It is critical that applicants follow the instructions in the Research Instructions for 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 goal of this Funding Opportunity Announcement (FOA) is to stimulate research focused on understanding and addressing disparities in minority and health disparity populations, in surgical care and outcomes. The NIH-designated health disparity populations include racial and ethnic groups (Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and other Pacific Islanders), less privileged socioeconomic status populations and population groups residing in rural medically underserved geographic areas.

For the purpose of this initiative, disparities in surgical care and outcomes include investigative and collaborative research, outcomes research, health services research, comparative effectiveness and clinical trial interventions in general surgical care and post-operative rehabilitation, as well as the specialty areas of trauma and critical care, anesthesia, emergency medicine care, obstetric and gynecologic care, orthopedic, cardiac and vascular, gastrointestinal tract, bariatric, pulmonary, organ transplantation, urologic and surgical oncology.

Although breakthrough surgical research, technologies and instrumentation have advanced the field, the delivery of safe, and quality surgical care and outcomes have not benefited all patient groups. Health outcomes data still show that an undesirable portion of surgical patients from disadvantaged backgrounds still experience significant morbidity, prolonged hospitalization and chronic disability or premature death. Access to clinically indicated surgical care and optimal outcomes is affected by socioeconomic status, age, gender, level of education, race, ethnicity, health care resources and availability, and hospital region. While insurance status or co-morbidity might be thought of as the most reliable surrogate for prediction of surgical outcome differences, the delay of surgery, referral patterns, facility or clinician volume and resources and suboptimal clinician-patient communication, and unconscious biases are but a few additional mechanisms that can lead to disparities in access to safe and quality surgical care and optimal outcomes.

Research suggests that as much as 11-30% of the global burden of disease requires surgical care or anesthesia management or both a figure that underscores the fundamental role of surgery as part of the essential health care. A recent report released by The Lancet Commission on Global Surgery reveals substantial growing trend in the global burden of disease that is amenable to surgical intervention. http://www.thelancet.com/commissions/global-surgery

According to the CDC, approximately 51 million inpatient surgical cases are performed in the U.S. each year. (2010). Outpatient surgical cases outnumber inpatient cases at 53 million, and procedures in both settings account for an appreciable share of the healthcare costs and resources. Health services research often fails to reflect the integral role of optimal access to safe surgical care and medical management as part of its goals. The structure and processes of care delivery dictate similar to non-surgical care, surgical outcomes. When suboptimal structure and processes are associated with patient characteristics, disparities in outcomes follow.

Some mechanisms or factors contributing to surgical disparities include patient characteristics, clinical care and quality, variations in surgical practice and referral patterns, clinician factors, healthcare system-level factors and post-operative care and medical rehabilitation.

Numerous patient characteristics have been identified as contributors to surgical disparities, including demographic (e.g. race), physiologic (e.g. immune status), health literacy and culture including beliefs, values and preferences. Compared to Whites, Blacks receive fewer reconstructions after mastectomy, arthritis-related knee and hip surgery and pulmonary resection for early stage lung cancers. Other factors such as socioeconomic status (SES) also impact these issues. Patients with low SES are less likely to receive appropriate surgical services, including bariatric surgery, hepatocellular carcinoma resection and transplants regardless of age. Low SES patients who receive needed surgical care often have worse outcomes and higher mortality than otherwise similar higher-income patients. Conversely, patients with higher income and higher education are more likely to receive appropriate surgical services and have better outcomes.

In meta-analysis of studies analyzing odds of death after trauma, African American patients had higher odds of death compared to White patients. In other studies analyzing surgical outcomes, certain racial and ethnic population groups were at signi?cantly higher odds of experiencing surgical complications than others. African Americans had higher operative surgical morbidity and post-surgical mortality than Whites. Disparities in postoperative mortality based on SES have been consistently demonstrated after major surgery. The elderly (and especially those from socially disadvantaged groups racial and ethnic, low SES) are less likely to receive appropriate treatment for surgically and potentially curable diseases such as abdominal aortic repair (AAA) or early-stage oncologic diseases. Likewise female gender and especially those from racial and ethnic minority groups, is associated with decreased probability of undergoing certain potentially life-saving surgical procedures, including revascularization for severe coronary artery disease surgery after acute myocardial infarction and certain cancers; e.g. curative intent versus palliative debulking in cervical cancer. Racial and ethnic minorities with chronic kidney disease on dialysis, are less likely to receive counseling about renal transplantation, be waitlisted for transplant, and receive transplant. Even though the some of the research shows that racial and ethnic minority patients are more likely than White patients to decline surgical procedures, overall differences in refusal rates tend to be generally low and patient refusals does not fully explain the persistent disparities in outcomes.

Disparities in clinical care and quality are often dictated by procedural mechanisms such as adoption of evidence-based clinical guidelines, quality improvement strategies that also focus on addressing disparities such as patient-centeredness, shared decision-making, satisfaction and perceived quality of care. Clinical decision-making due to bias and stereotyping can also lead to disparate outcomes among patients. Simulated studies demonstrated the impact of implicit bias on the clinician s decision-making, and require real-world clinical assessment. Surgical care and training has evolved as a result of carefully structured scientific investigations of evidence-based studies that have shown that many of the traditional approaches to surgical care, such as preoperative bowel clearance, the use of nasogastric tubes and drains placed in cavities, or use of slowly advanced diets are unnecessary or even harmful. Newer evidence-based practices have demonstrated that surgical recovery can be accelerated, recuperation decreased and co-morbidities minimized for all patient groups. An integrated approach focuses on enhancing recovery and reducing morbidity by implementing evidence in the fields of anesthesia, analgesia, reduction of surgical stress, fluid management, minimal invasive surgery, nutrition, and ambulation.

The potential mechanisms by which system-level factors influence outcomes in surgical disparities have been documented in the literature. Structural variation (in resources and practice pattern) is thought to be responsible for a large proportion of between-hospital quality differences in surgical outcomes, such that racial/ethnic minority patients living in low SES zip codes may be more likely to present to hospitals with low structural quality and suffer worse outcomes. Process entails the acts of care delivery; these may vary significantly both between and within hospitals. Process variations, including choice of procedure, adherence to guidelines, and specialty referral, have all been linked to racial/ethnic minority patient status.

While differences in the surgical outcomes associated with race and ethnicity have been well documented, less is known about other demographic associations, including immigration status, English language, fluency, health literacy, numeracy, rurality, sexual orientation, and gender identity. Research is needed to understand these demographic associations with poor outcomes, to address and promote use of clinician and/or health professional- and patient-centered technologies, redesigned surgical care pathways and systems demonstrations, including enhanced tracking and incentive strategies to yield high-value, equitable surgical care. In addition, there are research gaps in implementation of multi-level intervention strategies (patient and clinician or patient and clinician and healthcare system).

The goal of this FOA is to invite exploratory, novel studies that break new ground or extend previous discoveries toward new directions in understanding and addressing disparities in surgical care and outcomes, including the factors that influence the disparities. Overarching priority research questions for the initiative include the testing of various hypothesis that identifies new indications or approaches to improving access, care coordination, outcomes, safety and quality of surgical care for health disparity populations. While the goal is to better understand and explore effectiveness of potential intervention approaches for addressing surgical disparities, this initiative will also seek to identify strategies at the institutional and systems level. No preliminary data are required but may be included if available. Projects should be distinct from those supported through the traditional R01 mechanism.

Examples of research methods could include, but are not limited to:

• Decision science modeling and analysis in surgical care and outcomes for health disparity populations
• Participatory engagement of stakeholders (hospitals, surgical facilities, patients and caregivers, clinicians, surgical care teams, community groups, administrators, policymakers) in the formulation of the research and to the extent necessary, in the implementation of the research
• Use of large-scale longitudinal data sets, data mining techniques, registries, and integration of quantitative and qualitative analytical frameworks and techniques to address and inform implementation of interventions addressing surgical disparities.
• The ability to conduct subgroup analysis to determine which interventions work best for specific population groups, including medically underserved and under-represented groups with the intent to focus on reduction of surgical disparities.

Applications should be relevant to both the objectives of the funding opportunity announcement and to at least one of the participating Institutes and Offices' research interests. Researchers are strongly encouraged to review the general research interests of the participating institute or office.

National Institute on Minority Health and Health Disparities (NIMHD)

NIMHD is interested in several research priorities that could have significant impact on understanding and addressing surgical health disparities. Examples of potential topic areas include but are not limited to:

• Improvement and exploration of new and existing surgical quality indicators/metrics along the surgical care continuum: from pre-op planning and/or emergency or acute care through post-op planning, recovery management and rehabilitation with a focus on reducing the disparities.
• Care coordination and integration, and culturally competent surgical care and management guidelines for disadvantaged populations.
• Assessing and evaluating effective methods for incorporating patient preferences for surgical treatment, biases influencing physicians' clinical decision-making, patient-clinician interactions and expectations for outcomes in surgical decision-making with patients and caregivers.
• Leveraging evidence-based preventive care and medicine to reduce disparities and improve adoption of evidence-based surgical care.
• Understanding mechanisms for the racial/ethnic by gender differences in surgical outcomes and associated morbidity or mortality to inform effective interventions.
• Evaluating communication approaches regarding referral to surgery, preoperative evaluations, and postoperative or post-injury expectations for recovery and rehabilitation for health disparity populations and their caregivers.
• Patient-centered surgical outcomes research focused on methodologies and research in translation, implementation, and diffusion of research into practice and policy.

National Cancer Institute (NCI)

Examples of topics of interest to the National Cancer Institute:

• Patient access to and use of care (e.g. insurance coverage/type, distance, use of cancer centers, general surgeon versus one with specialty training in surgical oncology)
• Patient understanding of their illness and treatment options possibly as related to literacy and numeracy, to name a few
• Patient beliefs, values, and preferences
• Patient-clinician communication
• Caregiver/family role in decision-making and pre/post-surgical care
• Coordination of care, including access to patient navigators, between surgeons and medical and radiation oncologists, both before and after surgery
• Clinician characteristics, including sex, race/ethnicity, specialty training, time since graduation, volume
• Practice/system characteristics, including size, single versus multi-specialty, integrated versus not, participant in ASCO/ACoS/other quality initiatives, staffing/use of non-physician professionals

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Applicants who wish to submit clinical trial applications for consideration by NIAMS are encouraged to submit clinical trial applications to one of the FOAs listed at http://www.niams.nih.gov/Funding/Clinical_Research/clinical_main.asp.

Office of Research on Women’s Health

Comparison of male and female populations or subjects on the desired outcome is highly desired. Of particular interest are research activities which increase the understanding of sex/gender differences and factors that are determinant in health and disease, to support implementation of the NIH Strategic Plan for Women's Health Research, available at http://orwh.od.nih.gov/research/strategicplan/index.asp. ORWH is interested in understanding mechanisms at the intersection of race/ethnicity and sex/gender differences in surgical outcomes and associated excess morbidity or mortality to inform effective interventions within women and sub-populations of women at increased risk for disparity.

See Section VIII. Other Information for award authorities and regulations.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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 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. 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.

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.

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).

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.

It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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:

Regina Smith James, M.D.
Telephone: 301-496-3462
Fax: 301-496-3489
Email: [email protected]

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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.

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:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide..

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.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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

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.

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. 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.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

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.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

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?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

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 Guidelines for the Review of Human Subjects.

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 children 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.

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.

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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not Applicable

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

Not Applicable

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).

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).

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.

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 CSR, 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.

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 A. 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.
• Geographic distribution and/or regionality of research impact

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 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.

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.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually 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.

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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Regina Smith James M.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-496-3462
Email: [email protected]

Brenda A. Adjei, MPA, Ed.D.
National Cancer Institute (NCI)
Telephone: 240-276-6185
Email: [email protected]

Claudette Brooks M.D.
Office of Research on Women's Health (ORWH)
Telephone: 301-402-1770
Email: [email protected]

Kristy M. Nicks, Ph.D.
National Institute of Arthritis and Musculoskeletal Disorders
Telephone: 301-594-5055
Email: [email protected]

Gabriel B. Fosu, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-3562
Email: [email protected]

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: [email protected]

Sheila Simmons
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-9812
Email: [email protected]

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 Part 75.