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July 16, 2014

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles.

Addressing Unforeseen Administrative Issues After Submission

Last month we reviewed When NIH Accepts Late Submissions, but what about when you submit your application on time and you need to add an update before peer review? As with late applications, the situations in which NIH accepts post-submission materials are narrowly defined, and we’ll review them here.

Keep in mind, post-submission materials should be a product of unforeseen administrative issues. This is not an opportunity to patch omissions and mistakes on your original submission. Note that even if your post-submission materials are accepted, reviewers will still receive your original application intact with your post-submission materials included as a separate file.

The list of accepted post-submission materials includes:

  • Revised budget pages (e.g., change in budget request due to new funding or institutional acquisition of equipment).
  • Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator).
  • Letters of support or collaboration resulting from a change in key personnel due to the hiring, replacement, or loss of an investigator.
  • Adjustments resulting from natural disasters (e.g., loss of an animal colony).
  • Adjustments resulting from change of institution (e.g., PI moves to another university).
  • News of an article accepted for publication (a copy of the article should not be sent).
  • News of a professional promotion or positive tenure decision for any PI or key personnel.

NIH will not accept:

  • Updated Specific Aims or Research Strategy pages.
  • Late-breaking research findings.
  • Supplemental pages, meaning information not contained in the existing application.
  • New letters of support or collaboration that do not result from a change in key personnel.

Other Considerations

Videos or other media may be used to present demonstrations of medical devices or of experimental data with a temporal element (e.g., to show how something functions over time), but will be accepted at the discretion of the NIH scientific review officer (SRO), as explained in the September 27, 2012, Guide notice.

When a funding opportunity announcement includes specific guidelines for submitting post-submission materials, its instructions will supersede the general NIH policy.

For training grants with the activity codes T32 and T35, you are allowed three pages to submit updated information on your applicant pool, admissions, enrollment, faculty research support, or appointments and achievements including:

  • News of a trainee's or former trainee's graduation, employment, promotion, funding, publication or other professional achievement.
  • News of a faculty member's promotion, funding, publication, or other professional achievement.
  • News of an additional faculty member who will be involved in the training activity.

For more information, read the July 23, 2010, and January 29, 2013, Guide notices.

In Any Case

Your deadline to submit post-submission materials is 30 calendar days before the peer review meeting.

We strongly recommend that you email your post-submission materials to your SRO as a PDF attachment. This will allow the file’s text to be searched electronically. If the material needs a letter of explanation, ask your SRO for any special instructions. If the letter will be sent to the review panel, then page limits will apply.

Any post-submission materials that you send must demonstrate concurrence from your authorized organizational representative (AOR). To do so, you should email your post-submission materials to your AOR and then have him or her email the materials to the SRO. Copying the AOR on an email to the SRO is not sufficient.

Page limit restrictions apply to post-submission materials that are not required on a form page. Follow the length guidelines listed in the March 19, 2010, and July 23, 2010, Guide notices.

Keep in mind that although NIH allows a range of post-submission materials, they are ultimately accepted at the SRO’s discretion. For this reason, it is important that you inform the SRO if you need to send post-submission materials.

Header: Opportunities and Resources.

An Opportunity to Participate in Immune-Related Genomics Consortium

Formed in 2005, the HLA and KIR Region Genomics in Immune-Mediated Diseases Consortium, a cooperative research group, has been dedicated to defining associations between 1) polymorphisms in the human leukocyte antigen (HLA) and natural killer cell immunoglobulin-like receptor (KIR) genomic regions and 2) transplantation outcome or susceptibility or resistance to immune-mediated diseases.

Support for the program continues with two recent funding opportunity announcements (FOAs) that seek new and renewal applications. Projects funded under these FOAs will form a new cooperative research group with NIAID and NINDS as partners.

About the Program

The FOAs, a U01 and companion U19, will support prospective and/or retrospective studies investigating the role of the HLA and/or KIR genomic regions in immune-mediated diseases or transplantation outcome.

Key goals of the Consortium are to identify, map, and characterize how genetic variants within the HLA and KIR regions influence disease phenotype, progression, and severity; predict outcomes following organ transplantation; or direct treatment strategies.

In addition to supporting HLA and KIR region association studies, another of the program's major goals is to generate high-quality, high-resolution genetic data with accompanying phenotype information. The data generated from these projects will be submitted to public databases maintained by NIH, such as ImmPort, dbMHC, and dbGaP.

Your proposed project must focus on the correlation of sequence variations in the HLA and/or KIR genomic regions with disease risk, severity, progression, and response to therapy, or transplantation outcome in humans. Note: this FOA will not support animal studies.

We encourage studies that investigate associations with these regions and immune-mediated diseases that disproportionately affect specific racial, ethnic, or gender groups, especially minority populations.

For additional areas of research interest and application requirements, read the June 9, 2014, U01 and U19 Guide notices.

If you apply for the U19, find information on multiprojects in our Multiproject Awards SOP and Guidance for Preparing a Multiproject Research Application.

Contact NIAID Before Application Deadline

Before you start on your U01 or U19 application, we strongly recommend that you discuss your proposed project with Dr. Jeffrey Rice, NIAID's scientific/research contact for these FOAs. Touch base with him well before the submission deadline.

Applications for both FOAs are due on October 20, 2014. Although optional, we encourage you to submit a letter of intent by September 20, 2014.

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Now's Your Chance to Join Radiation Countermeasures Consortium

NIAID is once again soliciting applications from those interested in joining the Centers for Medical Countermeasures Against Radiation Consortium. CMCRC was established in 2005 to develop effective and comprehensive medical countermeasures to radiation exposure, particularly medical products that can assess, diagnose, mitigate, and treat the short- and long-term consequences of exposure.

Applicants to this funding opportunity announcement (FOA) will contribute to CMCRC’s goals of tracking biomarkers of tissue damage and recovery, producing new techniques and devices to measure radiation exposure in the human body, and developing novel therapies to minimize tissue damage, hasten tissue recovery, restore normal physiological function, and improve survival. This FOA uses the U19 cooperative agreement activity code.

In your application, you must propose a minimum of three research projects. Activities that can be supported under this program include:

  • Practical biodosimetry devices and techniques, biomarker assays, and other automated diagnostic systems to rapidly assess radiation exposure and tissue damage following an event and during the treatment and recovery phase.
  • Medical countermeasures to mitigate or treat acute or delayed radiation injuries to the hematopoietic, gastrointestinal, cutaneous, pulmonary, renal, cardiovascular, or central nervous system when administered at more than 24 hours after irradiation.
  • Therapeutic regimens with an emphasis on broad efficacy, safety, and ease of administration for at-risk populations, such as pediatric, geriatric, and chronically-ill groups.
  • Characterization of radiation injuries and countermeasures for treating at-risk populations.
  • Treatment of concomitant injuries (radiation exposure combined with burn, wound, infection, or other physiological trauma).
  • Mechanism of action of potential countermeasures in irradiated animal models predictive of human responses.
  • Manufacturing scale-up; Good Laboratory Practice (GLP) toxicology and pharmacology safety studies; pharmacokinetic, pharmacodynamics, and metabolism studies; development of GLP analytical methods for efficacy studies and product characterization; and completion of investigational new drug packages for FDA submission.

We will consider your application nonresponsive if you propose clinical trials or if your projects aim to develop medical products that must be administered before exposure or within 24 hours after exposure.

In addition to the research projects, your application must include an administrative core and may include optional cores for scientific services to be shared by your U19 subprojects. Your budget for these components cannot exceed $3.5 million total costs annually.

Your application must also include CMCRC-wide cores: a Coordinating Center Core, an Opportunities Fund Management Core, a Radiation Physics Core, as well as an optional Radiation Survivor Core. NIAID will select institutions to host each of these cores from among the grant awardees. Your total direct cost request for the entire CMCRC application cannot exceed $9.5 million annually.

Note that CMCRC will also have a Steering Committee to include each center’s PI and a Consortium External Advisory Committee. The membership of both will be determined by NIAID.

For full details, read the June 16, 2014, Guide notice.

Letters of intent are due September 3, 2014. The deadline to apply is October 3, 2014.

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Testing Immune Tolerance in Organ Donation

The Immune Tolerance Network (ITN), a clinical research consortium sponsored by NIAID, is seeking proposals for clinical tolerance clinical trials in transplantation using solid organs or islets from recently deceased donors.

The proposed trials should be hypothesis-driven, with a testable mechanism of tolerance induction and a strategy for assays to investigate this mechanism. Phase II trials, with approximately 5 to 30 patients, are preferred. Proposals should also include:

  • Preclinical data and/or evidence from clinical pilot studies.
  • HLA mismatched donors and recipients.
  • An immunosuppression withdrawal plan that includes biomarker use or discovery.

Note that if preclinical studies alone are used to support the proposal, they should include brain-dead donors or discuss why such studies are not needed.

As this request for proposals (RFP) is from ITN, rather than NIAID, the application process will follow the instructions laid out by ITN in the RFP Clinical Trials of Immune Tolerance in Transplantation Using Deceased Donor Organs.

To apply, submit a one-page Letter of Inquiry to Dr. Philip Bernstein no later than August 29, 2014. ITN will evaluate the Letters of Inquiry and then invite formal applications, which will be due in early October.

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Immune-Based Antiviral Products Solicitation On the Way

Researchers working on immune-based antiviral products to combat HIV-1 should stay on the lookout for a new opportunity from NIAID’s Division of AIDS (DAIDS), set to come out later this month.

This broad agency announcement (BAA) contract solicitation is meant to further our goal of stimulating immune effector functions needed for sustained suppression and eradication of HIV-1.

These contracts will support advanced development, manufacturing, and IND-enabling activities, as well as clinical study of candidate innovative, therapeutic immune-based products. We are particularly interested in clinical studies and immunological analyses to identify or confirm the mechanism of action in vivo.

For further information, see the July 9, 2014, presolicitation notice in FedBizOpps.

Header: Other News.

K99/R00 Applicants: Be Aware of Modified Instructions

Investigators planning to submit an application for the NIH Pathway to Independence Award (K99/R00), take note: NIH recently modified budget instructions by removing some information, including how much to enter for total and indirect costs.

All other information in the R&R Budget section of the funding opportunity announcement remains the same:

  • For the K99 phase, applicants should indicate nine person months effort for themselves.
  • In the initial application, applicants are not required to have an itemized budget for the R00 phase.
    • When moving to the R00 phase, applicant institutions will submit for each R00 budget period a detailed budget that reflects their direct and indirect costs.

Read the June 30, 2014, Guide notice for details on the modified budget instructions.

Learn more about the K99/R00 in our Pathway to Independence Awards (K99/R00) SOP and the K99/R00 section of the Career Development Grants questions and answers.

For K-related resources, go to our Career Development Awards (K) portal.

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News Briefs

New Web Tool Displays Timeline of Key Policy Changes. NIH's Grants Policy and Guidance Web page has a new feature that plots the effective dates of upcoming policy changes on a timeline. Each item on the timeline includes a short description and a link to the original Guide announcement.

Administrative Cores Now Optional in Parent P01. NIAID no longer requires an administrative core as part of an investigator-initiated program project (P01) application. See the June 27, 2014, Guide notice for more information.

Annual Requirement Dropped for NRSA Fellows at Foreign and Federal Institutions. NIH recently announced that fellows sponsored by foreign and federal institutions need to submit activation notices for only the initial year of support. Previously this was an annual requirement. For full details, read the July 3, 2014, Guide notice.

Annotated Forms Available to Guide Small Business Applicants. The next SBIR/STTR Omnibus deadline is fast approaching, with applications due on August 5, 2014. If you plan to apply, be sure to check out this handy set of Annotated Forms for field-by-field tips on avoiding common application errors.

Header: Advice Corner.

Big Grant Applications Need Our Approval

If your grant application requests $500,000 or more in direct costs in any year, get NIAID's approval well before you submit. Without our approval, NIH's Center for Scientific Review will reject your application without a review.

This policy doesn't apply to applications in response to requests for applications (RFAs) or any funding opportunity announcements (FOAs) that specify a budget limit.

Q. What do you mean when you say "well before you submit?"

A. When we say "well before you submit," we mean that by rule you have to ask for approval at least 6 weeks before you submit.

We prefer you contact your program officer as soon as you know your application will meet or exceed the $500,000 threshold.

Keep in mind that some funding opportunity announcements (FOAs) have special directions. For example, the NIAID Investigator-Initiated Program Project Applications (P01) FOA requires you contact us for consultation and approval at least 10 weeks before submitting your application.

Q. So, I can request up to $499,000 without NIAID approval?

A. Yes, but we suggest you get in touch if your application comes anywhere close to $500,000, for two reasons.

  1. Your grant out years could be more than $500,000, even if you don't request an annual increase.
  2. As your budget gets larger, it's more likely to contain items that reviewers could view as not integral to the science. Your program officer can help make sure your proposed costs are necessary and well-justified.

Also remember, as always, your program officer can advise you on NIAID's enthusiasm for your project and any extra requirements you'll have to meet before you apply. Learn more at When to Contact an NIAID Program Officer.

For instructions on getting approval, read the Big Grants SOP and learn more at Big Grant Applications questions and answers.

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.

"Is there a limit to the number of summer months that can be listed on an NIH budget proposal?"—Joel Fritzler, Northern Arizona University Flagstaff

Yes, there is a limit. Each person can have a maximum of 3.0 summer term months' effort, which is equal to 100 percent summer term effort. Remember, no personnel effort can be greater than 100 percent. For a full definition of person months, check out the Usage of Person Months Frequently Asked Questions.

"How does the new submission policy extend to renewal applications?"—Khalid Matrougui, Ph.D., Eastern Virginia School of Medicine

If you are submitting another application after an unsuccessful renewal resubmission (Type 2, A1), then your next submission must be a new (Type 1, A0) application. You can do so by further revising the previous application and submitting it as new or by significantly changing the project and submitting a new application.

In either case, you should improve your application based on reviewers' comments and input from your program officer. You can include any progress made since your last submission as preliminary data to support your application. But remember, your application should be written as a new application without any reference to a previous submission or submissions.

Header: New Funding Opportunities.

See other announcements at NIAID Funding Opportunities List.

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Last Updated July 17, 2014

Last Reviewed July 17, 2014