NIAID Funding News, April 6, 2016

NIH: National Institute of Allergy and Infectious Diseases

April 6, 2016 NIAID Funding News

Feature Articles

Give Your Application a Second Chance With OnPAR

Opportunities and Resources

In The News

Advice Corner

Accounting for Other Sources of Funding in Your Grant Application
Reader Questions
- Will there be a penalty to the institution or principal investigator if the investigator takes retirement before fully completing a project and the left-over funds are returned to NIH?
- I am a site leader for a multicenter U34 grant but not the program director for the entire project. Does this disqualify me as a new investigator for future R01 applications?

New Funding Opportunities

See the list

Give Your Application a Second Chance With OnPAR

If your meritorious application misses NIH's payline, a new private-public partnership pilot called Online Partnership to Accelerate Research (OnPAR

) could offer a second chance to receive funding.

How OnPAR Helps

OnPAR presents your qualifying application's abstract to interested private biomedical foundations, pharmaceutical and biotech companies, and other life sciences companies (OnPAR does not fund applications directly). Leidos Health Life Sciences

facilitates the OnPAR program for NIH. All grant activity codes are eligible for OnPAR funding.

These organizations choose applications for further consideration, select those they might want to fund, and negotiate funding with the applicants.

For this pilot, OnPAR has started with seven funding organizations on the Members

list.

You should Register

now even if your area of science may not match the interests of the current members. The OnPAR team will add more members regularly. Over one hundred additional foundations are interested in joining, as well as a half-dozen pharmaceutical companies.

From Registration to Funding

To have your application considered, you must meet the following requirements:

Have your summary statement from NIH.
Your application scored within the top 30th percentile of your study section.
You applied for a due date of May 25, 2015, or later.
Provide application information when you register with OnPAR.

See OnPAR's How to Apply

for more details on the process.

Because the funding organizations have finite resources, they may not match the indirect costs that NIH would normally pay. They may also offer to partially fund the project or provide a small bridge grant award.

More Information

See OnPAR's Frequently Asked Questions

and email questions to OnPAR@Leidos.com.

Also, check out the Open Mike blog post A Pilot Partnership to Find Private Support for Unfunded Applications.

Don’t Overlook Ongoing R01 Immunology Grant Opportunity

You may not have realized: The funding opportunity announcement (FOA) High-Priority Immunology Grants, which we issued in FY 2015 to encourage more applications in high-priority areas of immunology, did not expire!

We’ve again set aside $15 million for FY 2017 to fund 30 to 35 awards.

Through this FOA, we will support research that spans the spectrum of immunology. Topic areas include:

Innate and adaptive immune responses
Ontogeny of the human immune system
Basic immunology of immune-mediated diseases
Structural immunology
Mucosal immunology

This FOA follows Standard Due Dates and the next receipt date for new applications is June 5, 2016. The next deadline for resubmissions, renewals, and revisions is July 5, 2016. Keep in mind, the FOA doesn’t expire until January 8, 2018.

If you previously submitted a new (A0) application in the field of immunology to the NIH Parent R01 FOA and were not funded, you can resubmit your application (A1) directly to this FOA—see "Learn Our Lingo: The Nine Application Types" for terminology help. Be sure to use FORMS-D application forms and instructions, and apply early to allow time to correct any errors found in your application during the submission process.

Read the December 4, 2014 Guide announcement for complete details. The Division of Allergy, Immunology, and Transplantation staff members listed in the scientific/research contacts section of the FOA can answer any questions you have.

For HIV Researchers: A Funding Opportunity on Eliminating the Latent HIV Reservoir

Does the following describe you? If so, you might want to consider responding to a reissued U01 funding opportunity announcement (FOA).

I am an investigator who can design a clinical trial to test interventions—e.g., drugs, biologics, vaccines—aimed at eliminating latently-infected cells containing replication competent HIV provirus.

Areas of Research Interest

The FOA’s objective is to facilitate translating basic research findings into novel approaches and mechanistic clinical studies that will enhance the elimination of cells containing replication competent HIV in HIV-infected adults on effective long-term suppressive therapy.

You can propose a trial that may improve understanding of the types, location, and numbers of latently-infected cells. However, do not focus solely on detecting and measuring these cells; if you do, your application will be nonresponsive to this FOA and will not be reviewed.

Novel therapeutic vaccines and other immunological approaches that harness and enhance patients' immune response are of interest, including:

Interventions that target intracellular mechanisms that maintain latency or promote apoptosis of cells containing latent HIV
Immunological mechanisms employing broadly neutralizing or non-neutralizing antibody to boost antibody-dependent cytotoxicity or antibody-dependent cellular phagocytosis
Gene editing or genetic engineering approaches, either with or without an activation step
Therapeutic vaccines, including T cell-based vaccines that harness and enhance the individual’s immune response in order to target specific HIV targets or latently-infected cells

Read the FOA for other examples of responsive and nonresponsive studies. Also be sure to note the clinical trial planning activities that the FOA will not support.

Trial Requirements

Your proposed trial must 1) include HIV-infected adults who are on suppressive antiretroviral therapy and have sustained undetectable plasma viral load levels below the limit of detection (less than 50 copies/ml) for a minimum of two years, 2) be conducted at no more than two clinical research sites in the U.S., and 3) involve a small cohort, such as 30 subjects or fewer.

Note that if your application is funded, you will need to begin enrolling subjects for your clinical trial within nine months of receiving the Notice of Award.

Other Application Information

Read the March 10, 2016 Guide announcement for complete details, including FOA-specific application content, for example, a clinical protocol synopsis and milestone plan.

Optional letters of intent are due June 26, 2016. The application deadline is a month later on July 26, 2016.

Direct questions about the FOA to Tia Morton, NIAID's scientific/research contact for the FOA.

Improve Immunity in Neonates and Infants

NIH invites applications for a reissued U01 funding opportunity announcement (FOA) that seeks to ultimately improve infant and neonatal immunity. This FOA will support research that advances current knowledge of the developing immune system during the first year of life and encourages innovative approaches to understanding the distinctive characteristics of neonatal and infant immune responses.

Applications should examine the development and function of the immune system of neonates (0 to 28 days) and infants (29 days to 12 months). Additionally, proposed research should focus on grasping a better understanding of infant and neonatal immune development as well as aspire to improve public health by providing a foundation for the maturation of a healthy immune system, reducing the development of immune-mediated disorders, reducing susceptibility to infections and allergens, and improving immune responses to vaccines in vulnerable populations.

Specific research areas of interest include:

Mechanisms controlling innate immune function
Adaptive immunity
Understanding the influence of specific tissue microenvironments on immune development, including unique features of tissue-specific innate or adaptive immune responses to allergens, infection (including HIV), vaccination, pollutants, or toxins

Read the FOA for additional areas of interest, as well as research areas that will be considered nonresponsive and therefore will not be reviewed. Relevant animal models and human studies are permitted.

Application Budget and Restrictions

Application budgets are limited to $300,000 in annual direct costs, unless you propose using nonhuman primates. In that case, the budget cap is $350,000 in annual direct costs. The maximum project period is five years.

Funding after the first year of the award may be reduced depending on progress made in meeting the data- and other resource-sharing plans you'll negotiate with NIH after award and in accordance with achieving the goals of the program.

Application Submission

Optional letters of intent are due June 29, 2016. The deadline to apply is July 29, 2016. Be sure to use FORMS-D application forms and instructions, and apply early to allow time to correct any errors found in your application during the submission process.

Read the March 7, 2016 Guide announcement for complete details. Direct questions to the relevant NIAID scientific/research contacts listed in the FOA under Section VII. Agency Contacts.

Contractors: Check Out a Solicitation for Preclinical Development Support

Through a recent request for proposals (RFP), NIAID seeks proposals on preclinical development support for promising products that emerge from investigator-initiated research studies. We anticipate awarding one indefinite delivery/indefinite quantity contract for a seven-year period of performance beginning on or about March 2017.

If you're interested, see the March 10, 2016 solicitation. The response date is June 10, 2016, at 3:00 p.m. Eastern time.

Should you have questions, direct them to Kishan Patel, the primary point of contact for this RFP.

Submit Feedback on Clinical Trial Protocol Template

NIH and FDA recently published a draft template with instructional and sample text for NIH-funded investigators to use when writing a protocol for phase 2 or 3 clinical trials that require investigational new drug (IND) or investigational device exemption (IDE) applications. The final template will serve as a resource for investigators to improve the organization and completeness of their clinical trial protocols.

Before finalizing the template, NIH and FDA seek feedback from public stakeholders—investigators, investigator-sponsors, institutional review board members, and anyone else involved in protocol development and review.

You can read the full Protocol Template: Instructional and Sample Text on the Clinical Trials page of NIH’s Office of Clinical Research and Bioethics Policy.

After you’ve reviewed the document, submit your feedback at NIH and FDA Request for Public Comment on Draft Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies. The deadline to respond is April 17, 2016.

News Briefs

Register for NIH Regional Seminar Before Rates Increase on Friday.

Registration rates are set to increase this Friday, April 8, for the NIH Regional Seminar in Baltimore, Maryland, which will take place May 11 to 13, 2016. Take a look at theSample Agenda and sign up now if you like what you see!

See Updated Guidelines for Research With Recombinant or Synthetic Nucleic Acid Molecules.

In order to streamline the review process for human gene transfer protocols, NIH revised its guidelines for research involving recombinant or synthetic nucleic acid molecules. As noted in the March 23, 2016 Guide notice, changes impact:

The criteria for selecting protocols for in-depth review and public discussion by the NIH Recombinant DNA Advisory Committee
The process by which human gene transfer protocols are reviewed and registered with NIH
The streamlining of NIH protocol submission requirements under Appendix M-I-A of the NIH Guidelines

Read the March 22, 2016 Federal Register notice for the full guidelines.

New FORMS-D Application Instructions Clarify Biosketch Requirements.

Next time you apply for an NIH grant, do not simply update your biographical sketch from a previous application, as the biosketch instructions are changing. For example, you may have previously used a graphic or table, which is now explicitly unallowed. For a full list of changes, see theMarch 23, 2016 Guide notice.

Accounting for Other Sources of Funding in Your Grant Application

Suppose you have funding support from a private foundation, perhaps through one of the resources on our Finding Foundations and Other Funding Sources list. When you’re ready to submit your next application for an NIH grant, how should you account for that other support?

You are required to list "selected ongoing and completed research projects for the past three years (federal or non-federal support)" in each of your application's biographical sketches for senior/key personnel and other significant contributors (substantive contributors with an indefinite level of effort). Include project descriptions so your reviewers understand how your proposed research differs from any ongoing work, e.g., a similar project that is gathering only preliminary data.

When your application is selected for funding, you will detail for us your complete other support as part of the just-in-time process. This includes both active and pending other support. To do so, follow the instructions listed under "Part III Section 1.8 Other Support" in the Supplemental Grant Application Instructions. You will provide information for all senior/key personnel: project names, project numbers, funding sources, major goals, project dates, annual direct costs, percent effort in person months, and potential overlap.

As stated in Prepare Your Other Support Submission, NIAID will be looking primarily for commitment, scientific, and budgetary overlap. Essentially, we don’t want to pay for items or research effort already paid for by another source, nor will we allow any personnel to exceed 100 percent commitment of total effort across all projects.

As you complete your application and during the just-in-time process, be clear and specific about your other support and include your suggested solutions for potential overlap as this will be very helpful during our evaluation of the other support.

NIAID may adjust your level of funding downward to remove overlap if your new award will cause overlap with your other support. Should this happen, we will attempt to negotiate overlap with you if doing so will still in NIAID’s opinion allow a viable award to be made after removing the overlap.

Finally, a disclaimer: The advice in this article applies to research grants only. If you have questions related to other support for fellowship, training, or career development grants in which other support is limited or not expected, contact Laura Pone (for fellowship grants), Philip Smith (for training grants), or Jill Saletta (for career development awards).

Related Resources

Feel free to send us a question at deaweb@niaid.nih.gov. 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.

“Will there be a penalty to the institution or principal investigator if the investigator takes retirement before fully completing a project and the left-over funds are returned to NIH?”—anonymous reader

No, there will be no penalty. However, anytime the principal investigator has a continuous absence from a project for three or more months, prior approval is required, which may apply in this case. See Section 8.1.2 Prior Approval Requirements in the NIH Grants Policy Statement to learn more.

Go to our Prior Approvals for Post-Award Grant Actions SOP for instructions on how to make a request.