Opportunities and Resources
- FOA Focuses on Finding an HIV Cure Through Collaborations
- Add Dietary Supplements to Your Research
- Take Part in Mucosal Immunology Studies Team
In The News
- Notes From May Advisory Council—Budgets, Initiatives, and Ebola
- Concepts: Your Window Into NIAID's Priorities
- NIAID to Use Aggregate Rosters for Special Emphasis Panels
- News Briefs
- Avoid Adverse Consequences: Send Grant Closeout Reports on Time
- Reader Questions
New Funding Opportunities
Did you know that in FY 2014, NIAID awarded 158 competing small business awards, bringing our Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding total to 236 grants and $122.3 million?
In FY 2015 NIAID plans to fund SBIRs/STTRs at a comparable level. So, whether your small business is established or just getting started, now is the time to refresh your knowledge of the funding and resources that NIAID has to offer.
FY 2015 Omnibus Grant Solicitations
Earlier this month, NIH released the FY 2015 Small Business Innovation Research and Small Business Technology Transfer Omnibus Grant Solicitations. The funding opportunity announcements, which are reissues of the FY 2014 versions, are the main instruments through which NIAID funds small business research.
As we told you in the January 8, 2015, article “Plan to Shorten SBIR/STTR Grant Cycle Takes Effect,” the planned receipt dates for the FY 2015 SBIR and STTR Omnibus Solicitations changed. As a reminder, here are some key takeaways from that article:
- The next three receipt dates are September 5, 2015, January 5, 2016, and April 5, 2016.
- There will be no August 5, 2015, receipt date.
- There are no longer separate receipt dates for AIDS and AIDS-related applications.
Another key change in the FY 2015 Omnibus Solicitations is the administrative process for funding small business grants that exceed the hard cap set by Congress.
The normal expectation, based on statutory guidelines from Congress, is that total funding support (direct costs, indirect costs, and fees for the life of the award) will not exceed $150,000 for Phase I awards and $1 million for Phase II awards. The Phase I award periods should not exceed six months and Phase II award periods should not exceed two years. The statutory guidelines allow awards to exceed those budget amounts by up to 50 percent to hard caps of $225,000 for Phase I and $1.5 million for Phase II with appropriate justification from the applicant.
What's changed is that NIAID can now fund Phase I applications with budgets of up to $300,000 annual total costs for up to two years and Phase II or Phase IIB applications with budgets of up to $1 million annual total costs for up to three years. To do so, the application’s budget must be extremely well justified and its scientific area must be included in the list of NIH, CDC, FDA, and ACF Program Descriptions and Research Topics.
Contact an NIAID program official if you anticipate applying with a budget greater than the normal guidelines of $150,000 for Phase I awards and $1 million for Phase II awards. Keep in mind, regardless of your proposed budget, your application's review committee may recommend cuts to your proposed budget. In addition, NIAID may decrease the length of an award or the review committee's recommended budget for administrative, programmatic, or budgetary reasons.
Also, note that NIAID will not accept small business applications proposing clinical trials except under the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44).
FY 2015 Omnibus Contract Solicitations
Later this summer, NIH will release the FY 2015 Omnibus Contract Solicitations. In past years, the solicitations were released in August with a November due date. This year, we hope to release the solicitations in July with an October due date, so do not wait until August to begin monitoring for the solicitation announcement.
We are also working to make this year’s Omnibus Contract Solicitations an online application process. If you’ve submitted proposals in the past using only paper applications, know that this year you may need to do so electronically.
Learn more at Apply on the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR)website.
If you were unaware that NIAID launched a new Small Business Program portal, take some time to check it out. There you will find the information, resources, and advice you need to apply for NIH funding.
For example, we have posted five SBIR/STTR Sample Applications in Sample Applications & More. NIAID is the first institute to provide this valuable resource, and we thank the applicants who allowed us to use their excellent applications.
You can also review:
- High Priority Areas of Interest—a listing of the areas of science that we are most eager to fund as well as contact information for program officers whom you can contact to discuss your research.
- Our Team—contact information if you’d like to discuss the administrative, outreach, and business aspects of the small business program.
HIV researchers may be familiar with the Martin Delaney Collaboratory program, which was established in 2011. Its goal is to develop strategies that will either cure HIV infection by eradicating the virus from the body or achieving sustained viral remission.
The program continues through a recent funding opportunity announcement (FOA) that will support innovative strategies to achieve an HIV cure through academic, industry, government, and community partnerships.
Note that all applications will be new submissions since the activity code and application structure have changed from the first request for applications published five years ago.
Types of Research Sought
Examples of areas of research interest include the following. Read the FOA (find link at end of article) for others.
- Identifying and characterizing the cellular, tissue, and anatomical reservoirs of HIV that persist in individuals treated with effective antiretroviral drug regimens and serve as the source of rebound viremia following cessation of therapy.
- Developing physiologically relevant assays for quantifying replication-competent latent HIV reservoirs and identifying biomarkers for predicting viral rebound.
- Identifying therapeutic strategies that target latent/persistent HIV reservoirs or that may lead to control of viral rebound.
- Studies to establish how host factors and timing of antiretroviral treatment impact the HIV reservoir and efficacy of cure or eradication strategies.
Making Sure Your Project Fits the FOA
To ensure your project is appropriate for and meets the requirements of this FOA, here are some elements to keep in mind.
- Your proposed research:
- Should be innovative and must include a combination of basic, translational, and clinical research that is expected to evolve over time.
- Is expected to "push the envelope," that is, go beyond what is currently feasible by, for example, including high-risk research or developing improved methodology and technology.
- For your partnerships:
- Key investigators and institutions should provide a broad range of expertise and resources needed to accomplish the overall research goals.
- To maximize innovation, establish cross-disciplinary partnerships.
- International collaborations are allowed, but non-U.S. institutions cannot submit applications.
- To facilitate translating basic science findings to evaluating them in animals and humans, your application must include at least one private sector partner that will contribute materially and intellectually to the overall goals and objectives of the Collaboratory.
- In your research plan, you must integrate clinical research, as defined by NIH.
- If you include pilot or proof-of-concept clinical trials, which are encouraged but not required, they should be few in number and of small size (less than 50 subjects). Note that before you implement the trials, they will be subject to review by the Scientific Advisory Board and NIAID/DAIDS Clinical Science Review Committee.
- Each Collaboratory is expected to demonstrate an ability to provide regulatory support and infrastructure needed for carrying out clinical studies.
Last But Not Least
Read the May 21, 2015, Guide announcement for complete details and instructions, including requirements for the Research Strategy, which has several sub-sections. Also take note of the June 1, 2015, Guide notice that features a few corrections to the FOA.
We strongly encourage you to touch base with Dr. Diane Lawrence, NIAID's scientific/research contact, to discuss your proposed project.
If you'd like to submit an optional letter of intent, do so by November 7, 2015. The application deadline is a month later on December 7.
You can get administrative supplement funds for your existing grant, allowing you to investigate the role of dietary supplements in health maintenance and disease prevention. Your current research need not already be focused on dietary supplements; instead, you could use the extra money to add a dietary supplement aspect to your project.
NIH will give primary consideration for support to applications that:
- Propose dietary supplement research in areas where it is lacking or lagging.
- Clarify gaps, opportunities, and the balance between benefits and risks for dietary supplements where existing data are in conflict.
- Target special population groups where additional science on dietary supplements is needed.
- Focus on the use of dietary supplements in improving or maintaining health and reducing the risk of chronic disease.
The first application due date is October 15, 2015. For later due dates and full details, read the May 14, 2015, Guide announcement.
If you're an NIAID grantee, we suggest that you contact the program officer for your current grant with your questions or to discuss your idea.
A recent funding opportunity announcement (FOA) gives you a chance to be part of the Mucosal Immunology Studies Team. MIST is a cooperative research group focused on defining fundamental aspects of immunity at mucosal surfaces.
Consider applying if your research can break new ground; that is, introduce new ideas, approaches, and technologies to increase understanding of basic mucosal immune defense mechanisms.
Speaking of "new," NIAID encourages new investigators, particularly early-stage investigators, to participate in MIST. And don't worry if you haven't had previous funding for mucosal immunity-related projects; we welcome you to apply as a project director/principal investigator (PD/PI) or member of a multidisciplinary team.
Research Areas the FOA Will Support
We are interested in applications that address several research areas, such as the following. For additional examples of each category, see the FOA.
- Mucosal Epithelium—Examples: relative contribution of specialized mucosal epithelial cells to mucosal surveillance, immunity, and tolerance; epithelial factors influencing dendritic cell or T cell recruitment and differentiation.
- Mucosal Immunoglobulin and Mucosal B Cell Responses—Examples: role of T follicular helper cells in controlling IgA production; effects of IgA efficiency on immune defense and homeostasis.
- Mucosal Antigen Sampling, Processing, and Presentation—Examples: factors regulating trafficking of antigen presenting cells and T cells to mucosal sites; determining the tissue site for presentation of antigens taken up in the lung, intestine, or urogenital tract.
- Mucosal Immunity and Inflammation—Examples: identification of antigens that drive inflammatory Th1/Th17 or regulatory T cells mucosal responses; role of regulatory T cells in controlling immune responses to bacterial flora and harmless antigens.
- Cross-Talk Between the Neural and Immune Response in Mucosal Immunity—Examples: role of enteric neuron and enteric glia secretion of inflammatory cytokines (e.g., IL-1, IL-6, IL-8) in mucosal immunity and mucosal inflammation; mechanism by which TLR expression on enteric neurons influences mucosal immunity.
Research Areas the FOA Will Not Support
Applications will be considered nonresponsive and will not be reviewed if they propose clinical trials, studies that focus on the skin or epidermis, or other areas listed in the FOA.
Other Items of Note
Here are some noteworthy items you should be aware of.
- You don't need to have a MIST team in place to apply. Team formation will happen after award and will comprise all awardees.
- The research project budget may be up to $350,000 in direct costs per year. The award budget of $850,000 in direct costs per year in the FOA includes $500,000 for the Infrastructure and Opportunities Fund (IOF), which we talk about below.
- A steering committee composed of, at minimum, PDs/PIs of each award and an NIAID program officer will direct the overall efforts of MIST. The Committee's responsibilities will include developing a "MIST Plan" that articulates the goals of the MIST program and is used as a reference for recommending use of the IOF.
- An IOF of up to $500,000 in direct costs each year for the entire program will be made available to capitalize on emerging opportunities, and sharing of resources and expertise consistent with the goals of MIST.
NIH will choose one institution to manage the IOF for the entire MIST. Responsibilities will involve establishing an administrative structure, tracking funds, and establishing procedures for reporting status to NIH and the Steering Committee.
All applications should address a plan of how the IOF will operate to serve the MIST and include a letter from the PD/PI and the institution's signing official agreeing to take fiscal responsibility for managing the IOF, if chosen by NIAID to do so.
For complete details, including application and submission information, carefully read the May 26, 2015, Guide announcement. Optional letters of intent are due September 20, 2015. The application deadline is a month later on October 20.
If you have questions, touch base with Dr. Annette Rothermel, NIAID's scientific/research contact.
If you missed the May 18, 2015, advisory Council meeting, read our summary and watch the videocasts linked below.
NIAID Director Anthony Fauci explained how this fiscal year, our budget remained flat but we avoided programmatic adjustments—i.e., cuts to individual grants—and raised R01 paylines to the 12 percentile for established PIs and the 16 percentile for new PIs.
The President’s budget request for next fiscal year includes almost $200 million in additional funding for specific projects to combat antibiotic-resistant bacteria, research HIV/AIDS, develop universal flu vaccines, and support the NIH Precision Medicine initiative.
However, since the President’s budget directs us to dedicate that extra money for only those specific projects, we cannot use it to raise paylines.
Congress does not have to accept the President’s budget proposal and may change these numbers before it passes an FY 2016 budget bill. We’ll tell you how that affects our Financial Management Plan and NIAID Paylines later this year.
Important Research Discoveries and Congressional Retirements
Dr. Fauci updated members on NIAID discoveries related to HIV/AIDS, antibiotic-resistant bacteria, and peanut allergy.
He also shared news that two senior Senators and strong NIH backers, Senate Minority Leader Harry Reid (D-NV) and Senator Barbara Mikulski (D-MD), announced their intentions to retire at the end of this Congress. Senator Mikulski was instrumental in raising the profile of women’s health research and Senator Reid has supported NIH for decades.
Dr. John R. Mascola, head of NIAID’s Vaccine Research Center (VRC), explained how VRC’s preparation, scientific expertise, and research infrastructure enabled it to support NIAID’s response to the recent West African Ebola outbreak.
By the time the Ebola epidemic hit last year, VRC had already conducted years of extensive research into the disease, with a vaccine candidate that had shown promise in protecting nonhuman primates (NHPs) against lethal Ebola challenge. It had also made significant progress in understanding immune correlates of protection in the NHP model.
Working through long-established partnerships with industry and international health organizations, and buoyed by additional emergency appropriations from Congress, VRC was able to initiate and accelerate a number of new clinical studies and facilitate others carried out by NIAID and its partners during the epidemic.
By rapidly mobilizing its resources, VRC quickly demonstrated that its vaccine candidate was safe and immunogenic in a Phase I clinical study, an achievement critical to further development and testing of the vaccine.
Watch the entire Council presentation at NIAID Advisory Committee Meeting—May 2015.
Subcommittee Accomplishments and Initiatives
Learn more about NIAID's priorities and initiatives from Council subcommittee meetings, where NIAID staff discuss extramural research programs with advisory Council members.
See below for video of these subcommittees' open sessions:
- AIDS Research Advisory Committee
- Division of Allergy, Immunology, and Transplantation Subcommittee
- Division of Microbiology and Infectious Diseases Subcommittee
Council also approved a new slate of concepts. Read about these in the next article.
If you're not regularly following our funding opportunity concepts, you might be missing out on big insights into NIAID's strategic thinking—insights you can use to give your application its best chance at funding.
Concepts represent the earliest planning stage of all new initiatives, such as requests for applications (RFAs), program announcements (PAs), and requests for proposals (RFPs).
While there is no guarantee that a concept will become an initiative, savvy applicants often gear their investigator-initiated applications toward NIAID's research interests.
For small businesses, concepts foreshadow potential opportunities for grants and contracts under NIH's Small Business Innovation Research (SBIR) program.
To see a list of approved concepts, go to Concepts: Potential Opportunities. Find our most recent concepts on the following pages:
- May 2015 DAIDS Council-Approved Concepts
- May 2015 DAIT Council-Approved Concepts
- May 2015 DMID Council-Approved Concepts
For more about how concepts work, read Background on NIAID Funding Opportunity Planning and the Budget Cycle.
You may already know that the names of reviewers who participate in peer review are posted at NIH Scientific Review Group (SRG) Roster Index.
Beginning with the September 2015 Council meeting, NIAID will aggregate the rosters of small special emphasis panels (SEPs). Each aggregate roster will combine names from several SEP rosters.
NIAID uses small focused SEPs to review applications for certain grants—investigator-initiated program project (P01), investigator-initiated clinical trial planning (R34) and implementation (R01 or U01), and resource-related research project (R24) grants—as well as standing study section conflicts and applications in response to some requests for applications (RFAs).
As a result of aggregate roster requirements, there may be some delays in releasing the final rosters.
Reminder of Transition to PMS Subaccounts in FY 2016. As of October 1, 2015, NIH will use only Payment Management System (PMS) subaccounts to award grant funds. Grantees should ensure that they have adequate systems in place to receive payments. Find more information in the May 28, 2015, Guide notice and Payment (PMS Subaccount) Frequently Asked Questions.
Send Feedback as NIH Prepares a Prize Competition to Fight Antimicrobial Resistance. To help health care providers better identify bacterial infections, NIH will hold a prize competition to develop rapid, point-of-care in vitro diagnostic tests. We need your help to define the technical criteria and performance characteristics of the challenge. Weigh in online at Request for Comment for: Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge before July 17, 2015, at 5:00 p.m. EST.
Register Now for the Next Precision Medicine Initiative Workshop. The Participant Engagement and Health Equity Workshop, third in a series of workshops that support the Precision Medicine Initiative, will take place at the NIH campus in Bethesda, Maryland, on July 1, 2015, from 8 a.m. to 5:30 p.m. EST and July 2 from 8 a.m. to 12:30 p.m. EST.
When your grant ends, you aren't done yet; you must complete the closeout process by sending acceptable final reports on time. Take this seriously because for those who don't meet the requirement, NIH will begin a process called unilateral closeout and may also impose sanctions on the PI or the grantee institution.
When you send your reports on time and our staff find the reports acceptable, we follow the normal process, called bilateral closeout. We begin unilateral closeout only if the reports are late or unacceptable.
Watch the eRA Commons after your grant ends for a letter with instructions and timing for closeout. The letter will tell you that no later than 120 days after the project end date, you must send the following closeout reports through the Commons:
- Final Federal Financial Report (FFR)—not required for fellowship grants.
- Final Invention Statement and Certification—not required for fellowship, conference, training, or education grants.
- Final Progress Report (FPR)—not required for fellowship grants. Some grant types may include progress report information in the Research Plan of a renewal application instead of sending an FPR.
How to Respond
Send your closeout documentation through the Commons, not using email attachments or any other method. The Commons process requires both the PI and signing official to take actions.
Take seven minutes to watch the YouTube video Grants Closeout in eRA Commons. It demonstrates how to access NIH's information requests (called FRAM) and how to respond using the Commons.
You don't have to wait until all your reports are ready to send them; after your grant ends, we advise you to send each report as soon as you finish it. For example, if your FPR is ready but not your FFR, go ahead and send your FPR through the Commons.
Speaking of the FPR, for clinical research, be sure to attach your Cumulative Inclusion Enrollment Report to the FPR. You can't provide updates directly in the Inclusion Management System at this time.
NIH's current process is based on HHS policies and went into effect for grants with project end dates on or after October 1, 2014, as announced in the April 24, 2014, Guide notice.
Feel free to send us a question at email@example.com. After responding to you, we may ask your permission to include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.
No, you cannot automatically renew another PI’s grant. However, if a PI moves to another institution and your institution does not allow the PI to take the grant with him or her, then your institution can keep the grant and propose you as the new PI. If NIAID approves, you as the new PI can then apply for a renewal (Type 2).
If you plan to continue the research of another PI who has left your institution but are not already the PI (or coinvestigator) of the original grant, then submit a new application (Type 1) under your name and explain your situation in the cover letter.
For more information, contact the grants management specialist for the applicable grant and see the Change of Principal Investigator SOP.
No. You can hold any position on another investigator’s R01—even be listed as key personnel in the application—and still apply for a K23.
(Note that you cannot apply for a K23 if you’re PI on an R01.)
Keep in mind that if you were awarded the K award, you wouldn’t be allowed to continue to accept salary support from the R01.
Know that each type of career development (K) award has its own requirements. Read our Quick Facts on Research Training and Career Development Awards and other Training and Career information.
- RFP-NIAID-DAIDS-NIHAI2014013, NIAID Process and Analytical Support for Development of HIV Vaccines
- BAA-NIAID-DAIDS-NIHAI2015040, Staged Vaccine Development
- RFA-AI-15-033, Partnerships for the Development of Novel Assays to Predict Vaccine Efficacy
- PAR-15-275, Ethical Issues in Research on HIV/AIDS and Its Comorbidities (R21)
- PAR-15-274, Ethical Issues in Research on HIV/AIDS and Its Comorbidities (R01)
- RFP-NIAID-DMID-NIHAI2015036, Preclinical Services for Biopharmaceutical Product Development
- RFA-AI-15-024, Partnerships for the Development of Host-Targeted Therapeutics to Limit Antibacterial Resistance
- PA-15-273, Harnessing Big Data to Halt HIV
- PA-15-272, Exploiting RNA as a Target for HIV Interventions
- PA-15-271, Understanding HIV Persistence in Infants
- PA-15-270, PHS 2015-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR)
- PA-15-269, PHS 2015-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR)
- RFA-AI-15-032, Asthma and Allergic Diseases Cooperative Research Centers
See other announcements at NIAID Funding Opportunities List.