1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

• U.S. Territory or Possession

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM 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 (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. 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 which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• 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 SAM or 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.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

For grantees from a for-profit organization, this FOA does require cost sharing, as defined in the NIH Grants Policy Statement. More information on cost matching requirements is in Section IV.2 R&R or Modular Budget

3. Additional Information on Eligibility

Number of Applications

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Robyn Bent, M.S.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
One Democracy Plaza, Suite 800
Bethesda, MD 20892
Telephone: 301-594-5055
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

For this specific FOA, the Research Strategy Section is limited to 30 pages.

Other Attachments:

1. Applications must include an Intellectual Property (IP) strategy. Applicants are encouraged to prepare this attachment section in consultation with their institution's technology transfer officials. The section should be labeled "Intellectual Property Strategy.pdf" and may not exceed 3 pages. Include the Attachment even if IP issues are not a consideration for the project. Indicate: IP issues are not applicable , and explain why.

This section should describe a dissemination plan that involves patent protection and commercialization:

Describe the IP landscape surrounding their model system. Applicants should describe any known constraints that could impede sharing of their model system (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar model systems that are under patent protection and/or on the market, etc.) and how these issues could be addressed with achieving the goals of this program.
Include a letter from any entity who has ownership of the IP indicating whether they will provide the technology, if there are any limitations on the studies that can be performed with that technology, agreement about public disclosure of results (including negative results), and whether there is an agreement already in place.
If patents pertinent to the technology being developed under this application have been filed, the applicant should indicate the details of filing dates, what type of patents are filed, and application status, and associated US Patent and Trademark Office links, if applicable.
Describe future IP filing plans. For a multiple-PD/PI, multiple-institution application, applicants should describe the infrastructure of each institution for bringing the technologies to practical application and for coordinating these efforts (e.g., licensing, managing IP) among the institutions.
State how IP will be shared or otherwise managed if multiple PD/PIs and institutions are involved, consistent with achieving the goals of the BACPAC Research Program.

2. Applicants may propose one or more concept(s) for future Pilot Research Projects and Ancillary Studies.
Present a brief description of the goals, significance and feasibility for each of the proposed concepts, indicating whether it will be associated with one or more or the components of the BACPAC Research Consortium. Details on the technical approach and a detailed budget should not be included. Each concept description should not exceed one page. Concepts may propose exploring a research question or applying the applicants analytic or technology in a different experimental model, system or population elsewhere in the BACPAC research Program sites and Centers.

The DAC must have key investigators (PDs/PIs) with sufficient effort the following areas of expertise: 1) management of complex clinical trials and studies in back pain or musculoskeletal chronic pain conditions, 2) back pain phenotyping and biomarker signatures or profiles, and 3) the design and analysis of predictive, multi-stage, adaptive clinical trials. 4) bioinformatics, biomedical informatics, biostatistics, or related quantitative sciences (computer sciences, mathematics, physics and engineering, 5) evidence at a senior level of experience and expertise in integrating and interpreting large datasets of biomedical data, such as genomics, proteomics, metabolomics, imaging data and clinical study data; and 6) in-depth technical knowledge and experience of in programming, systems and database architecture, high performance computing and networking technologies.

The DAC must include a qualified full-time Project Manager and an administrator for the Funds Management Unit (FMU) which will administer, on behalf of the entire BACPAC Research Program, the Collaborative Research Fund for support of the Pilot and Ancillary Studies Projects and additional studies required for achieving the aims of the BACPAC Research Agenda. In addition, the FMU will manage funds to establish a future contract with EPPIC-Net.

All instructions in the SF424 (R&R) Application Guide must be followed.

Cost matching or documented in-kind contributions is required for for-profit organizations responding to this FOA. The for-profit awardee is required to 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.

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.

The For-profit organization 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. Applicants must submit budgets that clearly document the total costs, the source and amount of matching funds, and how valuation was determined in the case of in-kind contributions, as well as the Federal and Institutional (non-Federal) components of the budget. 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.

Budget Justification: 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.

To justify the personnel included in the budget, in addition to the standard biosketches including the tailored individual statement for key personnel, include a table outlining the expertise and effort proposed for the DAC. Relevant expertise includes, but not limited to, biostatistics in predictive modeling, bioinformatics and machine learning, bioinformatics, biomedical informatics, or related quantitative sciences, design and execution of predictive, sequential, adaptive clinical trials, PRO and PPR instruments, management of complex clinical trials or studies in back pain or musculoskeletal chronic pain conditions, back pain phenotyping and biomarker signatures/profiles, project management, computer expertise including database creation and management, and website development.

Include budget for key personnel travel to attend up to two face-to-face SC meetings with at least one to be held in the Bethesda, Maryland or Washington, DC general geographic area. Include a budget for a two-day meeting that includes the travel expenses of 20-30 experts to discuss a working definition of chronic low back pain and elements of a common data set.

The budget must include a separate item in years 1-5 to support the central database system for the BACPAC Research Program and the BACPAC Portal to facilitate data sharing and dissemination.

The budget must include a separate item of an intent to establish a future subcontract with the EPPIC-Net CCC in support of services for Phase 2CTs and other BACPAC collaborative clinical projects for a total of $4M/year in years 2 through 4 and for a total of $3.5M in year five. These costs should be placed in the Subawards/Consortium/Contractual Costs category.

The budget must include a separate item of an intent to establish future subcontracts with BACPAC recipient institutions in support of future Pilot and Ancillary Studies. These costs should not exceed a total of $1M per year in years 2 through 5. These costs should be placed in the Subawards/Consortium/Contractual Costs category.

Research Strategy: In lieu of a standard Approach section as described in the SF424 (R&R) Application Guide, the applicant must present a discussion of the planned activities to carry out functions in the following areas. The applicant must describe:

Clinical Registry, Data Integration and Coordination

• Approach to develop and finalize a consensus plan for case definition, minimal dataset, outcomes measures, and provide site training to facilitate adoption of the consensus plan for uniform data collection of common data elements.
• Capacity to establish and maintain a secure and efficient electronic database to host and harmonize a large amount of various clinical data, and offer easy access for data integration, analyses, modeling, and algorithm development and testing.
• Plan to collaborate with the DAC SBG to devise a strategy to support integration of biological and other types of datasets generated from the mechanistic studies with clinical datasets.
• Approach for data curation, quality control and quality assurance of clinical data entry to facilitate downstream data integration and analyses.
• Strategy for monitoring and improving subject enrollment and retention.
• Plans for oversight of protocol execution, subject accrual, the quality of data received from the CCs, and safety monitoring, staff training, and drug preparation.
• Plans to respond to issues/protocol changes that emerge during trials and initiate timely changes to training/procedures.
• A detailed plan for data sharing within the consortium.
• Applicants must provide a table detailing the characteristics of clinical trials or studies with longitudinal components in the last 5 years that demonstrate experience in coordination of multi-center clinical trials of similar complexity in back pain or musculoskeletal chronic pain conditions, including: clinical trial title, applicant's role in the trial, a brief description of the trial design, planned enrollment, actual enrollment, number of sites, whether the trial(s) were completed on schedule or not, publication reference(s).

Adaptive Design, Patient Reported Outcomes (PRO) and Biostatistics

• Capacity to improve current and develop novel predictive, targeted, adaptive clinical trial designs and predictive statistical modeling and analysis of data.
• Use of predictive data items, monitoring biomarkers, and early stopping rules with crossover to subsequent intervention(s), and modeling of group effect data. Approaches described should be flexible and able to adapt to interim analyses results such that phenotypes and/or individualized interventions can be added and/or eliminated.
• Capabilities to advise and facilitate appropriate selection of PRO and PPR instruments and experience with other large collaborative efforts.

Algorithm Development, Testing and Validation

• Capabilities for de novo modeling that combines individual patient data to give group treatment effect estimates using systems and machine learning approaches
• Approach toward and capacity to develop improved algorithms to incorporate new LBP phenotyping data, biomarker signatures/profiles, and other biological data to project treatment responses.
• Plans and clinical cohorts used for validation of new or improved algorithms.
• Capacity to acquire and process data from very large databases, such as those that can be extracted from electronic medical records.
• Applicants must also provide a table that documents experience in clinical data integration, de novo modeling, and patient-based algorithm development using systems and machine learning approaches, including: study title, study objectives, applicant's role in the study, types of clinical data analyzed, types of modeling and algorithms developed, and publications or websites where the algorithms are shared and validated.

Systems Biology and Bioinformatics

• Strategy for the development and testing of tools and software for the integration, annotation, analysis, retrieval, and presentation of data and meta-data from BACPAC clinical and analytic studies. Consider building flexibility to allow incorporation of new and diverse data types.
• Approach for assessing the application of existing bioinformatics tools to analyze and interpret BACPAC Research Program systems-level data.
• Plans to establish and maintain a technologically up-to-date toolset that can be readily used for systems-level analyses of data generated by the Consortium. Emphasis should be given to systems biology and other emerging computational approaches that can contribute to understanding, visualization, integration and analysis of multi-dimensional data, envisaged to be essential for the goals of the BACPAC Research Program.
• Approaches to advanced integrative analyses of high-throughput data sets generated by the Network. This includes established methodologies for statistical genetics and transcriptomics analysis (e.g., principal components analysis, data normalization, smoothing, clustering, association testing, eQTL mapping etc.). Examples of the types of analyses include: pipelines for genome-wide analysis and interpretation of RNA-seq and single cell RNA-seq data; pipelines and methods for interpretation of mass cytometry data, MRI and other imaging modalities, etc.
• Novel approaches to perform systems-level analyses of multiple different datasets (e.g., genetic, epigenetic, imaging, proteomic or clinical) and define clinically relevant modules and nodes, and integrate the data into a multi-scale model of LBP.
• Development and maintenance of a highly efficient database or highly efficient interoperable databases for storage and retrieval of data generated by the Network. The database must be able to store multi-dimensional data, such as image, numerical and multi-omics, and integrate those data with experimental (protocol) and clinical descriptive data as well as other existing datasets and to facilitate correlational and meta-analyses.
• Development of criteria or templates for uniform data collection, quality control and assurance, curation, standardization, and exchange and integrative modeling across multiple data types.
• Applicants must include a description of Database Building Capacity. The section should provide descriptions for the following:
  • Proposed database capacity for storage and retrieval of various types of data.
  • Proposed database capacity, types of data and multi-dimensional data, such as image, numerical and multi-omics data.
  • Proposed database capacity for integration of clinical, experimental and system biology data.
  • Proposed database capacity to include and integrate patient reported outcomes and patient preferences data, as well as other existing datasets and to facilitate correlational and meta-analyses.
  • Examples of criteria or templates for uniform data collection, data standardization, data exchange and integrative modeling across multiple data types. Consider use of existing biological ontologies as the basis for defining data standards.

Operations Management

• Approaches to support the BACPAC SC, EC, CMC and Functional Groups activities including organization of meetings, conference calls, webinars and generation of meeting minutes.

• Capabilities to provide funds management and oversight for the BACPAC Collaborative Research Projects, and ancillary and pilot projects, and negotiate clinical agreement and budgets with EPPIC-net and PIs of the Phase 2CTs.

• An administrative structure of the proposed DAC and how this structure facilitates communication and cooperation across BACPAC and with the NIH. Explain how the proposed structure will be able to react quickly to unexpected events.

• Capabilities for public and private website creation and maintenance.

• Past experience in obtaining regulatory approvals from local institution and the FDA.

• Institution's willingness to participate in a cooperative, central, or shared IRB.

• Capabilities to negotiate and execute agreements, subcontracts, with academic institutions and for-profit organizations for drug supplies and potential biospecimen handling.

• Plans for outreach and dissemination of BACPAC information and sharing of resources.

• Plans including specific metrics for evaluation of effectiveness of the BACPAC in achieving proposed goals.

• A detailed timeline for the planned activities.

Letters of Support

For-profit applicants must include a letter(s) of support confirming that the required secured cost matching (cash; 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.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

Do key personnel have appropriate expertise and experience in the analysis of clinical data and the use of bioinformatics and computational approaches to achieve the scientific objectives of the BACPAC program?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Renewals

Revisions

Intellectual Property

If applicable, is the IP Strategy adequate? Does it include descriptions of the IP landscaping surrounding the proposed model system, letters from IP owners, information about patents filed or to be filed? Does it address issues that may affect sharing of the model? Is the dissemination plan that involves patent protection and commercialization acceptable? If not applicable, does applicant provide an acceptable justification?

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Specific to this FOA: How likely is it that the plans for cost matching will be adequate?

2. Review and Selection Process

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

• Will receive a written critique.

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Additional language:
Special award condition specific to this FOA: A grantee 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, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018. See 45 CFR 75.306 for additional details. Matching funds must be non-Federal funds set aside for this project and are available from the source(s) identified in the application, as committed to by the recipient. Cost matching will be evaluated by the awarding office to ensure that this requirement is being met. Compliance with the matching requirement must be verified on an annual basis and must be documented in the annual and final FFR.

2. Administrative and National Policy Requirements

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

By accepting an award, the PI and Institution agree to become part of the Back Pain Consortium Research Program (BACPAC). The work to be carried out under the award will be conducted collaboratively with other members of the consortium and the NIH and will be subject to review and approval by the BACPAC Steering Committee prior to full implementation as specified in this RFA.

ROLES AND RESPONSIBILITIES
The PD(s)/PI(s) will have the primary responsibility for:

• Advancing and coordinating the activities at their Center (Site), scientifically and administratively;
• Serving as a voting member of the Steering Committee;
• Participating actively in the formulation and implementation of the BACPAC Research Program Agenda;
• Actively participating in BACPAC Functional Working Groups;
• Implementing common data elements, protocols, standards and policies approved by the Steering Committee or required by NIH/NIAMS;
• Providing the BACPAC Data Integration, Algorithm Development and Operations Management Center (DAC) with all clinical study data for management, quality control, and analysis, using procedures and standards determined by the BACPAC Steering Committee (SC), and the Executive Committee (EC) and the DAC;
• Providing the BACPAC Systems Biology Core with all research study data for systems level analysis, using procedures and standards determined by the BACPAC Functional Working Group, SC, EC and DAC;
• Sharing data publicly through dbGAP or other public portals designated by NIH, as appropriate and consistent with achieving the goals of the program;
• Establishing procedures within the Center and affiliated sites to ensure that all members of that center are aware of, and conform to, the data sharing and other resource-sharing plans;
• Establishing procedures within the center to ensure that all members of that center, including any scientists added via FMU support, share data with the BACPAC Systems Biology and Informatics Core and conform to the data sharing and other resource-sharing plans.

The NIH Project Scientist(s) will have substantial involvement that is above and beyond the normal stewardship role in awards, as described below:

• Cooperate and coordinate with recipients in performance of project activities;
• Facilitate collaborations with and access to other NIH-supported research resources including those supported by HEAL projects;
• Share information regarding promising new agents, strategies, and developments when appropriate;
• Identify scientific gaps and organize meetings to facilitate exchange of scientific and regulatory information; serve as liaison/facilitator among awardees and with the data portals such dbGAP;
• Participate on the Steering Committee as voting members and help coordinate Steering Committee activities and implementation of its recommendations, decisions, and policies.

The NIH Program Official will be named in the Notice of Award and will be responsible for the normal scientific and programmatic stewardship of the award, as described below:

• The Program Official will interact with the PI(s) on a regular basis to monitor progress. Monitoring may include: regular communication with the PI and their staff, periodic site visits for discussion with the awardee research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.
• Work with the PIs to develop performance milestones for the individual awards.
• Provide oversight for human subject protections and provide monitoring for any studies that involve more than minimal risk for participants or that involve vulnerable populations;
• Aid the Steering Committee in the development of procedures for evaluating the performance of research studies and monitoring any Clinical Trials;
• Oversee clinical site operations to include development of template informed consent documents as well as site specific consents for IRB submission, operational activation of clinical sites, and review and evaluation of site monitoring reports.

The Program Official may also identify other extramural staff who have appropriate experience and expertise to assist with the management and proper stewardship of the award.

Monitoring of Mechanistic Research Centers/Technology Sites Clinical Study/Clinical Trials

Trial Monitoring. The NIAMS Program Official or designee will oversee clinical site monitoring that evaluates Good Clinical Practice regulatory compliance, protocol implementation, internal quality assurance, and test article accountability at the network clinical sites. The site monitors, with or without accompanying NIAMS staff, will visit MRC and Tech Sites clinical sites periodically to review selected protocols, provide training on general protocol conduct, review internal QA/QC plans, and audit pharmacies.

Protocol review. The NIAMS Program Official or designee will review all clinical trial protocols and approval is required for initiation. The Project Scientist or designee will return comments and recommendations to the protocol team after review. The protocol team must address in writing all safety, regulatory, ethical, and conflict of interest concerns raised by NIAMS to the satisfaction of NIAMS before participant enrollment can begin. If a protocol is disapproved, NIAMS will not permit expenditure of NIH funds for the proposed investigation. If a protocol is not initiated within six months of NIAMS approval, re-review and approval by NIAMS will be required.

Safety Monitoring. The NIAMS Program Official or designee will participate in the development of appropriate safety monitoring plans for all planned clinical studies/trials and must approve the plan for all trials involving investigational drugs, devices, biologics, or other clinical interventions. The frequency and intensity of safety monitoring will be based on individual study characteristics and past experience with study products and may require review by an Independent Safety Monitor, Safety Monitoring Committee (SMC) or Data and Safety Monitoring Board (DSMB). Approval of the final monitoring plan, including the composition of the review committee, by NIAMS is required prior to study initiation. NIAMS independently supports Data and Safety Monitoring Boards (DSMB) that oversee clinical trials.

The NIAMS reserves the right to terminate or curtail a clinical study (or an individual component of the award) in the event of inadequate progress, data reporting, or insufficient use of this resource. Examples include, but are not limited to, risks to subject safety, failure to achieve recruitment goals, and reaching a major study endpoint substantially before schedule with persuasive statistical significance.

Clinical Data Access. NIAMS has the right of access to all clinical data generated (raw and analyzed) and may periodically review it. This includes data as recorded on the case report forms and in the central databases, and external checking against the original source documentation as required by federal regulation and NIH.

Phase 2 Clinical Trials

Trial Monitoring. The NIAMS Program Official or designee will oversee clinical site monitoring that evaluates GCP, regulatory compliance, protocol implementation, internal quality assurance, and test article accountability at the Phase 2 clinical sites. The EPPIC-Net Clinical Coordinating Center will coordinate site monitoring, with or without accompanying NIH staff, to review selected protocols, provide training on general protocol conduct, review internal QA/QC plans, and audit pharmacies.

Protocol review. The NIH Program Official or designee will review all clinical trial protocols and approval is required for initiation. The Project Scientist or designee will return comments and recommendations to the protocol team (composed by Trial PI, EPPIC-Net CCC and DMC PIs or designees) after review. The protocol team must address in writing all safety, regulatory, ethical, and conflict of interest concerns raised by NIH to the satisfaction of NIH before participant enrollment can begin. If a protocol is disapproved, NIAMS will not permit expenditure of NIH funds for the proposed investigation. If a protocol is not initiated within six months of NIAMS approval, re-review and approval by NIAMS will be required.

Safety Monitoring. The NIH Program Official or designee will oversee the development of appropriate safety monitoring plans for all planned clinical studies/trials and must approve the plan for all trials involving investigational drugs, devices, biologics, or other clinical interventions. The NIH EPPIC-Net CCC and DMC will work with the Phase 2T PI to determine the frequency and intensity of safety monitoring based on individual study characteristics and experience with study products and may require review by an Independent Safety Monitor, Safety Monitoring Committee (SMC) or Data and Safety Monitoring Board (DSMB). Approval of the final monitoring plan, including the composition of the review committee, by NIAMS is required prior to study initiation. Independently supported Data and Safety Monitoring Boards (DSMB) to oversee BACPAC Phase 2T will be arranged through the NIH EPPIC-Net.

The NIAMS reserves the right to terminate or curtail a clinical study (or an individual component of the award) in the event of inadequate progress, data reporting, or insufficient use of this resource. Examples include, but are not limited to, risks to subject safety, failure to achieve recruitment goals, and reaching a major study endpoint substantially before schedule with persuasive statistical significance.

Clinical Data Access. NIAMS has the right of access to all clinical data generated (raw and analyzed) and may periodically review it. This includes data as recorded on the case report forms and in the central databases, and external checking against the original source documentation as required by federal regulation and NIH.

An NIH Grants Management Official will be responsible for the normal monitoring of administrative and other non-programmatic aspects as described in the NIH Grants Policy Statement and will be named in the Notice of Award.

This monitoring may include: periodic site visits, review of grant management systems, fiscal reviews, and other relevant stewardship matters. In addition, the Grants Management Official or designee will attend all Steering Committee meetings as a non-voting observer.

Areas of Joint Responsibility include:

Steering Committee

The voting members of the Steering Committee include a single PD/PI from each: MRC (U19), Tech Site (UH2), each Phase 2CT (UG3), one Systems Biology/Informatics Core PI, the DAC (U24) PI, and a minimum of four NIH Officials. Note that although UH2, UG3 and the U24 may choose to utilize the multi-PI mechanism, each U19, UH2 and UG3 will have only one vote in all SC and relevant subcommittee meetings. Each member of the Steering Committee will have one vote. NIH representatives will be voting members, but will not serve as the Chair of the Steering Committee, or in aggregate represent more than forty percent of the total voting membership of the SC. All major scientific decisions will be determined by majority vote of the SC. All participants in the BACPAC Research Program are bound by the policies and procedures developed by the Steering Committee.

The Steering Committee responsibilities include:

• Compose, review and approve within three months after award a BACPAC Research Agenda establishing priorities for the entire program term. The Agenda will represent an integrated, synergistic view of individual center and technology site research projects, and the Clinical and Collaborative Projects but may include additional plans to foster collaborations among all the members of the BACPAC. The Agenda will include objectives, outputs, benchmarks and timelines that are linked to the overall goals of the BACPAC Program and can be clearly mapped back to the overall goals of
• Improve understanding of the mechanisms of low back pain
• Create an integrated model of LBP
• Produce rigorous, reliable patient based diagnostic and treatment algorithms
• Advance new therapies for LBP into Phase 3 clinical trials
• Oversee the development and implementation of the Clinical Projects at the MRCs and Tech Sites, including the associated mechanistic studies and the BACPAC Collaborative Project(s);
• Approve final Consensus Clinical Plans for common data and protocol elements and standardized processes and operating procedures for the BACPAC Research Program;
• Review and approve the plans for program-wide clinical and laboratory research data integration and analysis and ensure synergy with Center- and Site- level data analysis.
• Oversee the policies for use of the BACPAC Project Fund and the BACPAC Collaborative Research Fund;
• Review and approve data sharing and publication policies;
• Review and recommend to NIH/NIAMS new and transitioning projects.

Executive Committee

The members of the Executive Committee include the PI of the DAC, who will serve as the Chair, one MRC PI, one Tech Site PI, the BACPAC Program Manager from the U24 DAC, and one NIAMS Official. The MRC PI representative to the EC will be selected by vote of the MRC PIs. Similarly, the Tech Site PI representative to the EC will be selected by vote of the Tech Site PIs. The Executive Committee responsibilities include:

• Support the development of the Research Agenda by the BACPAC SC;
• Develop an implementation plan for the BACPAC Research Agenda
• Support the CMC development of a Clinical Consensus Plan
• Review of MRC and Tech Sites research projects together with the Functional Working Groups to identify synergies in accordance with criteria established by the SC and provide recommendations to the SC with respect to building synergies and interactions among the proposed research projects.
• Monitoring of BACPAC Research Projects along established timelines and milestones and ensure consistent adherence to common study protocols and standards across all participating research centers and sites
• Prepare and present to the SC periodic reports on study progress, identifying problems/obstacles and making recommendations for their resolution, and implement corrective/remedial actions as directed by the SC.
• Serve as the central point of contact for submission of proposals for new and transitioning research projects in accordance with policies, procedures and necessary documentation established by the BACPAC SC;

Data Sharing:

• The data sharing plan will be referenced as a term and condition of award. Applicant organization must comply with the Public Health Service (PHS) policies relating to distribution of unique research resources produced with PHS funding and sharing of research data and other research resources, as well as the grantee’s data sharing plan subject to decisions of the BACPAC Steering Committee. For further information, see the NIH Data Sharing Policy at https://grants.nih.gov/grants/policy/data_sharing/.
• The effectiveness of the data sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report.
• The NIH intends for the resource sharing plans for the data generated under the BACPAC Research Program to follow the policy and goals stated in the BACPAC FOAs. Specifically, consistent with achieving the goals of the BACPAC Research Program, all data generated (including clinical data, imaging data, patient-reported data, laboratory data, processed/analyzed data, standard protocols, forms and procedures, and algorithms and methods developed, etc.) are expected to be deposited into the BACPAC designated central database in a timely fashion for access by the BACPAC investigators, consistent with applicable laws, regulations, and policies and unencumbered by any intellectual property claims. The NIH, in consultation with the BACPAC Steering Committee, will make all final decisions concerning data deposition and data access policies, and all policies are subject to change by the NIH as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the program.
• Applicant organization will comply with and implement the recommendations and decisions of the NIH and the BACPAC Steering Committee with respect to the sharing of information, data, protocols, resources, and methods developed by BACPAC investigators under the BACPAC Research Program.

Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

A final Research Performance Progress Report (F-RPPR), invention statement, and the expenditure data portion of the Federal Financial Report, including Federal and non-Federal share for cost matching, are required for closeout of an award, as described in the NIH Grants Policy Statement .

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
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Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
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Wen G. Chen, MMSc, PhD
National Center for Complementary and Integrative Health (NCCIH)
Telephone: Email: 301-451-3989
[email protected]

Basil Eldadah, M.D., Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6761
Email:[email protected]

Yan Wang, M.D., Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: [email protected]

Grace Peng, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB )
Telephone:301-451-4778
Email: [email protected]

Susan Marden PhD RN
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6838
Email:[email protected]

David A. Thomas, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1313
Email:[email protected]

Jeremy Brown, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-8375
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Lois A. Tully, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5968
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Benyam Hailu, M.D., M.P.H.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8696
Email:[email protected]

Lisa Begg, Dr.P.H., RN
NIH Office of Research on Women’s Health (ORWH)
Telephone: 301-496-3975
Email:[email protected]

John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: [email protected]

Erik Edgerton
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301- 594-7760
Email: [email protected]

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email:[email protected]

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: [email protected]

Tijuanna Decoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email:[email protected]

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
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Priscilla Grant, J.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email:[email protected]

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email:[email protected]