viernes, 26 de febrero de 2016

NIAID Funding News, February 25, 2016

NIAID Funding News, February 25, 2016

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February 25, 2016 NIAID Funding News

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles. 

Nearing Excellence: National Academies’ Report on SBIR/STTR Programs at NIH

The National Academies of Sciences (NAS) recently released its report on Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) programs at NIH. According to the NAS findings, both programs are progressing towards meeting or exceeding their objectives but could use some fine-tuning in a few areas where they are falling short. 

Key Findings

NAS reported that NIH’s SBIR/STTR programs are having a positive impact and are meeting three out of four of their legislative objectives: 1) stimulating technological innovation, 2) using small businesses to meet federal research and development (R&D) needs, and 3) increasing private-sector commercialization of innovations derived from federal R&D.
However, the report also concluded that the SBIR/STTR programs need more work, such as:
  • Addressing underserved populations by fostering the participation of women and minorities
  • Improving commercialization outcomes by mitigating the challenges posed when conducting clinical trials
  • Improving program monitoring, evaluation, and assessment by collecting data across the entire program, including Congressionally mandated outcomes, commercialization, and demographic data for applicants and awardees
  • Improving program management in areas such as the application review system and funding gaps between Phase I and Phase II awards

Moving Forward With SBIR/STTR Programs at NIAID

As the second largest SBIR/STTR program at NIH, NIAID is excited about its positive impact. In light of the two new management models recommended in the NAS report, namely the "SBIR Development Center" model adopted by the National Cancer Institute, and the "Office of Translational Alliances and Coordination" model adopted by the National Heart, Lung, and Blood Institute, NIAID will also seek to gradually incorporate those new management models to strengthen our SBIR/STTR program oversight and enable better awardee transition to Phase III: Commercialization (read Three-Phase Program for a general overview of the NIH small business strategy).
NIAID is also actively working with NIH SBIR/STTR program officials to address shortfalls, most notably by strengthening outreach to women and other underrepresented groups, introducing new administrative funding initiatives, and leveraging new resources to support the success of NIAID awardees through FY 2017 and beyond.
For questions about the program, contact Dr. Natalia Kruchinin, NIAID's SBIR/STTR program coordinator.
Check out the full Report on SBIR/STTR at NIHExternal Web Site Policy for additional details on NAS’ analysis, findings, and recommendations.


Here are some quick reminders about ongoing SBIR/STTR program opportunities.
Header: Opportunities and Resources. 

Your Chance to Assist the DAIDS Regulatory Support Center

If you’re looking for a chance to manage and support the Division of AIDS (DAIDS) Regulatory Support Center (RSC), your opportunity has arrived.
NIAID is soliciting contract proposals to provide regulatory expertise and support to operate and manage the DAIDS RSC, which offers a wide range of clinical research activities and programs for the Division.
DAIDS RSC gives comprehensive regulatory support to: 1) perform DAIDS-funded and DAIDS-sponsored domestic and international clinical trial research; 2) provide training in key functions of clinical trial research to DAIDS staff, investigators, and collaborators; and 3) maintain all contract-associated data and records in the DAIDS Enterprise System and NIAID-Clinical Research Management System (N-CRMS), including the electronic submission of required regulatory information.
Offeror proposals will be evaluated against their qualifications, experience, and capability to perform multiple tasks, including:
  • Assisting with developing standard operating procedures, quality assurance/quality control plans, training, meetings with health authorities and stakeholders, administrative support, and other general tasks
  • Maintaining clinical study and study-related information as well as a library of documents in N-CRMS
  • Helping DAIDS prepare, negotiate, finalize, and distribute clinical trial agreements and other research agreements

About the Award

NIAID anticipates awarding one performance-based contract. The period of performance under this contract is one year, with options for six additional one-year terms granted at the government’s discretion, for a possible total term of seven years. The performance period will begin approximately February 15, 2017. 

Application Information

The deadline to apply is May 5, 2016, at 3 p.m. Eastern time. For complete details, read the February 4, 2016 solicitation.
Send questions to Ashley Virts, the solicitation’s primary point of contact. We strongly encourage you to submit questions by April 5, 2016, to allow for a timely response before the proposal deadline.
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Submit Your Proposal to Continue Clinical Site Monitoring

NIAID is soliciting contract proposals that will monitor new and ongoing Division of AIDS (DAIDS)-funded clinical trials to ensure they comply with applicable federal and international regulations.
Proposals should detail the offeror’s intentions to continue providing comprehensive clinical site and study monitoring services for the DAIDS clinical trial research portfolio, including the delivery of monitoring services for unanticipated DAIDS clinical research projects that may be required in response to emerging needs or public health emergencies.
Offerors should have the qualifications, experience, and capabilities to perform the following requirements (for a complete list, see the solicitation):
  • Conducting site initiation visits before clinical trial implementation to ensure compliance with DAIDS, U.S., and, where appropriate, country-specific regulatory requirements and guidelines
  • Conducting site closeout visits to ensure clinical trials are completed, clinical records are stored, and investigational products are disposed of appropriately
  • Preparing written reports on all site monitoring visits, including identifying problems and deficiencies, and recommending remedial or corrective actions
  • Remotely interacting with various NIAID systems such as the NIAID-Clinical Research Management System

Award Details

NIAID anticipates awarding one contract. The period of performance is one year, with options for six additional one-year terms granted at the government’s discretion, for a possible total term of seven years. The performance period begins approximately December 1, 2016.

Application Information

The deadline to apply is March 15, 2016, at 3 p.m. Eastern time.
Read the January 15, 2016 solicitation for complete details. Questions? Ask Patrick Finn, the solicitation’s primary point of contact.
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An Opportunity to Evaluate a "Universal" Influenza Viral-Like Vaccine

NIAID seeks Cooperative Research and Development Agreement (CRADA) partners to further develop and evaluate a novel, broadly protective influenza viral-like particle (VLP)-based vaccine.
Studies will be designed to 1) evaluate production and good manufacturing practice of the influenza VLP vaccine candidate and 2) further the clinical evaluation of the vaccine candidate in Phase I and Phase II clinical trials.
Prospective CRADA partners must provide a written Capability Statement that addresses each of the following selection criteria:
  • A description of the partner's ability, experience, expertise, and facilities to manufacture influenza viral-like particles and for conducting clinical trials.
  • A description of the partner's ability to perform supporting tests (i.e., biochemical, toxicological, and immunological testing) relevant to the study.
  • The technical expertise of the partner's principal investigator and laboratory group.
  • The availability and location of the facilities to carry out the study.
  • The ability to provide adequate funding to support performance of the research plan throughout the life of the CRADA. Note: NIAID will not be providing any funding to the CRADA partner.
Email the Capability Statement to Dr. Jenish R. Patel, the primary point of contact for this solicitation.
The response date is May 14, 2016 at 11:59 p.m. Eastern time. For complete details, see the January 14, 2016 solicitation.
Header: Other News. 

Process Changes for eRA Commons Registration

In case you missed NIH's announcements of changes to the eRA Commons registration process, here's an overview.

Electronic Signature Will Suffice

Instead of signing and faxing a copy of the Commons registration form to eRA, signing officials now just have to sign the form electronically. For the official word, see the January 20, 2016 Guide notice.

Preliminary Eligibility Assessment

Before starting the Commons registration process, NIH urges organizations with unique and complex situations* to make a preliminary assessment of eligibility. This will help streamline registration requirements and reduce administrative burden.
Get complete details in the January 25, 2016 Guide notice.
*Foundations that represent already existing recipient organizations; newly formed consortia where the consortium members are already individually recognized as NIH recipient organizations.
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Payline and Salary News for FY 2016

Here's the latest scoop on our paylines, salary cap, and stipend levels for FY 2016.
We have fiscal year NIAID Paylines for most grant types and interim paylines for small business grants. The R01 payline is set at the 13 percentile for established PIs and the 17 percentile for new PIs. Watch the page for news or Subscribe to Email Alerts for fiscal year payline notifications.
The salary cap for grantees and contractors is currently set at $185,100. We also have new fellowship and training stipend levels for FY 2016. See Salary Cap and Stipends for all the details.
As we get Financial Management Plan information for FY 2016, we will update you in an upcoming issue of this newsletter.
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News Briefs

Webinar, Eligibility Changes for NIAID G11 Funding Opportunity. 

Applicants interested in the Global Infectious Disease Research Administration Development Award for Low- and Middle-Income Country Institutions (G11), note that the eligibility criteria have expanded, as explained in the January 29, 2016 Guide notice. Any organization that received no more than $2.2 million in total NIH grant and cooperative agreement support (direct awards and subawards) in the last five years is now eligible to apply.

Additionally, we will host a Preapplication WebinarExternal Web Site Policy on April 7, 2016, from 9:30 to 11 a.m. U.S. Eastern Daylight Time. Prospective applicants and their corresponding U.S. hosts should participate. Send questions about the G11 funding opportunity to Dr. James Alaro by March 20, 2016, and we will address them during the Webinar. 
You can also review Questions and Answers for PAR-15-131, which we posted earlier this month.

Save the Date for 2016 NIH Regional Seminars. 

The 2016 NIH Regional Seminars will take place in Baltimore, Maryland, from May 11 to 13, and in Chicago, Illinois, from October 26 to 28. The seminars are comprehensive—topics include fundamentals of NIH, compliance, peer review, grant writing for success, preaward and postaward issues for administrators and investigators, animal and human subjects research, and how to interact electronically with NIH. Read the February 9, 2016 Guidenotice to learn more.

Register Now for iCOMOS Conference on Health, Policy. 

The second International Conference on One Medicine One ScienceExternal Web Site Policy (iCOMOS) in Minneapolis, Minnesota, from April 24 to 27, 2016, will address critical problems at the interface of human, animal, and environmental health. Consider attending if you are a policy maker, economist, ethicist, trainee, or a human, animal, or environmental health researcher.

This year's topics are: Role of Science in the Formulation of Local and Global Health Policies; Balancing Precision Medicine and Public Health; Air Quality, Environmental Exposure, and Health; and Water, Health Economics, and the Environment. In addition, workshops will cover: Developing Physician-Scientists, Global Food Security, Big Data, and a Team Science Case Study: Canine/Human Epilepsy. You can find abstract submission details on the iCOMOS website.

Attend Summer School in Computational Immunology. 

Are you an experimental immunologist (or computational biology graduate student) interested in mathematical and computational modeling techniques and their applications to problems in immunology? NIAID’s Modeling Immunity for Biodefense program is sponsoring the 11th annual Summer School on Computational ImmunologyExternal Web Site Policy at Yale University from June 20 to 23, 2016. Applications (to attend and for scholarship assistance) are due March 25, 2016.

Attendees will receive instruction on metadata management and standards for large-scale experiments; R scripting approaches to data analysis techniques including PCA, clustering, and differential expression; how to use experimentally motivated deterministic and stochastic models to explore hypotheses; and data mining, integration, and network analysis.

Header: Advice Corner. 

Get Opportunity Alerts by Area of Science

To pinpoint opportunities by area of science, use the NIH Guide's advanced search options and subscribe to emails. The approach described in this article gives you a more specific email than the ones we send through Email Alerts for NIAID funding opportunities.
Here's how to create an advanced search:
  1. Go to the NIH Guide's Advanced Search Options.
  2. Construct a search using a keyword such as Burkholderi, HIV vaccine, or whatever else fits your interests.
  3. Submit the search form to test the search. As an example, here’s a search using “HIV vaccine.”
  4. When you get to the results screen, find the blue "save this search" button on the upper right and click on it.
  5. The resulting page might look blank depending on your browser of choice. Scroll down to the bottom and you’ll find a form.
  6. Complete the form to get an email whenever your search criteria are met.
NIH also illustrates this process in the YouTube video NIH Guide for Grants and Contracts Subscribe FeatureExternal Web Site Policy.
Using the advanced search form, you could construct a series of these searches to maximize your chance of spotting a relevant opportunity. Try using synonyms, Latin names of organisms, or acronyms instead of the full term. Test your searches to see if you get unexpected results; for example, a search for "MERS" turns up a lot of Alzheimer's opportunities.
If you're worried you'll miss an NIAID-relevant opportunity, you may be better off checking all the opportunities we send through ourEmail Alerts.
Still can't find an appropriate opportunity? Use one of NIH’s Parent Announcements to send an investigator-initiated application instead. Read Five Steps to Finding NIAID's High-Priority Areas for more tips.
Contact an NIH program officer for more advice on opportunities and preparing an application. For NIAID, learn how to find a program officer relevant to your area of science at When to Contact an NIAID Program Officer.
Header: Reader Questions. 
Feel free to send us a question at 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.

“I applied for an R01 as a new investigator. The application was not funded. Can I apply for another R01 as a new investigator?”—anonymous reader

Yes, NIH’s definition of a new investigator depends on whether you were awarded certain types of grants, not whether you applied. So you can continue applying for an R01 and still be considered a new investigator.
We discuss NIH’s definition further at How to Qualify for New and Early-Stage Investigator Status.

“Is the PI considered senior/key personnel and therefore not required to obtain prior approval for reducing effort during a no-cost extension?”—anonymous reader

Yes, in every circumstance the principal director(s)/principal investigator(s) is always considered key personnel of a grant and will be named on the Notice of Award.
Additionally, note that key personnel do not need prior approval to reduce effort during a no-cost extension unless a specific amount of effort for those key personnel is stated in the terms and conditions of the Notice of Award.
Header: New Funding Opportunities. 
See other announcements at NIAID Funding Opportunities List.​​

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