Enhancements and Validations in Development

Important:  We post our plans for upcoming enhancement and fixes well in advance of their delivery to help system-to-system service providers plan for their own development efforts. We try our best to keep these documents current as our plans evolve. Please keep in mind that these are *draft* documents and are subject to change at any time. 

Which opportunities are processed by NIH eRA systems/services?

We process applications posted in Grants.gov under the following Grants.gov agency codes:

  • HHS-NIH11
The XML Extract Link to Non-U.S. Government Site - Click for Disclaimer that Grants.gov publishes daily includes agency code ("HHS-NIH11") and agency name ("National Institutes of Health") information. Although NIH posts all opportunities under the same agency code and agency name, others may have one agency name used for multiple agency codes.

FORMS-E Implementation

Most draft documents from the FORMS-E implementation were finalized and moved to our main System-to-System page early in 2018.

In January 2018 we added an ASSIST option for users to pre-populate parts of a human subjects/clinical trials study record from information in ClinicalTrials.gov based on an NCT number provided in field 1.5 of the PHS Human Subjects and Clinical Trials Information form. The following document may still be of interest to folks who want to implement a similar feature within their services.  

Validation changes:

Draft validations document - 11-16-2018

Change Target Date in UAT Target Date in Production
Update trigger for the following human subjects validation:
  • 034.6.1 (2.1 Conditions or Focus of Study)
  • O34.6.2 (2.2 Eligibility Criteria)
  • 034.6.3 (2.3 Age Limits Minimum Age)
  • 034.6.4 (2.3 Age Limits Maximum Age)
  • 034.6.8 (2.3 Study Timeline attachment)
  • 034.6.11 (2.3 Age Limits Minimum Age)
  • 034.6.12 (Age Limits Maximum Age)
Now Dec. 12
In order to accommodate the special needs of PA-18-936 (Admin Supplements to recover losses due to Harvey/Irma/Maria) we must reduce the severity of the following rules from errors to a warnings to allow for funded extensions beyond the awarded project period.  
  • 001.6.10 (verifies Federal Identifier is known to NIH, awarded and proposed project period of supplement is within the awarded period of parent)
  • 001.6.14 - this rule is redundant and will be disabled (was rolled into 001.6.10 when severity was raised from a warning to an error a while ago)
Update 10/24/2018: eRA Team discovered a separate check in eSubmission which blocks the workaround. Returning to Errors and addressing in different way.
Now Reduced to warnings: Oct. 3
Returned to errors: Oct. 24
Remove validations that prevent the use of human subjects exemption codes 7 and 8.
  • Disable 004.3.6 (Other Project Info form - error if exemption 7 and/or 8 is used)
  • Disable 034.5.6 (HSCT form - error if exemption 7 and/or 8 is used)
Now Dec. 12
Our ability to make Direct-to-Phase II SBIR awards was recently reinstated. Validations will be adjusted to take advantage of the Direct Phase II checkbox on the FORMS-E SBIR/STTR form. 
  • Disabled rule 023.20.2 (Warning if Direct Phase II selected)
  • Added rule 023. 20.19 (Error if applicant selects Application Type as “RENEWAL” on the SF424 R&R Cover AND selects Direct Phase II on the SBIR/STTR form)
Now Dec. 12
Additional small business application validations
  • Added rule 023.20.18 (warning if applicant selects Application Type as “New” on the SF424 R&R cover AND selects Phase II B on the SBIR/STTR form)
Now Dec. 12
The RL1 activity code was previously only awarded as a disaggregated piece of a U54 submission, but we plan to accept standalone RL1 applications soon and need to define application processing validations.
  • 001.42.4 (project period limited to 5 years)
  • 001.42.5 (project period limited to 5 years exception)
  • 020.52.1 (direct cost at or below $25K must use modular budget)
  • 010.3.4 (research strategy limited to 12 pages)
  • 010.3.5 (research strategy page limit exception)
Now Dec. 12
The following G08 validations were reduced from errors to warnings and the message was changed to append the text "unless otherwise stated in the opportunity announcement". Will remain warnings until further notice.
  • 020.87.1 and 022.96.1 (One budget period submissions must be less than or equal to $100k)
  • 020.87.2 and 022.96.2 (Two budget period submission must be less than or equal to $200K)
  • 020.87.3 and 022.96.3 (Three budget period submission must be less than or equal to $300K)
Now Now
New rule 014.6.3 (Progress report publication list is required when a submission is a resubmission of a renewal)

Resubmission of Renewal: Last submission would be a type 2
Now Dec. 12
New rule 034.8.17 (Provide error for a Study record  if response to masking is “Yes”, but Participant, Care Provider Investigator, Outcomes Assessor is not, selected) Now Dec. 12
We expect the page limits and validation messages to be changed for the following rules to accommodate a soon to be announced policy change.
  • 024.59.2 (Fellowship Supplemental form,  Description of Institutional Environment and Commitment to Training attachment)
    • Page limit change from 2 to 3 pages
    • Validation message (024.59.2) change to: The Description of Institutional Environment and Commitment to Training attachment on the PHS Fellowship Supplemental Form is limited to three (3) pages.
  • 013.9.2 (Career Dev Supplemental form,  Description of Institutional Environment attachment)
    • Page limit change from 1 to 2 pages
    • Validation message (013.9.2) change to: The Description of Institutional Environment attachment on the PHS 398 Career Development Award Supplemental Form is limited to two (2) pages.
TBD ~Jan. 14 for first use for Feb. 11, 2019 due date

Update 11/19/2018: on hold until all approvals are in place
Our authority for the Commercialization Readiness Program was also reinstated. Additional SBIR/STTR validation changes expected. 
  • Analysis underway


Known Issues That are Not Yet Scheduled

  • Image service - the image created for a single component of a multi-project application currently includes biosketch attachments. In multi-project applications, biosketches are only included as a summary in the full application image and should not display with components. Fix to remove bioseketches from component image is planned, but not yet scheduled. (Fix not yet scheduled)
  • Cosmetic issues for preview IER in PHS Human Subjects and Clinical Trials Information form (a few border lines missing) - change to Submission Image Library web service (SIL) needed

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