applications that propose clinical trial(s)
    • Only accepting applications that do not propose clinical trials
    • Accepting applications that either propose or do not propose clinical trial(s)
  • Expire existing (FORMS-D) clinical trial FOAs by January 24, 2018

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