NIAID Funding News January 8, 2015

Feature Articles

• New Funding to Support Ebola Research
• NIAID Review and Committee Volunteers Have Our Gratitude

Opportunities and Resources

• Small Businesses: Funding to Move Your Radiation or Nuclear Countermeasure From Concept to Development
• BAA Focuses on Therapies for Rare or Emerging Viral Diseases in Targeted Populations
• Responding to a Contract Solicitation? Take Note

In The News

• New Policy on Late Applications
• Plan to Shorten SBIR/STTR Grant Cycle Takes Effect
• News Briefs
  • Eligibility for Administrative Supplements Expands
  • Videos About Submission and Peer Review Posted
  • HHS Resource for Human Subjects Research Updated
  • ASSIST Options Expanding in 2015
  • New NSF Forum for Graduate Education

Advice Corner

• New Year's Resolutions for Investigators
• Reader Questions
  • I’m running out of time to use my remaining funds and finish my grant activities. What should I do?
  • If I am promoted to associate professor, will I lose my new investigator status?

New Funding Opportunities

• See the list

New Funding to Support Ebola Research

You may have heard that NIAID will receive $238 million to “prevent, prepare for, and respond to Ebola domestically and internationally.” This one-time appropriation from the Consolidated and Further Continuing Appropriations Act of 2015 is not part of our regular appropriation. Similar to the American Recovery and Reinvestment Act of 2009, these one-time funds are to be used for a specific purpose: in this case, our Ebola efforts in FY 2015 and FY 2016.

The additional support to fight Ebola does not come at the expense of any other programs or initiatives at NIAID. It is distinct from our FY 2015 budget, which is approximately $4.36 billion.

At this time, we do not expect to create new funding opportunity announcements using the Ebola response and preparedness money. Instead, most of the money will be dispensed through ongoing Ebola-related activities, such as funding clinical trials for existing candidate Ebola vaccines. A portion of these funds will also be used for preclinical testing and discovery of new vaccines, therapeutics and diagnostics, as well as to accelerate the evaluation of their toxicity, immunogenicity, and efficacy.

Overall, the Consolidated and Further Continuing Appropriations Act of 2015, which was signed into law on December 16, 2014, provides $2.742 billion to the Department of Health and Human Services for Ebola response and preparedness.

To learn more about NIAID’s progress in research against Ebola virus disease, read the NIH Director’s Blog post “President’s Visit to NIH Highlights Research on Ebola” and the NIH press release Ebola Vaccine Prompts Immune Response.

NIAID Review and Committee Volunteers Have Our Gratitude

Big thanks go out to all the volunteers who served on NIAID peer review committees, our advisory Council, or other such groups in FY 2014.

• For NIH Center for Scientific Review reviewers, see CSR Study Section Roster Index.
• For Council, go to Biographical Sketches of NIAID Council Members.

If you are an experienced investigator, help us fund the best science by volunteering for an NIAID peer review group. Your service could also give you invaluable insights into the review process for your future applications. Learn more about Serving on a Peer Review Committee, including How to Become a Peer Reviewer.

If you are on our Thank You list and spot any issues with your entry, email corrections to deaweb@niaid.nih.gov and accept our apologies.

Small Businesses: Funding to Move Your Radiation or Nuclear Countermeasure From Concept to Development

Do you have an observation or insight that could turn into a countermeasure for injuries resulting from a radiological or nuclear incident?

A new Small Business Innovation Research (SBIR) initiative can give you up to $3.6 million to help you develop your idea, with the ultimate goal of submitting an investigational new drug or investigational device exemption for FDA licensure.

If you're familiar with the SBIR program, you know that if your application is successful, you can receive up to $300,000 each year for up to two years to gather data, then up to $1 million each year for up to three years for preclinical development of your countermeasure.

Contact Dr. Carmen Rios, program officer in our Division of Allergy, Immunology, and Transplantation, to discuss your application.

For details, including a list of priority areas and examples of responsive topics, read the December 10, 2014, Guide notice.

Related Links

• Radiation and Nuclear Countermeasures Program
• NIAID's Apply portal, which links to sample SBIR applications and information about NIAID's small business program.

BAA Focuses on Therapies for Rare or Emerging Viral Diseases in Targeted Populations

NIAID's Division of Microbiology and Infectious Diseases (DMID) seeks proposals from offerors who can develop effective therapies or therapeutic strategies for rare and/or emerging viral diseases (non-HIV) in targeted patient populations.

In deciding whether this broad agency announcement (BAA) is appropriate for you, it may help to know how key terms are defined:

• Rare (or orphan) disease—generally considered to have a prevalence of fewer than 200,000 affected people in the U.S.
• Emerging viral diseases—infections that have newly appeared in a population, or have existed but are rapidly increasing in incidence in that population or geographic range.
• Targeted patient populations—children, the elderly, transplant recipients, pregnant women, and others for whom there is a significant unmet medical need for therapeutic options for rare or emerging viral diseases.

Since many of these diseases and the most affected patient populations may not be conducive to traditional product development or common clinical trial methodologies, NIAID encourages natural history studies.

That is, evaluating in a target patient population factors such as a disease's incidence, clinical presentation and variability in patients, causes of morbidity and mortality, and response to standard of care. The goal of these natural history studies is to provide data for designing interventional clinical trials.

Other eligible clinical studies or trials include:

• Interventional trials of safety and effectiveness for treatments for rare and/or emerging viral diseases (non-HIV) of medical importance in targeted patient populations and underserved by the pharmaceutical industry.
• Validation of biomarkers or surrogate markers of clinical responses and safety in antiviral therapy for the purposes of designing future clinical therapeutic studies.
• Exposure or exposure-response studies (using pharmacokinetic and pharmacokinetic/pharmacodynamic approaches) to optimize therapies.

Offerors responding to this BAA must have documented expertise not only in clinical research but clinical research in the patient population proposed or in the type of study proposed, and demonstrated knowledge of applicable regulatory guidelines.

For complete details, including a more comprehensive description of the types of viral diseases and infections that would be considered, read the December 15, 2014, FedBizOpps.gov solicitation. Proposals are due by May 12, 2015, at 3:30 p.m. Eastern time.

Responding to a Contract Solicitation? Take Note

We have a short—but important—message for anyone responding to a contract solicitation, such as a request for proposals or broad agency announcement.

Unless the solicitation specifies that you may use government resources, e.g., those from NIAID's intramural labs*, do not include such resources in your proposal since it will not proceed to peer review if you do.

The reasoning for this? If government resources are included in one offeror’s proposal, they must be made available to all potential offerors, which usually isn't practical. That's not to say you can't collaborate with intramural investigators or use intramural resources. You can once you have been awarded a contract.

*Including tissue samples, nucleic acids, and blood and bodily fluids, as well as intellectual resources, such as collaborators.

New Policy on Late Applications

If you are a principal investigator (PI) and have a valid reason for submitting your application late, check out NIH's newly harmonized policy on late applications, announced in a December 17, 2014, Guide notice.

The new policy is effective for due dates on or after January 25, 2015, and allows a two-week window for NIH to consider accepting your late application. The policy will not be applied retroactively.

What’s new? Previously, different application types had different length windows of consideration, and you couldn't apply late for requests for applications (RFA) or program announcements (PAR) with special due dates, even with a valid reason.

Now, any RFA or PAR will have the two-week window, but be sure to read the Guide notice for details on exceptions. For example, NIH can’t accept late applications for RFAs with a compressed review window or for funding opportunity announcements that already state “No late applications will be accepted.”

As before, explain the reason for your late application in your cover letter. See the SF 424 (R&R) Application Guide instructions for late applications. NIH will decide on a case-by-case basis whether to accept your application. Remember, there is no preapproval for a late application, so make sure your excuse is valid and that you thoroughly explain it in your cover letter.

Reasons Why NIH Might Accept a Late Application

Here are some examples from NIH of potentially valid reasons for lateness. In all cases, the PI must be the person affected, rather than a collaborator. On multiple PI applications, it may be just one of the PIs.

• Death of an immediate family member.
• Sudden, acute, and severe illness–you or your immediate family member.
• Full-time, temporary, or ad hoc service on an NIH advisory group in the two months before or two months after the due date. This includes serving on study sections, special emphasis panels, the Board of Scientific Counselors, Program Advisory Committee, or an NIH advisory Council.
• Delays due to weather, natural disasters, or other emergency situations that shut down the applicant organization. The application's lateness should not exceed the time your organization was closed. See NIH Extramural Response to Natural Disasters and Other Emergencies.
• Delays due to properly reported federal computer system issues. Follow the Guidelines for Applicants Experiencing System Issues and work with the appropriate help desk to promptly complete your application submission.

The Guide notice also provides a list of unacceptable reasons for lateness.

NIH's Continuous Submission and Natural Disaster policies remain the same.

Have more questions? Contact the Center for Scientific Review at csrdrr@mail.nih.gov or the NIH Office of Extramural Research atReviewPolicyOfficer@mail.nih.gov.

Plan to Shorten SBIR/STTR Grant Cycle Takes Effect

NIH is taking action to shorten the time period between application deadline and award issuance for small business grants. The table below lists the next four receipt dates for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant applications with related details:

Looking ahead, September 5, January 5, and April 5 will be the receipt dates in 2016, 2017, and beyond.

The transition to a shorter small business award cycle is the product of several changes taking place simultaneously, all of which are reflected in the table above.

First, NIH pushed back non-AIDS receipt dates for the FY 2015 SBIR/STTR Omnibus solicitations by five months. (Formerly the FY 2015 Omnibus receipt dates were planned for April 5, August 5, and December 5, 2015.)

Second, effective September 5, 2015, AIDS-related SBIR/STTR grant applications will no longer be accepted on AIDS and AIDS-Related Due Dates. The new SBIR/STTR grant application deadlines closely align with the AIDS due dates, so, in order to further simplify the process, the corresponding SBIR/STTR grant application due date will be used instead.

Third, NIH added a receipt date to the FY 2014 SBIR/STTR Omnibus solicitations. The additional funding will be paid for using FY 2015 set-aside money. This is a one-time change in the review cycle as NIH moves to the new receipt dates.

The extra FY 2014 Omnibus receipt date is April 5, 2015 (with AIDS/AIDS-related applications due on May 7, 2015, since the due date is part of the FY 2014 Omnibus), followed by an expedited Council meeting in August 2015 and award issuance beginning in September 2015. Thus, April 5, 2015, which was scheduled to be an FY 2015 Omnibus receipt date, is now an additional FY 2014 Omnibus receipt date.

The SBIR/STTR Reauthorization Act of 2011 and the Scientific Management Review Board’s Report on Optimizing the NIH Small Business Innovation Research and Small Business Technology Transfer Programs from August 2013, prompted the changes. The transition to later submission deadlines should reduce the timeline from solicitation close to award issuance.

For more information, read Important Change in Standard Due Dates for All HHS SBIR/STTR Grant Applications. The unique review and award cycle dates for SBIR/STTR applications are now noted at Standard Due Dates for Competing Applications.

News Briefs

Eligibility for Administrative Supplements Expands. Grantees funded through P2C, PM1, R21/R33, RM1, U2C, UG1, UH2/UH3, and UM2 funding mechanisms are now eligible to apply for Research Supplements to Promote Diversity in Health-Related Research and Research Supplements to Promote Reentry Into Biomedical and Behavioral Research Careers administrative supplements.

Videos About Submission and Peer Review Posted.In November, the Center for Scientific Review held four Meet the Experts in NIH Peer Review Webinars. You can view the presentations online by following the links listed below.

HHS Resource for Human Subjects Research Updated. The 2015 Edition of the International Compilation of Human Research Standards lists thousands of laws, regulations, and guidelines for human subject protections in 113 countries. Assembled by HHS'sOffice for Human Research Protections, the new edition includes hundreds of updates and six new countries: Ghana, Guinea, Liberia, Malaysia, Saudi Arabia, and Sierra Leone.

ASSIST Options Expanding in 2015. In the coming months, NIH will expand ASSIST’s options for application submission to include most competing grant and cooperative agreement programs. Small Research Grants (R03) and Exploratory/Developmental Grants (R21) will be part of the first set of increased options slated for the end of this month. For more information, read the December 17, 2014, Guide notice.

New NSF Forum for Graduate Education. You are invited to participate on the National Science Foundation's new NSF Graduate Education Forum. The forum will host moderated conversations among graduate students, faculty, university administrators, employers, and others in four broad topic areas: diversity and broadening participation; campus to careers; the graduate education experience; and mentoring.

New Year's Resolutions for Investigators

Best wishes for the new year! Are you looking for a few more resolutions? Here are our top five suggestions for 2015.

1. Don't Wait

Our top suggestion may seem obvious, yet we see investigators struggle with this far too often: don't wait until the last minute. Some examples:

• If you have a new idea for an application, contact your program officer early, after you have draft Specific Aims and before you start writing the new application.
  • Too many people wait until close to the application deadline to ask whether the idea fits NIAID’s interests or is responsive to the funding opportunity announcement, and they risk not getting an answer in time.
  • By asking questions early, you allow time for your program officer to respond, time to discuss with another institute (if applicable), and time to make adjustments that strengthen the application.
• Contact your business office as soon as you’ve decided to apply for a particular receipt date.
  • Confirm your institution's internal deadlines; they may be sooner than you think.
  • Factor those dates into your planning timeline to get letters of support, information from collaborators, and so on.
• Make sure your business office submits the application at least several days before NIH's deadline. That way, if there's a problem uploading the application files, you have time to resolve it.

2. Learn About NIAID's High-Priority Areas

If you have a lot of different ideas, you can focus by reviewing NIAID's scientific priorities. Learn more here:

• Review Council-approved Concepts.
• Pick a Research Project. Get advice and an approach for finding your unique research niche that builds on your expertise. Then follow an integrated strategy to identify a project within that niche.
• Researching Research Topics and Teammates. Assess what research is already funded to find gaps in your field.

3. Avoid These Pitfalls When You Reapply

If you send a resubmission or send a reworked application as new, we have two suggestions for you:

• If reviewers ask for additional data, or criticize an existing piece of preliminary data as being too weak, be sure to provide the additional supportive data in your next application. Arguing against their request in your introduction just wastes space.
• If your application didn’t get a fundable score after two revisions, we suggest major changes to the project or starting over with a new idea. Sending very similar applications over and over doesn't improve your chances of success. See What to Do if You Get Bad News and Options if Your Application Isn't Funded.

4. Watch the "Related Notices" Section of Guide Notices

One tricky aspect of NIH Guide notices is that when NIH issues a correction or update, the original notice's text may not change since NIH makes corrections to the original notice in some fields, but not others.

Therefore, it's vital to check the "Related Notices" section periodically for both types of notices:

• For funding opportunities, "Related Notices" lets you spot key updates that can affect your application. Also be sure to check when you're preparing a resubmission. Perhaps your intended due date was changed or cancelled. Maybe NIAID joined as a participant in an opportunity you found interesting. Eligibility requirements or forms might change while you're writing your application.
• For policy notices, "Related Notices" helps you find the older version of the policy as well as announcements related to the policy topic. And if NIH issues further clarifications or changes to a policy you're referencing, that's where you can find the newer information.

If you want to find these notices in a different way, we also list key amendments and policy notices on our Special Announcements page. NIH also offers a timeline view of announcements at Upcoming Changes in Grants Administration.

5. Plan Ahead to Comply With the Public Access Policy

We recommend that you think about Public Access Policy compliance as part of choosing a journal for your manuscript—not after publication. NIH offers some points to consider at Address Copyright.

Identify which method for submission to PubMed Central applies for the journal so that you’re prepared to take action once the paper is accepted for publication.

If your journal uses Method A, your article will be automatically added to PubMed Central. See the search box at Method A Journalsand check for your intended journal. Otherwise, read NIH's summary of Submission Methods for Method B, Method C, or Method D.

You should also regularly check MyNCBI. Since you are responsible for papers that cite your grant, see which manuscripts are affiliated with your grant. That gives you time to address any corrections well before you send your progress report. In addition, institutions may wish to use the Public Access Compliance Monitor.

Share Your Suggestions

Do you have any other grantsmanship resolutions? What tips or recommendations would you suggest to your fellow investigators? Let us know at deaweb@niaid.nih.gov and, if we get enough suggestions, we'll include the top ones in a follow-up article.

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.

"I’m running out of time to use my remaining funds and finish my grant activities. What should I do?"—anonymous reader

Consider using a no-cost extension, which allows you to extend your grant's project period one time for up to twelve months. Keep in mind, the no-cost extension does not provide additional funds.

If your grant was awarded as part of a response to a request for applications (RFA), you may need prior approval to get a no-cost extension. This requirement should be indicated in the RFA itself, or you can check with your grants management specialist or program officer.

For more information, read Manage Your Award, as well as the No-Cost Extension SOP.

Go to NIH's Closeout to learn about NIH's grant closeout requirements for when your project period concludes.

“If I am promoted to associate professor, will I lose my new investigator status?”—anonymous reader

No. Your new investigator status is not affected by changes in your career stage. Rather, new investigator status is affected only by your NIH award history.

Read Are You "New?" in our New Investigator Guide to NIH Funding to learn more.

• RFA-ES-15-004, NIH Big Data to Knowledge (BD2K) Biomedical Data Science Training Coordination Center
• RFA-OD-15-002, Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data

See other announcements at NIAID Funding Opportunities List.