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August 1, 2012

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles.

Sidestep These Application Missteps: Weak Project

We moved the content of this article into Sidestep These Application Missteps in our Strategy for NIH Funding.

Header: Opportunities and Resources.

DAIT Clinical Research Policies: Your Input, Please

Please send us your feedback on draft clinical research policies from our Division of Allergy, Immunology, and Transplantation.

DAIT is soliciting comments from grantees and others involved in its clinical research.  The draft policies cover a range of topics:

  • Essential documents at clinical research sites conducting clinical research funded or sponsored by DAIT.
  • Pharmacy facilities at DAIT-supported clinical research sites.
  • Source documentation in clinical research funded or sponsored by DAIT.

For links to the policies, instructions on sending comments, and more information, go to DAIT Clinical Research Policies and Standards.

Comments are due August 31, 2012.

Header: Other News. 

Items of Interest in New FDA Legislation

Signed into law on July 9, 2012, the Food and Drug Administration Safety and Innovation Act includes such provisions as user fees for processing new drug applications and incentives to develop new antibiotics.

Here are some highlights from the bill.

Generating Antibiotic Incentives Now Act. This legislation creates incentives to develop new antibiotics. It authorizes FDA to allow an additional five years of marketing exclusivity for antibiotics that treat infections with the potential to pose a serious threat to public health, including antibiotic-resistant infections such as methicillin-resistant Staphylococcus aureus.

Extension of user fees. For the next five years, FDA can continue to collect user fees to process applications for prescription drugs and devices. The act also creates similar programs for approving generic drugs and generic biologics.

Focus on pediatric clinical research. The Act also reauthorizes sections of the Best Pharmaceuticals for Children Act, which promotes pediatric clinical research.

You can read the full text of the legislation at S.3187—Food and Drug Administration Safety and Innovation Act.

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News Briefs

Extra Receipt Date for PA on Improved HIV Assays. You get one more chance to apply for the funding opportunity announcement HIV Incidence Assays With Improved Specificity. NIAID extended the expiration date to January 8, 2015. Read the July 10, 2012, Guide notice.

CCR Is No More. Central Contractor Registration has officially moved to the System for Award Management (SAM). Your institution must use SAM to register and update information. If your institution's registration was set to expire between July 15 and October 15, it has a 90-day extension; for details, read Additional Information About SAM Transition.

Join the August 14 Webinar on Financial Conflicts of Interest. If you're responsible for sending your institution's reports on financial conflicts of interest, register and tune in to an NIH Webinar on the revised reporting requirements and the new eRA Commons reporting module. Read the July 27, 2012, Guide notice for details.

Header: Advice Corner.

Keep Form Changes From Becoming Your Waterloo

“The more things change the more they stay the same” may be a wise French proverb but for grant applications, that mindset spells trouble.

A new SF 424 application package should get your frontal cortex neurons firing away: you may no longer be able to use the forms you are working on.

For example, NIH just published a new program announcement for conference grants, PA-12-212, NIH Support for Conferences and Scientific Meetings (Parent R13/U13), that has new forms and review criteria.

If you’ve already filled out the forms, you’ll need to redo them. Here’s how to proceed:

  • Copy the information from the old forms into the new ones.
  • Add or revise information if necessary.
  • Reattach the form documents.

You can keep up with news about form changes by signing up to the NIH Guide listserv. Each form package also gives you the option to sign up for change alerts.

Even if you haven't heard any news, it's a good idea to make sure you are using the right application package just before you apply.

Check your funding opportunity announcement’s NIH Guide announcement and Notable Changes Made to SF 424 (R&R) Application Guides (for grant types using the SF 424).

You can find a table of all NIH instructions and forms at NIH Forms and Applications. Remember that requests for applications and program announcements also have NIH Guide announcements that supplement these basic instructions.

To see all NIAID-relevant NIH Guide announcements except funding opportunities, go to our list of Special Announcements. Find our funding opportunities on our Funding Opportunities List.

For major form changes, go to Top Policy Changes.

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.

"Does NIAID support predoctoral fellowships? How are these applications reviewed?"—Katie Brouk, Washington University School of Medicine

Yes. We support NRSA Predoctoral Fellowships to Promote Diversity in Health-Related Research (F31) for members of underrepresented groups.

We do not participate in other opportunities for predoctoral fellowships.

NIH's Center for Scientific Review handles peer review. Fellowship applications are assigned to review groups based on scientific content, then clustered for review by fellowship type.

For more information on Fs, go to Fellowships in our Advice on Research Training and Career Awards.

"Do I need NIAID's permission for changes in key personnel on my grant?"—anonymous reader

Yes. Contact your grants management specialist if any of your key personnel want to withdraw, take more than three months off at a time, or reduce the time devoted to your project by 25 percent or more.

Keep in mind this rule extends to project and core leaders on multiproject awards, the investigator serving as contact on a subaward, and any other personnel named on your Notice of Award.

For instructions on requesting permission, read our Prior Approvals for Post-Award Grant Actions SOP. For more information, go to Some Actions Require Our Approval in the Strategy for NIH Funding.

Header: New Funding Opportunities.

See other announcements at NIAID Funding Opportunities List.

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Last Updated November 05, 2012

Last Reviewed August 01, 2012