miércoles, 6 de julio de 2016

NIAID Funding News, July 6, 2016

NIAID Funding News, July 6, 2016

NIAID News Release Logo

July 6, 2016 NIAID Funding News

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles. 

Get Acquainted With Administrative Supplements

Should there come a time when you unexpectedly need additional funds for your existing grant, you have an option: administrative supplements.
If you haven't heard—or want to know more—about them, here's an overview.

Definition, Purposes

Administrative supplements are funds added to an existing grant without peer review to pay for items within the scope of an award but unforeseen when a new or renewal grant application was submitted.
Grantees may request an administrative supplement for limited purposes. We list a few of them below; for others, see our Administrative Supplements to Grants and Cooperative Agreements SOP.
  • Reinstating:
    • Grant funds that the scientific review group approved but were cut due to NIAID’s 20 percent cap on renewal applications (first year only, approved in rare circumstances)
    • Scientific review group reductions of budget, time, or both
  • Using or preserving a unique research material or resource that may otherwise be lost
  • Addressing special time-critical cases, such as countering a major threat to public health

Costs, Project Period

Supplemental funding includes direct costs as well as associated facilities and administrative costs.
A supplement can start at any time during the budget period but must end on the last day of the budget period.
If the budget period ends and supplemental funding remains, funds can be carried over to the next budget period. However, if a grant does not have automatic carryover, the grantee institution will need to submit a written carryover request. NIAID staff will approve or disapprove such requests on a case-by-case basis. Read the Carryover Requests SOP for additional details.
Lastly, know that one institute or center (IC) can supplement the grant of another IC, provided it was assigned as secondary IC for advisory Council review.

Before Applying, Make Sure to Meet Requirements

Though grantee institutions may apply for an administrative supplement at any time, the basis of your request must meet the following Requirements:
  • A requested resource cannot be paid for by rebudgeting funds
  • Unobligated balances either cannot cover the request or total less than 10 percent of the annual award
Also, your grant cannot receive an administrative supplement when in the first or last year of the competitive segment. Exceptions are orderly closeout of a clinical trial and reinstatement of scientific review group reductions.
Keep in mind that administrative supplements cannot pay for increased costs due to an investigator's transfer or promotion or for a PI to move in a new scientific direction or use a new technology.
If you need additional funds for a significant expansion in project scope, request a revision (competing supplement) instead of an administrative supplement. See the Applying for a Revision to a Grant Award SOP.

How to Apply

If the parent award uses electronic submission, you have three ways to apply for an administrative supplement. If the parent award does not use electronic submission, you may use only option #3.
  1. Apply electronically through Grants.gov.
  2. Apply electronically through the eRA Commons.
  3. Apply using the PHS 398 forms.

Final Words of Advice

One: Contact your program officer when you're thinking about applying for an administrative supplement. He or she can further advise you about NIAID's criteria for supplements.
Two: Read the Administrative Supplements to Grants and Cooperative Agreements SOP for additional details, including what your request should include.
Header: Opportunities and Resources. 

New Exploratory/Developmental FOA on HIV-1 Provirus Silencing

Is epigenetically silencing HIV-1 proviruses a feasible approach to finding a functional cure for HIV-1 infection? NIAID seeks to find out through a new funding opportunity announcement (FOA) that is intended to identify new molecules as potentially useful HIV-1 cure agenda therapeutics.
Apply if you can propose highly innovative studies to understand how an epigenetic regulatory pathway can be exploited to develop novel small molecule or RNA therapeutics that can be useful for HIV-1 functional cure.
Your research project should:
  • Include hypothesis-driven target selection in an epigenetic pathway and validation of target(s) where drug or RNA action lead to HIV-1 provirus silencing
  • Propose and develop a robust screen that would be useful to identify small molecules or RNAs (e.g., aptamers, x-aptamers, noncoding RNAs) that mediate HIV-1 provirus silencing
  • Perform screen(s) and identify lead structures
We encourage projects that propose novel screening methodologies as well as applications aimed at developing, optimizing, and validating screening assays to discover new agents that could mediate the epigenetic silencing of HIV-1 proviruses.
Though not required, preliminary data may be included if they support or justify the proposed hypothesis.
For this FOA, you cannot propose clinical trials or studies required for clinical development of therapeutics such as animal model development, toxicological testing, or other IND enabling studies. Do so and NIAID will deem your application nonresponsive and not review it.

About the Activity Code

This FOA uses the bi-phasic R61/R33 activity code.
For the R61 phase, funded investigators will receive up to three years of support for the hypothesis and milestone-driven development of an epigenetic screening methodology and subsequent validation of the assay.
Before the R61 phase ends, awardees will submit the R33 transition package. It will include the progress report for the R61 that describes 1) the progress towards the initial milestones and 2) how screening activities during the R33 phase will be supported by completing the R61 phase validation study milestones.
NIH program staff will review the transition package and base their R33 funding decisions on the original R61/R33 peer review recommendations, successful completion of transition milestones, program priorities, and availability of funds.
Investigators who move on to the R33 phase may receive up to two years of support for studies performing the established screen(s).
Learn more about "The Path to Phase II: Understanding Phased Awards" from our May 4, 2016 issue.

About the Application

Since applications for this FOA will be assigned a single overall impact/priority score, it is essential that you be clear and thorough about specific goals and the feasibility of each phase and the transition milestones.
The Research Strategy must include:
  • Separate sections that describe the R61 and R33 phase. 
  • Proposed transition milestones for completing the R61 phase that detail 1) the suitability of the proposed milestones for assessing success in the R61 phase and 2) the implications of successfully completing these milestones for the proposed R33 phase. The milestones should also be:
    • Specific, quantifiable, and scientifically justified. Do not simply restate the Specific Aims for the R61. 
    • Sufficiently rigorous scientifically to be valid for assessing progress in the R61 phase.

Deadlines and Research Contact

Submit an optional letter of intent by November 7, 2016. Applications are due a month later on December 7.

Direct your questions to Dr. Tony Conley, NIAID's scientific/research contact for this FOA.
For complete details, read the May 26, 2016 Guide announcement.
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Explore Emerging Science and Technology in Transplantation

If you’re a researcher in transplantation immunology, take note of a new funding opportunity announcement (FOA) that encourages the application of novel science and technologies.
By applying approaches and technologies from other fields to transplantation, supported research will enhance our understanding of alloimmune responses, prevent rejection and prolong graft survival, and improve the outcome and quality of life for transplant recipients.
Applications must focus on one or more priority areas: microbiota, intravital imaging, and targeted therapeutic delivery. Projects funded under this initiative will participate in a cooperative research program. We encourage applicants to seek collaborators to develop an innovative and multidisciplinary approach.
Your study must be in the context of solid organ, vascular composite tissue allograft, or pancreatic islet cell transplantation and may use animal models or human specimens relevant to transplantation. Although this initiative does not support clinical trials, nonhuman primate (NHP) studies are permitted if appropriately justified and within budgetary restrictions.
Read the FOA linked below for complete details on research objectives and scope as well as types of projects that NIAID will consider nonresponsive.

Budget and Award Details

Application budgets cannot exceed $250,000 in annual direct costs unless proposed studies involve NHPs. For planned research with NHPs, application budgets cannot exceed $300,000 in annual direct costs.
The FOA will be funded through U01 cooperative agreements with a maximum project period of five years. To learn about U-series awards, read "Just for “U”: A Closer Look at Cooperative Agreements" from our May 4, 2016 issue.
NIAID plans to commit $2.5 million in FY 2017 to fund five to seven awards.

Application Information

Submit an optional letter of intent by September 20, 2016. The application deadline is October 20, 2016.
Find full information in the June 10, 2016 Guide announcement. If you have any questions, contact Dr. Jeffrey Rice or Dr. Nasrin Nabavi, the scientific/research contacts for the FOA.
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Understanding Infectious Disease Dynamics With Mathematical Models, Statistical Methods, and Computational Tools

Public health administrators need new and improved methods and computational tools to better understand and respond to emerging and reemerging infectious diseases.
To help, NIAID has joined a long-running funding opportunity announcement (FOA) from the National Institute of General Medical Sciences that supports research to develop mathematical models, statistical methods, and computational tools to study interactions between infectious agents and their hosts, disease spread, prediction systems, and response strategies.
The strongest applications will approach this challenge from both sides—infectious disease research and mathematical/statistical model research.
Infectious disease research can focus on public health preparedness, surveillance and detection, disease dynamics, response strategies, antimicrobial resistance and vaccine escape, human social behavior, animals as vectors, and even virtual reality.
Your research should also focus on conceptual development of models, model verification and validation, and software dissemination to relevant public health communities. The software products you develop need to be fully documented and easy to access, modify, and extend. Additionally, the software packages should be interoperable, portable to a variety of common platforms, and consistent with existing ontologies and controlled vocabularies. You’ll need to test, verify, and maintain the products as well.
NIAID is especially interested in funding research to:
  • Develop, validate, and implement mathematical and statistical models for transmitting naturally occurring infectious diseases and bioterrorism agents.
  • Develop mathematical and statistical models to evaluate the effectiveness of interventions involving surveillance and containment, vaccination, antimicrobials, social distancing, and other control strategies for infectious diseases.
  • Develop publicly accessible software and computational tools for the developed models and methods for studying infectious diseases that will assist public health decision makers.
This FOA uses the R01 activity code, which means the maximum project period you can propose is five years. There is no budget cap, but make sure your application budget matches the needs of your proposed project.
Standard application due dates (including standard AIDS dates) apply. The next deadline for non-AIDS applications is October 5, 2016, and for AIDS applications it is September 7, 2016.
For complete details, read the February 22, 2016 Guide announcement. Also, check out the Models of Infectious Disease Agent StudyExternal Web Site Policy website to learn more about the program’s past outcomes and ongoing research.
NIAID’s scientific/research contact for this program is Dr. Misrak Gezmu. Contact her if you have questions about our participation in the program.
Header: Other News.

Fellowship and Small Business Opportunities Reissued, F30 Award Split

If you plan to apply for a fellowship or small business award, be sure you respond to the recently reissued versions of the funding opportunity announcements (FOAs):


Small Business Awards

How the Reissued Fellowship FOAs Are Different

You may have noticed that there are now two parent F30 FOAs whereas there used to be one. The Physician-Scientist Workforceworking group recommended this change to ensure equitable peer review of applications from institutions that don’t already have NIH-funded predoctoral dual-degree training programs. See the June 3, 2016 Guide notice to learn more.
NIH also revised the parental leave policy for fellowship awards. Effective immediately, fellows may receive stipends for up to 60 calendar days (equivalent to 8 work weeks) of parental leave per year for the adoption or birth of each child. The policy is no longer premised on the condition that comparable training positions at the grantee organization already have access to the same level of paid leave. See the June 13, 2016 Guide notice for full details.
Beyond splitting the parent F30 FOA and revising the parental leave policy, the only other changes to the parent fellowship FOAs are those that accompanied the FORMS-D transition, which we detailed previously in our March 23, 2016 article “Policy Changes Accompany the FORMS-D Changeover.”
Check out Quick Facts on Fellowship Grants and the Fellowships section of our Advice on Research Training and Career Awards for help starting an application.

Points of Emphasis for the Small Business FOAs

If you are interested in applying for a small business grant through the parent announcements, be aware of a few important details involving the reissued FOAs.
First, you should review the 2016 list of NIH, CDC, FDA, and ACF Program Descriptions and Research Topics for the topics in which NIAID is most interested. Appendix A lists topics that have been preapproved for budget waivers, but you should still contact NIAID program officials before submitting any award budget in excess of $150,000 for Phase I awards and $1 million for Phase II awards. Another resource you should review before applying is the Annotated Form Set for NIH Small Business (SBIR/STTR) Grant Applications.
Second, the standard application due dates for small business grants now fall annually on September 5, January 5, and April 5. There are no separate due dates for AIDS-related small business grant applications.
Third, note that small businesses that are majority-owned by multiple hedge funds, venture capital operating companies, or private equity firms are eligible to apply for SBIR grants. NIAID has limits for how much of our small business set-aside funds can go to these types of small businesses, but that should not deter you from applying.
Go to NIAID's Small Business Program page to find additional information and resources.
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News Briefs

Early Registration Extended for October Regional Seminar in Chicago. 

The next 2016 NIH Regional Seminar on Program Funding and Grants Administration will take place in Chicago, Illinois, from October 26 to 28. Check out the seminar'sAgenda, then sign up before July 15 for early registration pricing.

Shortened Timeline for Submitting Late Materials to Zika R21. 

Because NIAID is accepting applications in response to Rapid Assessment of Zika Virus (ZIKV) Complications (R21) on a rolling basis, without exact due dates, the typical timelines for receipt, review, Council, and award do not apply. As such, the requirement that late materials be submitted at least 30 days before the peer review meeting has been shortened to 15 days. Read the June 15, 2016 Guide notice for full details.

Suggest Strategies to Innovate Graduate Education. 

The National Institute of General Medical Sciences issuedRequest for Information (RFI): Strategies for Modernizing Biomedical Graduate EducationExternal Web Site PolicyExternal Web Site Policy to solicit feedback on the current strengths, weaknesses, and challenges in biomedical graduate education; potential changes to improve efficiency and effectiveness; and barriers to achieving those changes. Submit your response using the web form linked above by August 5, 2016. 


Header: Advice Corner. 

Changing Institutions? A Quick Refresher to Make a Smooth Transition

Read below for some pointers when you attempt to transfer your grant to a new institution. Remember, grants are awarded to institutions, so when you leave, your institution must agree to relinquish the grant before you can take it with you.
(This article covers only administrative items related to your transfer request. Check with your current and new institutions about legal implications, professional responsibilities, and changes in budget, salary, and support.)

The Basics: Who, When, and What

  • Contact your program officer and grants management specialist as soon as you consider moving to another institution since they can help smooth the transition.
  • Start working on the required documents and actions several months before your move.
  • Prepare and submit your Change of Grantee Organization (Type 7 Parent) grant application.

IACUC, IRB Documentation

Confirm that your new institution has all certifications and assurances, e.g., institutional animal care and use committee (IACUC), institutional review board (IRB), necessary for your work.
We can't approve your transfer until you have your new documentation in place.

Take a Moment for DUNS, SAM, Grants.gov, and eRA Commons Registrations

Make sure your new institution has registered with Data Universal Number System (DUNS), System for Award Management (SAM), Grants.gov, and eRA Commons before sending in a request.
It may take up to six weeks to complete the registration process. If your new institution is outside the U.S., this process can take even longer. 

Touch Base With NIH Staff as Needed

It's always a good idea to contact your program officer and grants management specialist once you decide you want to move.
You'll definitely want to be lockstep with business officials at your old and new institutions because they'll send us whatever we need to process your transfer request.
And if you're heading to a foreign institution, contact us immediately to discuss timing for your move. Your request will need approval from our advisory Council, which could take several extra months depending on when you submit your paperwork and when Council meets.

Timing Is Everything

To ensure there are no disruptions to your funding, make sure we receive a transfer application and relinquishing statement at least two months before you switch institutions.
Once we receive the relinquishing statement, transfer request, and any further documentation we might need, we'll issue your new Notice of Award within 30 days, usually much sooner. However, as we near the end of the fiscal year, you may need to allow extra time given the heavier workloads facing your business office and NIAID staff.
We'll start your new award on the first day of whichever month we have all your paperwork. In other words, if we receive all your documentation on August 28, we'll issue your new award with an August 1 start date (even if we don't give you your actual notice until September).
End dates for your budget period and grant project period will remain the same. 

Approval Is Not Guaranteed

In some cases, we may not allow you to transfer your grant. There are many reasons, including those below, that apply except in rare circumstances:
  • Your old institution doesn't relinquish your grant.
  • You're in a no-cost extension.
  • Your grant is in its final year and you have spent most or all of your money.
  • Your grant supports a clinical trial.
  • You hold a program project (P01) or center (P30, P50) grant.
  • Your new institution lacks the resources or facilities to support your grant. 

Institutions New and Old—Who Does What?

Your new institution requests your transfer by following instructions in the Change of Grantee Organization (Type 7 Parent) announcement.
Your old institution submits a relinquishing statement through the eRA Commons. 

Spend Wisely

Take extreme caution when spending funds during your transition from one institution to another.
We cannot automatically fund you for the period between when you leave your old institution and when we issue your new Notice of Award—no matter how long you're at your new institution before your approval goes through.
Once you're approved, we will prorate your new budget based on the start date listed in the new Notice of Award.
Your new institution may pay your grant-related expenses within 90 days before your new grant start date, then charge those to your new award.
However, it does so at its own risk because we don't cover those costs if:
  • We reject your transfer request.
  • You exceed the amount approved in your Notice of Award.
  • Your charges are not allowed on your grant.  

Related Links

Header: Reader Questions. 
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.

“Is the 20 percent cap on the first year of an R01 renewal based on the first or the fifth year of the original grant's budget?”—anonymous reader

Use the final year or period of the original grant. We base the cap on the direct costs of the last noncompeting award minus the following:
  • Facilities and administrative costs for all subawards
  • Supplements
  • Equipment
  • Alterations and renovations
We then increase that amount by 20 percent to get the cap level.
For modular grants, if the cap results in a number between modular increments, we round up to the next module.

“For a renewal application, under the Progress Report Publication List, can submitted manuscripts be included?”—anonymous reader

Only if the submitted manuscript has already been accepted for publication. If the manuscript is peer-reviewed and accepted for publication in a journal, you must include it in your Progress Report Publication List. Submitted manuscripts that have not been accepted will be marked as not applicable.
In your progress report, you need to provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the journal submits articles directly to PMC on behalf of its authors, indicate “PMC Journal – In Process.”
After submission and with concurrence from your authorized organizational representative, you may provide news of an article accepted for publication (do not send a copy of the article). The scientific review officer must receive this documentation no later than 30 calendar days before the review meeting unless otherwise indicated in the funding opportunity announcement. See the Post-Submission Materials Policy FAQs for additional information. 

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