Opportunities and Resources
- New Opportunities to Better Understand Lyme Disease and Tickborne Co-Infections
- Investigate Immune Mechanisms to Advance New Tuberculosis Vaccines
- The "ImmPort" of a New Funding Opportunity
In The News
- NIAID Reissues Investigator-Initiated Clinical Trial FOAs
- News Briefs
- Remember to Get Prior Approval for Some Post-Award Actions
- Reader Questions
New Funding Opportunities
To successfully submit an electronic grant application, you need to pass two automated systems validations: Grants.gov and eRA Commons. As your application undergoes the validations, keep in mind that there exist two worst-case scenarios capable of derailing your application.
In both cases, waiting until the last minute to apply will limit your ability to resolve any problems that may arise.
Scenario 1: You Need to Address an Error Found During Validation
If your application does not pass the automated validations (error checking), you should immediately correct any errors and work with your authorized organizational representative (AOR) to resubmit the application.
However, being able to do so hinges on timing. You must submit the corrected application before 5 p.m. local time on the application’s due date. If you are late, you are out of luck.
Here’s where the problem lies: While Grants.gov validation typically takes only minutes, during a busy period the process can take hours. Likewise, eRA Commons validation may take several hours to complete. In addition, certain errors found during validation, such as a missing Multiple PI Leadership Plan, may take some time to resolve.
As reported in the Open Mike blogpost “A Grant Submission New Year’s Resolution,” 43 percent of R01 applications for the October 6, 2014 due date arrived the day of the deadline. That constitutes a busy period. If any of those applicants discovered a failed validation the next day, they would have already missed their opportunity to submit a corrected application.
Remember, NIH’s late application policy does not allow you to correct errors and address warnings after an application deadline if your application is the source of the problem, as explained in the December 17, 2014 Guide notice. Problems caused by our electronic systems are a separate matter—we will accept late applications only if the eRA Service Desk confirms a federal computer system issue and you are able to provide documentation that you contacted the Help Desk before the submission deadline.
Scenario 2: Your Application Passed Validations With Unflagged Content Errors
Always use the two-day viewing window that follows eRA Commons validation to manually verify that none of your uploads are blank, missing, duplicated, or corrupted. Correct and resubmit your application on or before the due date if you find an error.
Why is this necessary if you’ve already passed validations?
Because the automated validations aren’t perfect. They check for technically defined parameters of funding opportunity announcements and the SF 424 Application Guide, such as page length, but they do not flag content issues, such as a missing data table in the Research Plan, a blank attachment, or a corrupted image. Read Learn How We Check Your Application for Completeness for a full explanation.
Once again, timing matters. Your application needs a Grants.gov timestamp by 5 p.m. on the due date to be considered on time. If you submit your application on the day of the deadline, the two-day viewing window becomes irrelevant. Taking another example from the Open Mike blogpost, 51 percent of Small Business Innovation Research applications for the December 5, 2014 due date arrived on December 5. Those applicants would not have had sufficient time to spot and correct any upload errors, which may have had serious ramifications during peer review.
To be clear, it is the applicant's responsibility to submit the complete application on or before the due date. NIAID cannot correct an error spotted in your application after the receipt deadline on your behalf, even if an overlooked content error would render your application nonresponsive to a FOA’s requirements. Furthermore, if the errant application proceeds to peer review and scores poorly because of an unflagged content error, we will not accept appeals.
Most institutions have internal deadlines for investigators to send applications to their business offices before submission. Try to beat that deadline. The more time you have to verify that your application has passed validations and is free of content errors, the better.
Ideally your institution will submit your application at least one week before the corresponding due date, which should provide you with more than enough time to make corrections stemming from failed validations or content-related upload errors.
If you run into trouble, refer to Contacts for a chart of Help Desk contact information by submission topic.
To learn more about electronic submission, read Passing Validations section of Submit an Application
Opportunities and Resources
NIAID invites applications to support research that increases understanding of Lyme disease and co-infections transmitted by Ixodesticks. Two companion funding opportunity announcements (FOAs)—an R01 and an R21—encourage studies that address diverse scientific areas such as: 1) pathogenesis, 2) host response, 3) disease transmission, 4) vector biology and natural history, 5) vaccines, 6) diagnostics, and 7) therapeutics.
Both FOAs encourage applications focusing on gaps in the current understanding of Borrelia burgdorferi sensu lato infections, new Lyme-related borrelioses, and Lyme co-infections. The ultimate goal is to advance the field towards solutions for improved detection, prevention, and treatment of Lyme disease.
Specific research areas of interest include:
- Host and bacterial factors that may contribute to post-treatment Lyme disease symptoms
- Bacterial persistence in Lyme borreliosis and relevance to disease
- Approaches to new vaccines against Lyme disease, including traditional, vector-targeted and reservoir-targeted approaches
Read the FOAs for additional research areas of interest. Also, note that neither FOA will support clinical trials.
Application Budget and Restrictions
The award budget and award project period differ for the R01 and R21 opportunities as follows:
- R01 Research Project Grant: Application budgets are not limited but should reflect the actual needs of the proposed project. The maximum project period is five years.
- R21 Exploratory/Developmental Research Grant: Application budgets are capped at $275,000 in direct costs for the total project period and are limited to no more than $200,000 in a single year. The maximum project period is two years.
The FOAs have multiple due dates, the first of which is October 5, 2016, for the R01 and October 16, 2016, for the R21. We strongly urge you to apply early to allow time to correct any errors found in your application during the submission process.
NIAID seeks grant applications that propose innovative research into innate or adaptive immune responses induced by mycobacterial infections, Bacillus Calmette-Guérin vaccine (BCG), or candidate Mycobacterium tuberculosis (Mtb) vaccines in HIV-positive or uninfected people.
We encourage studies focused on immune mechanisms required for protection from Mtb infection or reinfection or progression to active disease in latently infected people.
Areas of Research Interest
Proposed research should provide data to advance new hypotheses on immune mechanisms that contribute to developing new tuberculosis (TB) vaccines, including in populations also infected with HIV.
Areas of research interest include the following; for other examples, see the FOA linked below.
- Elucidating mechanisms (host or pathogen) responsible for transition to active TB disease in susceptible individuals and how HIV infection may shift this balance
- Understanding how Mtb infection, BCG, or investigational vaccines influence specific cellular signaling pathways or cause epigenetic changes that impair immune cell functions to prevent or reverse infection, persistence, or reactivation
- Effect of prior or chronic exposure to nontuberculous mycobacterial infection, BCG vaccination, or candidate Mtb vaccines on subsequent immune responses to Mtb infection, TB reactivation, or disease reoccurrence in HIV-infected or HIV-uninfected people
Note that this opportunity does not support the following research topics:
- Sole focus on mechanisms of TB pathogenesis that do not include analysis of immune parameters
- Primary focus on reagent or animal model development
- Clinical trials
- Projects addressing Tuberculosis-Associated Immune Reconstitution Syndrome
Your application budget is not limited but must reflect the actual needs of your proposed project. The maximum project period is five years.
The first application due date is January 11, 2017. Subsequent due dates are January 11, 2018, and January 11, 2019, as listed in the May 27, 2016 Guide notice.
You may have used or read about NIAID's Immunology Database and Analysis Portal (ImmPort). If so, you may be interested in a recent funding opportunity announcement (FOA) focused on informatics methodology and secondary analyses for immunology data in ImmPort.
The FOA seeks applications that can meet the following two broad objectives. Address one or both in your application.
- Develop new or improved informatics tools and methods to improve and facilitate reusing shared data in ImmPort and other public data repositories. Examples include:
- Automated study data feature extraction and quality assessment
- User interfaces to enable cross-study analyses
- Innovative platforms to promote community participation in data sharing and analyses
- Conduct secondary analyses of existing immunology datasets in ImmPort and other public data repositories to address basic and clinical immunology questions. Examples include:
- Integrating immunology datasets to test specific immunological questions and validate a new analytical approach
- Developing immunology reference datasets
- Comparing human data with publically available experimental results from animal studies to generate new hypothesis
You can find other examples in the FOA, but we encourage you to touch base with Dr. Quan Chen, the scientific/research contact, for clarification about the opportunity's scope.
A Word About the Activity Code
This FOA uses the Exploratory/Developmental Cooperative Agreement Phase I (UH2) activity code, which may not be familiar to you.
In a nutshell, the UH2 supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research.
A UH2 grant application need not have extensive background material or preliminary data.
Budget and Deadlines
Direct costs are limited to $275,000 over a maximum project period of two years. You may not request more than $200,000 in any single year.
The first of three annual due dates is October 4, 2016. If you plan to submit an optional letter of intent, you have until 30 days before the application deadline to do so.
For complete details about this opportunity, read the May 10, 2016 Guide announcement.
To learn more about ImmPort, go to Beyond Data Storage—ImmPort Offers a Platform for Future Research Advances on NIAID'sBioinformatics and Systems Biology website.
If you’ve previously applied for investigator-initiated clinical trial (IICT) funding and plan to apply again, be aware of several points of emphasis in the set of IICT funding opportunity announcements (FOAs) we reissued in May.
First, your proposed budget must be sufficient to support your research. While this point is applicable to all grant applications, many applicants struggle to assess exactly how much funding they will need to complete a clinical trial. Thus, verifying that your proposed budget is sufficient will now be a point of emphasis in the application by the review panel and program staff.
Second, AIDS-related and non-AIDS-related IICT applications share common due dates but will be reviewed and sent to Council on separate timetables. Pay close attention to the Key Dates section of the FOA. The table below displays key deadlines corresponding to the next IICT application receipt date:
|Deadline||AIDS-Related IICT||Non-AIDS-Related IICT|
|Prior Consultation||June 2016||June 2016|
|Submission Due Date||September 13, 2016||September 13, 2016|
|Review Date||December 2016||February 2017|
|Council||January 2017||May 2017|
|Earliest Start Date||March 2017||July 2017|
Third, the IICT FOAs require a number of accompanying documents that equivalent investigator-initiated FOAs without clinical trials do not. In the past, applicants have routinely overlooked them. Avoid this mistake by paying close attention to the required documentation each FOA lists under the “Other Attachments” subsection of Section IV. Application and Submission Information.
The More Things Change, the More They Stay the Same
Fortunately, the scope and administrative processes for the reissued IICT FOAs are essentially unchanged.
You still cannot submit clinical trial applications in response to NIH's parent R01 and R21 announcements and request assignment to NIAID. This is not allowed, and your application will be transferred to another institute or withdrawn.
Instead, you will apply using one of our recently reissued IICT FOAs, listed below, following the process we laid out in the February 10, 2016 NIAID Funding News article “Initiate the Investigator-Initiated Clinical Trial Process Soon.”
- Milestone-driven Clinical Trial Implementation Grant (R01)—for investigators who are ready to begin a clinical trial that is not high-risk.
- Clinical Trial Implementation Cooperative Agreement (U01)—for investigators who are ready to begin a high-risk clinical trial.
- SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)—for small business investigators who are ready to begin a clinical trial.
- Clinical Trial Planning Grant (R34)—for investigators planning, designing, and preparing the documentation necessary for implementing an IICT.
Don’t wait to get started—you should initiate NIAID’s IICT prior consultation process at least 10 weeks before applying. To do so, reach out to one of the scientific/research contacts listed in the FOAs. Read the article linked above for full details on that process.
NIH's Office of AIDS Research (OAR) issued a request for information (RFI) soliciting public feedback to help refine and optimize the NIH HIV/AIDS research agenda for FY 2018. To respond, email OAR_RFI18@od.nih.gov your comments about the topic areas listed in the May 11, 2016 Guide notice by next Friday, June 10.
NIAID will accept applications proposing studies on Zika in response to the open funding opportunity announcement Immunity in Neonates and Infants (U01). Zika research supported by this FOA is limited to analysis of the impact of Zika virus infection on the developing immune system and characterization of neonatal or infant immune responses to vaccines post-Zika virus infection. Act quickly—applications are due July 29, 2016. See the May 27, 2016 Guide notice for more information.
NIAID is rebuilding its website to make it easier for you to find what you need, including research funding information, scientific career opportunities, and policy updates. We will launch the new website in early September. Until then, we will post any critical information about the website rebuild in this space.
Once you receive a grant award, keep in mind that you'll have to get NIAID's permission before making some changes to your funded project.
Not getting this prior approval can result in your grant's receiving special award conditions or enforcement actions such as cost disallowances, suspensions, or termination.
When Is Prior Approval Necessary?
We've seen cases where prior approval should have been requested but was not. For example, when a principal investigator (PI):
- Withdrew from the project or was absent for three continuous months or more
- Changed or modified Specific Aims
- Started working with vertebrate animals (VA) or human subjects (HS) when the peer-reviewed grant application did not cite their use in the work proposed nor incorporate the required HS or VA section
- Added new foreign work or a foreign component to a grant
- Wanted to overcome a restriction from using funds. A restriction can be lifted only through a revised Notice of Award (NoA).
You must get prior approval for actions such as modifying the scope of your grant, transferring a grant from one institution to another, or changing from a single to multiple PI award, or vice versa. For the complete list, see our Prior Approvals for Post-Award Grant Actions SOP.
Note that there may be items specific to your grant award for which you need prior approval, so read your most recent NoA, which you can find in your eRA Commons account. Critical NIAID special terms of award, when added, are listed towards the end of the NoA.
Give yourself plenty of time to obtain NIAID approval for any change by making your request at least 30 days before you want it to take effect. To be safe, you may want to check with your grants management specialist and program officer about how much time you'll need for the type of change you're seeking to be approved.
When Is Prior Approval Not Necessary?
You can make some changes without first getting NIAID's permission. For instance, you can extend a project period for up to 12 months without additional funds, i.e., request a no-cost extension. You still need to notify us, but you can take action without waiting for our approval.
This authority may be taken away only by NIAID and would be added as a term and condition on the NoA.
To Get Prior Approval or Not
If you're unsure whether prior approval is required, it's best to err on the side of caution and contact your grants management specialist and program officer.
For additional information, go to:
- Grantees Can Take Many Actions Independently in Changes to Project or Budget
- Manage Your Award—see the section on Prior Approval for Changes
Feel free to send us a question at firstname.lastname@example.org. After responding to you, we may ask your permission to include your question in the newsletter, incorporate it into the Find a Funding Opportunity site, or both.
Meetings consist of open and closed subcommittee sessions, full Council review of applications and subcommittee actions, special presentations, and remarks by NIAID Director Dr. Anthony Fauci. Check the NIAID Council Agenda for specific details.
You can watch Dr. Fauci's remarks live by viewing the NIAID Advisory Council videocast at 10:30 a.m., as well as the AIDS Research Advisory Committee at 1 p.m., the Division of Microbiology and Infectious Diseases Subcommittee at 1 p.m., the Division of Allergy, Immunology and Transplantation (DAIT) Subcommittee (Session I) at 1 p.m., and the DAIT Subcommittee (Session II) at 2:55 p.m.
You can find Center for Scientific Review (CSR) study section rosters at CSR’s Roster Index for Regular Standing Study Sections and Continuing SEPs.
Find rosters for NIAID's chartered review committees at Council and Federal Advisory Committees, NIAID, NIH:
- Acquired Immunodeficiency Syndrome Research Review Committee
- Microbiology and Infectious Diseases Research Committee
- Allergy, Immunology, and Transplantation Research Committee
If you applied in response to a request for applications, find a roster for most of NIAID's ad hoc review committees on NIH's Special Emphasis Panels web page. We usually post the roster approximately one month before a review meeting.
- PAR-16-297, Native American Research Centers for Health (NARCH)
- PA-16-107, Modeling of Infectious Disease Agent Study Research Projects
- PA-16-289, Research Supplements to Promote Reentry into Biomedical and Behavioral Research Careers (Admin Supp)
- PA-16-288, Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)
- PA-16-287, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Admin Supp)
- PA-16-286, Successor-in-Interest (Type 6 Parent)
- PA-16-285, Change of Grantee Organization (Type 7 Parent)
- RFA-AI-16-038, Silencing of HIV-1 Proviruses
- PA-16-294, NIH Support for Conferences and Scientific Meetings (Parent R13)
- RFA-AI-16-050, Systems Approach to Immunity and Inflammation
- RFA-AI-16-031, Limited Interaction Targeted Epidemiology (LITE) to Advance HIV Prevention
- PAR-16-275, Serious Adverse Drug Reaction Research (R01)
- PAR-16-274, Serious Adverse Drug Reaction Research (R21)
- RFP-NIAID-DMID-NIHAI2016061, Structural Genomics Centers for Infectious Diseases
- RFA-HG-16-016, BD2K Open Educational Resources for Skills Development in Biomedical Big Data Science
- RFA-AI-16-047, Partnerships for Structure-Based Design of Novel Immunogens for Vaccine Development
- PAR-16-272, NIAID Clinical Trial Planning Grant
- PAR-16-271, NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement
- PAR-16-270, NIAID Clinical Trial Implementation Cooperative Agreement
- PAR-16-269, NIAID Clinical Trial Implementation Grant
See other announcements at NIAID Funding Opportunities List.