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Announces the launch of a new eRA system to manage human subjects and clinical trials information. HSS will replace the existing Inclusion Management System (IMS) and will be used by NIH staff, grant applicants, and recipients as of June 9, 2018.
Note that grantees are required to complete any in-progress enrollment records by June 8. If they are working on their RPPR on or before June 8, they will be unable to submit any in-progress inclusion data until the entire RPPR is submitted. In this situation, they should plan to submit the entire RPPR by June 8 or wait until June 9 to enter inclusion data in the new system. Records that have not been submitted by June 8, 2018 will not be available in the Human Subjects System and will need to be re-entered. For more information please see NOT-OD-18-179.
For training videos and other resources, see the eRA intranet page on HSS.
Establishes stipend levels for FY18 Kirschstein-NRSA awards for undergraduate, predoctoral, and postdoctoral trainees and fellows and announces increases in the institutional allowance for postdoctoral trainees and fellows. For more details please see NOT-OD-18-175.
Details policies on FY 2018 funding levels, NRSA stipend levels, how we are prioritizing applications from early stage investigator (ESI) principal investigators, 2018 salary limits, and more. For more details please see NOT-OD-18-180.
Transition from Inclusion Management System to New Human Subjects System (HSS) as of June 9, 2018
Additional Awards Eligible for PA-18-586 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)
Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2018
OER is launching a new eRA system to manage human subjects and clinical trials information. This Human Subjects System (HSS) will replace the existing Inclusion Management System (IMS) and will be used by NIH staff, grant applicants, and recipients as of June 9, 2018. To learn more, see our:
Clarification of NIHs Policy Regarding a Change in Program Directors/Principal Investigators Status
Update on Additional Awards that Permit Eligibility for K01, K08, K23, and K25 Career Development Awards
Career Award (K) Policy Update: Temporary Adjustments to Percent Effort or Part-Time Institutional Appointment
Career Award (K) Policy Update: Concurrent Support from a Mentored K Award and a Research Grant
Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests
NOT-OD-18-133 Beginning with RPPRs due on or after October 1, 2019 and applications submitted for due dates on or after January 25, 2020, NIH anticipates that it will mandate that required training data tables submitted with T32, TL1, T90/R90, and T15 applications and progress reports be created via the xTRACT system. Learn more about xTRACT.
NOT-OD-18-128 This notice clarifies application instructions to be clear the human subject form is not available in most training grant application packages (except for D43 and K12) and indicates that, while not required, applicants can provide additional information regarding potential or current involvement of appointed trainees in human subjects research in the Proposed Training section of the Program Plan attachment on the PHS 398 Research Training Program Plan form.
This notice reminds all participants in the NIH peer review process of possible consequences that may ensue and actions that the NIH may take in response to a breach of integrity in peer review. See NOT-OD-18-115.
If you missed in, you may be interested in the Open Mike blog post about a recent peer review issue.
Unfortunately, the FORMS-E application instructions are not quite accurate. As this notice indicates, most training grant applicants that answer “yes” for human subjects do not need to provide additional information. If they choose to they can put addition information regarding potential or current involvement of appointed trainees in human subjects research in the "Proposed Training" section of the Program Plan. See NOT-OD-18-128
Please help us spread the word to applicants. NOT-OD-18-126
Revises NIH policy and guidelines on the Inclusion of Children. Changes to the policy include (1) the applicability of the policy to individuals of all ages, including children and older adults; (2) clarification of potentially acceptable reasons for excluding participants based on age; and (3) a requirement to provide data on participant age at enrollment in progress reports. The policy applies to competing grant applications for due dates on or after January 25, 2019. Ongoing, non-competing awards will not be expected to comply with this policy. For R&D contracts, the policy will apply to all solicitations issued on or after this effective date. See NOT-OD-18-116
NIH is removing the funding pause on the provision of new or continuation funding for gain-of-function research projects. NIH will continue to accept applications for research projects including studies that are reasonably anticipated to create, transfer or use enhanced potential pandemic pathogens and will identify meritorious research applications meeting the scope of the HHS P3CO Framework for a multidisciplinary, department-level review prior to any funding decision. See
Interested in “playing” with a sample FORMS-E application package to become familiar with the new application forms including the PHS Human Subjects and Clinical Trials form? You’re in luck! eRA has provided a non-production ASSIST sandbox. See attached instructions for creating accounts and using the sandbox and FORMS-E test opportunities representing various grant programs.
Unfortunately, we are unable to provide production credentials to allow you to check out actual published FOAs in ASSIST. This Grants.gov “How Do I Preview Forms in a Grant Application” video, which only runs 53 seconds, details steps you can take to preview (in a read only format) the forms posted for a specific production FOA.
Do you work on R&D contracts involving human subjects? If so, learn about the requirements for contract officers, contract officer representatives, contractors and others on a new intranet page dedicated to this topic.
Program officials should help PIs understand that these outcomes should:
- Be written for the general public in clear and concise language
- Be suitable for dissemination to the general public
- Not include proprietary, confidential information or trade secrets
- Not be more than half a page
See NOT-OD-18-103 for more info.
Encourage applicants to submit early to allow time to work through any unforeseen issues! See NOT-OD-18-009
It was reported that Grants.gov was experiencing technical issues impacting applicants’ ability to access application packages, submit, check status of a submission and access their website today. These issues impacted NIH’s ability to process applications and some features in ASSIST. It appears that service to Grants.gov has been restored and NIH is now processing all submitted applications. These issues may have been related to a wider Internet issue. If you get questions, please advise applicants that if any issues with Federal systems impact the ability to submit on time to NIH due dates, the applicant must document the issue with the eRA service desk by the application deadline. See dealing with system issues.
The new version is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2017. Previous versions of the NIHGPS remain applicable as a standard term and condition for all NIH grants and cooperative agreements with budget periods that began prior to October 1, 2017. See NOT-OD-18-005
To protect the credibility of published research, authors are encouraged to publish papers arising from NIH-funded research in reputable journals. Look for an upcoming Open Mike blog on this topic. See NOT-OD-18-011.
Provides information about upcoming funding opportunity announcements and explains support for independent clinical trials and clinical trial research experience for these applicants. See NOT-OD-18-001
NIH will be issuing these announcements in November 2017 for applications targeting due dates on or after January 25, 2018. NOT-OD-18-010
Guidance for applicant and grantee institutions in the U.S. Virgin Islands and Puerto Rico. See NOT-OD-18-002
These notices detail the additional review criteria that NIH will apply for clinical trial applications for due dates on or after January 25, 2018, and applications in which trainees, fellow, or career development awardees propose to gain research experience in an ongoing clinical trial led by a mentor or co-mentor. The review criteria for clinical trials page is also available on the extramural staff intranet.
Consistent with NIH practices over the last decade, NIH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). Upward adjustments to awarded levels will be considered after FY 2018 appropriations are enacted. See NOT-OD-17-124.
Reminding the community that when delays occur because the applicant or recipient organization is officially closed due to a natural disaster or other emergency, the NIH will consider accepting applications late, on a case-by-case basis, in certain circumstances. See NOT-OD-17-113
This notice announces additional review criteria that NIH will apply to clinical trial applications for research projects submitted to due dates on or after January 25, 2018. See NOT-OD-17-118
Language in published FOAs (with the exception of clinical trial FOAs and parent announcements) with due dates after January 25 is being updated to reflect clinical trial allowability, FORMS-E, and select other information. Updates will be completed by October 6. See NOT-OD-17-114
The NIH Policy on the Use of a sIRB for Multi-Site Research becomes effective for applications with due dates on and after January 25, 2018. This public webinar addresses the implementation of the NIH Single IRB Policy, how to write the single IRB plan, and how to request an exception. See NOT-OD-17-120
This notice provides additional detail on the special considerations being given to impacted institutions, including: information on late application submissions, post-submission materials, salary payments, and financial and progress reporting. See NOT-OD-17-111
To increase the protection of privacy of research participants, as of October 1, 2017, NIH funded researchers who are who are collecting identifiable, sensitive information as part of their NIH funded research will automatically be issued a CoC as part of the term and condition of their award. There is no need for them to apply for a CoC. Compliance with the privacy protections afforded by the CoC is also a term and condition of award. All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this policy is issued a Certificate through this policy. See NOT-OD-17-109
See: Open Mike Blog on the Updated Case Studies to learn about the types of topics that got further clarified (yes, case study 18 is one of them!)
Expect these resources to continue to evolve as we get additional feedback and questions.
As you continue to reach out to your grantees and contractors about the clinical trial changes, remember to refer back to the Clinical Trial Communications Toolkit for the latest versions of resources. Corrections have recently been made to fix typos on presentations and the flier, and we continue to update the resources regularly.
Newly added: Presentation on NIH Clinical Trial Reforms. Why the Changes?
This notice announces a new policy implementing special funding consideration for early and mid-career (early established) investigators. See policy summary below. This policy supersedes previous notices on new and early stage investigators. We anticipate that ICs will seek to fund other more senior investigators who are new to the NIH system through specific programs as well as select pay. Read more in the Open Mike blog on the policy and Open Mike blog on Data on Trends According to Career Stage. Note that NIH’s website on new investigators has been replaced with Early Stage and Early Investigator Policies (there is a redirect from the old page to the new one). See NOT-OD-17-101 for more information.
When delays occur because the applicant or recipient organization is officially closed due to a natural disaster or other emergency, the NIH will consider accepting applications late. Read more about NIH responses to natural disasters in the Open Mike blog on Monitoring the Impact of Hurricane Harvey on Research. See NOT-OD-17-106
This notice clarifies and updates the guidance on full-time training. See NOT-OD-17-095
This notice describes when it is allowable for a recipient institution to supplement the NIH salary contribution on K awards. See NOT-OD-17-094
Since clinical trial-related materials will be required in the new PHS Human Subjects and Clinical Trials Information Form, they will no longer be allowed in the Appendix for due dates on or after January 25, 2018 unless specifically stated as required in the funding opportunity announcement. See NOT-OD-17-098
The NIH Fiscal 2017 eRA End of Year deadline dates have been established. Wednesday, September 27, is the last day to release FY 2017 awards, supplements and revisions for additional funds in IMPAC II. The End of Fiscal Year Grants Calendar and Frequently Asked Questions are now posted on the Resources page. For additional reference, visit the new NIH–wide Combined Year-end Communications SharePoint Site.
We are updating our application forms to FORMS-E for due dates of Jan 25, 2018 and beyond. FORMS-E includes a brand new form. Check it out using the resources below.
· Video tour of the new Human Subjects and Clinical Trial Information form on YouTube. - public
· Preview of FORMS-E Grant Application Form Changes - public
· Annotated Form Set for NIH Grant Applications - FORMS-E Series - public
· Draft Instructions for the Human Subjects and Clinical Trial Information form - staff only
You can! Federal RePORTER is a searchable database of science award information that enables studies of the portfolio of federal science investments. While it is currently updated annually, its database of ~900,000 projects from 17 agencies is a great resource. See the attached presentation given at the EPMC meeting this week to learn more!
Effective June 30, 2017, all SBIR/STTR Phase II final reports must be submitted through the eRA Commons using the Final RPPR rather than the Final Progress Report. See NOT-OD-17-085
This notice makes final what was previously interim guidance. Direct salary support is limited to Executive Level II of the Federal Executive pay scale. The Executive Level II salary was previously set at $185,100, and increased to $187,000 effective January 8, 2017. See NOT-OD-17-087
NIH is extending the effective date of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research to January 25, 2018. The policy will apply to all competing grant applications for due dates on or after January 25, 2018. For R&D contracts, the policy will apply to all solicitations issued on or after this effective date. See NOT-OD-17-076
Establishes stipend levels FY 2017 Kirschstein-NRSA awards for undergraduate and predoctoral trainees and fellows. See NOT-OD-17-084
Effective June 23, 2017, NIH will implement the requirement that foreign NGOs that agree not to perform or actively promote abortion as a method of family planning, or provide financial support to any other foreign non-governmental organization that conducts such activities, will remain eligible for global health assistance funding. See NOT-OD-17-083
Loan repayment programs have been announced for application period September 1 through November 15 (see NOT-OD-077 through NOT-OD-081).
Revision: Ruth L. Kirschstein National Research Service Awards (NRSA) Predoctoral Stipends, Training Related Expenses, Institutional Allowance, and Tuition/Fees Effective for Fiscal Year 2017
In April NIH announced that we will be moving to Forms-E for application submissions targeting due dates of January 25 and beyond.
- This week we walked the IC eSubmission Liaisons through the details of the form changes, timing of how the new forms will roll out, as well as the latest changes at Grant.gov etc. See the meeting summary for a detailed view of what is happening.
- If you are not yet familiar with the new Human Subjects and Clinical Trial Information Form and want to get a feel for it, check out the annotated form.
We thought you might be interested in this video of a presentation given by Dr. Mike Lauer, NIH Deputy Director for Extramural Research, at the recent NIH Regional Seminar, in which he shares his thoughts about applying a scientific approach to understanding NIH’s extramural program.
This notice provides the limitations on the use of funds on NIH grant, cooperative agreement, and contract awards for FY 2017. See NOT-OD-17-075 for more information.
NIH recently announced the Next Generation Researchers Initiative to enhance funding to early-stage and mid-career investigators and help stabilize and strengthen the biomedical research enterprise. This initiative shifts NIH’s approach away from the Grant Support Index to more directly support early-stage and mid-career investigators. We will be developing FAQs and issuing updated policies in the near future. In the meantime, learn more through:
NIH Director’s Statement
Next Generation Researchers Initiative Web Page
Presentation to the Advisory Committee to the NIH Director
Now citations to issued patents are allowable post-submission materials. For more information see NOT-OD-17-066.
Help us get the word out about the NIH Regional Seminar in Baltimore. Its a great way for investigators and administrators newer to NIH to learn the process and policies behind getting and managing NIH funding. See NOT-OD-17-073 for more information.
Dos and don’ts for the authentication plan for applicants proposing the use of established key biological and/or chemical resources. NOT-OD-17-068
Failure to submit complete and accurate progress and financial reports may affect future funding to the organization and may result in a delay of continued support. For more information see NOT-OD-17-074
Effective immediately, the NIH Office of Financial Management (OFM) will continue payment of grants and cooperative agreements to Federal departments and agencies through the Interagency Payment and Collection method (IPAC). See NOT-OD-17-052 for reference.
Request for Information on the Development of the FY 2019 Trans-NIH Plan for HIV-Related Research
This notice makes no changes to current policy; it simply consolidates 7 previous notices related to continuous submission to provide a single source for the policy. For more information see NOT-OD-17-042
Notice of Clarification on the Publication of the Final Rule on the Federal Policy for the Protections of Human Subjects (Common Rule)
NIH retains the renewal application policy and in order to do so, we will implement an Interim-RPPR policy to reduce administrative burden on grantees by not requiring an additional Final-RPPR if the renewal application is not funded. See NOT-OD-17-037 for more information.
The final rule is intended to enhance protections for human research participants, facilitate valuable research, and reduce burdens for investigators, research institutions, and Institutional Review Boards (IRBs). See NOT-OD-17-038 for more information.
Make plans to join NIH, HHS and your peers in New Orleans, Louisiana for this valuable and unique opportunity occurring May 3-5! See for more information.
Beginning in CY2017 the standard application due dates for F31 - Diversity applications will be the same as all other F Series Fellowship applications (April 8, August 8, and December 8). See NOT-OD-17-029 for more information.
The new policy eliminates most appendix material from grant applications. All allowable materials are listed in the notice. See NOT-OD-17-035 for more information.
Inauguration Day (January 20, 2017) Impact on NIH Grant Application Due Dates and Support. See NOT-OD-17-033 for more information.
We have updated the recommended font list and no longer require use of black text for applications submitted for due dates of Jan 25, 2017 and beyond. See NOT-OD-17-030 for more information.
NIH is extending the effective date of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research to September 25, 2017. These FAQs, as well as other resources related to the single IRB policy, can be found on the Office of Science Policy website. See NOT-OD-17-027 for more information
All FY 2017 awards previously issued using FY 2016 stipend levels will be revised to adjust stipends to the FY 2017 level. Appointments to institutional training grants that have already been awarded in FY 2017 must be amended to reflect the FY 2017 stipend levels once the training grant award has been adjusted by the NIH. For more information see NOT-OD-17-003.
The Final Research Performance Progress Report (F-RPPR) will replace the Final Progress Report (FPR) for closeout effective January 1, 2017. On or after that date, NIH will no longer accept FPRs. Transition to F-RPPR for SBIR/STTR awards will occur in a few months. Read more on NOT-OD-17-022
SRO’s, please be sure to use the newly updated NIH Reviewer Orientation and Reviewer Guidance on Rigor and Transparency, both updated just yesterday, and the Sex as a Biological Variable Decision Tree for Reviewers, from August, for the upcoming review round (for May 2017 council). These materials are available on the OER Consolidated List of Reviewer Documents.
OER’s Grants Information service desk answers thousands of general inquiries a year related to grants policies, processes, and funding opportunities on behalf of NIH. You may have noticed their contact information on funding opportunities, notices, and more. Unfortunately, scammers got a hold of our Grants Information phone number, requiring us to change it to 301-945-7573. We updated FOAs and notices posted in the NIH Guide for Grants and Contracts as well as OER websites. If you reference the Grants Info number on any of your resources, please note the change.
NIH seeks comments on data management and sharing strategies and priorities in order to consider: (1) how digital scientific data generated from NIH-funded research should be managed, and to the fullest extent possible, made publicly available; and, (2) how to set standards for citing shared data and software. More discussion on this topic may be found in the OD Office of Science Policy blog, Under the Poliscope, "The What and How of Data Sharing." For more information: NOT-OD-17-015
The newly revised NIH Grants Policy Statement (NIHGPS) applies to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2016. Previous versions of the NIHGPS remain a standard term and condition for grants with budget periods that began prior to October 1, 2016. The new NIHGPS incorporates notices of changes issued since the previous version, and makes clarifications. See this summary of significant changes for more detail.
Eligible recipients of Kirschstein-NRSA institutional training grant and individual fellowship awards that support currently active postdoctoral trainees and fellows at levels 0, 1, and 2, ending after December 1, 2016, may apply for a one-time administrative supplement to support the stipend increase. Learn more at NOT-OD-17-002.
NIH seeks input on the use of interim research products in NIH applications and reports, and the standards for reporting them. We want to know if interim research products can increase the rigor and impact of NIH funded research. We also want to know how to ensure that interim research products arising from NIH funds can be created and used with integrity.Learn more at NOT-OD-17-006.
The continuing resolution continues government operations through December 9, 2016 at 99.504 percent of the FY 2016 enacted level. NIH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). Upward adjustments to awarded levels will be considered after FY 2017 appropriations are enacted. Learn more at NOT-OD-17-001.
NIH recently announced various changes to enhance stewardship and improve visibility of clinical trial activities and results information. The following references summarize the related Guide notices, the new regulation, and articles published by NIH leadership in scientific journals.
- For an overview and rationale for the various clinical trial related changes, the Open Mike and Under the Poliscope blog, Building Better Clinical Trials through Enhanced Stewardship and Transparency
- For information on the regulation and new NIH policy on registering clinical trials and reporting summary results in ClinicalTrials.gov, the Open Mike and Under the Poliscope blog: Improving Visibility of NIH-supported Clinical Trial Activities and Results Information
Post-submission application materials are those submitted after submission of the grant application but prior to the initial peer review. This notice simplifies and consolidates current policy concerning post-submission materials. Read more in NOT-OD-16-130.
NIH is eliminating most appendix materials for applications submitted for due dates on or after January 25, 2017. Application instructions and other materials will be updated by November 25, 2016 to reflect this change. See more at NOT-OD-129.
NIH announces projected stipend levels for postdoctoral trainees and fellows supported by Kirschstein-NRSA awards in Fiscal Year (FY) 2017. These projected new stipend levels are planned to be effective December 1, 2016. The projected new stipend levels reflect recognition of the significant contributions of postdoctoral researchers to the NIH, AHRQ, and HRSA missions, and also align with the spirit of the U.S. Department of Labor’s (DOL) recently issued revisions to the rules on paid overtime under the Fair Labor Standards Act (FLSA). Read more in NOT-OD-16-134.
The National Institutes of Health (NIH) is issuing this policy on the use of a single Institutional Review Board (IRB) for multi-site research to establish the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States. The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections. The shift in workload away from conducting redundant reviews is also expected to allow IRBs to concentrate more time and attention on the review of single site protocols, thereby enhancing research oversight. See this notice for more information.
The NIH Loan Repayment Programs (LRPs) are a set of programs established by Congress and designed to recruit and retain highly qualified health professionals into biomedical or biobehavioral research careers. See notices NOT-OD-16-119, NOT-OD-16-118, NOT-OD-16-117, NOT-OD-16-116, NOT-OD-16-115 or visit https://www.lrp.nih.gov/ to learn more.
Between March 31 and June 3 NIH reissued all Parent funding opportunity announcements (FOAs). These FOAs include the FORMS-D application packages required for application submissions of May 25, 2016 and beyond.
The FORMS-D application guide is now available. NIH's approach to the delivery of application guide information has changed considerably. See NOT-OD-16-084 for a summary of changes.
Note that the Forms-D application must be used for due dates of May 25 and beyond. The new application forms are being added to funding opportunity announcements 30-60 days before the first due date for that announcement that requires Forms-D. Some FOAs are being reissued, so pay attention to the Related Notices and Announcement Type sections of the FOA.
See NOT-OD-16-064 for special instructions for continuous submission and late applications.
See NOT-OD-16-068 for transition plan for administrative supplement, successor-in-interest and change of institution opportunities.
- High-level list of FORMS-D form changes
- Annotated Form Set for NIH Grant Applications
- Do I Have the Right Form Version For My Application?
- Form Update 2016 - Frequently Asked Questions
Applications submitted for due dates on or after May 25, 2016 should follow the newly clarified biosketch instructions and should use the new consolidated biosketch format for research, institutional research training, institutional career development, research education, fellowship, and dissertation awards, as well as diversity supplements. See NOT-OD-16-080 for details.
Applicants must use FORMS-D for due dates on or after May 25, 2016 and must use FORMS-C for due dates on or before May 24, 2016. FORMS-D implements a number of changes to grant application policies and instructions. For a reminder of what is changing, check out NOT-OD-16-081.
Find the latest resources and news in the most recent NIH eSubmission Items of Interest. FORMS-D application changes, timing, impact on continuous submission, impact on administrative requests and identifying which form version was used for an application are among the topics covered in this edition.
Find the latest resources and news in the most recent NIH eSubmission Items of Interest. ASSIST expansion, ASSIST Copy Application feature, reminders of 2016 policy changes and a look back at 10 years of electronic application submission are among the topics covered in this edition.
A revision to the NIH Grants Policy Statement (Rev. 11/2015) is now available (NOT-OD-16-030). This revision is a standard term and condition for all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2015.
Revised SF424 (R&R) application guides and supplemental instructions are available for application due dates on and between January 25, 2016 and May 24, 2016 (NOT-OD-16-029).
Find the latest resources and news in the most recent NIH eSubmission Items of Interest. Form and policy changes coming in 2016, manual post-submission application checks, and biosketch compliance are among the topics covered in this edition.
Find the latest resources and news in the most recent NIH eSubmission Items of Interest. Continuing to use application forms beyond the expiration date, plans to update application guide instructions, help desk rebranding and browser support for eRA systems are among the topics covered in this edition.
Find the latest resources and news in the most recent NIH eSubmission Items of Interest. Submission options, managing application access in ASSIST, importance of keeping eRA Commons profiles up-to-date and tips for creating system-friendly PDF attachments are among the topics covered in this edition.
Find the latest resources and news in the most recent NIH eSubmission Items of Interest. eRA Commons profile changes related to animal welfare assurance numbers, a new PHS Additional Indirect Costs form for multi-project applications and straight talk about application requirements are among the topics covered in this edition.
The NIH's ability to issue competing and non-competing awards may be delayed for two weeks from May 19, 2015 until June 3, 2015 due to software upgrades to NIH accounting and business systems. Examples of activities that may be impacted include: issuance of awards; establishment or changes to Employer Identification Numbers; processing of No Cost Extensions; and processing of Fellowship activations. See NOT-OD-15-088 for additional information.
Find the latest resources and news in the most recent NIH eSubmission Items of Interest. How to submit budget forms for subawards that are not active for all periods of the prime, determining if an application fits within a direct cost limit and timeline for ASSIST support of single-project applications are among the topics covered in this edition.
Presentation Video and Interactive Q&A
Thursday, March 12, 2015
Learn more about recent and upcoming changes to NIH policy as a result of the publication of HHS' regulations implementing OMB's Uniform Guidance, and how it affects the grants process. The video and Q&A combination provides a great opportunity to get clarification and additional information from NIH Office of Policy for Extramural Research Administration (OPERA) policy officials.
Participation is as Easy as 1…2…3…:
1. Watch the pre-recorded PPT Presentation Video at your convenience (approximately 30 minutes long).
2. Develop any questions you have for NIH policy experts.
3. Register for the Interactive Q&A and either ask questions in advance, ask during the live event on March 12, or just listen in.
Find out more at https://grants.nih.gov/grants/webinar_docs/webinar_20150315.htm
Over 65 Grants Management, Program, Review and Policy officials from NIH & HHS will be on hand to share their expertise and answer your questions at the NIH Regional Seminar on Program Funding and Grants Administration in Baltimore, Maryland. This unique event includes a 2-day seminar (May 7-8) and four optional pre-seminar workshops (May 6). The workshops are filling fast, so check out the agenda details to see if the specific training you need, is offered. General registration rates are available until April 3. After that, late rates apply so don’t wait. Research trainees (postdocs and graduate students can save an additional $50 with proof of status.) The NIH Regional Seminar provides a comprehensive overview of the NIH grants process, including policies, on-line tools and resources, the eRA Commons, Peer Review and so much more! For more information, visit the NIH Regional Seminar-Baltimore website athttp://regionalseminars.od.nih.gov/baltimore2015/.
NIH is currently revising the policy requirements in the NIH Grants Policy Statement to align with DHHS's regulations (45 CFR Part 75) implementing OMB's Uniform Guidance. The NIH Interim Grant General Conditions document must be used until those revisions are in place. These conditions are effective for Notices of Award issued on/after December 26, 2014 that obligate new or supplemental funds. (NOT-OD-15-065; FAQs)
Applicants now have the option to use NIH's online ASSIST system to prepare and submit their R03 and R21 grant applications. ASSIST users benefit from pre-submission checks against NIH business rules and the ability to preview their application image in the NIH format prior to submission. Use of ASSIST is optional - Grants.gov downloadable forms and institutional system-to-system solutions remain viable submission options, as well. (NOT-OD-15-062)
NIH and AHRQ grant application due dates that fall on or between February 13 and February 18, 2015 will move to February 19, 2015 to accommodate a Grants.gov extended outage over the Presidents Day weekend. (NOT-OD-15-057)
Find the latest resources and news in the most recent NIH eSubmission Items of Interest. Availability of ASSIST for R03 and R21 applications, expansion of Unicode support to include application form fields, and February due date adjustments to accommodate extended Grants.gov downtime are among the topics covered in this edition.
Registration is now open for the 2015 NIH Regional Seminar on Program Funding and Grants Administration taking place in Baltimore, Maryland. Along with the 2-Day Seminar, May 7 & 8, the NIH is offering optional pre-seminar workshops on May 6. Session tracks for the 2-Day Seminar, May 7 & 8 include topics for both administrators, new investigators, and anyone new or with limited experience working with NIH. This seminar provides a comprehensive overview straight from NIH and HHS Program, Grants Management, Review, and Policy officials. In addition to the 2-Day Seminar, the NIH is offering optional pre-seminar workshops on May 6. Register today at http://regionalseminars.od.nih.gov/baltimore2015/.
NOT-OD-15-053 provides an updated diversity statement that describes NIH's interest in the diversity of the NIH-funded workforce.
NOT-OD-15-054 provides information on the statutory provisions that limit the use of funds on NIH grant, cooperative agreement, and contract awards for FY 2015.
Find the latest resources and news in the most recent NIH eSubmission Items of Interest. Simplified late policy, important submission reminders, ASSIST becoming an option for most NIH grant programs in 2015 and future NIH seminar are among the topics covered in this edition.
Mark your calendar for the 2015 NIH Regional Seminar on Program Funding and Grants Administration in Baltimore, Maryland – May 6-8, 2015. This 2-day seminar, with an optional 3rd day of pre-seminar workshops, is ideal for anyone in the extramural research community who is new to working with NIH grants: administrators, new and early stage investigators, grant writers, etc. Registration will open in early 2015. In the meantime, access more information and a listserv option at https://grants.nih.gov/grants/seminars.htm. Note: If these dates don’t work for you, a 2nd seminar will be offered in late summer or early fall of 2015 in San Diego, California. NIH Guide Notice: NOT-OD-15-042.
Find the latest resources and news in the most recent NIH eSubmission Items of Interest. Updated grant application resources, SciENcv, and Commons ID requirement for Fellowship sponsors are among the topics covered in this edition.
NOT-OD-15-015 revises the definition of clinical trial, clarifying the distinction between clinical trials and clinical research studies and is designed to enhance the precision of the information NIH collects, tracks, and reports on clinical trials.
As of October 17, 2014, the National Institutes of Health (NIH) requires grantees to submit all type 5 progress reports using the Research Performance Progress Report (RPPR) module in eRA Commons. Annual progress reports submitted in any format other than the RPPR will not be processed by the NIH and will require resubmission through the RPPR. For additional information and links to related announcements and resources, visit NIH Guide Notice NOT-OD-15-014.
NIH is providing special accommodations for application submission and grant reporting for program directors/principal investigators responding to the West Africa Ebola outbreak. See NOT-OD-15-010 for details.
The Department of Health and Human Services (HHS), including NIH, operates under the Continuing Appropriations Act, 2015 (H.J.Res. 124) signed by President Obama on September 19, 2014. This Act (CR) continues government operations through December 11, 2014 at 99.9 percent of the FY 2014 enacted level. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-001.html for more info.
Find the latest resources and news in the most recent NIH eSubmission Items of Interest.Systematic application compliance checking, a new Tips for Electronic Grant Submission Success video, and important reminder to Early Stage Investigators are among the topics covered in this edition.
Last year, NIH announced that we are moving to a system that uses subaccounts, meaning that grantees draw down funds from award-specific accounts in the Payment Management System (PMS). Now, as described in NIH Guide Notice NOT-OD-14-103, "Revised Timeline for Administrative Changes to NIH Domestic Awards to Transition to Payment Management System Subaccounts," this implementation timeline has been revised. Please read the full NIH Guide notice for details.
Find the latest resources and news in the most recent NIH eSubmission Items of Interest. Grants.gov form behavior changes, inclusion data form reminders, website changes and tips for avoiding Adobe pop-ups at time of submission are among the topics covered in this edition.
NIH currently requires use of the RPPR module to submit progress reports for Streamlined Non-competing Award Process (SNAP), fellowship, and multi-year funded awards. This requirement will be extended to all type 5 non-SNAP progress reports as well, beginning with type 5 non-SNAP progress reports submitted on or after October 17, 2014. See the NIH Guide for details.
Registration for the 2014 NIH Regional Seminar on Program Funding and Grants Administration is in full swing. Offered only once this year, the event will take place in Baltimore, MD (June 25-27). There is still time to save some extra money with the Early Bird Registration Rate through Monday, March 17. NIH Regional Seminar participants experience an unparalleled opportunity to gain a better perspective of NIH policies, programs, and the grants process directly from NIH & HHS officials, network with peers, gather helpful NIH contacts, and to return to the office or lab with useful information, resources, and tools to assist in obtaining and managing NIH awards. Additional Trainee Discount for Postdocs, Predocs, and Grad Students. For more information, see the 2014 NIH Regional Seminar website.
NIH will expand to all institutions the opportunity to submit type 5 non-SNAP progress reports using the RPPR on April 25. NIH anticipates requiring all grantee institutions to use the RPPR for non-SNAP progress reports beginning on October 17, 2014. Read the Notice for details.
On January 17, President Obama signed the FY 2014 Consolidated Appropriations Act, 2014 (Public Law 113-76) into law, which provides funding to NIH for the fiscal year ending September 30, 2014.
The following related guide notices describe NIH implementation of this legislative mandate, and the 2014 fiscal policy:
- NIH Fiscal Policy for Grant Awards – FY 2014 (NOT-OD-14-055)
- Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2014 (NOT-OD-14-046)
- Notice of Salary Limitation on Grants, Cooperative Agreements, and Contracts (NOT-OD-14-052)
- Notice of Legislative Mandates in Effect for FY2014 (NOT-OD-14-053)
Due to the rescheduled meetings in the January 2014 council round, some CSR study section meetings in the May 2014 council round will be held on a delayed schedule in March 2014. New Investigators whose new R01 (A0) applications are being reviewed in these delayed CSR meetings may wish to take advantage of the next round resubmission option for their A1 applications. To allow New Investigators reviewed in March 2014 meetings sufficient time to prepare a next round resubmission application (A1) for the October 2014 council, a staggered resubmission deadline is being instituted. Specifically, these eligible New Investigator resubmitted A1 applications will be due 30 days after release of the summary statement for the original A0 application. See NOT-OD-14-050.
NIH has reissued the parent funding opportunity announcements (FOAs) for the following Research Career Development (K) Awards:
- PA-14-042: NIH Pathway to Independence Award (Parent K99/R00)
- PA-14-044: Mentored Research Scientist Development Award (Parent K01)
- PA-14-045: Independent Scientist Award (Parent K02)
- PA-14-046: Mentored Clinical Scientist Research Career Development Award (Parent K08)
- PA-14-043: Mentored Patient-Oriented Research Career Development Award (Parent K23)
- PA-14-047: Midcareer Investigator Award in Patient-Oriented Research (Parent K24)
- PA-14-048: Mentored Quantitative Research Development Award (Parent K25)
Please see the NIH Guide announcement NOT-OD-14-036 for more information.
Are you ready for our move to updated electronic application forms (FORMS-C) for Fellowship, Career Development and Training programs? Are you submitting a multi-project grant application to NIH electronically? Find the latest resources and news in the most recent NIH eSubmission Items of Interest.
NIH reminds awardee institutions that annual reports are due to the NIH Office of Laboratory Animal Welfare (OLAW) by January 31. See the NIH Guide Notice for more information and links to helpful resources.
Grants.gov has scheduled downtime Friday, December 6, 2013 through Sunday, December 8, 2013 in order to perform system maintenance. As a result, December 2013 NIH application due dates that fall in that timeframe will be adjusted. See the NIH Guide Notice NOT-OD-14-022 for the new due dates, and as always, submit early!
NIH Guide Notice NOT-OD-14-014 provides additional clarification to the previous guidance (NOT-OD-14-007) on resumption of NIH extramural activities following the recent lapse in appropriations. This includes specific language clarification and rescheduled standard due dates.