Important NIH Notices – News & Announcements

Dear Colleagues:

The following summaries of NIH Guide Notices may be of interest to faculty and researchers. Please review and forward to faculty, researchers and others, as appropriate.

Questions regarding these notices should be directed to your assigned Contract and Grant Officer.

Update to NIH Management of Genomic Summary Results Access
(NOT-OD-19-023) National Institutes of Health

NIH is committed to maximizing public benefit from genomic information generated through NIH-supported research in a manner consistent with current scientific and ethical considerations. In support of this goal and the promotion of scientific advances while protecting research participants’ privacy interests, NIH is updating its data management procedures under the GDS Policy to allow unrestricted access to GSR from most NIH-supported studies for health or research purposes. NIH anticipates that this updated GSR access model will be appropriate for the majority of genomic datasets available through NIH-designated data repositories under the NIH GDS Policy (e.g., dbGaP), and that it will thereby reduce the need to request controlled-access to individual-level genomic data unless it is necessary to address specific research questions. For more information, please see the detailed message that was forwarded to members on this list on 11/13/18.

Revised Process for SBIR/STTR Life Cycle Certifications
(NOT-OD-19-025) National Institutes of Health

The SBIR and STTR Policy Directives require that small businesses certify at certain milestones that they are meeting the program’s requirements during the life cycle of the funding agreement. The Life Cycle Certification is intended to ensure ongoing compliance of the awardee with the assurances it provided in the Funding Agreement Certification prior to award. SBIR and STTR awardees indicate compliance with these certification requirements included in the terms and conditions of award by drawing or requesting funds from the Payment Management System (PMS). NIH, CDC, and FDA did not previously require recipients to submit the actual certifications but rather complete and maintain them within their official files in accordance with the records retention policy in Section 8.4.2 of the NIH Grants Policy Statement.

The purpose of this Guide Notice is to announce that NIH is updating its policy to collect all Life Cycle Certification forms consistent with the SBIR and STTR Policy Directives. Effective January 1, 2019, NIH will require the submission of all SBIR/STTR Life Cycle Certification forms in each Interim and Final Research Performance Progress Report (I-RPPR and F-RPPR) submitted for SBIR/STTR grant awards. This update is also relevant for CDC and FDA SBIR awardees. See full notice for more information.

Notice of Clarification Regarding Letters of Support for PAR-17-025, “Aging Research Dissertation Awards to Increase Diversity (R36)”
(NOT-AG-18-037)
National Institute on Aging

The purpose of this Notice is to clarify the application instructions regarding letters of support for PAR-17-025, “Aging Research Dissertation Awards to Increase Diversity (R36)”. Diversity eligibility letters do not need to be submitted as a separate attachment. See full notice for additional information.

Request for Information (RFI): Soliciting Input on Priorities and Progress in Alzheimer’s Disease-Related Dementias Research
(NOT-NS-19-011)
National Institute of Neurological Disorders and Stroke
National Institute on Aging

The purpose of this time-sensitive Request for Information (RFI) is to seek input from scientists, clinicians, patients, families, caregivers, advocates, and the broader dementia community on the most important needs and promising opportunities for Alzheimer’s disease-related dementias (ADRD) research. See full notice for additional information.

Notice of Change to PAR-18-952 Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R03 Clinical Trial Not Allowed)
(NOT-TR-19-011)
National Center for Advancing Translational Sciences

The purpose of this notice is to update the funding opportunity instructions to read as, “No studies aimed at determining the safety, pharmacokinetics, efficacy, or effectiveness of an intervention (drug, biologic, device, etc.) in humanswill be supported through this mechanism.”

Notice of Change to PAR-18-953 Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
(NOT-TR-19-012)
National Center for Advancing Translational Sciences

Notice Announcing Frequently Asked Questions Page and Webinar for PA-18-932 “Increasing Uptake of Evidence-Based Screening in Diverse Adult Populations (R01 Clinical Trial Optional)”
(NOT-OD-19-027) Office of Disease Prevention

The FAQ document for this FOA is now posted. Additionally, an informational webinar will be held on December 4, 2018, from 1:00pm to 2:00pm (Eastern Time) for all prospective applicants interested this program announcement. During the webinar, staff from the NIH will provide an overview of the FOA and answer questions from prospective applicants. See the full notice for more details, including registration information.

Harassment and Discrimination Protections in NIH Training Applications
(NOT-OD-19-029) National Institutes of Health

The purpose of this notice is to inform applicants for NIH’s institutional training grants (T15, T32, T34, T35, T36, T37, T90/R90, TL1, TL4) of a new mandatory requirement to include a letter on institutional letterhead signed by a key institutional leader that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices. This letter should be combined with all other Letters of Support as one single PDF file in the application. This policy applies to applications submitted for due dates on or after January 25, 2019. See the full notice for more details on this new requirement. Additional information regarding UCI’s implementation of this policy will be disseminated at a later date.

Notice of Legislative Mandates in Effect for FY 2019
(NOT-OD-19-030) National Institutes of Health

The Department of Defense and Labor, Health and Human Services, and Education Appropriations Act for fiscal year 2019 was signed into law on September 28, 2018 and provides funding to NIH for the fiscal year ending September 30, 2019. The Act also lists 12 limits / conditions that remain in effect for the use of funds on NIH grant, cooperative agreement, and contract awards for FY 2019. For example, Salary is limited in that none of the funds appropriated can be used to pay the salary of an individual at a rate above the Executive Level II ($189,600). See notice for a complete list of all limitations and conditions.

Notice of Changes to RFA-AG-19-020 “Clinical Trial on Effects of Statins in Older Adults without Clinical Cardiovascular Disease (U19 Clinical Trial Required)”
(NOT-AG-18-038)
National Institute on Aging
National Heart, Lung, and Blood Institute
National Institute of Neurological Disorders and Stroke

This Notice is being issued to inform potential applicants of changes to the referenced Request for Applications due to an increase in NIA funding commitments. Specifically, revisions have been made to the key dates, scope, funds available and anticipated number of awards, award budget, and application instructions. See full notice for more details about these changes.

Addition of SBIR Direct-to-Phase II Program to PAR-18-588, Assistive Technology for Persons with Alzheimers Disease and Related Dementias and Their Caregivers (R43/R44 Clinical Trial Optional)”
(NOT-AG-18-042)
National Institute on Aging

This application is being amended to allow the ‘Direct-to-Phase II’ SBIR award phase flexibility to apply to this Application Request.

Addition of SBIR Direct-to-Phase II Program to NIA PAS-18-187, “Advacing Research on Alzheimer’s Disease (AD) & AD-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)”
(NOT-AG-18-043)
National Institute on Aging

This application is being amended to allow the ‘Direct-to-Phase II’ SBIR award phase flexibility to apply to this Application Request.

Notice of Updated Application Forms Package for NIBIB Supplements to NCATS CTSA Programs to Support NIBIB Translational Research Scholars (Admin Supp Clinical Trial Optional)
(NOT-EB-18-033)
National Institute of Biomedical Imaging and Bioengineering

This Notice is to advise that the application forms package originally posted with this FOA included inappropriate forms. A new application forms package has been posted in Grants.gov identified by a Competition ID of ‘FORMS-E-REVISED’. If you initiated an application using the original (FORMS-E) package, you must move the application information to the FORMS-E-REVISED application package to successfully submit. If you are not sure which application package you are using, review this resource.

Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to NIH FOA PA-17-147
(NOT-MH-18-070)
National Institute of Mental Health

This application is being amended to allow the ‘Direct-to-Phase II’ SBIR award phase flexibility to apply to this Application Request.

Notice of Expiration of PA-18-474 “Self-Management for Health in Chronic Conditions (R15 Clinical Trial Not Allowed)”
(NOT-NR-18-023)
National Institute of Nursing Research

The purpose of this Notice is to alert potential applicants to the early expiration of PA-18-474. NINR will no longer accept applications for this FOA after the January 8, 2019 expiration date.

Notice of NINDS Policy for Submission of Applications to PA-19-055 “NIH Research Project Grant (Parent R01 Clinical Trial Required). NINDS Only accepts Clinical Trial Applications Proposing Mechanistic Studies for Clinical Trial Parent R01
(NOT-NS-19-012)
National Institute of Neurological Disorders and Stroke

The purpose of this Notice is to announce NINDS’s policy for submission of applications to PA-19-055 “NIH Research Project Grant (Parent R01 Clinical Trial Required).” Note that NINDS will only accept applications to the NIH Research Project Grant (Parent R01 Clinical Trial Required) Funding Opportunity Announcement (FOA) and its reissues that propose human mechanistic trials/studies that meet NIH’s definition of a clinical trial and that fall within the NINDS research priorities. See full notice for additional information.

Notice of Change in Key Dates in RFA-NS-18-026 “NINDS Morris K. Udall Centers of Excellence for Parkinson’s Disease Research (P50 Clinical Trial Optional)”
(NOT-NS-19-015)
National Institute of Neurological Disorders and Stroke

The purpose of this notice is to advise of revisions to Key Dates. See full notice for all revised dates.

Notice of Change in Key Dates in RFA-NS-18-027 “Exploratory Grant for NINDS Morris K. Udall Parkinson’s Disease Research Center Without Walls (P20 Clinical Trial Optional)”
(NOT-NS-19-016)
National Institute of Neurological Disorders and Stroke

The purpose of this notice is to advise of revisions to Key Dates. See full notice for all revised dates.

Notice of Correction to Key Dates for RFA-NS-19-002 “BRAIN Initiative: Team-Research BRAIN Circuit Programs – TeamBCP (U19 Clinical Trial Required)”
(NOT-NS-19-018)
National Institute of Neurological Disorders and Stroke

The purpose of this notice is to advise of revisions to Key Dates. See full notice for all revised dates.

Notice of Correction to Key Dates for RFA-NS-19-003 “BRAIN Initiative: Team-Research BRAIN Circuit Programs – TeamBCP (U19 Clinical Trial Not Allowed)”
(NOT-NS-19-019)
National Institute of Neurological Disorders and Stroke

The purpose of this notice is to advise of revisions to Key Dates. See full notice for all revised dates.

Notice of Change to PAR-18-940 Clinical and Translational Science Award (U54 Clinical Trial Optional)
(NOT-TR-19-010)
National Center for Advancing Translational Sciences

This Notice amends PAR-18-940 with updates to the Key Dates, Informatics component, Network Capacity component, and Institutional Career Development Award component. See full notice for details.

Notice of Change in Receipt Date for the Emerging Global Leader Award (K43) (Independent Clinical Trial Not Allowed)
(NOT-TW-18-009)
John E. Fogarty International Center
National Human Genome Research Institute

The purpose of this Notice is to advise of the change in Application Due Dates for PAR-17-001. See full notice for revised due dates.

Sandra M. Stevens

Associate Director, Sponsored Projects