Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Center for Complementary and Alternative Medicine (NCCAM) National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Clinical Trials and Interventional Studies of Non-Pharmacological Approaches to Managing Pain and Co-Morbid Conditions in U.S. Military Personnel, Veterans, and their Families (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	RFA-AT-14-003
Companion Funding Opportunity	Fill in FOA number, then copy activity code and description from activity code list above and paste over the example below. If not applicable, replace with none RFA-AT-14-004, R34 Pilot and Feasibility Studies RFA-AT-14-005, R01 Health Services/ Observational Studies
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.213; 93.279
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) seeks applications proposing Clinical trials or Interventional research on non-pharmacological approaches to symptom management for pain and associated problems (e.g., post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), substance use disorder (SUD), depression, anxiety, and sleep disturbances) among U.S. military personnel and Veterans. Research related to personnel and Veterans of all branches of the military (e.g., Army, Navy, Marines, Air Force, Coast Guard, U.S. Military Reserves, National Guard) is of interest. For this FOA, research related to individuals who are serving or have served in Operation Enduring Freedom (Afghanistan), Operation Iraqi Freedom (Iraq), and Operation New Dawn (OEF/OIF/OND) is of special interest due to the public health need to address issues confronting returning troops.

Posted Date	July 1, 2013
Open Date (Earliest Submission Date)	September 11, 2013
Letter of Intent Due Date(s)	September 11, 2013
Application Due Date(s)	(Extended to November 1, 2013 per NOT-OD-14-003), Originally October 11, 2013, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	February/March 2014
Advisory Council Review	May 2014
Earliest Start Date	July 1, 2014
Expiration Date	(Extended to November 2, 2013 per NOT-OD-14-003), Originally October 12, 2013
Due Dates for E.O. 12372	Not Applicable

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of this Funding Opportunity Announcement (FOA) is to accelerate clinical trial or interventional research on non-pharmacological approaches to symptom management for pain and associated problems (e.g., post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), depression, anxiety, sleep disturbances, substance abuse) among U.S. military personnel, Veterans, and their families. For this FOA, the research population must be active duty personnel or Veterans, of any branch of the military (e.g., Army, Navy, Marines, Air Force, Coast Guard, U.S. Military Reserves, National Guard), or their family members. Research related to individuals who are serving or have served in Operation Enduring Freedom (Afghanistan), Operation Iraqi Freedom (Iraq), and Operation New Dawn (OEF/OIF/OND) is of special interest. Applications proposing clinical trial planning or pilot studies should use companion funding opportunity announcement RFA-AT-14-004 (Pilot and Feasibility Studies). Applications proposing Health Services research, Observational studies, or secondary data analysis should use the companion funding opportunity announcement RFA-AT-14-005 (Health Services/Observational).

With U.S. military forces serving in Iraq and Afghanistan, there have been approximately 2 million troops deployed and approximately 3 million deployments. As a result of these military operations, 202,281 cases of TBI have been recorded between 2000-2010 (http://dcoe.health.mil/ ); rates of PTSD vary, typically from 9% to 24% (Wells, et. al., Int. Rev Psychiatry, 2011); combat exposure is consistently correlated with PTSD (Ramchand, J Traumatic Stress, 2010); and high co-morbidity rates are reported among the following psychiatric conditions: PTSD, TBI, SUD, and Depression (Seal, et. al., Drug & Alcohol Dep, 2011). Furthermore, studies show nearly 50% of veterans report that they experience pain on regular basis (Otis, et. al., Pain Medicine, 2009; Kerns, et. al., J Rehab Res Dev, 2003) and there is significant overlap between chronic pain, PTSD, and persistent post-concussive symptoms (Lew, et. al., Phys Med & Rehab, 2009). Estimates are that costs of providing disability compensation benefits and medical care to the veterans from Iraq and Afghanistan will be from $350 - $700 billion (Blimes, JFK SOG-Harvard RWP07001, Jan. 2007; Otis, et. al., Pain Medicine, 2009). Addressing the needs of military personnel, veterans and their families is a tremendous public health issue and there is a paucity of evidence-based treatment research to guide practice for the treatment and management of pain and co-morbid conditions.

The Office of The Army Surgeon General’s Pain Management Task Force released their Final Report in May 2010, Providing a Standardized DoD and VHA Vision and Approach to Pain Management to Optimize the Care for Warriors and their Families , and have launched a Comprehensive Pain Management Campaign Plan. One of the objectives specified in the final report is to incorporate complementary and integrative therapeutic modalities into patient centered plans of care. (http://www.amedd.army.mil/reports/Pain_Management_Task_Force.pdf)

In a separate but related effort, the 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a public health problem. In June, 2011, the Institute of Medicine (IOM) released a Consensus Report on "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. (http://iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx) The report notes that chronic pain affects an estimated 116 million American adults more than the total affected by heart disease, cancer, and diabetes combined. Pain also costs the nation up to $635 billion each year in medical treatment and lost productivity. The IOM report encourages federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments. The report also notes that ideally, most patients with severe persistent pain would obtain pain care from an interdisciplinary team using an integrated approach that would target multiple dimensions of the chronic pain experience - including disease management, reduction in pain severity, improved functioning, and emotional well-being and health-related quality of life.

Data from the most recent National Health Interview Survey (NHIS) [http://www.cdc.gov/nchs/data/nhsr/nhsr012.pdf] show that many complementary approaches are used for pain and symptom management by the American public. Research has suggested that some approaches hold promise for helping individuals manage chronic pain conditions and for the amelioration of symptoms but additional research is warranted (Chou, et. al., Ann Intern Med, 2007; Sherman, et. al., Arch Intern Med, 2011; Strauss, et. al., VA Ev Based Syn Program, 2011). The current health care needs of military personnel and veterans and the substantial interest by veteran and military entities in incorporating complementary approaches to pain and symptom management is an opportunity to study utilization, mechanisms, efficacy, and effectiveness of promising complementary approaches. Military and Veteran health care systems have large patient populations and have the capability to utilize large datasets.

For the purposes of this FOA, non-pharmacological, complementary, and integrative approaches include, but are not limited to, the following: a) mind-body interventions such as mindfulness- or meditation-based stress reduction approaches, b) yoga, c) acupuncture, d) art therapy, and e) cognitive-behavioral interventions that are designed to improve both pain management and symptoms of other co-morbid conditions (such as PTSD, TBI, SUD, Depression). Non-pharmacological, complementary, and integrative approaches to health care could also include assessments of multidisciplinary or integrated models of care. Multidisciplinary or integrated models of care could include, but are not limited to, models that include physicians, physical therapists, psychologists, or complementary therapists, etc. Examples of settings that may include such models are pain clinics, VA hospitals, and academic departments of clinical health centers that include pharmacological, psychological, and complementary/integrative treatment modalities. Approaches relevant to this FOA also include non-pharmacological approaches used in pain management care in conjunction with pharmacological approaches to reduce prescription drug use or prevent prescription drug abuse.

Applicants should provide a clear and convincing rationale for pursuing study of the complementary approach or a conceptual model describing how or why the approach may work and reasonable evidence suggesting the promise of the approach for the indication(s) proposed.

To be responsive to this FOA, applications proposing to test interventions must measure pain outcome as a primary outcome variable. Also, any proposed study population must include military personnel, veterans, and/or their families. Collection of data regarding pain and/or pain management using tools such as NIH’s Patient Reported Outcomes Measurement Information System (PROMIS) (http://www.nihpromis.org/) is highly encouraged. Use of NIH Toolbox tools (http://www.nihtoolbox.org/Pages/default.aspx) is also encouraged.

Many primary conditions, whether acute (such as injury), recurring (such as migraine), or chronic (such as arthritis) are significantly complicated by co-morbid pain disorders and/or co-morbid mental health disorders. Some pain conditions are unassociated with other primary diagnoses. Chronic pain is widely believed to represent a disease itself, causing long-term detrimental physiologic changes and requiring unique assessments and treatments. The following acute, recurring, or chronic pain conditions of interest in the context of this FOA include but are not limited to:

• Headache
• Musculoskeletal pain, including back pain
• Pain with multiple contributing injuries or morbidities
• Phantom limb pain
• Spinal cord injury pain
• Inflammatory Pain
• Visceral pain
• Neuropathic pain

The following conditions co-morbid to pain are of special interest in the context of this FOA:

• Post-Traumatic Stress Disorder (PTSD)
• Prescription Drug Use/Abuse and other Substance Use Disorders
• Sleep Disturbance/Insomnia
• Anxiety
• Depression
• Traumatic Brain Injury (TBI)

Strategies to Improve Pain Management and Symptoms of Pain and Co-morbid Conditions

The objective of this FOA is to stimulate research on non-pharmacological approaches for pain management and co-morbid condition symptom management in military or veteran populations (and/or family members). Fully powered randomized controlled clinical trials or effectiveness studies are appropriate in cases where pilot data suggests feasibility and preliminary evidence of efficacy or effectiveness. In other cases, clinical trial planning or pilot studies are encouraged (see companion funding opportunity announcement RFA-AT-14-004, Pilot and Feasibility Studies). Applications proposing Health Services research, observational studies, or secondary data analysis should use the companion funding opportunity announcement RFA-AT-14-005, Health Services/Observational.

Examples of Research Projects include but are not limited to the following:

• Studies of the efficacy or effectiveness of non-pharmacological or integrated (pharmacological and non-pharmacological) approaches for management of pain and co-morbid conditions (PTSD, anxiety, depression, sleep disorders, TBI, substance use disorders).
• Studies of the efficacy or effectiveness of non-pharmacological approaches used in pain management care in conjunction with pharmacological approaches to reduce prescription drug use, prevent prescription drug abuse, or reduce adverse events associated with continued opioid therapy.
• Studies of the efficacy or effectiveness of complementary or integrative pain management approaches and strategies for which reasonable evidence suggests safety and promise and which are increasingly used by the public and in military settings (e.g., acupuncture, meditative approaches).
• Cluster randomization studies using various cohorts.
• Phased implementation of clinical intervention(s) studies.
• Projects studying the efficacy or effectiveness of mobile technologies or DoD developed technology or applications such as BioZen, a meditation smartphone app that collects biofeedback data (http://t2health.org/apps/biozen).
• Projects studying the efficacy or effectiveness of art therapy for symptom management and improved quality of life.
• Projects studying the efficacy or effectiveness of complementary health practices in populations affected by health disparities.

Non-pharmacological approaches are most often used to manage symptoms of underlying diseases and conditions. These approaches may be helpful in managing symptoms and, in some cases, they may also engage biological processes relevant to the underlying disease. The primary purpose of this FOA is to encourage research on the efficacy or effectiveness of complementary health approaches for management of pain and co-morbid conditions. Study of potential biological mechanisms of action or biomarkers in the context of an efficacy or effectiveness trial is also of interest.

Applications must be well-aligned with the mission of at least one of the participating organizations. Applicants are strongly encouraged to consult the Scientific/Research contacts for this FOA, listed in Section VII, to discuss the relevance of their proposed work to organizational research priorities, as well as to ensure that proposed studies do not duplicate projects currently supported. Applicants are strongly encouraged to consult NCCAM's strategic plan (http://nccam.nih.gov/about/plans/2011). NCCAM will decline applications that are not considered central to the NCCAM mission and research priorities.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The participating organizations intend to commit approximately $3.0 million (total costs) in Fiscal Year 2014 with which it is expected that 5 to 7 new grants will be funded across three FOAs: R01 FOA (RFA-AT-14-005, Health Services/Observational), R01 FOA (RFA-AT-14-003, Clinical/Interventional), and R34 FOA (RFA-AT-14-004, Pilot/Feasibility). NCCAM expects to fund 3-4 new grants and will commit $2 .0 million in Fiscal Year 2014. NIDA expects to fund 1 new grant and will commit $500,000 in Fiscal Year 2014. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of meritorious applications.
Award Budget	Budgets for direct costs may not exceed $500,000 per year or $2,500,000 over a five-year project period.
Award Project Period	The total project period for an application submitted in response to this FOA may not exceed five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• 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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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:

Kristen Huntley, Ph.D.
Program Officer
Division of Extramural Research
National Center for Complementary & Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
(for FedEx delivery use 20817)
Telephone: 301-594-9346
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

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

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: The budget should include funds necessary for up to two key personnel to travel to and participate in an in-progress programmatic/science review, lasting not more than two days and including up to two overnight stays, for each year of the project period.

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

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: Applicants should provide a clear and convincing rationale for pursuing study of the complementary approach or a conceptual model describing how or why the approach may work and reasonable evidence suggesting the promise of the approach for the indication(s) proposed.

Discuss in the application how economic resources would be available ultimately for the use of these approaches in real world settings. Interventions should be practical and have potential, if successful, for implementation and integration in real world health care settings (e.g., in terms of cost of training, staff, office space and patient burden).

For projects involving both males and females, potential applicants are strongly encouraged to pose sex-difference-based hypotheses and analyze the data for sex differences. When sex-based hypotheses and analyses are not proposed, scientific justification should be provided.

In the application, please describe data regarding patient acceptability of treatment approaches and methods to increase acceptability for approaches which may be unappealing to the target population or which have low rates of referral follow-up.

The description of the research project should include concrete indicators of progress and how these indicators will be used to inform the next phase of research. Appropriate indicators may include, but are not limited to, recruitment schedules and/or a timeline for administrative and scientific accomplishments. Progress indicators should be included in each annual progress report and as part of the final report for the grant.

Applicants are strongly encouraged to consider and should address data sharing in the application. Data collection, data description, and management procedures should be designed and piloted with future data sharing in mind (e.g., development of data quality assurance procedures, and/or inclusion of relevant language in consent forms to allow future data sharing where appropriate).

Letters of Support: If research is proposed to be conducted in a DoD or VA setting, evidence of appropriate institutional clearance and support from the DoD or VA site should be included in the application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

This initiative is not subject to intergovernmental review.

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.

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.

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.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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? Does the project address an important problem or critical barrier to progress in pain management in military or Veteran populations? Could the intervention be implemented in a real world setting?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

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? 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? Is there a reasonable timeline with appropriate indicators of progress?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? If there are no gender/sex-based hypotheses or plans to analyze the data by sex/gender, is adequate scientific justification provided?

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? If research is proposed to be conducted in a DoD or VA setting, does the application provide evidence of appropriate institutional clearance and support from the DoD or VA site?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

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) Genome Wide Association Studies (GWAS).

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCCAM, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• 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.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report 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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]

Kristen Huntley, Ph.D.
Program Officer
Division of Extramural Research
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-9346
Email: [email protected]

Dave Thomas, Ph.D.
Program Officer
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1313
Email: [email protected]

Dale Birkle Dreer, Ph.D.
Chief, Office of Scientific Review
Division of Extramural Activities
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-451-6570
Email: [email protected]

George Tucker, MBA
Director, Grants Management
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-9102
Email: [email protected]

Christine Kidd
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-12372
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.