NIAID Funding Newsletter, April 17, 2014

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April 17, 2014

Feature Articles

Big News on Application Submission Policy

Opportunities and Resources

In The News

News Briefs

Advice Corner

Know When You Do—and Don't—Have to Get NIAID's Prior Approval
If Preaward Spending Is Okay With Your Institution, It's Okay With Us
Reader Questions
- Does NIAID sponsor individual researchers to attend conferences?
- What is the submission deadline for an AIDS-related F32 application?

New Funding Opportunities

See the list

Big News on Application Submission Policy

For the past few years, you could resubmit just one time if your initial application didn't succeed.

Now you can send a new (A0) application without NIH requiring you to make substantial changes to the scientific direction or scope. This means after an unsuccessful application, you can send a new application in the same scientific vein.

A new (A0) application always gets a new serial number, and there is no formal link between it and any prior application.

You can follow a resubmission (A1) application only with an A0 application.
If you are submitting a new application after an unsuccessful competing renewal (Type 2) application, the next application must be new (Type 1 A0).
Apply on the new application due date, not the renewal date.

For the official announcement, including reasons for the change, see the April 17, 2014, Guide notice. Also see the updated FAQ on Resubmissions of NIH Applications.

The New Policy Is Already In Effect

You can take advantage of this for your next due date since the policy kicked in for due dates after April 16. The first standard due date affected is May 7, 2014, for AIDS and AIDS-related applications.

You must wait for your summary statement from the previous application's review before sending a new application or else NIH might consider it an overlapping application with the previous one. An application is considered under review until the summary statement is released (that rule is still in effect). Also, you can't send an overlapping application while a prior similar one is under appeal. Learn more at Evaluation of Overlapping Applications.

Now that you aren’t obligated to make substantial changes in scientific direction or scope after an unsuccessful application, you'll have to decide whether that's the right move. See our advice below and discuss with your program officer.

Our Advice

We're still working on site updates to reflect this breaking news. Meanwhile, our advice probably sounds familiar: always strive to enhance your next application.

For all applications:

Strengthen your next submission of the application using reviewers’ feedback in the summary statement, from your program officer, and from your mentoring colleagues
Add the latest preliminary data and new publications.
Ensure your application reflects the most current science.
Consider which study section and institute or center assignments you want for this application and make that request in your cover letter.
Use the latest funding opportunity announcement (FOA) and forms associated with your planned receipt date.

For an A0 application in the same vein as a prior application, also do the following:

Take a hard look at whether another attempt using the same idea is likely to result in funding.
- Even if you submit your previously reviewed application as new (an A0), it may go to the same study section and reviewers are likely to remember it from before. You won't have the benefit of an introduction to address the prior comments. Therefore, make sure you have taken reviewers' suggestions into consideration when writing your application.
- We don't anticipate substantial improvement in paylines, so don't count on that.
- Consider adjusting or completely overhauling your proposal as needed.
Follow the FOA's procedures for new applications.
- Don't respond directly to comments from prior reviews. Just use them to improve the application.
- Omit the introduction.
- For type 2, also omit the progress report.
- Get prior approvals again as required. For examples, see the Big Grants SOP and Conference Awards SOP.
- Confirm you still meet any eligibility criteria (career stage or other qualifiers.)

One last note: if you plan to send multiple applications on non-overlapping topics, consider staggering your timing so they don't both end up in the same study section for the same round of initial peer review. Otherwise, you're competing with yourself.

As we update our site, we'll list the changes on Latest Funding Updates. We'll also share any new advice for you in follow-up articles.

If you have any questions or feedback about how this new policy affects you, email us at deaweb@niaid.nih.gov.

An Opportunity to Lead the Network for Atopic Dermatitis Research

Since 2004, NIAID has supported the Atopic Dermatitis Research Network (ADRN), which conducts clinical research studies to better understand host defense mechanisms in the skin.

We encourage applicants to respond to a funding opportunity announcement (FOA) that supports the continuation of the ADRN.

Areas of Research Interest

The FOA has several research areas of interest, such as:

Studies of the microbiome in atopic dermatitis (AD) and its role in disease pathogenesis, including:
- Studies of alterations in the cutaneous or other microbiome in patients with AD compared to healthy controls.
- Longitudinal studies of the skin microbiome.
- Evaluation of the effects of microbiome changes on cutaneous host defense.
Cutaneous application of antimicrobial peptides and altering the skin microbiome.
Evaluating the immunologic, genetic, and epigenetic mechanisms underlying therapeutic interventions.
Understanding the susceptibility of subjects with AD to viral infections (eczema vaccinatum and eczema herpeticum) and bacterial infections (colonization and infection with Staphylococcus aureus, including MRSA).

The majority of research that ADRN conducts should involve human subjects, but animal studies may be included if they 1) provide information that can't be obtained by human studies and 2) are directly linked to ongoing or planned human studies.

Projects to Be Included

A multiproject application is required and must include both clinical and mechanistic study projects.

Clinical projects fall into the following categories. In addition to the required four clinical projects (two for each category), applicants may propose up to two others (either interventional clinical trials or clinical studies).

Interventional clinical trials—aimed at modulating viral or bacterial colonization/infection of the skin and/or the immune response to these infectious agents.
Clinical studies—include observational studies, genetic and/or epigenetic studies, studies of the skin microbiome or longitudinal studies to identify and characterize AD phenotypes pertaining to clinical presentation, skin and peripheral blood immunologic responses and patterns of cutaneous host defense.

Mechanistic studies, which should involve human subjects, must be part of both interventional clinical trials and clinical studies projects and be aimed at:

Understanding the mechanisms of either the disease or action of a treatment modality.
Identifying biomarkers that predict disease severity or progression from sensitization to allergy, or the ability of a treatment modality to affect efficacy or safety.

For complete details, including further information on research studies and objectives, read the March 20, 2014, Guide notice.

Deadlines, Writing Help

Optional letters of intent are due June 8, 2014, with applications due a month later on July 8.

For help in writing a multiproject application, as well as information on electronic submission, go to Guidance for Preparing a Multiproject Research Application.

Improved Understanding of Immunity Through Improved Computational Models

NIAID has issued a funding opportunity announcement (FOA) for multiproject cooperative agreements (U19) to develop computational models of immunity to infectious diseases. Using computational modeling and immunological experimentation, applicants will develop, refine, and validate models of immune responses either during or following infection or before and after vaccination.

Applicants will propose two to four research projects arranged around a central scientific theme.

Areas of interest include the dynamics of innate immune responses, mechanisms of adaptive immune pathways, and homeostatic mechanisms that maintain protective immunity.

Be sure to follow the eligibility requirements listed in the FOA, including:

One immunologist and one computational modeler must be included as multiprogram directors/principal investigators of the entire U19.
At least one project must focus on computational model development, refinement, or validation.
At least one project must focus on immunological experimentation and at least one aim of the immunology project(s) must include human primary cells or tissues.

In addition, the following are not permitted:

Clinical trials, although the use of data obtained from independently-funded clinical trials is allowed.
HIV/AIDS and related studies.
In vitro studies using only human cell lines.
Epidemiological studies.
Projects that focus primarily on:
- Data analysis tool development.
- Computational models in the absence of biological experimentation.
- Pathogen infection, replication, and dissemination either within a host or at the population level.

Applications must include an Administrative core and an Infrastructure and Opportunities Fund (IOF) Management core. They may also propose Optional Service cores. For advice on writing an effective multiproject application, see Guidance for Preparing a Multiproject Research Application.

NIAID intends to fund three or four awardees. Following review, NIAID will choose one institution from among the successful applicants to manage the IOF for the entire network. All awardees are expected to share their computational models and data through a publicly accessible repository(ies).

Optional letters of intent are due June 18, 2014. Applications are due July 18, 2014.

For full details, including examples of our specific areas of research interest, see the March 21, 2014, Guide notice.

Big Data Meets Small Business

Attention small businesses: Check out two funding opportunity announcements (FOAs) to develop new approaches, standards, methods, tools, software, and competencies to improve scientific use of "big data."

For each opportunity, you'll have a chance to focus on technologies for biomedical computing and informatics across all of NIH's research areas.

If that seems exceptionally broad to you, we concur—and that's the point.

These opportunities are looking for dynamic, innovative projects that have the potential to generate major changes in how scientists conduct research, from basic biomedicine to research targeted to organ systems and diseases.

NIH's Division of Receipt and Referral will send us applications that fit within our mission area, but as always, you may request assignment to NIAID in your cover letter.

Read the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) FOAs for details, including topic areas, application instructions, and NIAID contacts.

These funding opportunities come from NIH's Big Data to Knowledge (BD2K) program, an effort to improve biomedical use of data sets and databases that are too large or complex for conventional research approaches.

Learn more about it at Big Data to Knowledge (BD2K). Also see other BD2K Funding Opportunities and Notices.

Innovative Research to Overcome Barrier to HIV Cure

Antiretroviral therapy cannot fully eliminate latently-infected CD4+ T cells, which is a major obstacle to achieving an HIV cure. NIAID now seeks an approach that can selectively eliminate HIV-1 latently-infected cells without depending on viral reactivation or viral protein expression.

Toward that end, we are looking to fund R01 research projects that:

Identify biomarkers or molecular signatures of latently-infected cells that could be used for targeting.
Offer a novel approach to selectively eliminating latently-infected cells that do not require reactivation or HIV gene expression.
Permanently inactivate integrated HIV provirus.

Innovative thinking and cutting-edge technology are imperative. To ensure your application is eligible, read the March 25, 2014, Guidenotice for specific examples of nonresponsive areas of research, such as clinical trials or studies that rely solely on intensification of antiretroviral therapy.

Send optional letters of intent by June 15, 2014. Apply by July 15, 2014.

News Briefs

eRA Database Downtime Scheduled for Late May. The electronic Research Administration (eRA) system will be offline for scheduled maintenance from 9:00 a.m. on May 23 until 7:00 a.m. on May 27, 2014. As a result, due dates that fall on or between May 25 and May 28, 2014, will move to May 29, 2014. If you are preparing a multiproject application using ASSIST, you will not have access to your application during the downtime and should plan accordingly.

SBIR/STTR Webinar Resources Available Online. Materials from the NIH SBIR/STTR Presubmission Updates Webinar are now posted, including video, slides, and transcript.

Two Requests for Information About Chimp Facilities. In an April 4, 2014, Guide notice, NIH recommended that the primary living space of chimpanzees be at least 250 square feet per animal. NIH now seeks feedback from researchers with experience maintaining chimpanzees, as requested in two RFIs—NOT-OD-14-067 and NOT-OD-14-075—with responses due April 30, 2014, and June 2, 2014, respectively.

You Can Nominate an SBIR/STTR Champion. Nominations for the prestigious 2014 Tibbetts and SBIR Hall of Fame Awards are open until May 2, 2014. In June 2014, winners will attend a White House Awards Program in Washington, D.C. and be honored at the annual SBIR National Conference in National Harbor, Maryland.

Upcoming International Grants Management Workshop. An NIAID Grants Policy and Management Training Workshop will take place in Dar es Salaam, Tanzania, from June 23 to 25, 2014. Check out the Agenda and Register now.

Save the Date for Future Small Business Conferences. This year's NIAID SBIR/STTR Workshop will take place in Cambridge, Massachusetts, on September 4 and 5, while the NIH SBIR/STTR Conference will be held in Albuquerque, New Mexico, from October 21-23.

Know When You Do—and Don't—Have to Get NIAID's Prior Approval

Before you make changes to your grant, know whether you need to get NIAID's permission in advance.

Prior Approval Is Necessary

You must get our prior approval for some actions, like modifying the scope of your grant, transferring a grant from one institution to another, and changing from a single to multiple PI award, or vice versa. For the complete list, see our Prior Approvals for Post-Award Grant Actions SOP.

Keep in mind that there may be items specific to your grant for which you need prior approval, so check your Notice of Award.

Give yourself plenty of time to get approval by making your request at least 30 days before you want your proposed change to take effect. To be safe, you may want to check with your grants management specialist about how much time you'll need for the type of prior approval you're seeking.

Note: though your program officer can advise you, your grants management specialist is the one who will approve or disapprove your prior approval request.

Prior Approval Not Necessary

You don't need a green light from us to take the steps described in Grantees Can Take Many Actions Independently in the Strategy for NIH Funding.

If you have questions or are unsure whether you need prior approval, contact your grants management specialist.

If Preaward Spending Is Okay With Your Institution, It's Okay With Us

You're waiting for your Notice of Award and want to start your project, but you need money to get it underway. What are you to do? Consider this: ask staff in your institutional business office for approval on preaward spending.

Getting permission before you spend is absolutely essential since your institution is responsible for your expenses in the event that we reduce your award or cannot issue your grant.

It's also important to keep in mind these key points:

Incurring preaward costs in anticipation of a competing or noncompeting award does not put NIH under any obligation to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover preaward costs incurred.
Preaward costs result in borrowing against future support. This borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

If your institution gives you the green light to use its money, the only preaward spending costs you can incur are those that: 1) are needed to conduct the project and 2) would be allowable under the grant, if awarded, without NIH prior approval.

For competing grants, you can charge allowable preaward costs incurred up to 90 days before your initial Notice of Grant Award's budget period start date.

For noncompeting grants, you may incur preaward costs before the beginning date of a budget period without regard to the time parameters above. Check to see what expenses your business office will allow.

If you have any questions, contact your grants management specialist.

Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.

"Does NIAID sponsor individual researchers to attend conferences?"—anonymous reader

No. You may have noticed a recent funding opportunity announcement (FOA) called NIH Support for Conferences and Scientific Meetings. This FOA supports the scientific conferences themselves through the R13/U13 mechanism, which may include defraying registration costs for attendees, but not an individual's conference and travel expenses.

"What is the submission deadline for an AIDS-related F32 application?"—anonymous reader

May 7, 2014, for Cycle I. NIAID follows NIH's AIDS and AIDS-related dates for all activity codes, including the NRSA Individual Postdoctoral Fellowship (F32).