June 3, 2015

Feature Articles

Crossing the R56-Bridge if You Come to It

Opportunities and Resources

In The News

Advice Corner

When and How to Contact a Program Officer
Reader Questions
- The December 5, 2014, Guide notice about biosketches says we can list non-publication research products such as data and research materials. Does that mean we can include preliminary data in the biosketch?
- I am part of a multiple PI application, but my collaborator’s institution applied for the grant. Do I need an eRA Commons account? How do I get one?

New Funding Opportunities

See the list

Crossing the R56-Bridge if You Come to It

Being nominated for a High-Priority, Short-Term Project Award (R56) might not be as glamorous as being up for an Academy Award, but it's still a big deal. That's because an R56-Bridge, as it's commonly known, provides one year of funding for programmatically important R01 applications that missed the payline, allowing investigators to continue research and gather additional data to reapply for an R01 grant.

Here we give a brief introduction to the R56-Bridge for those unfamiliar with this interim award as well as information for those who are recommended for and receive one.

And the Nominees Are...

Two points to which we alluded above are worth noting.

First, you must be nominated for an R56-Bridge award; you do not apply for it. Program officers recommend applications based on a project's relevance to NIAID's mission, scientific merit, and potential to produce results within one year, which would increase the likelihood of a successful resubmission.

Second, R56-Bridge awards are for investigator-initiated R01 applications only, whether new, a resubmission, or a renewal.

R01 applications in response to requests for applications and program announcements with set-aside funds are usually ineligible, as are activity codes other than R01, foreign grants, and applications proposing new clinical trials or epidemiological studies. To see what else is ineligible, see the NIAID R56-Bridge Award SOP.

Action Items

As a nominee, you don't need to take any action—unless your program officer recommends that your award be reduced by at least two modules or 25 percent from the study section-recommended level*.

In that case, you'll have to provide information and a few documents to your program officer. Find out more in the NIAID R56-Bridge Award SOP.

*NIAID generally funds R56-Bridge awards at the study section-recommended level, but the funding level depends on NIAID's Financial Management Plan at the time of award.

The Approval Process

The road to getting an R56-Bridge goes like this: After program officers recommend candidates, directors of each program division (DAIDS, DAIT, and DMID) rank the nominees, limiting the number of awards to funds available, and present the nominations to NIAID’s Office of the Director for approval. Each division reports its R56-Bridge awards at the NIAID pre-Council meeting.

Action Items

If you are approved for funding, your grants management specialist will request just-in-time (JIT) information, which your institutional business official should submit through the eRA Commons. Your program officer and grants management specialist will contact you if additional documentation is needed.

After you receive an R56-Bridge Notice of Award, you should start thinking about and writing either a resubmission or new R01 application.

You should also plan accordingly to avoid the possibility of a lapse in funding. For more on this, go to the following resources:

Options if Your Application Isn't Funded in the Strategy for NIH Funding
April 16, 2015, Funding News article "Losing Your Funding: Avoid a Gap, Survive a Gap"

Also, for additional general information, check the R56-Bridge Awards and Selective Pay Questions and Answers.

Funding for NHP Consortia for HIV Vaccine and Cure Research

If you have demonstrated experience with nonhuman primate (NHP) models for AIDS, consider partnering with NIAID on a collaborative multidisciplinary consortium to investigate vaccine approaches for HIV/SIV prophylaxis and cure.

As a member of this consortium, you will receive up to five years of support to demonstrate how your vaccine protects NHP from infection and how your immune-based strategy might eliminate SIV/SHIV reservoirs or lead to sustained remission after discontinuation of highly active antiretroviral therapy.

A few points to consider before you apply:

You’ll need a prophylactic vaccine that has already demonstrated some success in protecting NHP.
You need to propose both a prophylactic and a cure component for HIV in the application.
Your approach to eliminate SIV/SHIV reservoirs needs to address feasibility and safety in preparation for clinical use.
You need to have established assays to measure the immune response and viral reservoir.

Read the April 29, 2015, Guide notice for more information, including application instructions and scientific contacts.

Send optional letters of intent by June 29, 2015. Application deadline is July 29, 2015.

A Chance to Be a Lasker Clinical Research Scholar

As an early-career clinical researcher, would you jump at the chance to develop into an independent scientist while receiving NIH funding for up to 10 years? If so, you may want to check out the reissued funding opportunity announcement (FOA) for the Lasker Clinical Research Scholars Program.

The two-phased program combines a period of research experience as a tenure-track investigator in the NIH Intramural Research Program (IRP) with additional years of independent financial support either within the IRP or at an extramural research institution.

Phase 1 (intramural Si2 phase)—work five to possibly seven years as a tenure-track investigator in a participating NIH institute or center.
Phase 2—after completing the first phase, choose one of two options:

Remain in the IRP with continued intramural funding and potential progression to tenured senior investigator status.
In the extramural R00 segment, continue research at an extramural institution after obtaining an extramural position and undergoing NIH programmatic review of progress during the Si2 phase. The extramural Lasker Scholars Grant provides direct costs of up to $499,000 each year for up to three years.

Are You Eligible?

To be eligible, you must have:

An M.D., M.D./Ph.D., D.O., D.D.S., D.M.D, R.N./Ph.D., or equivalent clinical doctoral degree from an accredited domestic or foreign institution.
A professional license to practice clinically in the U.S.
Completed core residency by June 2005 or more recently.
Demonstrated sufficient patient-oriented research experience to qualify for a tenure-track level appointment.

You do not have to be a U.S. citizen or permanent resident, but if selected, you must qualify for and maintain appropriate visa or residency status throughout both phases of the program.

Consult With Staff Early On

Each participating institute or center (IC) has preferred areas of clinical research interest. For NIAID, they are hepatitis, allergy, and antimicrobial resistance.

To get feedback about whether your proposed research is appropriate to the goals of the IRP, we strongly encourage you to consult with IC staff at least 10 weeks before the application due date. NIAID's scientific/research contact is Dr. Karyl Barron.

Get Letters of Reference

You must arrange to have four letters of reference submitted on your behalf. If your application is missing these letters, it will not be reviewed.

NIH will not accept late letters, so check that they are submitted before the deadline. Remember, your application will be incomplete if these letters are not submitted on time. You can monitor the status of letters in your eRA Commons account.

To submit letters, your referees can use the Commons' Submit Reference Letters feature starting July 27, 2015. The deadline is August 27, 2015, at 5 p.m., which is also when your application is due.

Read the FOA for details on what you need to provide to those writing your letters and what they need to do.

Application Information

Be sure to carefully read the Application and Submission Information in the FOA. As mentioned above, your application is due by August 27, 2015.

If you are an NIAID intramural investigator, make sure you contact Dr. Ken Santora at least 10 weeks before submitting your application to register in the eRA Commons and discuss submission deadlines for Grants.gov.

For complete details, read the April 28, 2015, Guide notice, and go to the Lasker Clinical Research Scholars website.

Reminder: Application Form Instructions for Subawards Have Changed

The next time you submit an application that includes a subaward, take heed of the February 26, 2015, Guide notice, which provides instruction for submissions that include a subaward not active in all budget periods of the prime applicant. These instructions supersede those within the General Application Guide SF 424 (R&R)–Forms Version C, which are not yet updated to reflect the change.

In short, the R&R Budget forms will not allow for “empty” budget periods for subawards that will be inactive during prime grant budget periods.

The budget periods of the subaward whether active or not, must always align with the budget periods of the prime grant—the start and end dates must match exactly. To accomplish this, complete the required fields by providing the following minimum information for each subaward budget intended to be inactive in a particular budget period:

Organization DUNS
Budget Type = Subaward/Consortium
Budget Period Start/End Dates (align with budget periods and dates of the prime budget)
In section A: Senior/Key Person, provide a single entry including the following:

Subaward lead investigator first and last names (can be a project director/principal investigator (PD/PI) in multiple PI applications)
Project Role (may default to PD/PI; can be adjusted as needed)
Calendar Months = .01 (smallest amount effort allowed in the field)
Requested Salary = $0
Fringe Benefits = $0

Explanation of the inactive budget periods in the budget justification

Failure to match the budget period dates of the subaward and prime grant will cause the system to tabulate your total direct costs incorrectly. As a consequence, you may inadvertently qualify for additional requirements based on direct costs, e.g., big grants.

News Briefs

Publication Reporting Instructions for Training, Career Development, and Research Resource Mechanisms. NIH clarified which publications should be included in progress reports and renewal applications for training, career development, and resource sharing awards. Remember, you are responsible for ensuring public access compliance for those publications that directly arise from your award. See the May 25, 2015, Guide notice for full details.

Late Applications Due to Severe Storms in Oklahoma and Texas Are Okay. As explained in the May 29, 2015, Guide notice, your submission delay should not exceed the number of days your organization was officially closed. Be sure to include a cover letter that explains the delay so NIH staff can determine whether to accept the late application.

Clarifications to NIH-PEPFAR Collaboration FOAs. If you read last issue's article "HIV Researchers: Check Out NIH-PEPFAR Collaboration FOAs" and plan to apply, know that NIH has revised the FOAs to clarify the research objectives. To learn more, read the May 27, 2015, Guide notices for the R01 and R21.

When and How to Contact a Program Officer

You're trying to get a hold of your program officer but are having no luck. What should you do? We provide suggestions here as well as a few key points to keep in mind.

Find Contact Information

You can find addresses and phone numbers for staff in our three program divisions—DAIDS, DAIT, and DMID—listed in each program officer's NIH Enterprise Directory (NED) entry (NIH's electronic Yellow Pages).

You should also be able to find updated phone numbers in your Commons account.

That said, take note: When program officers move to new positions or locations, NIH may need some time to update their contact information.

If you call and find that the number doesn't work, email or try calling your program officer's division using its main number. Someone there should be able to direct you to the person you're trying to reach.

Division of Acquired Immunodeficiency Syndrome (DAIDS)—301-496-0545
Division of Allergy, Immunology, and Transplantation (DAIT)—301-496-1886
Division of Microbiology and Infectious Diseases (DMID)—301-496-1884

Ask Yourself Two Questions

Do I have the right person? Check your Commons account to make sure the program officer for your grant award or application hasn't changed. The name on a summary statement or Notice of Award might not be the person currently assigned, so your call or email may have to be re-routed, which causes delays.

Do I have the person I need? Before you email or leave a voicemail for your program officer (or even while waiting to hear back), ask yourself: Am I certain he or she is the person I need to answer my question or resolve my issue?

Remember, you should reach out to him or her for scientific, funding, and programmatic matters related to NIAID funding. Learn more about When to Contact an NIAID Program Officer.

You should contact someone else for other issues, such as:

Your grants management specialist for administrative elements of your grant award, i.e., negotiation, reporting, budgeting, and management.
A scientific review officer for information about the conduct of review meetings or whether your proposed research fits well within a particular study section.
The scientific/research contact listed in a funding opportunity announcement (FOA) for questions about that particular FOA. Be sure to keep in mind, however, that this contact may refer your question to a program officer likely to be assigned your application.
The activity coordinator for any specific topic or service covered on an NIAID website. Find his or her contact information by searching NED.

Know That Certain Times Are Busier Than Others

Program officers are always busy, but they're likely to be busier at certain times of the year. During these periods, you may need to wait a bit longer than usual for a response.

For instance, right after NIH publishes a FOA, program officers—not just the scientific/research contacts listed—get inundated with inquiries, which take time to address.

Also, around this time of year, program officers are busy meeting internal deadlines for end-of-fiscal-year activities and attending study section meetings, so they may not be able to answer you immediately.

If, however, you are trying to resolve a bar to award or other pressing issue that affects your getting funding, your program officer should be in contact with you as soon as possible. In such cases, it's a good idea to copy your assigned grants management specialist on your email so he or she can do what's needed on the grants management end.

Similarly, know that grants management specialists face an especially busy period in the summer as the end of the fiscal year approaches, while scientific review officers tend to be busiest during the fall and winter.

Get a Response and the Information You Need

Help your program officer help you get a timely response by following these tips.

Be crystal clear.
- When emailing or leaving a voicemail:
  - Provide your grant number.
  - Fully explain why you are getting in touch.
  - Clearly describe what you want—and when you need it. If it's urgent, say so.
    - Give a time frame in your email's subject line so messages are read in a timely manner. For example, "Urgent question for R15 application due June 25."
Follow up, provide alternate contact info.
- If you emailed, follow up with a phone call, and vice versa.
- Give additional email addresses or phone numbers, if you have them, so your program officer has other ways to get in touch with you.

If you don't get a response within the time you need it, try these alternate paths:

For DAIDS, email the Science Planning and Operations Branch at sciops@niaid.nih.gov.
For the other two program divisions, call the general number or speak to a branch chief listed on the following pages:
- DAIT—301-496-1886
- DMID—301-496-1884

Related Links

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.

“The December 5, 2014, Guide notice about biosketches says we can list non-publication research products such as data and research materials. Does that mean we can include preliminary data in the biosketch?”—anonymous reader

No. If you have unpublished preliminary data in support of the proposed work, it belongs in your Research Strategy as usual.

In the biographical sketch, you can highlight contributions to science, but you're not including actual data there. Instead, as an example, you might note that you contributed to science by adding data to an unpublished source such as a repository.

For more on biographical sketches, see NIH's Frequently Asked Questions on Biosketches.

“I am part of a multiple PI application, but my collaborator’s institution applied for the grant. Do I need an eRA Commons account? How do I get one?”—anonymous reader

Yes, you need an eRA Commons account. Check with your institution's business officials; they may already have a Commons account for your organization and can set one up for you.

If not, your institution would need to register with eRA Commons and then set up your account. Learn more at eRA’s Registering Institutions and Organizations.

Now, suppose you are serving as key personnel but not in a PD/PI role: In that case, you would not need a Commons account at the time of submission but once funded you would need an account if your effort is included in a progress report.

Also, an eRA Commons ID is required for anyone with a postdoctoral, graduate, or undergraduate role who worked at least one person month per year during the reporting period, as noted in the August 2, 2013, Guide notice. The Commons ID is required for people supported by a reentry or diversity supplement, too. For all other project personnel, the Commons ID is strongly encouraged but currently optional. Read 6.4 Section D—Participants in the NIH and Other PHS Agency Research Performance Progress Report (RPPR) Instruction Guide for more details.