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April 3, 2014

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles. 

Step Ten to a Winning Application: Write to Excite

We moved the contents of this article into Ten Steps to a Winning R01 Application. As part of the Strategy for NIH Funding, the ten steps give you a path to funding success if you're applying for an R01.

Header: Opportunities and Resources.

An Opportunity to Lead NIAID's Food Allergy Consortium

For almost a decade, NIAID has supported the Consortium for Food Allergy Research (CoFAR), which focuses on immune and other intervention strategies for preventing and treating food allergy.

We recently released a new funding opportunity announcement (FOA) to support the continuation of CoFAR. The mission of CoFAR is to:

  • Explore the pathophysiology of human IgE-mediated food allergy and related conditions, IgE-mediated food allergy-associated anaphylaxis, and IgE-mediated food allergy-associated eosinophilic esophagitis.
  • Develop and evaluate clinical approaches to prevent and treat these diseases.
  • Use integrated state-of-the-art studies to learn more about the mechanisms of these diseases.

Your U19 multiproject application must include clinical and mechanistic study projects, which should provide new insights into food allergy and therefore should not duplicate ongoing or completed studies, including those of the two previous Consortia.

Clinical projects fall into two categories: interventional clinical trials for prevention or treatment and clinical studies, such as observational and genetic studies. In addition to the required four clinical projects, you may propose up to two others.

Mechanistic studies involve human subjects and are aimed at 1) understanding the mechanisms of either the disease or action of a treatment modality and 2) identifying biomarkers that predict disease severity or progression from sensitization to allergy, or the ability of a treatment modality to affect efficacy or safety.

Another goal of the Consortium is to foster close interactions between basic scientists and clinical investigators to accelerate the translation of basic research advances into clinical application.

For complete details, read the February 26, 2014, Guide notice. Applications are due on June 19, 2014.

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

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Creating Diagnostics for Pan-Drug Resistant Infections

Robust diagnostics are needed to better combat drug-resistant, hospital-associated bacterial pathogens. You can take part in their development through a new R01 funding opportunity announcement (FOA): Partnerships for Diagnostics to Address Antimicrobial Resistance of Select Bacterial Pathogens.

Be aware of the specific guidelines that eligible applications must follow, which concern your diagnostic product or prototype, your industry partner, and the application itself.

Diagnostics should:

  • Detect one or more of the following Gram-negative bacteria pathogens: Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species, or extra-intestinal pathogenic Escherichia coli.
  • Identify target pathogens in normally sterile samples, such as blood, urine, cerebrospinal fluid, or pleural fluid.
  • Take less than three hours to perform, be culture independent, and meet or exceed the performance of current FDA-cleared tests.

Industry Collaboration

  • At least one industry participant must provide substantive investment and participation in the project.
    • “Industry” is defined as large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, or chemical companies, or nonprofit agencies with demonstrated experience in product development.
    • “Substantive investment” is defined as a commitment of one or more resources including: product or prototype development support and guidance, personnel, in-kind contributions of materials and/or reagents, provision of animal or other laboratory models for evaluation, subcontracts, data management resources or regulatory support.
  • The project budget can include support for industrial partner activities.
  • Industry PIs are not required to have partners.

Application Requirements

  • Include a Product Development Strategy.
  • Incorporate data supporting proof of concept.
  • Do not propose clinical trials. However, you may use human-derived material in preclinical studies.

For full details on the objectives and scope of this FOA, see the March 12, 2014, Guide notice.

NIAID intends to fund 10 to 15 awards, so don't miss out! Apply before the June 19, 2014, deadline.

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FYI: Fellowship FOAs Were Reissued

Early last month, NIH reissued funding opportunitiy announcements (FOAs) for National Research Service Award (NRSA) fellowship grants. See the March 7, 2014, Guide notice.

Use these latest FOAs to apply for the upcoming April 8 deadline and subsequent due dates.

Note that NIAID:

If you're interested in the NRSA Individual Predoctoral M.D./Ph.D. or Other Dual-Doctoral Degree Fellowship (F30), take note: NIH further clarified the eligibility criteria. Read the March 20, 2014, Guide notice for details.

For more information about fellowships, go to our Fellowship Grants (F) portal.

Header: Other News. 

Check Out New Concepts Approved by Council

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 a list of recently approved concepts, go to Concepts: Potential Opportunities. Here are some examples from January 2014:

While there is no guarantee that a concept will become an initiative, savvy applicants often gear their investigator-initiated applications toward NIAID’s research interests. See Concepts May Turn Into Initiatives and Use Our Concepts List, Blend Approaches for additional information.

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Hassle-Free GWAS Online Submission

Investigators who receive NIH funding to conduct genome-wide association studies (GWAS) must make their data available for secondary research through the NIH GWAS data repository. That’s now easier, as NIH’s database of Genotypes and Phenotypes (dbGAP) has gone digital.

The new online system is convenient—it allows information to be copied from other sources, automatically fills data fields, and has a user-friendly interface.

Interested? Your first step is to register. Contact your program officer and an NIAID GWAS Program Administrator to discuss your project, data sharing plan, and certification process.

Conversely, investigators who want to perform secondary research can apply for access to dbGaP data directly through the online dbGaP system. You will need to provide a description of the proposed research use of the requested data, a data security plan, and a Data Use Certification agreement.

For full details, as well as video tutorials, check out the March 5, 2014, Guide notice.

Also, see the Data Sharing for Grants: Genome-Wide Association Studies (GWAS) SOP for additional instruction.

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News Briefs

Request for Information From NIH Office of Laboratory Animal Welfare. OLAW is soliciting feedback on new "significant changes" guidelines for prompting Institutional Animal Care and Use Committee review. See the March 11, 2014, Guide notice for full details. Send responses to olaw@od.nih.gov by May 15, 2014.

May Event Focused on Human Subjects Ethics. The Office for Human Research Protections is sponsoring a daylong Research Community Forum in Cincinnati, Ohio, on May 21, 2014, to discuss innovations and ethical issues for protecting human subjects.

Header: Advice Corner.

The More Things Stay the Same: Administrative Supplements

We've had a few questions on administrative supplements since NIH renewed the parent announcement, so here's our advice.

Though there's a recent notice in the NIH Guide about the availability of administrative supplements for grants and cooperative agreements, this was not a solicitation for applications. The notice merely announced the renewal of the parent announcement for administrative supplements should you require one. There is no new set-aside of money. Funding for administrative supplements is still provided based on a case-by-case assessment of the request and need.

An administrative supplement is still allowed only in strictly defined circumstances, as explained in the Administrative Supplements to Grants and Cooperative Agreements SOP. The supplement is for expenses that fall within the scope of the approved award but were unforeseen when you applied or sent your progress report.

And although the parent announcement has an "Apply Electronically" button, resist the temptation to click that as a first step. Instead, we advise you to take this approach:

  1. Work with your business office to rebudget funds or tap into unobligated balances.
  2. If you can't find a solution, compare your circumstance with the requirements in the SOP.
  3. If an administrative supplement still seems appropriate to you, contact your program officer to assess whether your situation may qualify.
  4. If so, then apply using the button in the parent announcement or one of the other methods listed in the SOP.

If your new plans would constitute a change in scope, an administrative supplement would not be appropriate. Learn more at What Constitutes a Change in Scope? and the Revision of a Grant SOP.

Related Links

Header: Reader Questions. 

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.

"If I withdraw my application, does it still count as a submission?"—anonymous reader

That depends on the timing of your withdrawal. Applications withdrawn before initial peer review do not count as a submission, while applications withdrawn after peer review do. See the Investigator Withdrawal of an Application SOP for further information.

"Am I required to share model organisms? Who pays for that?"—anonymous reader

Yes. All applicants and offerors applying for a grant or contract who aim to produce new, genetically modified variants of model organisms must include a plan for sharing those organisms in their grant applications or contract proposals, or state why sharing is not possible.

You can request funds to create and disseminate model organisms in your budget section. See the Sharing Model Organisms SOP for details.

Header: New Funding Opportunities.

See other announcements at NIAID Funding Opportunities List.

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Last Updated April 03, 2014

Last Reviewed April 03, 2014