NIAID Funding News - April 19, 2017

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities


Feature Articles

Where Are They Now? NIAID’s Apply for a Grant Webpages

Our Research Funding website content migrated to a new NIAID website structure in September 2016, as discussed in the March 1, 2017 article “Where Are They Now? NIAID’s Top Extramural Webpages” and the March 15, 2017 article “Where Are They Now? NIAID’s Find a Funding Opportunity Webpages.”

In Part III of our series about popular relocated content, we cover the Apply for a Grant section—located within the “Grants & Contracts” tab of the top navigation bar—which includes the following pages:

Sample Applications, Forms, and Other Resources

Sample Applications & More. View successful R01, R21, F31, small business, and additional grant applications and summary statements that have been shared by investigators to assist our applicants. On our list of NIAID and NIH Sample Forms, Plans, Letters, Emails, and More, find examples of data and model organism sharing plans, just-in-time emails from NIH, and other resources.

Qualifying for NIAID Grant Programs

Determine Eligibility for NIAID Grants. Learn how to evaluate whether NIAID’s mission and grant programs are a good fit for your area of science, expertise, and career level and whether your institution qualifies for support.

Go to Information for New Investigators to explore special programs and funding approaches for researchers seeking their first independent NIH research grant.

If you are a foreign investigator, work on foreign projects, or are part of a foreign institution seeking funding, consult International Applications.

Whether you’re a new or established investigator, see Identify Collaboration Opportunities to learn more about working with scientists in different laboratories, including NIAID intramural researchers.

Prepare Your Application

Prepare Your Application. Follow the steps outlined in this section as you assemble your NIH grant application. To help you stay on track, we recommend viewing or printing the checklists on the right side of section pages.

To begin, Draft Specific Aims, NIH’s term for research objectives. As you Outline Your Experiments, address special policies and instructions pertaining to investigator-initiated clinical trials and research involving human subjects, vertebrate animals, select agents, and other areas.

In Know Your Audience, explore how to craft your application for its primary audience, the peer review group. Then, consult our extensive guidance on how to Write Your Research Plan, which includes organizing and formatting the plan and developing your Research Strategy.

Plan and Develop Your Budget and Team

Plan Your Budget & Personnel. Go to Salary Cap & Stipends for current grantee and contractor salary caps and stipend levels for trainees and fellows, which are set by Congress.

Are you considering using co-investigators, multiple principal investigators, consultants, or collaborators to add valuable expertise to your planned project? View Build Your Team for points to bear in mind.

Also, take into account the equipment, facilities, and other support your institution will provide. See Determine Institutional Resources for guidance on these factors, which will affect your costs and reviewers’ evaluation of your project’s feasibility.

As you Create a Budget, present and justify the expenses needed to achieve your Specific Aims. Include project scope, duration, and level of effort in your calculations.

Create a Bibliography, Biosketches, Resource Sharing Plans, and More

Additional Application Elements. Read our advice on preparing a bibliography, Appendix, cover letter, biosketches, and resource sharing plans. You’ll also find information about using the optional PHS Assignment Request Form to list expertise needed to review your application, exclude reviewers, and request an institute assignment.

Adhere to Special Research Requirements: Human Subjects, Vertebrate Animals, Select Agents

Research With Special Considerations. If your project involves human subjects, vertebrate animals, or select agents, you must comply with the regulatory and policy requirements discussed in this section.

Submit Your Application, Plus What To Do if Your Application Isn’t Funded

Submit an Application. New to the application process? Explore submission requirements and how to avoid common pitfalls that could derail your application.

NIH accepts few late applications and only under certain circumstances; check out the rules in Late Applications & Post-Submission Materials.

If your application does not fare well during peer review, consult Options if Your Application Isn’t Funded for help in analyzing what went wrong and determining your next steps.

Next Up in This Series

Watch for the next article in this series, in which we’ll cover the After You Submit an Application section of NIAID’s redesigned website.


Opportunities and Resources

Another Chance To Join the CFAR Program

NIH’s Centers for AIDS Research (CFAR) program supports research coordination, emerging research opportunities, and shared core facilities among institutions that receive significant HIV/AIDS funding from NIH.

We provide funding to CFAR institutions using center core grants (P30), which enhance collaboration and coordination in activities not easily accomplished through standard research awards.

Recently, NIAID and its partner institutes reissued the funding opportunity announcement (FOA) for new and renewal CFAR applications.

Eligibility Requirements

An institution must receive at least $10 million annually for its HIV/AIDS funded research base* (FRB) to be eligible for a CFAR award. The size of the annual award depends on the size of the institution’s FRB.

Tier

FRB

Base Total Cost

1

Minimum $10 million but less than $40 million

$1.5 million

2

Minimum $40 million but less than $80 million

$2.25 million

3

Minimum $80 million

$3 million

Note that institutions are limited to one CFAR award.

Multi-institutional CFARs are allowed, but must designate a lead institution, demonstrate shared leadership positions, and provide detailed coordination agreements.

*The NIH HIV/AIDS FRB is compiled from NIH’s Office of AIDS Research. To determine eligibility, applicant institutions may contact Candice Beaubien.

Core Requirements

CFARs support HIV/AIDS researchers and collaborating organizations by making available multiple cores and core services. Explain in your application how your institution will establish and leverage the following cores:

  • Administrative Core—responsible for managing, coordinating, and overseeing CFAR activities.
  • Developmental Core—provides short-term funding for HIV/AIDS research awards and mentoring for early-career investigators.
  • Basic Science Core(s)—provides equipment, training, services, quality control, expertise, and advice for research activities.
  • Clinical Science Core(s)—provides resources for HIV/AIDS translational research among collaborating clinical, social and behavioral, and basic scientists.
  • Additional Cores—proposed as needed to advance local HIV/AIDS research efforts (e.g., bioinformatics core, biostatistics core, sociobehavioral core).
  • Scientific Working Groups—promote multidisciplinary collaborations on critical HIV/AIDS issues that are neglected or underdeveloped at the institution.

CFAR institutions are also subject to oversight by NIH’s CFAR Steering Committee.

Read the March 30, 2017 Guide announcement for additional details.

Developmental CFARs

Interested institutions that meet the $10 million FRB threshold can choose instead to apply for a Developmental CFAR (D-CFAR) award, which functions similarly to the CFAR but limits its base total cost to $750,000 annually.

The companion opportunity is designed to support institutions ultimately seeking a standard CFAR. In addition to proposing cores and core services, D-CFAR applicants should identify and describe gaps or deficiencies that hinder development of a competitive CFAR application as well as core facilities that would reduce or eliminate those gaps.

Read the March 30, 2017 Guide announcement to learn more.

Deadlines

The first of three annual due dates for both the CFAR and D-CFAR FOAs is August 1, 2017. Submit your letter of intent at least 30 days before the application due date.

Contact Ann Namkung Lee, NIAID’s scientific/research contact for these FOAs, if you have any questions.


Provide Manufacturing and Characterization Services for Vaccines and Other Biologics

A new request for proposals (RFP) seeks services to develop multiple vaccines and biologic candidates that emerge from third-party sources. 

The resulting contract will support the preclinical development pathway focusing on product manufacturing and characterization and spans research and development through Phase I/II regulatory submission. The successful offeror will provide the following services:

  • Product development plans and feasibility studies
  • Product screening, construction, optimization, and process development
  • Product manufacturing, including current Good Manufacturing Practices (cGMP)-compliant manufacturing, to support Phase I/II clinical studies
  • Quality and regulatory support, including audits

Note that this RFP does not request clinical trial services.

NIAID plans to award one indefinite quantity contract with multiple task orders based on programmatic need. The individual task orders may include differing cost-reimbursement structures such as firm fixed price, cost plus fixed fee, and level of effort.

The 10-year period of performance begins on May 1, 2018. You may need to arrange consortium agreements, partnerships, subcontracts, or consultants to ensure you can offer the full spectrum of expertise and facilities. 

All proposals are due by noon Eastern time on June 7, 2017.

For complete details, including the RFP's technical evaluation criteria, read the March 10, 2017 FedBizOpps.gov solicitation.


Contractors: New RFP for Developing Interventional Agents for Infectious Diseases

Consider a new request for proposals (RFP) if you:

  • Have a wide range of development-oriented capabilities
  • Can provide NIAID with nonclinical product development support for promising interventional agents for human infectious diseases or diseases caused by infectious agents
  • Can help Institute staff with preclinical or nonclinical activities to support investigational new drugs, new drug applications, or biologic license applications for advanced products

NIAID anticipates awarding 10 multiple award indefinite quantity contracts and expects the performance period to begin summer of 2018.

The response date is June 28, 2017, at 2:00 p.m. Eastern time.

For complete details, including the RFP’s technical evaluation criteria, read the March 29, 2017 FedBizOpps.gov solicitation. If you have questions, contact Jonathan Bryan, the primary point of contact for this RFP.


Grantees: Act Quickly To Take Advantage of Cancer Immunotherapy Opportunity

For a limited time, administrative supplements are available to fund collaborative pilot projects seeking to reduce the incidence or severity of auto-inflammatory or autoimmune adverse events following cancer immunotherapy. While our central goal is to control non-specific inflammation and autoimmunity in the setting of immuno-oncology, a secondary priority is identifying predictive biomarkers of cancer patients at risk for developing immune-related adverse events.

Applicants are encouraged to propose studies that focus on:

  • Applying knowledge of mechanisms of immune tolerance and autoimmunity to reduce the incidence and severity of off-tumor-target inflammatory or autoimmune responses
  • Enhancing the tumor-targeted specificity of the immunotherapeutic using tissue-specific antigen distributions and vulnerabilities to immune-related adverse events

More specifically, we seek to fund research on:

  • Regulating "off-target" inflammatory responses using checkpoint blockades that do not impede anti-tumor immune responses
  • Identifying tolerance pathways that could be exploited to prevent “on target, off-tumor” adverse events resulting from engineered anti-tumor immune cells (T or NK cells) attacking healthy tissues
  • Identifying cancer targets that can be safely and effectively targeted to discriminate cancers from normal tissues
  • Using immunomodulators in combination therapies that avoid or diminish destructive inflammatory or autoimmune toxicities that currently limits their clinical utility
  • Addressing cancer immunotherapy in patients with underlying autoimmune diseases, including those that disproportionately affect racial and ethnic populations, e.g., lupus

Applications investigating differences in mechanisms contributing to immune-related adverse events among racial and ethnic populations are encouraged.

A Focus on Collaboration

One important requirement for funding is that your application includes both a principal investigator (PI) funded by the National Cancer Institute and a PI funded by NIAID. This requirement arises from the initiative's focus on interdisciplinary collaboration.

Budgets are limited to no more than $200,000 in annual direct costs, such that $100,000 will go toward supporting each PI’s parent grant.

The two PIs can belong to the same or different institutions. Any PI on a multiple PI parent grant is eligible to apply for administrative supplements.

Your administrative supplement application can request one or two years of funding. For whichever funding period you choose, both parent grants must have at least as many years of active funding remaining (not including no-cost extensions) at the time of anticipated award (August 15, 2017).

Each of the PIs on the collaborative team should submit the same application (indicating the budget for each PI collaborator’s component), so that each institute, NCI and NIAID, can award a supplement to its own PI.

Additional Administrative Details

Remember, administrative supplements must be spent on research that is already within the scope of the parent grants, but can include new research objectives within that original scope. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.

Both parent grants must be one of the following activity codes: P01, P50, U19, UM1, UM2, U54, R00, R01, R35, R37, or U01.

These awards are noncompeting, meaning supplement requests will be evaluated and approved by NCI and NIAID staff.

Applications are due by June 15, 2017. You don’t need to send a letter of intent beforehand.

For complete details, read the April 3, 2017 Guide notice.

If you have any questions, contact Dr. Lakshmi Ramachandra, NIAID’s scientific/research contact for the initiative.


In The News

Guidance on Citing Interim Research Products in NIH Grant Applications

Investigators who want to accelerate dissemination and enhance the rigor of their work can now cite interim research products anywhere other research products are cited in a grant application or progress report. NIH announced this new policy last month.

Be sure to read the Guide notice linked below for complete details. We provide an overview here.

Interim Research Products Defined

They are complete, public research products that are not final. For example:

  • Preprint—complete and public draft of a scientific document that is typically an unreviewed manuscript written in the style of a peer-reviewed journal. Note: the NIH Public Access Policy does not apply to preprints since they are not published in peer-reviewed journals.
  • Preregistered protocol—an advance public declaration by a scientist of a research protocol’s key elements
    • Note: This Guide notice does not apply to registering clinical trials. For more on that, see ClinicalTrials.gov.

Citing Is Not Required

Reporting interim research products is an option, not a requirement.

That means you do not have to cite such products in a grant application nor must you create interim research products as part of a grant award.

When, Where, and How to Cite

If you choose to cite interim research products, you may begin doing so with 1) grant applications that have a May 25, 2017 due date and after and 2) Research Performance Progress Reports (RPPR) submitted on or after May 25, 2017.

Citations can go in various places, including the Bibliography & References Cited section of the R&R Other Project Information Form and the Products part of Section C in the RPPR. For others, see the Guide notice below.

In a citation, you must include the Digital Object Identifier (DOI) and the Object type (e.g., preprint, protocol). You must use a service offered by a DOI Registration Agency. See the list of DOI Registration Agencies to find the agency that can best meet your needs. Also list any information about the document version, such as most recent date modified as well as the date the product was cited, if relevant.

For More Information

Read the March 24, 2017 Guide notice for complete details, including criteria to consider for repositories and guidelines for claiming interim research products as products of NIH awards.

You may also want to read the March 28, 2017 Open Mike blog entry.


Coming Soon: Opportunity To Add Regenerative Medicine Component to Ongoing Research

The 21st Century Cures Act provides funding to further the field of regenerative medicine (RM) using adult stem cells, including autologous cells.

This fiscal year, NIH will distribute that money to ongoing clinical research studies through competing revision (Type 3) grants. Competing Revisions support an expansion of the ongoing grant’s approved scope or research protocol in the current budget period. Applicants must apply and undergo peer review.

For this initiative, your Type 3 application should propose research on biologics (e.g., growth factors, cytokines) and biomaterials (e.g., extracellular matrix, scaffolds) that stimulate host adult stem cell growth, differentiation, and function, or otherwise directly act upon adult stems cells to support innate host healing mechanisms, treat disease, or restore function.

Further, your Type 3 application should seek solutions to widely recognized issues in developing safe and effective RM therapies. Propose to improve tools, methods, standards, or applied science that support product manufacturing, quality, safety, or effectiveness.

To be eligible, your ongoing award’s activity code must be R01, R24, R41/R42, R43/R44, U01, U54, UM1, UM2, UC4, U24, P41, or P50.

Additionally, the 21st Century Cures Act stipulates that this initiative’s grantees match new NIH funding using nonfederal funds (e.g., contributions from foundations or the private sector).

Read the March 31, 2017 Guide notice to learn more.

NIH will publish the funding opportunity announcement later this month or in May with an application due date set in May or June.


News Briefs

Your Application Will Be Withdrawn if You Don’t Follow NIH’s Appendix Policy

As of January 25, 2017, NIH is enforcing the application Appendix materials policy announced in the August 12, 2016 Guide notice. That policy eliminated most previously accepted Appendix materials. 

Your application will be withdrawn and not reviewed if you include Appendix materials that are not specifically listed as allowed or required in either the Guide notice linked above or the funding opportunity announcement to which you’re applying.

R03, R21 Opportunities on Primary Immunodeficiency Diseases Will Expire Early

June 16, 2017, will be the last day to apply for Small Grants on Primary Immunodeficiency Diseases (R03) or Exploratory/Developmental Investigations on Primary Immunodeficiency Diseases (R21). Previously, these funding opportunity announcements (FOAs) were set to expire on July 17, 2019. NIAID plans to replace the FOAs with similar opportunities.

Several BD2K Roadmap Initiatives Cancelled, New Initiatives Planned

NIH recently cancelled the final receipt dates of a set of BD2K funding opportunities, in part to make way for new initiatives to support strategies for improving data discoverability, utility, and sustainability for the biomedical research community. See Big Data to Knowledge for more information.


Advice Corner

Understanding Indirect Costs

Having trouble distinguishing between direct and indirect costs for your federally funded research project? Check out the Office of Extramural Research’s (OER) YouTube presentation Indirect Costs 101. Pressed for time? Not to worry. We’ve listed a few key points below to help you better understand indirect costs.

NIH Has a Long History With Indirect Costs

NIH first began paying indirect cost rates during the 1950s, which were initially capped at 8 percent of the total award, then later increased to 20 percent. Additional guidance released in the 1958 Office of Management and Budget (OMB) Circular A-21 further defined indirect costs and explained what these costs could cover. In 1991, the indirect cost rate cap was again raised to 26 percent of the Modified Total Direct Cost (MTDC), but this cap applied to only administrative costs at universities and institutions of higher education.

Lastly, Uniform Guidance released in 2014 explained that federal agencies must accept and apply negotiated indirect cost rates to all federal awards, grants, and cooperative agreements. Exceptions are made to cap indirect costs only when the cap is required by a statute or is approved by the awarding federal agency head. This means that indirect cost rates are not typically required to adhere to a rate cap, depending on the program.

Knowing Which Costs to Consider Is Half the Battle

Totaling and attributing the sum of indirect costs can be as simple as a math equation, if you know what costs to consider.

Direct costs can be directly linked or assigned to a specific research project and consist of line items, such as equipment, personnel, and travel.

Indirect costs (also referred to as “facilities and administrative” or “F&A”) are infrastructure costs that are not directly related to the project itself but are required to conduct the research and are critical to the success of the project and organization as a whole. Indirect costs would include line items such as payroll, departmental administration, building depreciation, student services, and the like.

Indirect Cost Rates Are Not Established by NIH, Except in Specific Cases

Indirect cost rates for colleges, universities, nonprofits, hospitals, and state and local governments are established in good faith by “cognizant agencies,” other than NIH. This determination, referred to as “cost negotiation cognizance,” is set by the HHS Division of Cost Allocation or Department of Defense’s (DoD) Office of Naval Research. Your project’s indirect cost rate will be set by the agency you are receiving most of your funding from; e.g., HHS or DoD. However, once a federally-funded rate is negotiated and established, it applies to all government funding agencies that are going to support your grantee institution.

NIH sets indirect cost rates only when the grantee is a commercial organization. In these cases, the Division of Financial Advisory Services, Office of Acquisition Management and Policy will set the rate for the grantee organization.

In instances where the grantee institution does not have a negotiated rate at the time of its award and it does not wish to pursue negotiations to establish one, it can elect to receive a "de minimus" rate, which is 10 percent of MTDC. If the grantee institution does elect to use the de minimus rate, such rate must be used for all federal awards granted to that grantee institution, unless it chooses to negotiate for a rate, which it may apply to do at any time.

NIH also provides F&A costs without the need for a negotiated rate for certain classes of awards. See the following for additional information: What F&A costs will NIH provide for training, education, and career development grants? and What F&A costs will NIH provide for awards to foreign organizations, international organizations, and domestic grants with foreign components?

Total Cost Awards Have Drawbacks Too

Total Cost Awards (TCA) provide grantees with a previously determined funding level for an award, regardless of the indirect cost rate. Using a TCA, the funding federal agency can provide a total available award amount up front, but the grantee will need to work backwards and determine which portions of the award can be spent on indirect and direct costs.

TCA grants at NIH are rare. Though Total Cost Awards tend to be easier for the funding agency to budget, we've seen investigators misjudge the amount of money available to complete their research. For this reason, NIH prefers to specifically list the amount of the award designated to direct and indirect costs.

Furthermore, to maximize fairness and competitiveness in peer review, NIH typically specifies the funds available for awards in direct costs. This way, peer reviewers judge applications' science in the context of comparable costs (e.g., direct costs).

Note that a funding opportunity announcement that specifies a cap on direct costs is not necessarily a TCA, and in fact, it usually isn’t. Capping direct costs is simply a means by which NIAID can control costs and maximize the number of awards for that initiative.

One Hundred Percent of NIH Research Funding Supports Research

NIH research funding supports both direct and indirect costs associated with research. But non-research and research activities costs must be separated since NIH negotiates the indirect cost rate based on the F&A costs associated with research activities only. Instructional activities and other activities should be explicitly separated from research activities costs.

Additionally, facilities costs are also limited to the spaces that will be used only for research. Though separating activity costs may not seem beneficial, doing so ensures that the reimbursements issued on NIH grants solely support the conduct of research.

To learn more about indirect costs, see OER's Develop Your Budget, including What is the difference between allowable direct costs and allowable facilities & administrative (F&A) costs? For questions, contact NIH’s Division of Financial Advisory Services (DFAS).

More information is also available at Grants and Funding.


Reader Questions

You can ask us a question at deaweb@niaid.nih.gov. After responding, we may ask your permission to include your question in the newsletter.

“What is the minimum level of effort required on a grant?”—anonymous reader

NIH does not have minimum effort requirements for principal investigators of unsolicited research project grants, although some individual funding opportunity announcements may set a minimum effort requirement for the principal investigator.

That said, reviewers will look at your proposed effort and make their own determination of whether that effort is sufficient to meet the needs of the proposed studies. Your grant score could be affected if you propose less effort than deemed necessary by the reviewers.

However, it does have requirements for Small Business Technology Transfer (STTR), career development, training, and fellowship grants.

For an explanation of how to calculate person months, go to NIH's Usage of Person Months frequently asked questions.

 “Is my application confidential?”—anonymous reader

Yes, NIH and its institutes follow strict rules to protect confidentiality for unfunded applications.

Members of peer review committees must leave the room during discussions of grant applications or contract proposals in which they or close associates have an interest that could bias their evaluations. Reviewers may not take materials from peer review and use them without attribution.

If your application is funded, NIH makes the title and abstract public through RePORTER. You should not put confidential or proprietary information in those sections. For advice on preparing your abstract, see Hone Your Abstract and Narrative.

For more information, read our Conflict of Interest in Peer Review SOP. You might also want to review our March 4, 2015 article “Your Grant Information Can Be Made Public,” which discusses the rules surrounding Freedom of Information Act requests.


New Funding Opportunities

See other announcements at Opportunities & Announcements.​​

Content last reviewed on April 19, 2017