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. 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. 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. 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. 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.  

Last Reviewed: 12/04/2018