sábado, 5 de noviembre de 2016

NIAID Funding News - November 3, 2016 | NIH: National Institute of Allergy and Infectious Diseases

NIAID Funding News - November 3, 2016 | NIH: National Institute of Allergy and Infectious Diseases


NIAID Funding News - November 3, 2016

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Feature Articles

Frequently Asked Questions: Asked and Answered

Going through the entire grants process—from finding an appropriate funding opportunity to managing an award—can be challenging, so it's not surprising that investigators have many questions along the way.
We cover some of the most frequently asked here and will address others in upcoming issues.

Top Questions Program Officers Receive

Unless you have questions about peer review or business and policy issues, you'll likely reach out to program officers for answers. They field numerous inquiries, including those that come up quite often. We give a sampling below.
You may want to keep these Q&As in mind or for reference before contacting a program officer directly. It could save both of you time.
Before Applying
If you are planning your first grant, you may wonder whether having a faculty position or preliminary data is necessary to apply.
Do I need a faculty appointment to apply for an award?
While NIH does not have eligibility requirements for principal investigators, reviewers expect a certain level of achievement for an independent award, and your institution may have policies you'll need to comply with. Read more at Determine Eligibility for NIAID Grants.
NIH also has fellowships and career awards that are intended for students, postdoctoral fellows, and junior researchers that have not progressed to the point in their careers where they would hold a faculty position—go to Training and Career Development Grant Programs.
Do I need preliminary data?
For an R01 application, you will need preliminary data, though reviewers expect fewer preliminary data from new investigators.
Some grant types, e.g., the exploratory/developmental research grant (R21), do not require preliminary data. For information on small grants, go to Comparing Popular Research Project Grants: R01, R03, or R21.
After Peer Review
Once your application goes through initial peer review, you'll likely have questions like these:
When can I see my summary statement?
You will receive your summary statement within 30 days after peer review (no later than March 10, July 10, or November 10 for new investigator R01 applications, depending on review cycle).
Look for your summary statement to appear in your eRA Commons account. No need to contact your program officer because he or she does not get a copy any earlier than you do.
If my application misses the payline, should I resubmit or wait? Could I get funded through selective pay?
We advise you not to wait to see if you are funded later in the fiscal year. It's better to get a head start either improving your application based on the feedback from the review or submitting a new application.
Be sure to discuss your resubmission strategy with your program officer. Get more help in Options if Your Application Isn't Funded.
It is possible to get funded through selective pay. Program officers nominate a very small number of applications that score above the payline for selective pay funding. Our advisory Council then ranks those nominations in priority order.
You cannot apply for select pay, but you may ask an NIAID program officer about your likelihood of being nominated. Scientific merit and relevance to our mission are key factors in selecting and ranking applications, and we give some special consideration to new investigators.
Towards the End of Your Grant
If you’re considering a no-cost extension, which allows you to extend a project period one time for up to 12 months (with some exceptions), this question might come to mind:
How do I apply for a one-year no-cost extension to my grant?
Contact your institution's signing official. He or she will make a request through the eRA Commons using the instructions at No-Cost Extension (NCE) on the eRA website.
To learn more about extending your grant's project period and whether you're allowed to do so, read our No-Cost Extension SOP.

Opportunities and Resources

Help Advance Vaccines to Prevent Mycobacterium tuberculosis Infection

Apply to a new R01 funding opportunity announcement (FOA) if you can propose a milestone-driven project to identify promising lead vaccine candidates or advance preclinical development of established leads targeting infection with Mycobacterium tuberculosis (Mtb) and/or tuberculosis disease (TB).

Research Goals

This initiative supports proof-of-concept and preclinical development activities for candidate vaccines; your application must propose one or both. Refer to the FOA linked below for a list of projects that will be considered nonresponsive and will not be reviewed.
Proof-of-Concept Activities
Translational activities to establish proof-of-concept must begin with candidate vaccines that have demonstrated capacity to elicit an immune response in a relevant animal model for Mtb infection and/or TB. 
Examples of proof-of-concept studies supported by this FOA include:
  • Evaluation of vaccine candidates in functional in vitro assays
  • Determination of efficacy in relevant animal modelsEvaluation of efficacy in appropriate animal challenge models
  • Iterative optimization of candidate vaccines or vaccine and adjuvant combinations
  • Head-to-head comparison of candidate vaccines
We expect the completion of these studies to result in a candidate vaccine or related product appropriate for subsequent preclinical product development.
Preclinical Development Activities
Preclinical activities to advance a lead candidate vaccine toward licensure should consider the ultimate potential of the lead candidate to elicit safe and protective responses in a diverse human population. 
Projects may include one or more product development activities, such as:
  • Optimization of lead vaccine candidate
  • Evaluation of safety, toxicity, and immunogenicity in animals
  • Evaluation of efficacy in appropriate animal challenge models
  • Optimization of dose and route of delivery in preclinical evaluation
  • Scale up and production of candidate vaccines
We do not expect you to complete the product development process up to the point of readiness for clinical trials or validation or to create a final product within the project time frame.
Requirement for Industry Participation
Your application must demonstrate substantive investment by at least one industry participant. For instance, a pharmaceutical or biotechnology company could make a significant commitment of one or more resources to the project, such as providing product development support, contributing materials or reagents, or renovating facilities to address biohazard concerns. 
Though principal investigators (PIs) may be affiliated with industry or an academic organization, the application must identify an industrial partner if the PIs are from academia.
Application Information
Your application budget is limited to $750,000 in annual direct costs. In addition, you may request up to $300,000 in direct costs in the first year of the award for major equipment needed to meet research objectives and contain biohazards, totaling $1,050,000 in direct costs. The maximum project period is five years.
Applications are due March 2, 2017. For complete details, read the October 5, 2016 Guide announcement
Direct questions to Dr. Michael Schaefer, NIAID’s scientific/research contact for the FOA.

Small Business Awardees: Find Your Niche

If you have an active Phase I small business award, NIH’s Niche Assessment Program can help you get market insights and data to optimize your commercialization and marketing plans. 
Interested? Act fast because there are only 150 spots available and enrollment is on a first come, first served basis. 
How the Niche Assessment Program Works
Foresight Science and Technology, an NIH contractor, analyzes potential markets and applications for your technology. 
Then for one viable application of the technology, Foresight provides an in-depth report on a number of items, including:
  • Your competitive advantages
  • Your estimated market size and potential market share 
  • Its recommended strategy for your market entry strategy
Foresight will also identify companies or funding agencies that are qualified to serve as potential commercialization partners for your business.
You can use the report’s information to develop a commercialization plan for a Phase II application to NIH.
Eligibility and Registration
You are eligible if you have an active Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) Phase I—including Fast-Track—grant or contract. Register using the NIH SBIR/STTR Setup Form.
See the October 3, 2016 Guide notice for more details on this year’s program. Direct general questions about the Niche Assessment Program to Robert Vinson, Jr.

NIAID Adds to the Research Objectives and Scope of Tuberculosis Opportunity

Investigators interested in Mechanisms of Mycobacterial-Induced Immunity in HIV-Infected and Uninfected Individuals to Inform Innovative Tuberculosis Vaccine Design (R01), take note of revisions to the opportunity’s Objectives and Scope section, which focus on exploring immune responses in the lung to inform tuberculosis (TB) vaccine design. 
NIAID invites R01 applications to study immune mechanisms that will contribute to the advancement of new TB vaccines, including in populations also infected with HIV. Studies that focus on the pulmonary immune mechanisms required for protection from Mtb infection or progression to active disease in latently infected individuals are highly encouraged.
Research approaches should go beyond descriptive information about immune response to Mtb infection and vaccines, and should include mechanistic analyses or characterization of the timing, anatomical location, and contribution to disease outcome of mucosal or systemic immunity. 
Application due dates are January 11 of 2017, 2018, and 2019, for both AIDS-related and non-AIDS applications.
For complete details about the revised research objectives and scope, read the October 21, 2016 Guide notice.

In The News

Find International Clinical Regulations Info on the Improved ClinRegs Site

NIAID launched ClinRegs in 2014 as a public online resource for country-specific clinical research regulatory information. Since then, the site has received over 17,000 visitors.
ClinRegs includes plain language descriptions of country-specific clinical regulations, links to official documents, and English translations of official documents from non-English speaking countries (where available).
Recently, ClinRegs added several new features:
  • Country Selection: An improved homepage map for easier country selection
  • Search: A search option with filtering by country


Screen shot of ClinRegs showing country selection.


ClinRegs has an improved homepage map for easier country selection and a search option with filtering by country.
  • Table of Contents: On left side of each country page for improved navigation
  • Quick Facts: On each country page 


Screen shot of ClinRegs showing country page.


Each county page on ClinRegs features improved navigation and quick facts.
  • Comment: Users can suggest updates or provide other feedback
  • Print and Share: Icons to print a specific section or email it to colleagues


Screen shot of ClinRegs showing feedback and sharing functionality.


You can provide feedback and share specific sections from ClinRegs.
Check out ClinRegs and see if it can help you.

More Details About NIAID’s T32 and T35 Grant Application Due Dates

Currently, NIAID accepts NRSA Institutional Research Training Grant (T32) and NRSA Short-Term Institutional Research Training Grant (T35) applications once annually, on January 7 for AIDS-related applications and September 25 for non-AIDS applications.
But we’re changing that policy.
Beginning with grant applications for FY 2018 funding*, NIAID will accept training grant applications on two annual submission dates, as listed below:
  • January 25 and September 25 for non-AIDS applications
  • May 7 and January 7 for AIDS-related applications 
So the application due dates for T32 and T35 grants at NIAID will proceed as follows:
Receipt DateApplication TypeEarliest Start DateFiscal Year Funding
January 25, 2017Non-AIDSDecember 2017FY 2018
May 7, 2017AIDSDecember 2017FY 2018
September 25, 2017Non-AidsJuly 2018FY 2018
January 7, 2018AIDSJuly 2018FY 2018
January 25, 2018Non-AIDSDecember 2018FY 2019
May 7, 2018AIDSDecember 2018FY 2019
September 25, 2018Non-AIDSJuly 2019FY 2019
January 7, 2019AIDSJuly 2019FY 2019
We hope that the more frequent receipt dates will be convenient for applicants, especially those who choose to revise and resubmit an unfunded application.
Note that the budget for our T32 and T35 programs is not increasing. We have added the new receipt dates so those applicants who are submitting revised applications do not have to wait until the next annual submission date. In fact, NIAID will likely follow a conservative interim payline to start FY 2018 until we have a greater sense of how the additional receipt dates will impact the volume of applications we receive.
If you have any questions about the T32 or T35 grant, contact NIAID’s Training Officer Dr. Shawn Gaillard. You can also learn more by reviewing NIAID’s Training Grants (T) page.
*There is one remaining AIDS-related T32 and T35 receipt date, on January 7, 2017, that is not affected by the policy change to twice-annual receipt dates.

Try Nephele, NIAID’s Newest Resource for Microbiome Data Analysis

Generating microbiome data is challenging, but the effort needed to analyze that data just got easier. Using NIAID’s new resource Nephele, you can upload data quickly and easily; choose from a variety of standardized analysis pipelines assembled using tools that include QIIME, mothur, and bioBakery; and then download visualizations and easy-to-interpret results.
Nephele runs on the Amazon cloud, and we are currently sponsoring the use of this platform by the microbiome research community. You can register for free access and start analyzing data right away.
Once you have an access code, simply choose the appropriate pipeline and data type for 16S, 18S, ITS, or WGS analysis, provide your data files through upload or a URL link, optionally set a few processing parameters, and click submit.


Nephele, NIAID’s Newest Resource for Microbiome Data Analysis


Nephele, NIAID’s Newest Resource for Microbiome Data Analysis.
Once processing is complete, you can interpret the results with help from Nephele’s tutorial videos or our Pipeline Output Guidepdf. Typical outputs include BIOM files, heat maps, bar plots, and taxonomy tables, among other reports and visualizations.
Learn more by visiting the Nephele website, subscribing to the Nephele newsletter, or sending questions to nephele@mail.nih.gov(link sends e-mail).

News Briefs

NIAID Sets Interim Paylines for R03, R21 Grants
NIAID has set interim small research grant (R03) and exploratory/developmental research grant (R21) paylines at 26 overall impact/priority score. Go to NIAID Paylines to learn more, including why NIAID’s Paylines and Budget Information Changes Throughout the Year.
NIH Disaster Policy Applies to Hurricane Matthew
The NIH disaster policy allows institutions to submit late applications following natural disasters and other emergencies, with the delay not to exceed the number of days the organization was officially closed. If you need to take advantage of this policy, include a cover letter detailing the delay so that NIH staff can confirm the late application is justified.
Provide Feedback on Workforce Diversity Among Small Business Grantees
NIH is considering a new supplement designed to encourage increased participation of women and minorities in its small business programs. To help ensure the initiative’s success, NIH is soliciting public feedback to better understand the barriers that prevent small business awardees from participating in the existing diversity supplement program. 
Read additional details in the October 18, 2016 Guide notice, then submit your response before the December 16, 2016 deadline.

Advice Corner

NIAID Can Help Publicize Your Research

When you have research findings to publish, NIAID’s News and Science Writing Branch (NSWB) can help garner attention for your work through a variety of communication vehicles.  
Let your program officer and your institution’s press office know when you’ve submitted a research paper to a journal and when it has been accepted. The more notice you can give us about an upcoming publication, the better.
NSWB staff will read your paper and determine if and how NIAID can best publicize your work. We may do this through a press release, media availability, or social media promotion.
If your institution decides to issue a news release about your work, we’ll also help spread the word by posting a link to it on NIAID-Funded Research News.
For a weekly rundown of news releases issued by NIAID-supported institutions and businesses, go to NIAID Email Updates, log in to your profile page, and select the News Releases option.

Reader Questions

You can ask us a question at deaweb@niaid.nih.gov(link sends e-mail). After responding, we may ask your permission to include your question in the newsletter.
“For administrative supplements, how does NIAID define significant unexpended balances?”—anonymous reader
We don't define a specific number for a significant unexpended balance. When judging whether a balance is significant, we consider the nature of the work and the amount of the supplement.
For example, if you ask for a supplement of $50,000, but still have $80,000 remaining in your annual award that isn’t obligated (i.e., an unexpended balance of $80,000), we might deny the request and suggest you rebudget instead.
Keep in mind that these are just examples, not actual situations. Again, we look at the entire request, including the type of work you are doing.
“Can my salary increase every year?”—anonymous reader
Yes, although NIH will not pay a salary for an investigator beyond the Executive Level II Salary Cap, currently set at $185,100. See Salary Cap & Stipends
Your institution, however, can use its own money to pay beyond the limit NIH sets each year.
If the limit changes, you can rebudget funds to pay for a higher salary without prior approval, but you can't get more money from NIH.

New Funding Opportunities

See other announcements at Opportunities & Announcements.

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