NIAID Funding News, December 9, 2015

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December 9, 2015 NIAID Funding News

Feature Articles

Application Missteps—Flawed Project Design

Opportunities and Resources

In The News

Advice Corner

Navigating the SBIR/STTR Program Process
Reader Questions
- Can I reduce my personal effort on a K24 award from 50 percent to 35 percent?
- Can an investigator be listed as a PI on more than one scientifically distinct application in response to an RFA?

New Funding Opportunities

See the list

Application Missteps—Flawed Project Design

Think carefully about project design during the early planning stages of your application, as even minor flaws can spell trouble. Here's some advice to help you avoid this potentially damaging misstep.

Note: We cover a few basics of project design in this section. To learn more, see Design a Project in our Strategy for NIH Funding, linked below.

Build Your Foundation: Hypothesis and Specific Aims

As the driving forces for your project, the central hypothesis and Specific Aims are essential to its design. For more information on both elements, go to the resources in Related Links below. Our participating program officers touch on a few additional points here.

A central hypothesis is crucial since reviewers will examine it closely, but it can be difficult to develop, especially if you're proposing a brand new project or one that changes direction. In such cases, you may have to include a fair amount of descriptive preliminary data to define basic parameters. Unfortunately, descriptive data often do not excite reviewers. Keep this in mind as you design your project and write your application.

Wolfgang Leitner, a program officer in our Division of Allergy, Immunology, and Transplantation (DAIT), has these tips for you:

"Make sure to a) keep the descriptive ('model-development/characterization') aspects of the project to a minimum and b) justify them well (ask yourself: Do I really need to conduct a comprehensive characterization in order to proceed with the mechanistic aims or would a more targeted and selective characterization provide enough information?)."

In designing your project, be mindful to develop Specific Aims that are based on, and test, your hypothesis. Also establish a close link between the two. You'll need to demonstrate this connection clearly to your reviewers, as another DAIT program officer points out:

"Reviewers like to see a central hypothesis and how the Specific Aims address this hypothesis. It can be helpful to fully lay out the hypothesis in the aims section, then conclude with a clear summary of what knowledge will be gained at the end of the award, how that fits with the hypothesis and thus drives the field forward, and where the project could go in the future."—Annette Rothermel

As for the Specific Aims themselves, Annette Rothermel cautions against having them depend on one another:

"Applicants shouldn't have aims build on each other since if one fails, the entire project may fail. Always have contingency plans, and design the project so that the aims work together but that one aim doesn't require the 'success' of another."

A scientific review officer has this advice for investigators responding to a request for applications (RFA), though it applies to investigator-initiated applications too:

"There should be a simple testable hypothesis that is supported by preliminary data. Show preliminary data relevant to each aim and clearly tie the data to the aim (highlight your data when applicable)." —Frank DeSilva, Scientific Review Program (SRP)

For additional information click on the following links below: Choose a Testable Hypothesis and Draft Specific Aims to Test Your Hypothesis.

Consider Other Critical Components

Here are some additional thoughts from SRP's Frank DeSilva on other key elements to ponder when designing your project (though his focus is on RFAs, the advice applies across the board). You'll need to address them all in your application to show that you've considered every angle.

"Demonstrate significance of your proposed work. Justify choice of methods and convince reviewers that you have full competence in using the proposed methods. If you don't, show that you've enlisted collaborators who can do what you propose. Describe potential pitfalls and alternative approaches, and address future directions."

Take Time to Consider Timing

An important part of designing your project is figuring how long it will take to complete. In tackling this step, many investigators tend to underestimate, so plan your research with the understanding that it may take more time than you might think.

To come up with an educated "guesstimate," consider as many actions or circumstances that will play into the amount of time you'll need for your project, start to finish.

A program officer in our Division of AIDS (DAIDS) suggests asking yourself questions, such as:

"Have you anticipated potential pitfalls and ways to overcome them? Have you considered the time needed to get samples from an off-site collaborator? If conducting human subjects research, do you have a contingency plan for accruing human subjects if you can't meet your goals with the initial performance sites? Have you allowed sufficient time from when the last human subject is off the study and when the grant ends so that samples can be tested and data analyzed?"

As a planning tool, consider mapping out a timeline to visualize what you hope to accomplish in each year of your grant. Keep in mind that the most you can request for an R01 is five years, so it's crucial to assess whether you can do what you set out to in the limited number of years you ask for (which doesn't necessarily mean you'll get it). Moreover, you will likely be writing your renewal application before the first award period is over, so ask yourself where you will be at the time you need to write the next proposal. Will you have key data in hand by then?

With that in mind, having a timeline can give you a clearer picture of whether you're planning to do too much, as DAIT's Wolfgang Leitner points out:

"New investigators in particular, are frequently criticized for being unrealistic and overly ambitious by proposing too much. Therefore, it helps greatly to prepare a detailed timeline which takes into account potential delays and the time it takes to repeat experiments. Applicants should also consider including a high-level version of this timeline (space-permitting) in the application."

Bring In Collaborators

Quite likely, you'll need additional expertise to execute parts of your research. That's why you should carefully contemplate in what areas you'll need help and whom you'll choose to provide that help.

Think about this sooner than later as you design your project since identifying the need for additional expertise early on will give you adequate time to get feedback from those you seek out and to make adjustments.

Our participating program officers agree that if you have a gap in expertise somewhere, fill it with a collaborator. It's better to bring in reinforcements than to leave reviewers wondering why you didn't. That said, be sure a collaborator is truly that by having an active role in the research.

Annette Rothermel states:

"It's a misstep not having a collaborator for an area of expertise that a PI doesn't have documented evidence of mastering. However, it's important to have a collaborator who provides a strong letter of support, has assisted in the design of the proposed work, and reviews what is written in the grant application. Reviewers will question whether there's a real collaboration if they find a disconnect between the stated collaboration and flaws in the project design."

If you think that bringing in collaborators will be seen as a weakness, think again. In fact, trying to do everything yourself may be more detrimental than having others take an active part in your project. Wolfgang Leitner offers some insight:

"Investigators, especially those who are new, should not try to do everything 'in house' in an attempt to demonstrate independence. They should not hesitate to recruit collaborators for different aspects of the project, or at least consultants who are willing to assist intellectually with aspects for which applicants do not have well-documented (in the form of publications) expertise. In any case, it's crucial that investigators clearly describe the roles and contributions of collaborators and consultants."

Our DAIDS program officer provides a warning worth heeding while also stressing the importance of addressing collaborators' roles:

"Avoid name dropping. Don't include senior-level collaborators thinking their name alone will aid your project. This can backfire on you if their role isn't apparent to reviewers. Be clear about the level of involvement, expertise, and role played by the people named in your application.
Also, get feedback from the collaborators. If reviewers find flaws in the design, they'll check to see whether appropriate expertise was involved."

If you are still working at the same institution where you did your postdoctoral training, think twice before including your former mentor as a collaborator. If he or she can contribute a unique and needed expertise, then this can be beneficial, but be clear in your application that you are working independently of your former mentor.

For Clinical Research, Consider the Scope

If you're interested in proposing a clinical research project or responding to a clinical research RFA, consider the scope of the project. Sometimes, what you or an institutional review board considers clinical or human subjects research may actually be a clinical trial. Since the Revised NIH Clinical Trial Definition is very broad (listed at Clinical Research Policy alongside a decision tree, case studies, and questions and answers), you should get clarification from a program officer.

Designing a project that involves a clinical trial has many facets, so you should have experienced clinical investigators, physicians, biostatisticians, and project managers on your team. Before getting too deep into your proposed project, we recommend talking to a program officer or others who are knowledgeable about this area.

One big misstep: Proposing a clinical trial in an application submitted in response to a funding opportunity announcement (FOA) that does not accept clinical trials. Also be careful when proposing clinical research that it does not meet the NIH definition of a clinical trial.

Note that NIAID supports investigator-initiated clinical trials through planning grants (R34), implementation grants (R01), or implementation cooperative agreements (U01, U44) using a defined policy and process. We frequently issue FOAs that permit clinical trials, using a variety of grant and contract mechanisms, but be sure that your proposed trial is consistent with what is requested in the FOA. We do not support investigator-initiated clinical trials through the Parent Announcements.

For more information, see Investigator-Initiated Clinical Trial Resources and the NIAID Policy on Investigator-Initiated Clinical Trials, linked below.

Study Radiation and Nuclear Countermeasures With Aging Animal Models

Apply for a UH2/UH3 Phased Innovation cooperative agreement on the impact of aging on currently employed animal models of disease and chronic conditions. Awardees will assess how that impact affects responses to therapy, intervention, or environmental exposures.

Six NIH institutes are participating in the funding opportunity announcement (FOA) and together they plan to fund 10 to 15 awards for an estimated total of $2.1 million.

As one of the opportunity's participating institutes, NIAID seeks research that will expand understanding of the natural history of radiation injury. Your application should focus on:

The long-term effects on health and disease due to accidental ionizing radiation exposure caused by the intentional deployment of a nuclear device, industrial accident, or accidental release
How aging affects sensitivity to ionizing radiation and, conversely, how radiation affects aging
How gender affects sensitivity to and the long-term effects of ionizing radiation

Responsive and Unresponsive Applications

Your application must meet these criteria to be considered responsive:

You must have already published with the animal model you plan to use for this application.
Your laboratory must have live breeder pairs when you apply.
You must have a history of funding, current funding, or pending funding for studies using this animal model that do not address aging as an experimental parameter. This might not be known yet at the time of application or review, so an administrative review panel will check this criterion before award.

Your application will be considered unresponsive if you propose to do any of the following:

Create, develop, or characterize an unpublished animal model for these studies.
Develop new assays for the animal model to be studied.
Use a premature or accelerated aging animal model (animals with altered genotypes that yield earlier average-age of death compared to the parental strain).

UH2/UH3 Cooperative Agreement Requirements

This opportunity uses the cooperative agreement mechanism for funding. Under this approach:

NIH staff take roles of scientific officer and program officer to support and stimulate the award's activities.
They serve as active partners but are not meant to assume direction, prime responsibility, or a dominant role.

Your UH2/UH3 application will reflect two phases as follows:

UH2 phase
- Duration: Maximum of three years
- Budget: No more than $150,000 total for this phase with a maximum of $100,000 in any year

Goal: Breed enough aged animals to prepare for the next phase
Benchmarks (conversion to the UH3 phase is contingent on completing benchmarks in the UH2 award period):
- Animal cohorts. Breed cohorts for studies using older animals. Plans should account for loss of animals due to aging. Animals will be maintained to ages at least up to the 75 percent survival level.
- Feasibility studies. Determine feasibility of using aged animals by preliminary testing of key experimental features and outcomes essential to proceed to the UH3 phase of the study.
- Study-specific. Identify benchmarks that are specific for the application’s model.

UH3 phase
- Duration: Maximum of three years and the entire award project period may not exceed five years total
- Budget: No more than $450,000 total for this phase with a maximum of $175,000 in any year

Goal: Test the hypothesis that "Older ages of animals impact the experimental outcomes."
Benchmarks:
- Disease/condition. Characterize the degenerative condition or disease in the older animals versus young adults.
- Treatment/exposure effect. Characterize the parameters of treatment, intervention, or response to exposure in the older animals versus young adults.

Because all applications will test the same hypothesis in the UH3 phase, you will propose inherently observational work, even if the existing animal model has been established to test a molecular mechanism.

More Information

Read the November 2, 2015 Guide announcement for elaboration on benchmarks, the full description of what to include in the Research Strategy, required meetings and workshops, cooperative agreement details, and more.

Optional letters of intent are due by December 6, 2015. The application deadline is January 6, 2016.

If you plan to apply in NIAID's area of science for this opportunity, direct your questions to Dr. Francesca Macchiarini.

Participate in Human Immunology Project Consortium

Through a reissued funding opportunity announcement (FOA) for the Human Immunology Project Consortium

(HIPC), NIAID seeks applicants to produce human immune profiling data using systems biology approaches. Funded investigators will join an existing network of human immunology research groups from Emory University, Icahn School of Medicine at Mount Sinai, and La Jolla Institute of Allergy and Immunology.

The purpose of the FOA, which uses the U19 activity code, is to characterize human immune responses or mechanisms triggered by vaccines, adjuvants, and naturally occurring infection by capitalizing on recent advances in immune profiling technologies.

Studies supported under this FOA will measure the diversity and commonalities of human immune responses using primary human cells or tissues under a variety of conditions and detailed clinical phenotyping in well-characterized human cohorts.

This FOA will not support clinical trials requiring an investigational new drug (IND). However, it will support the analysis of samples from clinical trials supported by other means or clinical trials that are IND-exempt. For examples of other studies that NIAID will consider nonresponsive, see the FOA.

Each proposed project must generate human immune response profiles obtained (1) during or after infection, (2) before and after vaccination against an infectious disease or diseases, and/or (3) before and after administration of an adjuvant that targets an immune component.

Specific Areas of Research Interest

These include:

Measuring dynamic changes in immune profiles following vaccination or infection that correlate with clinical outcome
Comparing longitudinal immune profiles among ethnically diverse or special populations after infection, vaccination, or adjuvant treatment
Identifying immune profiles that correlate with vaccine efficacy or surrogates of efficacy
Comparing immune profiles in vaccinated populations to populations with naturally acquired infections
Identifying immune profiles that correlate with adjuvant function or antigen/adjuvant formulation, administration regimen, and/or route of delivery

Sharing Data

Under HIPC, awardees will develop common resources and data standards to accelerate the discovery of immune response profiles that correlate with infection or vaccination outcomes. They will rapidly share collected data publicly through two online resources:

ImmPort—an integrated online data warehouse that provides public access to a variety of immunological studies, including data from HIPC.
ImmuneSpace —an HIPC Web portal that provides public access to data from human immune profiling studies together with compiled results and analytical tools.

Application Components, Advice

Each application must include two or three Research Projects, an Administrative Core, a Data Management and Analysis Core, and a Clinical Core. Service cores are optional.

Be sure to read Questions and Answers for RFA-AI-15-041, Human Immunology Project Consortium (U19). We will routinely update that page with additional questions and answers as we receive them from prospective applicants.

For advice on writing and submitting a multiproject application, see Guidance for Preparing a Multiproject Research Application. You may also want to touch base with one of the scientific/research contacts listed in Section VII. Agency Contacts of the FOA.

Due Dates, Other Info

Send optional letters of intent by February 17, 2016. The application deadline is March 17, 2016.

For complete details, including a full list of special research areas, see the November 18, 2015 Guide announcement.

Commercialization Readiness Pilot Program: Where SBIR/STTR Innovation Meets the Market

Are you at a small business that could benefit from assistance with getting your innovation(s) to the marketplace? You may be in luck.

NIH is seeking applications for its Commercialization Readiness Pilot (CRP) Program. The Program aims to facilitate the transition of previously funded Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase II projects to the commercialization stage by providing support for technical assistance and later-stage research and development (R&D) not typically supported through Phase II or Phase IIB grants or contracts.

The goal of this funding opportunity announcement (FOA) is to help applicants pursue the steps necessary to advance a product or technology to market by encouraging business relationships among NIH’s SBIR/STTR awardees, third-party investors, and strategic partners.

To facilitate this innovation advancement, the Program provides assistance in one or a combination of the following areas:

Independent replication of key studies
Investigational new drug-enabling studies
Clinical studies
Manufacturing costs
Regulatory assistance

About CRP Awards

Though a significant amount of the work in a CRP award may be subcontracted to other institutions, the small business is expected to maintain oversight and management of the R&D throughout the award. SBIR/STTR awards may not support other activities important for commercialization, such as product development and market planning, market research, and costs related to license agreements and partnerships.

Note that the FOA uses the SB1 activity code. Awards issued to small businesses will support technology development, testing, evaluation, and commercialization assistance for SBIR or STTR Phase II technologies. Support for clinical trial-related activities will not be provided.

Additionally, only applicants who have recently received Phase II or Phase IIB funding from one of the FOA’s participating institutes are eligible to participate in this program since CRP awards are considered renewals (Type 2) of Phase II or IIB SBIR/STTR awards.

For more information, see Section VI. Award Administration Information of the FOA.

Budget and Application Information

Application budgets are limited by NIAID to $1 million total support (direct costs, indirect costs, fee) annually, with a maximum project period of three years. The scope of the proposed project will determine the project period.

The FOA has three due dates, the next of which is January 5, 2016. Optional letters of intent are due 30 days before the application deadline. We strongly recommend that you speak with a program officer before submitting an application.

Complete details are available in the November 2, 2015 Guide announcement. Direct questions to Dr. Natalia Kruchinin, the scientific/research contact for the FOA.

More about CRP

For more information about the CRP program, see HHS Commercialization Readiness Pilot Program Informational Webinar.

Criteria Now Set for Research on Organ Transplantation Between HIV-Infected Donors and Recipients

The wait is over for investigators anticipating criteria for conducting research related to solid organ transplantation from one HIV-infected person to another. HHS developed and published the criteria—as mandated in the HIV Organ Policy Equity (HOPE) Act*—in the Federal Register. See the November 25, 2015 notice.

Representatives from NIAID, the National Institute of Diabetes and Digestive and Kidney Diseases, and CDC developed the criteria with input from other federal agencies, transplantation experts, and HIV medical professionals.

The criteria:

Provide the framework for clinical studies of organ transplantation from HIV-infected donors to HIV-infected recipients to begin in the U.S. as early as 2016
Aim to ensure that research in HIV-positive to HIV-positive organ transplantation is conducted safely and will provide a basis for evaluating the safety and effectiveness of this intervention
Cover six broad categories:
- Donor eligibility
- Recipient eligibility
- Transplant hospital criteria
- Organ procurement organization responsibilities
- Prevention of inadvertent transmission of HIV
- Required outcome measures

Find criteria details in the Final HOPE Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV.

For additional background information, see the November 25, 2015 NIAID Bulletin.

*The HIV Organ Policy Equity (HOPE) Act was signed into law on November 21, 2013, and allows scientists to carry out research into organ donations from one HIV-infected person to another. Before the HOPE Act became law, organ transplantation from HIV-positive people was illegal in the U.S.

Remember to Use Updated Application Guides for Due Dates on or After January 25

NIH posted updated FORMS-C application guides on November 25, 2015, at SF 424 (R&R) Application and Electronic Submission Information. Use the new guides when completing applications with due dates on or after January 25, 2016 but before May 25, 2016.

Thus, for AIDS and AIDS-related applications due on January 7, 2016, you should not use the updated application guides. Instead use the FORMS-C application guides published on November 25, 2014.

As detailed in our November 4, 2015 article “Timeline for NIH Transition to New Application Forms,” changes in several policy areas accompany the forms update. Follow the new guidance to ensure you account for each policy change.

Rigor and Transparency

For research and career development grant applications, your research strategy should describe:

Scientific premise of the proposed research
Rigorous experimental design for robust and unbiased results
Consideration of relevant biological variables
Authentication of key biological and/or chemical resources

See Rigor and Reproducibility for more information.

Vertebrate Animals

For research and career development grant applications, in the Vertebrate Animals section of the Research Plan, you are no longer required to:

Describe veterinary care.
Justify the number of animals.
Describe and justify the method of euthanasia unless the method is not consistent with American Veterinary Medical Association guidelines.

See Office of Laboratory Animal Welfare—Vertebrate Animals Section for additional details.

NIH Definition of a Child

"Child" under the NIH inclusion policy is now defined as a person under 18 years old. Previously a child was defined as a person under 21 years old.

See Inclusion of Children—Policy Implementation to learn more.

Research Training Grants

For institutional research training grants (e.g., T32 and T35), applicants should:

Focus on recruitment in the "Recruitment and Retention Plan to Enhance Diversity" section.
Describe how the institution will ensure that trainees participate in only exempt human subjects research or nonexempt human subjects research that has institutional review board (IRB) approval in the “Human Subjects” section. A list of potential grants trainees may work on with associated IRB information is not needed.
Describe how the institution will ensure that trainees participate in only vertebrate animal research that has institutional animal care and use committee (IACUC) approval in the “Vertebrate Animals” section. A list of potential grants trainees may work on with associated IACUC information is not needed.
For renewals, report publications from work conducted by supported trainees when you Prepare Your Just-in-Time Information, rather than in the “Progress Report” section.

Supplements Moving to Payment Management System

Be aware that if you receive a competing or administrative supplement (Type 3), NIH will issue funds using a Payment Management System (PMS) subaccount, as announced in the November 19, 2015 Guide notice. Previously, domestic Type 3s were issued in the same account as the parent award (pooled accounts).

As of October 1, 2015, NIH no longer uses institution-specific pooled accounts since award-specific subaccounts better meet HHS objectives for financial data integrity and financial closeout. For more information, see the May 28, 2015 Guide notice and Payment (PMS Subaccount) Frequently Asked Questions.

Help Us Improve the NIAID Website!

We are improving the NIAID website and need help from subject matter experts like you!

If you use the site to find information on research funding, scientific career opportunities, or research policies, take our simple Tree Test for Researchers

. If you use the website for other purposes, take our Tree Test for Non-Researchers

. These tests will help us evaluate how easy it is for you to find content on the site.

The tree test is quick, anonymous, and accessible—you can take it on any computer at any time. The test should take approximately 10 to 15 minutes to complete, and you must do so in one sitting.

The survey deadline is December 23, 2015.

If you have any additional questions, email niaidwebteam@nih.gov. We thank you in advance for your participation and feedback.

News Briefs

Request for Information: Diversity in the Physician-Scientist Workforce.

Members of underrepresented groups face unique barriers to careers as physician-scientists. NIH is considering strategies to enhance the diversity of the physician-scientist workforce and seeks public input on programs that could improve success along educational and career pathways. Send your comments online by December 28, 2015, at Request for Information (RFI): Strategies to Enhance Diversity in the Physician-Scientist Workforce.

Remember to Submit OLAW Reports Next Month.

Awardee institutions are required to submit annual reports for the 2015 calendar year to NIH's Office of Laboratory Animal Welfare (OLAW) by January 31, 2016.

Read the November 16, 2015 Guidenotice for instructions, as well as Annual Report to OLAW for a sample report.

NIH Ending Support for Biomedical Research on Chimps.

NIH Director Dr. Francis Collins announced that NIH will retire its colony of research chimpanzees. To learn more, read Dr. Collins' November 18, 2015 press release "NIH Will No Longer Support Biomedical Research on Chimpanzees."

Clarification of K99/R00 Applicant Eligibility.

NIH Pathway to Independence Award (K99/R00) applicants cannot have more than four years of postdoctoral research experience as of the relevant application due date, regardless of whether the application is new or a resubmission. The change is in effect for the February 12, 2016 due date and after. See the November 17, 2015 Guide notice to learn more.

Use ASSIST for Fellowship Grant Applications.

ASSIST, NIH's online system for preparing, submitting, and tracking grant applications, is now available for fellowship applications, as announced in the November 19, 2015 Guide notice. Most activity codes are now compatible with ASSIST, as seen in the

Target Timeline for Single-Project ASSIST Support.

Navigating the SBIR/STTR Program Process

Figuring out which application option of the Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) program your small business qualifies for can seem like a daunting task.

But fear no more. Following is a bit of insight on both programs that may help when navigating the process.

Three Phases, One Idea

The conventional method of progressing through the SBIR/STTR program consists of completing the following three phases:

Phase I: Establishes the merit, feasibility, and commercial potential of the proposed research and development (R&D) efforts, explains the core concept of the innovation, and determines the quality of performance of the small business.
Phase II: Continues R&D efforts initiated in Phase I and extends funding based on the results achieved in Phase I as well as the scientific and technical merit and commercial potential of the project proposed in Phase II. Only Phase I awardees can proceed to Phase II.
Phase III: Supports small businesses pursuing commercialization opportunities resulting from Phase I and Phase II R&D activities; however, no federal support is awarded for this phase.

There are additional options that may be more appropriate, especially for small businesses that are pressed for time.

Direct to Phase II

If your small business has already accumulated R&D data, established a core concept, and addressed the commercial potential of an innovation similar to what would be expected from the end of a Phase I award, applying for the Pilot Direct Phase II Award may be an option to save time. However, keep in mind that this option is designed specifically for small businesses that have completed Phase I-type milestones without any federal support or funds. Also, this option is limited to the SBIR program only.

Fast-Track

Using the “Fast-Track,” small businesses can save time by submitting an application to Phase I and Phase II concurrently. With this option, both the Phase I and Phase II applications are reviewed together and will receive one summary rating for the entire application. Fast-Track is available for both the SBIR and STTR programs, and is a useful mechanism for reducing or eliminating the funding gap between phases, since both phases undergo review simultaneously.

Which Option Is Best to Use?

We suggest that you first thoroughly read the entire funding opportunity announcement (FOA) for the award for which you would like to apply. The FOA typically contains in-depth information about the participating institutes and centers (ICs), program contacts, deadlines, award guidelines, and the scope of the innovations that will be eligible for funding.

Additionally, before submitting an official application, you should reach out to an SBIR/STTR program contact by sending an abstract containing your Specific Aims and commercialization objectives. By touching base early on, the IC contact can consult with scientific experts on our staff about what stage of the process your small business is in and ensure that the proposed project falls within the mission and scope of the intended IC or NIH in general. The IC contact can then consult with you to determine which phase and option of the SBIR/STTR program is best for you to apply for. To find an NIAID contact, go to NIAID Small Business Program Team.

We also suggest browsing NIH RePORTER, a searchable public database containing information about NIH-funded research projects. This database is a good resource for potential applicants seeking to get an idea of the types of projects that NIH funds, the phases and ICs that other small businesses applied to, their awarded amounts, and any competitors.

More About SBIR/STTR

To learn more about the SBIR and STTR programs, see NIAID's Small Business Program.

Questions? Contact NIAID's SBIR/STTR Program Coordinator Dr. Natalia Kruchinin.

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.

“Can I reduce my personal effort on a K24 award from 50 percent to 35 percent?”—Pat Wirattigowit, University of California San Francisco

Yes, since the K24 requires that you commit three to six person months of effort. However, since the reduction in effort is greater than 25 percent of the original effort level, you will need prior approval. Find out how to request prior approval at Prior Approvals for Post-Award Grant Actions SOP.

“Can an investigator be listed as a PI on more than one scientifically distinct application in response to an RFA?”—anonymous reader

It depends on the opportunity. Every Guide announcement for a request for applications (RFA) includes “Number of Applications” within Section III. 3. Additional Information on Eligibility.

There the announcement will answer your question with text that is likely similar to these examples:

“Applicant organizations may submit more than one application, provided that each application is scientifically distinct.”
“Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.”

Remember, if you're submitting more than one application, you may ask for a combined level of effort that exceeds 100 percent (e.g., 60 percent on one application and 60 percent on another). If both applications are funded, we'll adjust your effort to be no more than 100 percent when we negotiate your awards.