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- Unlocking the Commercial Potential of Scientific Advances
- Solicitation for Radiation-Induced Lung Injury Treatments
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New Funding Opportunities
Early Insights From FY 2014 Application Totals
As we near the final FY 2014 Council on June 2, we looked at our current R01-equivalent* application numbers. The figures are not official, as the fiscal year has not yet ended.
*R01-equivalent applications consist of R01s, R37s, and R56s.
To date, NIAID has received 2,617 R01-equivalent applications for FY 2014, as compared to 2,693 for FY 2013, a drop of 3 percent.
Taking a longer view, over the past 10 years—from FY 2004 to FY 2013—R01-equivalent applications rose by 3 percent from 2,612 to 2,693. At the NIH level, R01-equivalent applications also rose by 3 percent during the same timeframe.
R01-equivalent applications make up 46 percent of the total research project grant (RPG) applications received so far in FY 2014. This is lower than their 50 percent share of all RPG applications in FY 2013, and lower still than their 54 percent share of all RPG applications in FY 2004.
While R01-equivalent application rates have hardly increased since FY 2004, R21 application rates have risen dramatically at NIAID over the same time period.
This may be due in part to an increase in the use of the R21 mechanism, especially by new investigators, but it also may be impacted by the fact that several NIH institutes no longer accept R21 applications in response to the parent R21 FOA. Thus, some of these R21 applications that historically were assigned to other institutes may now be assigned instead to NIAID.
This could also be due in part to the NIH policy that eliminated the “A2” resubmission starting January 25, 2009. Investigators might have required an R21 to gather preliminary data to be able to submit R01 applications in a different scientific area, although we don’t have direct evidence to prove this.
Despite the rise in R21 applications, the NIAID Office of Strategic Planning and Financial Management sets paylines that keep the R21 success rate in line with the R01 success rate. Thus, re-drafting a great, but unfunded, R01 application into an equally-great R21 application is probably not a worthwhile way to increase your odds of funding. Your research needs should guide your decision of whether to apply for an R21 or R01.
FY 2014 has also seen a rise in the number of R01 applications to the Division of AIDS, compared with the last fiscal year. The increase in applications was likely driven by an increase in FOAs for solicited initiatives.
It should be noted that the above data do not specifically address any impact of the sequester cuts, nor unusual changes in the ratio of solicited versus investigator-initiated R01s and R21s over the time period examined.
Lastly, FY 2014 may mark a turning point in the budgetary trends that we’ve experienced since FY 2007. NIAID’s R01 paylineincreased from 8 to 9 percent—a modest gain, but positive news nonetheless. It’s the first increase since FY 2001.
Unlocking the Commercial Potential of Scientific Advances
Does your institution house a bevy of entrepreneurs and innovators? Then consider applying to become a proof-of-concept center as part of the NIH Research Evaluation and Commercialization Hub (REACH) program.
Each REACH site will help to translate promising biomedical technologies to the private sector by performing feasibility studies, technical evaluations, and market research, as well as establishing business partnerships.
Flexibility is critical. Each hub must have access to expertise in business plan development, market research, intellectual property protection, regulatory and reimbursement processes, project management, and clinical studies. Your hub will support projects that range from laboratory-based technology validation studies to early phase clinical testing. Then, using a milestone-driven approach, your hub will transition technologies to strategic partners for commercialization.
Institutions may submit only one application each. Those that participate in the National Science Foundation I-Corps Siteprogram or the Institutional Development Award program are strongly encouraged to apply.
NIH plans to fund up to three U01 cooperative agreements, for a maximum period of three years and a maximum annual budget of $1 million in total costs. The expectation is that each hub will also find nonfederal funding and become self-sustaining by leveraging support from partnering institutions and revenue from sources such as licensing, milestone payments, and royalties.
See the April 25, 2014, Guide notice for full details. Applications are due June 26, 2014.
Solicitation for Radiation-Induced Lung Injury Treatments
NIAID's Division of Allergy, Immunology, and Transplantation is seeking contract proposals for medical countermeasures (MCMs) to combat radiation-induced lung injury following exposure to a radiological or nuclear incident. MCMs should mitigate the delayed effects of acute radiation exposure, including pneumonitis and fibrosis.
We expect candidate MCM projects to cover various stages of the pipeline pathway, from early research and development to post marketing evaluation, so each offeror is expected to provide a Statement of Work that details the effort needed to advance MCM development.
Note, we will evaluate both the scientific merit and the feasibility of your proposal. To succeed, proposals must include adequate personnel, facilities, equipment, and project management in addition to supporting efficacy data and a suitable methodology and approach.
We anticipate that two to four cost reimbursement, completion type contracts will be awarded for a three year period, with an annual total cost between $1 million to $2 million for each contract awarded.
For details on how to respond, see the April 14, 2014, broad agency announcement. Submit your proposal by July 28, 2014.
Inclusion Reporting Expands to Progress Reports
There is an updated format for providing sex/gender, race, and ethnicity information in progress reports for clinical research studies. NIH is also moving to a new eRA Commons module—the Inclusion Management System (IMS)—that will be used for reporting this information. IMS will replace the Population Tracking System this summer.
Pay close attention. Whether you use the previous Inclusion Enrollment Report format or the new Cumulative Inclusion Enrollment Reportdepends on when your award start date falls. Instructions on how to submit the inclusion enrollment information vary based on the date you submit the progress report.
For award dates before October 1, 2014, use the previous Inclusion Enrollment Report:
- For Research Performance Progress Reports (RPPRs) submitted before July 18, 2014, continue to use the link in the RPPR that brings you to the current Population Tracking System.
- Starting July 18, 2014, the link in the RPPR will go to a PDF of the Inclusion Enrollment Report, which you will attach to section G.4.b of the RPPR.
- PHS 2590 reports will use the PDF of the Inclusion Enrollment Report as well.
For award dates after October 1, 2014, use the Cumulative Inclusion Enrollment Report:
- For RPPRs filed between July 18 and October 16, 2014, use the Cumulative Inclusion Enrollment Report and upload a PDF of this to section G.4.b.
- Starting October 17, 2014, RPPR will link directly to IMS in section G.4.b (where you will enter information directly, instead of attaching a PDF).
- PHS 2590 reports will use the PDF of the Cumulative Inclusion Enrollment Report.
See the April 30, 2014, Guide notice for a more detailed explanation.
Regardless of your award date, you will be able to access and update your inclusion enrollment data in IMS beginning October 17, 2014. NIH will migrate existing data from the Population Tracking System to IMS on your behalf, as announced in this April 30, 2014, Guide notice.
News Briefs
FY 2014 Paylines Posted. NIAID Paylines now has final FY 2014 paylines posted for all grant types.
eRA Systems Offline for Upgrades Over Memorial Day Weekend. Both eRA Commons and ASSIST will be down from 9 p.m. on Friday, May 23 until 7 a.m. on Tuesday, May 27 for an upgrade to enable use of Greek and other scientific characters.
Changes to Grant Closeout Policies Are On the Way. NIH is planning to revise certain closeout policies and procedures, with a focus on condensing the timeline to reconcile financial discrepancies and other post-submission issues. The changes will affect grants with project end dates after September 30, 2014. See the April 24, 2014, Guide notice for more information.
New Application Instructions for K22 Awards. As announced in the May 7, 2014, Guide notice, applicants to the K22 award must now provide a budget justification at the time of submission. Another change allows the applicant's current postdoctoral advisor to explain any future role and support he or she will give the candidate during the candidate’s early phase as an independent investigator.
SBIR/STTR Applicants Required to Use New Forms for Summer Receipt Date and Beyond. If you are submitting an application due on or after August 5, 2014, you must use forms from the FORMS-C set. Read the May 12, 2014, Guidenotice for details.
What to Do After You Apply, Before Your Application's Peer Review
If you think your work is done once you submit your application, think again. Even after the viewing window closes, you can still improve your chances of success.
Use this checklist to make sure you're covering all your bases.
1. Check Your Study Section Assignment
Log in to the eRA Commons to check that your application is assigned to a study section you requested in your cover letter.
NIH's Center for Scientific Review (CSR) inputs your assignment as soon as it assigns your application to a study section. However, it may take as long as 10 days, so keep checking if you don't see your assignment immediately.
If you did not get the study section you requested, check carefully that you are assigned to one that has the expertise needed to understand your application. CSR may have more than one study section with the expertise you require and sometimes creates ad hoc groups to fill in gaps. You might also be assigned to an ad hoc group because there are too many conflicts with the standing study section panel—note that these ad hoc groups are labeled “ZRG” followed by a number. Find out more from your scientific review officer.
If you feel your application was not assigned to an appropriate study section, you can request a change. For instructions on how to do so, read .
2. Check Your Institute Assignment
When you check your study section assignment, also check your institute assignment.
If you didn't get the right assignment or you think you chose the wrong institute, contact your program officer.
Your application stands the best chance of getting funded if it goes to an institute that considers your research high-priority, and program officers are in the best position to make that assessment and advise you what to do.
When you speak to your program officer, you may want to ask for dual assignment with NIAID and another institute (if you haven't already requested dual assignment in your cover letter).
3. Send Additional Information as Needed
Keep track of changes in your budget, equipment, and personnel, or new professional accomplishments for you or your key personnel.
Should anything change, you may notify your scientific review officer until 30 days before your review date. NIH accepts the following items after you apply:
- Revised budget page(s) (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 senior/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).
- Letter of acceptance that a manuscript has been accepted for publication (a copy of the article should not be sent).
- News of a professional promotion or positive tenure decision for any PIs or key personnel.
Keep in mind that the parenthetical examples are usually the only items NIH will accept, and your scientific review officer has the final authority over what to accept.
For training grants, you may send other items, e.g., enrollment data and changes in the applicant pool.
For a full list of information you're allowed to send late and instructions on how to do so, go to Late Applications & Post-Submission Materials.
Some words of caution:
- Check your funding opportunity announcement (FOA) for any limitations or deviations from this policy. Your FOA trumps all other instructions or guidance.
- NIH cannot accept anything you send after 30 days before the review meeting.
4. Check for Changes in Your Study Section's Roster
Continue to review your study section roster to make sure it still has the expertise necessary to understand your application.
Compositions of study sections vary somewhat from one review round to another as standing members finish their terms and scientific review officers add new, sometimes temporary members to fill in gaps in expertise.
During this time, address any concerns to your scientific review officer.
He or she may be able to address your concerns, but if not, you'll have to decide whether to proceed with peer review or withdraw your application.
Note: In your cover letter when you apply, you should identify competitors and note all expertise necessary to understand your application, but we recommend that you do not suggest specific reviewers. For this checklist, we're just talking about double-checking that your study section still suits your application.
5. Give Your Application a Fresh Look
Review all parts of your application again (not just your Research Plan). Do you see any flaws? Data errors? Problems with your presentation?
When you step back and look at your application without the pressure of an application deadline and when not thinking about every detail, you may see new problems or opportunities to make significant improvements.
Since you cannot amend or correct your Research Plan, you may find it advantageous to withdraw your application and try again for a later receipt date. For more on that, see the next item on our list.
6. Withdraw if You Must
You want to do everything you can to convince reviewers your work is significant, high-impact, and able to drive knowledge in your field to a higher level.
Withdrawing your application—with the intention to apply at a later date—may get you the best review result if you see serious flaws or spot opportunities to incorporate new scientific discoveries that elevate the significance of your work.
7. Read More About These Topics
For additional information and advice, read the following pages of our Strategy for NIH Funding:
- Write a Cover Letter—more about how to note expertise, exclude reviewers, and request institute and study section before you apply.
- Late Applications & Post-Submission Materials—advice on sending late materials or withdrawing your application.
- Application Assigned to a Review Group—how to confirm you have the right institute and study section after you apply.
- First-Level Peer Review—overview of peer review and how reviewers are selected.
And related SOPs:
Also see NIH's resources:
- Frequently Asked Questions about post-submission materials
- The Assignment Process
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.
"Do I need to submit a final progress report if I am applying for a renewal?"—anonymous reader
No. If you submit a renewal application before the due date of your progress report, you do not need to submit a final progress report because you must document progress in your renewal application.
For more on renewals, read Apply for a Renewal.
However, if you are unsuccessful and the project period has ended, you must submit a final progress report.
"Do site visits usually occur before or after review?"—anonymous reader
After, although there are exceptions. Sometimes we need to conduct a site visit after review but before awarding a grant. Other times we will conduct a site visit after award. If a site visit is necessary, your program officer will make arrangements with you and send a letter that includes the reason for the visit, a list of participants, and an agenda.
Grants Management Program staff can also schedule site visits after award when there is concern for serious administrative or accounting deficiencies.
Institutions can also request a visit; send a letter to the NIAID staff listed on your Notice of Award. See the 
Site Visits, Grantee SOP for more information.
- RFA-AI-14-008, Sustained Release for Antiretroviral Treatment or Prevention (SRATP) of HIV Infection
- PA-14-215, HIV Vaccine Vector-Host Interactions: Understanding the Biology and Immunology (R01)
- PA-14-214, HIV Vaccine Vector-Host Interactions: Understanding the Biology and Immunology (R21)
- PA-14-218, Fc Receptor (FcR) and Antibody Effector Function in HIV Vaccine Discovery
- PA-14-217, NK Cells to Induce Immunological Memory to Prevent HIV Infection
- PA-14-216, B Cell Help Immunology Program for AIDS Vaccine Strategies
See other announcements at NIAID Funding Opportunities List.