Q. What is the NIH HEAL InitiativeSM and how do these BACPAC FOAs support the objectives of HEAL?

The NIH HEAL (Helping to End Addiction Long-termSM) Initiative is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. This Initiative will build on extensive, well-established NIH research. NIH will work with partners from the biopharmaceutical industry to develop a data sharing collaborative, new biomarkers for pain and a clinical trials network for testing new pain therapies. NIH will also enhance the pipeline of treatments for pain and enhance clinical practice for pain management. The BACPAC FOAs seek research projects aimed at improving understanding and treatment of chronic low back pain and, as such, address a priority research objective of the NIH HEAL InitiativeSM

Q: Are there opportunities for start-up companies via SBIR/STTR grant applicants to be involved?

Small business entities are eligible to apply using the funding mechanism described in the BACPAC RFAs. SBIR and STTR Programs have special application guidelines governed by the Small Business Administration. SBIR and STTR applications are not accepted in response to these FOAs. For-Profit applicants have a cost-matching requirement.  A for-profit organization that participates as sub-awardee receiving funds from a parent non-profit institution would not have a cost-matching requirement.

Q. I’m a small business without a negotiated Indirect cost rate agreement with the Government, can I still request Indirect costs?

For-profit applicants regardless of whether they are SBIR/STTR applicants without a negotiated indirect cost rate may receive the SBIR/STTR F&A rate of 40%

Q. What types of contributions can be used to meet the matching requirement for For-Profit applicants?

  • Cash match can be state or local funds, private or corporate donations or any other nonfederal funds. An application must identify both the source and proposed use for cash match.

In Kind

  • Volunteer Services
    • Services furnished by third-party professional and technical personnel, consultants and other skilled and unskilled labor may be counted as cost-sharing if the service is an integral and necessary part of the approved project.
    • Rates must be consistent with those paid for similar work by the non-Federal entity
    • When a third-party organization furnishes the services of an employee, these services must be valued at the employee’s rate of pay plus an amount of fringe benefits that is reasonable, necessary, allocable, and otherwise allowable, and indirect costs.
  • Donated property
  • Loaned equipment or space: the contribution shall not exceed its fair rental value of comparable space as established by an independent appraisal of comparable space and facilities in a privately-owned building in the same locality.
  • Supplies: the contribution shall be valued at the fair market value of the supplies at the time of the donation.
  • Land, equipment or space: If a third-party donates land, buildings, or equipment and tit le passes to a grantee, value assessed to donated property included in the cost sharing or matching share must not exceed the fair market value of the property at the time of donation
    • The use of facilities and equipment already owned by the grantee may not be counted as a direct cost contribution where the cost or value of such use is reflected in the applicable F&A rate as depreciation or use charges.
  • Unrecovered F&A Costs
    • If matching or cost sharing is offered by the applicant in the form of unrecovered F&A costs through lower than negotiated rates, these rates should be reflected and formally noted in the NoA.
    • Example of unrecovered F&A: Recipient has a negotiated rate of 60%, but only requests F&A cost reimbursement at 50%. The 10% unrecovered F&A costs may be counted toward their matching requirement. All costs and contributions used to satisfy a matching or cost sharing requirement must be documented by the recipient and are subject to audit.
    • All for-profit recipients without a negotiated rate (i.e. 40%) rate may devote

Q. Will awardees through this RFA collaborate with those from other HEAL projects?

Yes, we expect that investigators who perform clinical trials will work collaboratively through a consortium within the BACPAC and across other HEAL clinical trial networks to standardize data elements, pain assessments, study endpoints and outcomes as appropriate.  

Q. What is EPPIC-Net and what is the relationship between EPPIC-Net and BACPAC?

The Early Phase Pain Investigation Clinical Network (EPPIC-Net) is part of the NIH Helping End Addiction Long-term (HEAL) initiative. Led by the National Institute of Neurological Diseases and Stroke, EPPIC-Net will provide a robust and readily accessible infrastructure for the rapid implementation and performance of high-quality, comprehensive studies of patients with well-defined pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain. The network will be charged with testing novel, efficient study designs including adaptive and platform designs, validation studies of biomarkers, and biomarker-informed proof of principle or target engagement studies in phase 2 trials of interventions from academic and industry partners. EPPIC-Net will make clinical, neuroimaging, biomarker, and preclinical data, as well as biosamples, available through public access data and biospecimen repositories. It is anticipated that EPPIC-Net will be able to run at least five Phase 2 trials concurrently, in addition to deep clinical phenotyping and biomarker validation studies. 

EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (hubs).

EPPIC-Net will be able to provide data management, coordination, and clinical study coordination activities.  EPPIC-Net will have patient cohorts and some of the EPPIC-Net hubs will establish clinical cohorts of patients who will be eligible to participate in the BACPAC adaptive design collaborative study and the BACPAC phase 2 trials. We expect the greatest level of interaction will be around the phase 2 clinical trials. The BACPAC Data Integration, Algorithm Development and Operations Management Center (DAC) will facilitate interactions with EPPIC-Net in terms of patient enrollment and recruitment; around specific scientific aspects of the project including trial design and management; data monitoring; and safety plans.

Applicants to the BACPAC Research Program Phase 2 Clinical Trials, Multidisciplinary Research Centers and Technical Sites contemplating clinical studies are encouraged to carefully consider the capabilities and resources that are anticipated will be provided by EPPIC-Net. However, applicants must include all trial related costs in their BACPAC application. Once the BACPAC Consortium is launched, the BACPAC Steering Committee together with the EPPIC-Net Principal Investigators and NIH staff will determine which BACPAC clinical studies are most likely to effectively leverage the resources and capabilities of EPPIC-Net.   Funding for clinical study related EPPIC-Net costs will be provided via a subcontract established by the BACPAC (DAC) and EPPIC-Net.  The funds will be administered and overseen by the DAC. This activity will  start in year two and continue through the duration of the clinical project. 

Q. Who should I contact if I have questions about information in the RFA?

You should contact the NIH BACPAC inbox (BACPAC-NIH@mail.nih.gov) for general questions regarding the structure and components of the BACPAC research program. For questions on the scientific scope of a specific BACPAC FOA, you should contact the program officer named under Scientific Research Contacts in the FOA.

Q. Should I contact NIH program staff before I apply?

It is always a good idea to speak with the program director identified in the FOA to inquire about the Institute’s level of interest.

Q. To which institute will my application be assigned?

All applications will be assigned to the NIAMS.

Q. Can foreign institutions submit proposals?

Foreign sites are allowed to apply in response to RFA-AR-19-29, RFA-AR19-28 and RFA AR-19-26.

Only domestic sites are eligible to apply to RFA-AR-19-27.

Q: Is a letter of intent required?

A letter of intent is desired, but not required.  Letters of intent are helpful for NIH staff, as they allow us to better manage the workload involved in reviewing applications. They also help program staff try to ensure that your application will be responsive to the RFA.

Q. Can I be a PI on an application for one FOA and be a PI or multi-PI on an application submitted to another FOA?

Yes, however, your participation as a PI is limited by your available percentage effort.

Q. Will the applications submitted to all the FOAs be reviewed in one study section?

Applications submitted in response to each FOA will be reviewed by an individual special emphasis panel (SEP) convened by the NIAMS. Each SEP will include reviewers with expertise relevant to the scope of the FOA.

Q. What are “U” grants and how do they differ from R01s?

These FOAs use the cooperative agreement funding mechanism, which is known as a “U” mechanism. A cooperative agreement supports discrete, specified, circumscribed projects to be performed by investigators in an area representing their specific interest and competencies and is used when substantial and continuous NIH programmatic involvement is anticipated.

Q: The UH2/UH3 FOA states that applicants may propose a project from one of four categories that are at different technology development phases (Exploratory Research for Technology Development; Focused Technology Research and Development; Iterative Technology Research and Development; Research and Development for Technology Optimization). Does the proposed research project need to be exclusively focused in one of the four categories or can it expand over more than one catego

In response to this FOA, investigators may propose a project that spans over different technology development phases for the UH2 and the UH3 phases. However, applicants should clearly indicate which technology developmental category the project falls into, because there are specific review criteria for each of the technology development phase categories that will be used during the review of the Technology Sites applications.  Investigators should   identify in the application one category that encompasses the majority of the work described in the Approach section for the UH2 phase and one category for the majority of work proposed for the UH3 phase. Investigators have flexibility to plan the activities of the UH2 and the UH3 phases, considering the scope of work, technical and regulatory requirements, timelines and availability of BACPAC and EPPIC-Net resources.

Q. Can the UH2 have both exploratory and iterative research components? ¬

Yes.  The FOA allows the applicants to propose the best approaches to pursue the scientific goals of the project. We're looking for a diversity of approaches in the BACPAC Research Program and expect that approaches will be modified and refined after award, so projects may benefit from interactions with the PIs of other components of the Consortium.

Q. Is biomarker discovery work allowed under the UH2/UH3 FOA?

Biomarker discovery or validation projects for chronic pain that are not directly applicable to chronic low back pain are not considered responsive to this FOA.  NIAMS is participating in HEAL FOAs (RFA-NS-18-041 and RFA-NS-18-046) that solicit research projects specifically designed for biomarker development for acute and chronic pain.  NIH has several initiatives focused on trying to understand conditions characterized by chronic pain and the mechanisms of chronic pain and discovery of signatures and biomarkers for chronic pain.  Applicants have the option to select and respond to the FOA that most closely captures the overall goals of their project.

The study of biomarkers in the context of chronic low back pain is included in the scope of the BACPAC Research Program and we expect biomarkers will be used for phenotyping and sub-phenotyping in clinical trials so that is included. If the candidate biomarker is for chronic pain and the relation to chronic low back pain is not clear, applicants should consider applying in response to other HEAL Pain FOAs. Studies developing, validating or using biomarkers to characterize various types of chronic low back pain patient populations would appropriate in the BACPAC research program.

Q. For applications responding to the UG3/UH3 Phase 2 Clinical Trial RFA, is multisite required? If so, can they be any sites or do they have to be the EPPIC-Net sites?

There is no requirement for Phase 2 CTs to be designed as multisite studies. The application should clearly describe the patient recruitment capabilities for proposed single or multi-site CT.  The application should describe the best approach based on the cohort(s) at hand and the type of study the investigators propose to do.  Given that most studies require multiple recruitment sites for effective recruitment, working with the EPPIC-Net Clinical Hubs will be encouraged. We hope that the implementation phase (UH3) for a phase 2 trial will last, on average, two years. Depending on the size and complexity of the trial, multiple clinical sites outside and within EPPIC-Net will be needed to enroll patients efficiently.  The BACPAC Research Program and the NIH will have significant input into the decision of whether the study is more likely to succeed if carried out as a single or a multi-site clinical trial.  The PI of the UG3/UH3 will have primary responsibility and leadership of the clinical trial. 

Q. Regarding the U19, are multiple institutions preferred for this RFA?

We encourage the development of multi-disciplinary teams whether they are in one or multiple institutions. Investigators have the flexibility to design the structure of the MRC to best suit the scientific goals. Each U19 will have a Director at the applicant institution. The Associate Director and Project and Core Leads may be located at the same single or at multiple institutions. A clearly articulated communications plan and organizational structure should be included in the application to assist the reviewers and NIH staff understand how the workflow and decision making will occur.

Q. For the U19, does the $15.1M described in the FOA represent the total funds available during year 1 of funding only, for all projects funded? Or does the $15.1M represent the total funds available for all projects over all years of future funding (up to the maximum project period of 5 years).

The NIAMS intends to commit up to $15.1M in FY 2019 to fund 3-5 awards.  This is the total to be spent in fiscal year 2019 on the new 3-5 awards.  While there is no specific limit for the budget for the U19 centers in years 2 through 5, the scope of work of the proposed center and the budget should be aligned. 

The only direct cost cap in the U19 FOA is in the Clinical Core in year 1 where the FOA states that the Clinical Core budget should not exceed $1.5M.

Q. We are preparing to submit for a U19. Can you tell me whether a PI of a Research Project would lose ESI status if the U19 is funded?

If an ESI is assigned a PD/PI (Center Director) role for the overall multi-project application, the individual will lose their ESI status when the award is made. If the ESI is the lead of a project or core, but not the PD/PI for the overall application, the individual will retain ESI status when the award is made.  https://grants.nih.gov/policy/early-investigators/faqs.htm#5563

Q. Can you elaborate more on the type of applications that are desired for the UH2/UH3 FOA? The RFA appears to focus more on technology/sensors and less on biomaterials/therapeutics. Are biomaterials to treat novel chronic low back pain mechanisms not desired for this initiative?

The types of technologies described in the FOAs illustrate examples of areas of interest but are not intended to be limiting. The study and development of technologies/biomaterials specific for chronic low back pain is within the scope of the FOA.   Investigators interested in developing biomaterials-based treatment and or technologies for multiple chronic pain conditions that are not being directly and specifically targeted to cLBP should consider applying under other HEAL FOAs.

Q. Can NIH provide additional guidance on including milestones in the application?

All cooperative agreements are goal driven and require milestones. Milestones are intermediate steps towards the completion of concrete goals and must include clear and quantitative criteria for success. Quantitative milestones are required to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years. The application must include clearly-specified, well-defined milestones, quantitative go/no go decision points and timelines for assessing progress.

Applicants must provide a timeline and detailed quantitative annual milestones spanning the funding period. If selected for funding, applicants will work with NIH staff to develop more granular quarterly milestones for each year of funding. 

Q. What are some examples of quantitative milestones?

Quantitative milestone should be results-focused and well-defined with measures that are appropriate to the proposed research project. They would allow NIAMS program officials to be able to determine if the project succeeded in accomplishing its specific aims.  For example, quantitative milestones for clinical trials include, but are not limited to, enrollment numbers, completion of enrolled patient follow up and data deposition into the NIH designated database.  Note that prior to an award, NIH staff and the applicants will finalize an agreed upon set of milestones that will be included in the notice of grant award.

Q: You outlined the goals of data harmonization and central integration. Can we use our existing infrastructure for the data collection? Or are we required to use a separate/3rd party collection system?

Investigators should describe the data elements they plan to include in the characterization of the patient populations they' propose to study and the systems that they have in place to collect and analyze the data. Applications should include a description of (and budget for) the proposed data collection system that is appropriate for the patient population. Applications should also include the proposed working definition of chronic low back pain that will be used in the study.  After award, there will be a significant effort by the BACPAC Research Consortium Steering Committee coordinated by the DAC to develop a centralized data integration registry where all the data eventually will reside.

Q. What are the plans for data and resource sharing for this program?

Data from all awards will be submitted and stored in a central NIH-HEAL Initiative pain data repository. See the RFA for more details about data sharing requirements. 

Q. I understand that there is a matching requirement (cost sharing) associated with these awards. What is the requirement, exactly?

Only grantees from a for-profit organization funded under this announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount (direct costs, as well as facilities and administrative costs), as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.  NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement.  See 45 CFR 75.306 for additional details.

Federal funds may not be used as a source of matching funds. Generally, cost matching requirements may not be met from the following sources:

a) Costs borne by another Federal grant or sub award;

b) Costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract or any other award of Federal funds;

c) Cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient);

(d) Program income and

(e) Patient incentives.

All for-profit applicants must document the matching (non-Federal) component and the federal (non-matching) component in the total project budget. That is, the requested budget plus the cost-matching budget must be detailed in tabular format to document the cost-matching (non-Federal) component and the federal (non-cost matching) component. The amount of matching is subject to adjustment based on total allowable costs incurred.  All costs and contributions used to satisfy the matching requirement must be documented by the recipient, including how the value for in-kind contributions was determined, and are subject to audit. The cost matching requirement is not negotiable for for-profit organizations.

For-profit applicants must include a letter(s) of support confirming that the required secured cost matching (cash or in-kind commitments, such as salary, consultant costs, equipment) is available and confirm that the essential personnel have the authority within the organization to allocate resources.  

Q. How should I reflect the matching requirement in my application?

Expense Category

NIH

Applicant

NIH- Subaward

Subaward-Match

Fed Budget

Match

Personnel: Salary and Fringe

$150,000

$110,000

$100,000

$46,250

 

 

Supplies

$25,000

 

 

 

 

 

Services

$25,000

 

 

 

 

 

Total Direct

$200,000

$110,000

$100,000

$46,250

$300,000

$300,000

F&A

$50,000

 

$50,000

 

$100,000

 

F&A on Sub-awards

$12,500

 

 

 

 

 

Unrecovered F&A

 

 

 

 

 

$50,000

Total Costs

$262,500

$110,000

$150,000

$46,250

$412,500

$206,250

Last Reviewed: 12/04/2018