viernes, 17 de octubre de 2014

NIAID Funding News, October 16, 2014

NIAID Funding News, October 16, 2014



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October 16, 2014

Feature Articles
Opportunities and Resources
In The News
Advice Corner
New Funding Opportunities
Header: Feature Articles.

An Update on the FY 2015 Budget Situation, Paylines, and Success Rates

NIAID has not yet received a budget for the 2015 fiscal year. Congress has, however, passed a continuing resolution (CR), which will fund NIAID through December 11, 2014. The CR contains no additional funding compared to the FY 2014 budget ($4,392 million).
When we do receive a budget, it will likely be flat relative to the previous year’s budget. The President’s Fiscal Year 2015 Budget proposal would increase NIAID’s budget by 0.7 percent to $4,423 million, which includes a $15 million funding increase for the HIV Cure Initiative. The President’s budget also includes an increase of $20 million for the Cures Acceleration Network (part of the National Center for Advancing Translational Sciences), and $50 million for the Common Fund (part of the NIH Office of the Director).
Until we have a new budget, our interim financial management plan provisionally sets R01 paylines at the 10 percentile for established investigators and the 14 percentile for new investigators. The small grant (R03) and exploratory/developmental research grant (R21) interim paylines are both provisionally set at an overall impact/priority score of 23, which matches their FY 2014 levels. To learn more about paylines, go to NIAID Paylines.
We have not planned any programmatic adjustments or cuts to competing research initiatives at this time.
R01 Paylines Go Up; Success Rates Won't
An NIH policy change in April now allows you to submit an unsuccessful application as a new application without making substantial changes in scientific direction. NIAID has received about 15 percent more unsolicited R01 applications for the October 2014 and January 2015 Council rounds than we did during last year’s first two Council rounds. R21 application totals also continue to rise, consistent with growing interest in this activity code over the past several years.
We can't raise our payline high enough to accommodate this surge in applications. With more R01 applications competing for the same pool of money, success rates will probably drop slightly. We estimate that increased application numbers will combine with our provisional paylines to lead to success rates around 21 to 23 percent.
Meanwhile, we still have to fund existing awards and new initiatives approved by our advisory Council.
While this isn't perfect news, we want you to understand the fiscal situation and its impact on your chances of getting funded. The payline is rising, the ease of resubmission is improving, but the net effect will be a decrease in success rates.
More Applications but Business as Usual
Most, possibly all, of the surge in new applications stems from applications on topics that were previously submitted but not funded.
We can't say for sure because NIH databases do not allow us to identify previous applications on the same topic without manually reviewing every application and comparing to previous submissions.
In the meantime, remember that we will not review any applications that reference earlier reviews. Read our October 1, 2014, article "Make Sure That New Application Is New."
Header: Opportunities and Resources.

Support Services Needed for Radiation Countermeasure Products

NIAID’s Division of Allergy, Immunology, and Transplantation (DAIT) is soliciting contract proposals to develop medical countermeasure (MCM) products that treat injuries from radiological or nuclear exposure.
Solicitation Aims
The overarching goal of the solicitation is to advance MCMs toward FDA approval or licensure for acute radiation syndrome (ARS) or delayed effects of acute radiation exposure (DEARE). Candidate MCMs can enter the evaluation and development pathway at various stages, from early research to post marketing.
Task Areas will include Administrative and Technical Support, Animal Model Development and Efficacy Testing of Candidate Medical Countermeasures, Nonclinical Studies in Support of IND, NDA, and BLA, Phase I Clinical Studies, and Chemistry, Manufacturing, and Control Support Services.
Proposal Evaluation
DAIT anticipates that one Indefinite Delivery, Indefinite Quantity contract will be awarded for a five-year period of performance.
NIAID will evaluate proposals based on:
  • The comprehensiveness, soundness, adequacy, and suitability of the proposed scientific approach and methodology used to support the advancement of candidate MCMs towards FDA approval or licensure under the Animal Efficacy Rule.
  • Organizational capabilities, experience, and understanding of MCM development against radiological and nuclear agents.
  • Adequacy of the scientific and technical personnel, facilities, equipment, Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP) compliance and project management.
For full details, read the September 2, 2014 FedBizOpps.gov solicitation. Contact Deborah Blyveis with questions.
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Check Out New Funding Opportunities for Carbohydrate Research

Carbohydrates play a role in virtually every infectious disease we study, and you can get funding to develop new tools and technologies to study certain carbohydrates called glycans.
Why Glycans?
Microbes and viruses use glycans to bind to and infect host cells, and nearly all infectious disease vaccines target glycans present on the disease-causing organism.
But despite glycans' importance for infectious disease research, we don't know how to easily synthesize and sequence them, or to study their biological functions.
Funding Opportunity Announcements
If you can help us fill in that gap, we have several funding opportunity announcements (FOAs) that you should investigate.
One-Year Planning Grants
Consider applying for a clinical trial planning grant (R34) of up to $150,000 in direct costs for one year to identify the time and resources needed to organize an inclusive, community-driven project that can provide a framework for integrating structural, analytical, and functional data for carbohydrates and glycoconjugates.
At the end of your grant project period, you'll have a chance to compete for a cooperative agreement in a subsequent FOA to support a full-fledged project.
Exploratory and Developmental Grants
You can also get up to two years of exploratory/developmental research grant (R21) support to develop new, more easily accessible tools, reagents, and technologies to facilitate identifying, tracking, manipulating, and analyzing glycans with their biological binding partners and determine their functions.
Feel free to take risks. You don't need preliminary data and if your project is successful, you may have a chance to build on your discovery by competing for a subsequent cooperative agreement.
Cooperative Agreements
In addition to the grant opportunities mentioned above, look into either of two U01 cooperative agreement FOAs, where NIAID staff will assist, guide, coordinate, or participate in your project activities.
One FOA seeks new methods and technologies to facilitate the rapid and affordable synthesis, production, and use of biomedically-relevant glycans and glycoconjugates representing mammalian glycomes or microbial glycans.
Get details, instructions, and examples of application topics in the Facile Methods and Technologies for Synthesis of Biomedically Relevant Carbohydrates (U01).
Our other FOA asks for new, more easily accessible tools, reagents, and technologies to facilitate identifying, tracking, manipulating, and analyzing glycans with their biological binding partners and determine their functions.
For this opportunity, your application must discuss, as applicable, factors for scale-up, efforts to make instrumentation broadly accessible and cost-effective for the end-user, and compatibility of data generated with integration into existing databases.
NIAID is especially interested in developing high specificity/affinity monoclonal antibodies to glycan determinants unique to pathogenic organisms and tools to identify glycan changes associated with autoimmune conditions (e.g., the viral envelope of HIV). Such tools are considered crucial for rational vaccine design studies. Read more in Novel and Innovative Tools to Facilitate Identification, Tracking, Manipulation, and Analysis of Glycans and Their Functions (U01)
These funding opportunities come from NIH's Common Fund, an effort to support transformative research that cuts across the mission areas of individual NIH institutes.
Webinar and Related Links
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Insights on Submission and Peer Review

Interested in strengthening your grasp on how the application submission and peer review processes work? Then check out this upcoming series of Webinars from the Center for Scientific Review (CSR).
CSR will host four Meet the Experts in NIH Peer Review Webinars next month on several topics, including application receipt and referral, how your application is reviewed, and jumpstarting your career with CSR’s Early Career Reviewer Program.
Each Webinar will have a 30-minute Q&A session and focus on a different award type:
Webinar Focus
Date
Academic Research Enhancement Awards (R15)November 4, 2014
Fellowship AwardsNovember 5, 2014
Small Business Grants (SBIR/STTR)November 7, 2014
Research Project Grants (R01)November 10, 2014
To join a Webinar, you'll need to register by Tuesday, October 28. For instructions and other details about the Webinars, read the October 2, 2014, Guide notice.
Header: Other News.

Summary of September's Advisory Council Meeting

As you may know, NIAID's advisory Council met on September 15. Here's a recap and a few items of note.
Director's Remarks
In his opening remarks, NIAID Director Dr. Anthony Fauci touched on various subjects, including perhaps the most anticipated: the FY 2015 budget. Read more in the article above "An Update on the FY 2015 Budget Situation, Paylines, and Success Rates."
In other news, he covered topics such as NIAID intramural scientists who garnered prestigious honors and awards, scientific conferences that NIAID participated in, and recent scientific developments that affect NIAID's research priorities.
Departing members
Dr. Fauci also acknowledged the service of five members whose terms end on October 31:
  • Dázon Dixon Diallo, M.P.H
  • Michael J. Holtzman, M.D.
  • Norma Sue Kenyon, Ph.D.
  • Velma P. Scantlebury, M.D.
  • Jerome A. Zack, Ph.D.
As they leave Council, new members will take their place. We will introduce them in an upcoming issue.
For all of Dr. Fauci's remarks, watch the videocast NIAID Council Meeting—September 2014.
Subcommittee Synopses
Learn more about NIAID's priorities and initiatives from Council subcommittee meetings, where our staff discuss extramural research programs with advisory Council members. See below for video of these subcommittees' open sessions:
Concept approval
The subcommittee meetings also covered concepts for clearance.
As you may know, before NIAID announces a new initiative, such as a request for applications (RFA), a program announcement (PA), or a request for proposals (RFP), our advisory Council must first approve a corresponding concept.
To see which were approved at last month's meeting, go to the following pages at Concepts: Potential Opportunities:
It's important to note that there is no guarantee that a concept will become an initiative. Even so, they can be very helpful. Since they reflect NIAID's research interests, you can use them for possible topic ideas for an investigator-initiated application.
Get our advice on using concepts to your advantage at Use Our Concepts List, Blend Approaches and other sections of Choose Approach and Find FOAs in the Strategy for NIH Funding.
Also, learn more about how concepts work by reading Concepts May Turn Into Initiatives in the NIAID Funding Opportunity Planning and the Budget Cycle.

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Important Instructions for NRSA Fellowship Applications

NIH issued new guidance for the Additional Educational Information section of National Research Service Award (NRSA) fellowship applications. Take note if you plan on applying for any of the following:
  • Individual Predoctoral M.D./Ph.D. or Other Dual-Doctoral Degree Fellowship (F30)
  • Individual Predoctoral Fellowship (Parent F31)
  • Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31-Diversity)
  • Individual Postdoctoral Fellowship (Parent F32)
For the F30, F31, and Diversity-F31, you need to include a separate attachment titled “Additional Educational Information.” In it, your graduate or dual-degree program director or department chair must provide a full description of the graduate or dual-degree program in which you are enrolled. For a list of required details, see the Guide notices linked below.
  
For the Diversity-F31, applicants are required to also attach a letter from the institution certifying eligibility of the applicant. The certification letter must be on institutional letterhead and scanned as a PDF file so that the signature of an institutional official is visible. Name this attachment “Certification Letter.”
The NRSA F32 application does not require an Additional Educational Information attachment. Instead, give a description of the resources available to you, including those provided by an institutional Office of Postdoctoral Affairs (or the equivalent), under the Other Project Information Form, Facilities & Other Resources attachment.
For full details, see the September 24, 2014, Guide notices for the F30F31Diversity-F31, and F32 grants.

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News Briefs

Type 5 Non-SNAP Grants Move to RPPR on October 17. Streamlined noncompeting award process (SNAP), fellowship, and multiyear funded awards are required to use the Research Performance Progress Report (RPPR) for submitting progress reports. As of this Friday, October 17, all Type 5 non-SNAP awards will have the same requirement, as announced in the May 16, 2014,Guide notice and covered in our March 19, 2014, article "Changes to Progress Reporting on the Horizon." If you've only ever submitted paper progress reports, set aside additional time to review the NIH RPPR Instruction Guide before completing your November 1 progress report.
Phone Number Changes for NIAID's DEA. The Division of Extramural Activities, which includes the Grants Management ProgramScientific Review Program, and Office of Acquisitions, is moving to a new building this month. The move will include new phone numbers. If you are trying to contact someone in DEA and the phone number does not work, search for the person you are trying to reach in the NIH Enterprise Directory and use the updated information listed there.
Niche Assessment Program Returns for 2014. Small businesses with NIH Phase I awards are eligible to apply for the Niche Assessment Program. The program provides market insight and data so awardees can optimize their commercialization and marketing plans. Act now: there are only 136 spots available and enrollment is on a first come, first serve basis. See the October 6, 2014, Guide notice for more information.
NIH Seeks Feedback on Physician-Scientist Initiative. Weigh in now on a new initiative designed to better aid the transition of physician-scientists from training to independence. Specific instructions are listed in the October 10, 2014, Guide notice. Send responses by November 3, 2014, using the Web form at Request for Information: Physician-Scientist Specific Grant Program to Facilitate the Transition From Training to Independence.
Deadline Extended for Sex as a Biological Variable RFI. The response date to submit your input for Request for Information: Consideration of Sex As a Biological Variable in Biomedical Research has been extended to October 24, 2014. See the September 11, 2014, Guide notice for more details.
Header: Advice Corner.

Peer Reviewers and Council Members: A Not So Confidential Reminder About Confidentiality

It's no secret that maintaining confidentiality in peer review is a matter NIH takes seriously. Peer reviewers and advisory Council members should do the same. If you serve in either capacity, we want to remind you of your responsibilities as well as the consequences of breaching confidentiality.
Confidentiality Responsibilities: Peer Reviewers
A good rule of thumb to follow is "what happens in a review meeting, stays in a review meeting."
As a reviewer, that means you cannot, for example:
  • Share applications, R&D contract proposals, or confidential meeting materials with colleagues, lab members, fellows, students, applicants, offerors, employees of an offeror, or anyone else who's not officially allowed to participate in the peer review process.
  • Disclose to them information about committee deliberations, discussions, evaluations, or documents.
  • Use information that's in an application or proposal for your personal benefit or make such information available for the personal benefit of any other person or organization.
Confidentiality Responsibilities: Council Members
As a member of an advisory Council, you are held to the Standards of Ethical Conduct for Employees of the Executive Branch.
Therefore, you have a duty to protect and maintain the confidentiality of government records, e.g., grant applications, R&D contract proposals, and related documents. You cannot use, or allow anyone else to use, such records for purposes other than those for which you were authorized.
You are also prohibited from using, or allowing the improper use of, nonpublic information—which includes confidential information gained in peer review—to further your own or someone else's private interests.
Breaches of Confidentiality
Violating confidentiality rules can have grave repercussions. You could be fined or imprisoned if you knowingly and willfully:
  • Falsify, conceal, or cover up by any trick, scheme, or device a material fact.
  • Make any materially false, fictitious, or fraudulent statement or representation.
  • Make or use any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry.
If NIH determines that a situation involves a bona fide breach of confidentiality, it may take remedial steps, such as:
  • Notifying the peer reviewer or Council member in question as well as his or her institutional research integrity officer or other similar, senior institutional official.
  • Terminating the Council member's or reviewer's term, if he or she is a standing member of an NIH chartered committee.
  • Referring the matter to the NIH Office of Management Assessment and possibly to the HHS Office of Inspector General, which could result in criminal penalties, fines, imprisonment, or all three.
Reporting a breach
If you learn about or suspect a breach of confidentiality, notify Dr. Matthew Fenton, NIAID's research integrity officer.
Learn More
For additional information about maintaining confidentiality in peer review, read the March 28, 2014, Guide notice, and go to NIH'sConfidentiality in NIH Peer Review Web site.
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.
"Where can I find the character limits for items in the SF 424 application form?"—anonymous reader
Use the SF 424 (R&R) Application Guide for NIH and Other PHS Agencies to find specific instructions. For example, your project's title should be 200 characters or less (including spaces and punctuation), as noted in section 4.2, while the file name for any PDF attachments should be 50 characters or less, as noted in section 2.3.2.
"If awarded an R21 during the final two years of a K23, can the awardee reduce the level of effort on the K23 to below 75 percent?"—anonymous reader
The awardee may reduce the level of effort on the K23 to no less than 50 percent (six person months), provided he or she:
  • Remains in a mentored status.
  • Is named a PD/PI on a competing NIH research grant application (e.g., R01, R21) or a subproject director on a competing multicomponent research or center grant or cooperative agreement application (e.g., P01, U01). 
  • Receives prior approval from his or her grants management specialist. Contact the specialist for information on how to do this.
Note that the K23 must have been active when the competing grant application was submitted.
For further details, read the NIH Grants Policy Statement, section 12.3.6.2 Concurrent Support for career development awards.
Header: New Funding Opportunities.
See other announcements at NIAID Funding Opportunities List.

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