NIAID Funding News, August 24, 2016

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August 24, 2016 NIAID Funding News

Feature Articles

Institutional Officials: You’re Responsible for Monitoring Financial Conflicts of Interest

Opportunities and Resources

In The News

Advice Corner

Before Pursuing a Small Business Opportunity, Complete Registrations
Reader Questions
- Should I include intellectual property in my application?
- Should I use FORMS-D for my resubmission if my previous application used FORMS-C?

New Funding Opportunities

See the list

Institutional Officials: You’re Responsible for Monitoring Financial Conflicts of Interests

In accordance with federal regulations on financial conflict of interest (FCOI) for grants or cooperative agreements in 42 CFR Part 50 Subpart F—Promoting Objectivity in Research, institutions are responsible for implementing policies and procedures that provide a reasonable expectation that the design, conduct, and reporting of research are free from bias.

To successfully fulfill this responsibility, institutions must establish a written policy on FCOIs, document possible conflicts during the grant application or contract proposal process, and report new FCOIs for ongoing contracts or grants.

Establish a Written Policy

Your institution’s written policy should designate you (as the institutional official) responsible for identifying financial conflicts of interest, enforcing institutional policy, and reporting conflicts to NIAID. Remember, institutions—not NIAID—review disclosures of significant financial interest to determine whether they constitute an FCOI.

As you draft or update your policy, refer to the Checklist for Policy Development to ensure you’ve accounted for each aspect of the federal regulations, such as setting up procedures for maintaining records and a policy for subrecipient requirements.

Document Possible Conflicts and Report New FCOIs

Your institution’s policy should require that all investigators, offerors, subawardees, contractors, and collaborators document any FCOIs before submitting a grant application or contract proposal to NIH.

This documentation is not submitted as part of the grant application or contract solicitation package. Instead, your institution will separately report the FCOIs before spending any award funds. For grants, you will report the conflicts through the eRA Commons. For contracts, you should report conflicts in writing to Chuck Grewe, director of NIAID's Office of Acquisitions.

The report should list:

Grant or contract number
Principal investigator or contact PI if the grant or contract is a multiple PI award
Name of the person with the conflict
Which method—management, reduction, or elimination—was used to protect NIH-funded research from bias
Name of the entity with which the investigator has a conflict
Nature of the conflict (e.g., equity, consulting fees)
Value of the financial interest or a statement that it cannot be readily determined
Description of how the financial interest relates to NIH-funded research and the basis for the institution's determination of a conflict
Key elements of the institution's management plan

If you learn of a new FCOI for an ongoing contract or grant, you must report it to NIAID within 60 days, following the same process listed above.

How NIAID Responds to FCOIs

Reported FCOIs do not typically result in termination of the grant or contract. Instead, you’ll most likely be required to send an annual report on the status of the FCOI and list any changes to the award’s management plan. You should submit this report at the same time as the award’s progress report.

If, however, NIAID staff determine that a particular FCOI will bias the objectivity of funded research to such an extent that corrective action is needed, we may impose special award conditions or suspend funding as necessary to resolve the matter.

Related Resources

HHS Omnibus SBIR Contract Solicitation for FY 2017 Is Now Open

Small businesses, take note: You have until 5 p.m. EDT on October 21, 2016, to submit a contract proposal in response to HHS Small Business Innovation Research (SBIR) Program Solicitation PHS 2017-1.

Successful offerors must be a small business concern, as defined by the Small Business Administration (see our article below “Before Pursuing a Small Business Opportunity, Complete Registrations”). Also, the principal investigator’s primary employment must be with the small business concern at the time of award and during the conduct of the proposed project.

To be considered responsive, your proposal must focus on a topic listed in the solicitation. The topics are divided by sponsoring organization. NIAID’s topics of interest are:

Effective Targeted Delivery of RNA-Based Vaccines and Therapeutics
Simplified Sequencing for TB Drug Resistance Testing
Qualitative HIV RNA Home Test
Adjuvant Development
Vaccine Adjuvant Screening and Discovery
Database Resources Integration
Rapid Point-of-Care Diagnostics to Detect Serologic Status of Individuals for Select Viral Infections
Development of Microbiome-Based Products for Infectious Diseases
Noninvasive Rapid Diagnostics for Respiratory Diseases in Children
Phage-Based Diagnostic Platforms for Rapid Detection of Bacterial Pathogens

Within the solicitation, each contract topic lists instructions about which types of research—Phase I, Phase II, Fast-Track, or Direct to Phase II—applicants may propose. Be aware that the SBIR program phases correspond not only to stages of research but also to NIH limitations for your proposed project period and budget. See NIH's Three-Phase Program to learn more.

Provide a written notice of intent to NIAID’s Contracting Officer Charles Jackson if you plan to submit a contract proposal in response to one of our SBIR topics. He will notify you if any of our topics are modified or cancelled before the solicitation's closing date.

Keep in mind, while an overall impact/priority score is the basis for a grant award determination, for an SBIR contract the basis for award includes peer review score, negotiation of technical deliverables, and budget.

When you’re ready to submit your proposal, you must use the electronic Contract Proposal Submission (eCPS) website. For directions on using eCPS, go to How to Submit an Electronic Proposal.

For additional details, review the August 1, 2016 FedBizOpps.gov solicitation and the accompanying August 1, 2016 Guide notice.

Opportunity to Research Pathophysiology of Radiation Injury in the Vasculature

NIAID’s Radiation and Nuclear Countermeasures Program supports the development of post-exposure countermeasures and treatment approaches against radiation-induced injuries, specifically to the endothelial cell and vasculature. Toward that end, we’re seeking applications for a new cooperative agreement program to research endovascular injury and develop treatments for endothelial cell and vascular dysfunction.

Our understanding of the pathobiology of radiation-induced vascular/endothelial-related multi-organ events is incomplete. New research is needed to elucidate the pathways involved, before then identifying targets for mitigation and developing medical countermeasures.

For this cooperative agreement, our areas of special interest include:

Studies to test and evaluate candidate medical countermeasures to mitigate or treat radiation-induced endovascular injuries in appropriate in vivo models
Mechanistic studies to determine radiation’s effect on endothelial cells and signal transduction, biomarkers/surrogate markers of injury, progression, and predictors of outcome in in vitro or in vivo models
Experiments to identify pathways to target for developing medical countermeasures to address complications from acute radiation syndrome and delayed effects of acute radiation exposure
Medical countermeasures to address radiation-induced vascular dysfunction such as leakage, coagulopathies, and chronic inflammatory processes resulting in late organ/systemic complications

Conversely, we will deem applications nonresponsive if they propose:

Studies testing radiation protectant medical countermeasures (intervention prior to radiation exposure)
Studies administrating candidate medical countermeasures at times earlier than 24 hours after radiation exposure
Drug screening and production
Human clinical trials
Work in radiation dose ranges or exposure parameters that are not relevant to a radiation accident or attack
Studies investigating the vasculature merely as a conduit of systemic dissemination of signal molecules

To identify the state of the science, gaps, and medical countermeasures, NIAID recently held a workshop titled "Exploration of Radiation Injury to Endothelial Cells and the Vasculature: Identification of Mitigators/Treatments." Review the meeting report inRadiation Research

before you apply.

Administrative Requirements

This opportunity is a cooperative agreement, which means NIAID will have substantial scientific involvement—see “Just for ‘U’: A Closer Look at Cooperative Agreements” from our May 4, 2016 issue. An NIAID program official will serve as the project scientist, providing advice and guidance on technical issues, design of activities, selection of sources or resources, data collection and analysis, management, and technical performance. See “Cooperative Agreement Terms and Conditions of Award” in Section VI. Award Administration Information of the funding opportunity announcement linked below.

Your application budget is limited to $350,000 in annual direct costs. The maximum project period is five years.

Send your optional letter of intent by October 10, 2016. The deadline to apply is November 10, 2016.

Read the August 2, 2016 Guide announcement for complete details.

Joint NSF/NIH Big Data Opportunity: NIAID Participating, Deadline Approaching

You may have heard that as of July 21, NIAID is participating in the Joint NSF/NIH Initiative on Quantitative Approaches to Biomedical Big Data (QuBB). Whether you plan to start—or have already begun—an application, keep in mind that the first annual deadline is just a month away on September 28.

Brief Background on Biomedical Big Data

The QuBB program is designed to support novel mathematical, statistical, or computational approaches to the challenges of biomedical big data, which according to the NSF solicitation:

"...encompasses health- and disease-related data from biological, biomedical, behavioral, social, environmental, and clinical studies. It includes genomics data from next-generation sequencing, data from different imaging modalities, real-time and static data from wearable electronics, mobile devices, and environmental sensors, and clinical data from hospitals, insurance, and electronic medical records."

Your Proposed Research

Your research should address critical application areas at the intersection of the biomedical and data sciences. The areas are those that NIH's Big Data to Knowledge initiative supports, including biomedical, behavioral, clinical, and translational sciences.

Examples of appropriate research areas include developing methods for:

Mobile health (mHealth) data, where mHealth includes new data not traditionally used in the biomedical sciences (e.g., data from mobile devices, social networks, wearable electronics, sensors)
Precision (or personalized) medicine, whose goal is to develop a targeted treatment (or prevention) regimen that takes into account unique characteristics of an individual such as genetic makeup, environmental factors, and lifestyle

Demonstrate Collaboration

The QuBB program is designed to foster and support new inter- and multi-disciplinary teams of investigators. The key word here is "new," which means none of the biomedical scientists have previously collaborated with any of the quantitative scientists.

Previous collaborations include having joint publications or being listed as key personnel on the same grant. If there are pre-existing collaborations within your team, you should apply for other NSF or NIH funding opportunities.

Also, if you have a team of junior investigators, consider applying since the QuBB program encourages applications from such teams.

Application Details

Prepare and submit your application following instructions in NSF's Grant Proposal Guide, January 2016. You will submit your application to NSF, not NIH.

NSF will receive and review all applications. NIH program staff will be involved in the review process to identify applications of interest to NIH.

NSF will fund one group of applications and will request that investigators of other favorably reviewed applications withdraw their NSF applications, convert them to an NIH Research Demonstration--Cooperative Agreement (U18), and resubmit to NIH. Since these applications will have already been reviewed during the NSF process, they will not be reviewed again and will be funded by NIH.

More Information

For additional details on the opportunity, see NIH's July 5, 2016 Guide notice and NSF's Program Solicitation.

NIH Announces Projected Stipend Levels to Reflect FLSA Revisions

Earlier this year, the U.S. Department of Labor issued revisions to the rules on paid overtime under the Fair Labor Standards Act (FLSA), raising the salary level for professional employees to be exempt from paid overtime to $47,476. In recognition of this rule change, NIH plans to raise National Research Service Award (NRSA) stipend levels for FY 2017 above that threshold, effective December 1, 2016.

NIH will provide supplements to active NRSA awards to increase stipends to the new levels and will release more information about these supplements shortly. As most NRSA awards will be in the middle of their project period on December 1, the supplements will make up the difference in salaries only for the remainder of the award year.

The following table displays projected stipend levels for FY 2017:

Career Level	Years of Experience	Actual Stipend for FY 2016	Projected Stipend for FY 2017	Monthly Stipend for FY 2017
Postdoctoral	0	$43,692	$47,484	$3,957
	1	$45,444	$47,844	$3,987
	2	$47,268	$48,216	$4,018
	3	$49,152	$50,316	$4,193
	4	$51,120	$52,140	$4,345
	5	$53,160	$54,228	$4,519
	6	$55,296	$56,400	$4,700
	7 or more	$57,504	$58,560	$4,880

Again, these levels are applicable to postdoctoral trainees and fellows supported by an NRSA award, such as the Individual Postdoctoral Fellowship (Parent F32).

While many institutions use the NRSA salary levels as a guide to set salary levels for postdoctoral researchers on other NIH grants, these thresholds do not represent requirements. Institutions may choose to track postdoctoral researchers’ hours and pay overtime, or else raise their salaries to levels above the new FLSA threshold to qualify them for the paid overtime exemption.

Read the August 10, 2016 Guide notice for more information on this policy. For a more nuanced discussion of this topic, see NIH Director Francis Collins’ blog entry “Fair Pay for Postdocs: Why We Support New Federal Overtime Rules

.”

Comments Wanted on Two Topics: Stem Cell Guidelines and HIV Datasets

Here's your chance to share your thoughts on possible changes and processes NIH and NIAID are exploring.

Stem Cell-Related Issues: NIH Guidelines, Steering Committee

NIH wants your input on these important matters: 1) proposed changes to the NIH Guidelines for Human Stem Cell Research(Guidelines) and 2) the proposed scope of research that an NIH Steering Committee will consider when providing input on certain human-animal chimera research.

You may know that NIH published the Guidelines in July 2009, then announced in a September 23, 2015 Guide notice that it would not fund research that involved introducing human pluripotent cells into nonhuman vertebrate animal pre-gastrulation stage embryos. This funding moratorium was to stay in place while NIH considered possible policy revisions.

Now, NIH is exploring the two aforementioned areas in the interest of moving forward the field of human-animal chimera research while continuing to assess and oversee this emerging area.

Read the August 4, 2016 Guide notice for further details, including specifics on the type of feedback NIH is seeking. You have untilSeptember 6, 2016, to submit your comments, which you can do in either of two ways:

Online at NIH consideration of certain research proposals involving human-animal chimera models
By mail to Office of Science Policy, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892

Note that during the public comment process, the September 23, 2015 notice remains in effect.

Datasets for Examining HIV Transmission Dynamics, Estimating Impact of Prevention Intervention

Through a recent request for information, NIAID's Division of AIDS (DAIDS) wants to know:

What existing datasets are suitable and available for examining HIV transmission dynamics as a tool to estimate the potential impact of HIV prevention interventions?
If a repository of HIV datasets could be created and made available to investigators to perform modeling and simulation studies, what standards should be followed to make the repository and the individual databases as useful as possible for these purposes?

DAIDS is interested in datasets that capture U.S. and international epidemics and sub-epidemics, especially those that include broadly representative populations, adolescents, young women, transgender people, and men who have sex with men.

To find out the kind of information DAIDS is looking for, read the August 9, 2016 Guide notice. Email your responses to DAIDS atNIAIDHIVRFI@mail.nih.gov with the subject "HIV datasets." Comments are due next month on September 23.

News Briefs

Steven Holland Named Director of NIAID's Division of Intramural Research.

Congratulations to Dr. Steven Holland, whom NIAID has selected to lead the Division of Intramural Research. Dr. Holland previously served as chief of NIAID’s Laboratory of Clinical Infectious Diseases, since 2004, and as deputy director for NIH Intramural Clinical Research, since 2011. In addition to his new role, Dr. Holland will continue to serve as chief of the Immunopathogenesis Section.

Deadlines Fast Approaching for Three Small Business Opportunities.

Take note of these important dates: 1) Next Tuesday, August 30, is the application deadline for the Commercialization Accelerator Program, 2) next Wednesday, August 31, is the end of early bird registration

for the 18th Annual HHS SBIR/STTR Conference

in Orlando, Florida, and 3) as soon as possible, interested applicants should complete Conference Registration for the NIH Multi-IC Small Business Workshop 2016 in San Antonio, Texas, which begins two weeks from today.

Double-Check Your Web Content When We Re-Launch Ours.

Most links corresponding to NIAID’s current website will no longer function following our transition to a new website in early September. We advise organizations that link to our online content to update those links after the transition, as necessary. If you are currently syndicating content from NIAID, a list of topics that will no longer be available will be posted soon. Topics we continue to support may experience lag time during the website launch but will resume availability within 24 hours.

New Public-Private Partnership Will Combat Antimicrobial Resistance.

HHS is launching a new partnership called the Combatting Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). Learn about it in the press release "HHS Forges Unprecedented Partnership to Combat Antimicrobial Resistance." As the release notes, NIAID will provide in-kind research support, including preclinical research expertise, and technical support related to early-stage antibiotic drug discovery and product development.

OLAW Updates Format of Assurance Agreement Identifiers.

NIH's Office of Laboratory Animal Welfare (OLAW) has implemented a new Animal Welfare Assurance numbering system. Institutions with an Assurance will receive a new number (D00-00000) and may use either the new or old (A000-01) Assurance number in communications with NIH. See the August 2, 2016Guide notice for details.

NIH Halts Plans to List Project Personnel in RePORTER.

NIH no longer plans to release in RePORTER names of project personnel listed in section D (Participants) of annual Research Performance Progress Reports. The policy will undergo further review. For more information, see the August 2, 2016 Guide notice.

Before Pursuing a Small Business Opportunity, Complete Registrations

We want to remind all small business applicants about the eligibility and registration requirements needed to apply for and receive a grant or contract award.

Essentially, a small business concern is defined as a for-profit, domestically owned and operated organization with no more than 500 employees. There is more nuance to the official Small Business Administration (SBA) definition, which accounts for the full spectrum of possible corporate arrangements, e.g., a business that is up to 50 percent owned by a foreign private equity firm. See Small Business Eligibility Criteria to determine whether your small business qualifies.

Assuming your organization does qualify, you’ll need to complete the five registrations listed below before you submit a grant application.

Data Universal Numbering System (DUNS)—all registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin System for Award Management (SAM), SBA Company Registration, and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management—applicants must complete and maintain an active registration, which requires annual renewal. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations that have not already been assigned a CAGE Code.
SBA Company Registration—see “SF 424 (R&R) Other Project Information Component” in Section IV. Application and Submission Information, for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a DUNS number to complete this registration. SBA Company Registration is not required before SAM, Grants.gov, or eRA Commons registration.
eRA Commons—applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov—applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Since registrations can take six weeks or more, we encourage you to start the process early. Keep in mind, as stated in Simplifying the NIH Policy for Late Application Submission, failure to complete registrations in advance of a due date is not a valid reason for late submission.

To respond to a contract solicitation, you’ll need to complete the DUNS, SAM, and SBA registrations listed above, as well as any additional registrations listed in the solicitation. As an example, you’ll need to register for electronic Contract Proposal Submission (eCPS) to submit a proposal in response to HHS Small Business Innovation Research (SBIR) Program Solicitation PHS 2017-1.

Once you’re registered, check out NIAID’s High-Priority Areas of Interest and Current Small Business Funding Opportunities to find an opportunity that matches your small business’ area of research interest.

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.

“Should I include intellectual property in my application?”—anonymous reader

We recommend that you don't include any intellectual property that isn't protected by copyright or patent, or at least submitted for one. Read more in Get Started Writing the Research Plan and Write the Research Strategy in the Strategy for NIH Funding.

Be aware that if we fund your application, your abstract becomes a public document in NIH's RePORTER database. If you decide to include confidential or proprietary information in your application, don't put it in that section.

“Should I use FORMS-D for my resubmission if my previous application used FORMS-C?”—anonymous reader

Yes, you will use FORMS-D. In addition, you are responsible for following any NIH policies currently in effect, even if they were not in effect when you previously applied. For example, you must account for the policy changes detailed in our March 23, 2016 article "Policy Changes Accompany the FORMS-D Changeover."

See Notices of NIH Policy Changes for additional changes.