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August 15, 2007

News Articles

Opportunities and Resources

Advice Corner

New Funding Opportunities

News Articles
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Deadline Extended for Peer Review Surveys

Your opinion on peer review is so important to NIH that it has extended the peer review survey deadline to September 7. If you're not an NIH employee, submit your responses to the NIH survey NIH System to Support Biomedical and Behavioral Research and Peer Review. If you are a NIH employee, submit responses through the NIH Internal Survey.

NIH's external and internal working groups created the Web-based surveys to seek your opinion on reforming peer review. As fields of science change, NIH wants to ensure that its processes are efficient and effective for investigators and reviewers. In the future, these NIH working groups will develop an implementation plan and launch pilots to develop a new NIH peer review policy.

Here are a few things to think about for some of the topics.

Challenges for the NIH System of Research Support

NIH funds different types of research and investigators at different stages of their careers, so NIH needs a complex system of support mechanisms. But is the system too complex?

Any changes NIH makes to grant mechanisms or duration of grants still need to enable institutes to reach their public health goals within their budgets.

Challenges of the NIH Peer Review Process

As the number of applications goes up, NIH needs more reviewers. However, many reviewers find it hard to travel to meetings. NIH faces not only the difficulty of finding the most talented reviewers but also meeting diversity and conflict-of-interest requirements.

NIH is also grappling with the complexity of today's science and how peer review can accommodate it.

Peer Review at Different Career Stages

NIH already gives new investigators special consideration, but what about established investigators and people whose grants train many less experienced investigators?

Should NIH use different strategies to assess investigators at the beginning of and later in their careers? Perhaps NIH should consider different mechanisms of support based on career stage.

Read more in the July 6, 2007 and August 9, 2007 Guide notices, and our July 5, 2007, article "Reviewing Peer Review." You can also check out the Enhancing Peer Review at NIH Web site.

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Medicare Announces New Clinical Trial Policy and Proposal

On July 9, 2007, Centers for Medicare and Medicaid Services (CMS) released a new clinical trial policy. It clarifies language that CMS will pay for items and services under investigation in a clinical trial if they are covered outside a clinical trial as long as they are "reasonable and necessary."

For more information, see the Decision Memo for Clinical Trial Policy.

CMS also wants your feedback on a newly released proposal that clarifies standards important to patient safety and will require study sponsors and PIs, including federally funded PIs, to certify that their study meets these standards. The comment period closes August 18, 2007.

For more information on the proposal, see Medicare Announces New Proposed Clinical Research Policy Press Release.

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Windows Vista Not Supported by Grants.gov

Does your computer run on Microsoft Windows Vista? If it does, you'll have to use a different computer to submit your grant application. Grants.gov does not support the Windows Vista operating system.

However, you can convert most of your application to Acrobat portable document format (PDF) on any computer and then attach it to the application using a computer without Windows Vista.

See Grants.gov's Download Software: PureEdge Viewer for system requirements.

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Faster Resubmissions for All New Investigators

Beginning with the next review meetings, all new investigators will receive their summary statements early enough to be able to resubmit their R01 applications for the next review cycle.

This move follows NIH's pilot to enable new investigators to resubmit R01s for consecutive review cycles, saving four months.

Whereas applying early can be advantageous, the shorter timeframe gives applicants only around three weeks to revise. For various reasons, many people found that was too little time. During the pilot, approximately 13 percent of eligible new investigators applied for the next cycle.

For more information, see the August 9, 2007, Guide notice and our April 30, 2007, article "NIH Extends Pilot Study to Shorten the Review Cycle."

Opportunities and Resources
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Develop New Therapeutics Against Biodefense Pathogens

Wanted: New drugs against key biodefense pathogens. For this announcement, we are seeking proposals for advanced development of therapeutic candidates, especially those with broad spectrum activity or that address antimicrobial resistance, for the following pathogens:

  • Smallpox
  • Filoviruses: Ebola and Marburg
  • Anthrax
  • Gram negative bacteria (broad spectrum)
  • Influenza

Supported activities may include investigational new drug, new drug application, and biologics license application-enabling studies.

For more information, read the announcement at BAA-NIH-NIAID-DMID-08-20.

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Foreign Researchers: E-Application Tips Just for You

As a foreign investigator, what should you know about applying electronically for a grant? Find helpful pointers in the new NIH eSubmission Tips for International Applicants.

This handy resource covers the following and more:

  • Getting an eRA Commons account.
  • Obtaining a NATO Commercial and Government Entity code and other requirements for registering with Grants.gov (for your institution).
  • Preparing application components, such as a detailed budget.
  • Checking submission status in the eRA Commons.

For more details, see NIH's Quick Overview of NIH Electronic Submission and Electronic Application Process as well as Plan Ahead for Electronic Application in NIAID's New Investigator Guide to NIH Funding tutorial.

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Small Businesses: In the News

Three new resources may help small business grantees.

Find Partners Online

NIH has set up a collaboration Web site to help small businesses move their innovations down the development pipeline. NIH licensees and Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awardees can use the site to display technologies and connect with potential partners and investors.

Go to the Pipeline to Partnerships (P2P) Web site to submit your technology, search by category and stage of development, and find links to sites of listed organizations. Postings are voluntary and subject to NIH approval.

SBIR Grantees -- Find Your Niche

If you have an SBIR grant, you may want to take advantage of an NIH contractor that can help you assess other potential uses of your technology than you may have considered. The resulting "technology niche analysis" may also help you prepare the commercialization plan for your SBIR phase II application.

NIH has 75 openings -- 50 for FY 2007 and 25 for FY 2008 -- it will fill on a first-come, first-served basis. For details, see the July 31, 2007, Guide notice.

Commercialization Aid for SBIR Phase II Grantees

Need help developing your business and moving your product to market? Try CAP, NIH's Commercialization Assistance Program.

CAP gives you access to people who are expert in the maturation of life science businesses. Participants benefit from a customized program of mentoring, workshops with industry experts and investors, an opportunity to present to investors and partners, and more.

To participate, you must apply by August 24, 2007. You are eligible if you have been an NIH SBIR phase II awardee since January 1, 2002. Find application and other information in the CAP Program Summary.

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New Activity Code Book

The new and reorganized Activity Codes, Organizational Codes, and Definitions Used in Extramural Programs book is here. Not only are similar items grouped together, but this manual also includes new organizational codes and activity codes, as well as a glossary.

Instead of printing the 58-page book, check out NIAID Extramural Activity Codes for a shorter list. Remember, no one Institute uses all the possible mechanisms.

Advice Corner
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K-Award Progress Report Questions

Some readers are asking questions about annual progress reports for their career development (K) awards.

Remember to submit paper progress reports two months before the beginning of the next budget period, except for T32s and T35s, which are due four months before the next budget period. eSNAP progress reports are due 45 days before the beginning of the next budget period.

Late or incomplete progress reports are major contributing factors to late awards. For more information, see our Noncompeting Progress Reports and Program Officer Approval SOP.

Should I include a budget in the progress report?

No. Career awards are issued under streamlined noncompeting award process (SNAP) and do not require a budget.

Do I need to submit an Inclusion Enrollment Form in my progress report?

Yes. You must provide the Inclusion Enrollment form only if you participated in research involving human subjects not reported in the progress report of another PHS-supported project.

If you are conducting clinical research, you must report the annual cumulative enrollment of subjects and their distribution by sex/gender and ethnicity/race using the Inclusion Enrollment Report.

Also, the Inclusion Enrollment Report is not included in the two-page summary limit.

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Reader Question

An anonymous reader asks:

"Do I have to be part of an underrepresented racial or ethnic group to apply for the Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships (F31) to Promote Diversity in Health-Related Research?"

No. This award is also for people with disabilities or from disadvantaged backgrounds.

Remember that underrepresentation varies depending on the setting. If your institution can show that you belong to an underrepresented group, you are eligible.

For more information, see the December 12, 2006, program announcement.

New Funding Opportunities
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See these and older announcements on our NIAID Funding Opportunities List.

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