Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Funding Opportunity Title	Addressing Health Disparities in NIDDK Diseases (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of PA-09-262
Related Notices	October 19, 2016 - This PA has been reissued as PA-17-021. April 27, 2016 - Notice to Extend and Update Scientific/Research Contact for PA-13-183. See Notice NOT-DK-16-017. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) November 6, 2015 - Notice of Correction to SF424 (R&R) Senior/Key Person Profile Instructions for PA-13-183. See Notice NOT-DK-16-001. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PA-13-183
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.847
Funding Opportunity Purpose	The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) seeks research to improve understanding of the causes of high priority diseases in the United States and to develop and test more effective interventions for reducing/eliminating health disparities. Research is encouraged in the following high priority diseases within the scientific mission areas of the NIDDK: diabetes, obesity, nutrition-related disorders, hepatitis C, gallbladder disease, H. Pylori infection, sickle cell disease, kidney diseases, urologic diseases, hematologic diseases, metabolic, gastrointestinal, hepatic, and renal complications from infection with HIV.

Posted Date	April 5, 2013
Open Date (Earliest Submission Date)	May 5, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, 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)	Standard AIDS dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply.
Advisory Council Review	Standard dates apply.
Earliest Start Date	Standard dates apply.
Expiration Date	New Date September 8, 2016 per issuance of NOT-DK-16-017. (Original Expiration Date: May 8, 2016)
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

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

There are many diseases and disorders that disproportionately affect the health of underserved populations in the United States. African-Americans, Hispanic Americans, American Indians, Alaska Natives, some Asian-Americans, Native Hawaiians and other Pacific Islanders, and rural populations experience much higher risks of and poorer health status than the general population. Several of the diseases that disproportionately afflict underserved populations are high priority research areas for the NIDDK. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) seeks research to improve understanding of the causes of disparities in health and disability in the United States and to develop and test more effective interventions for reducing/eliminating health disparities directly related to the scientific areas within the mission of the NIDDK http://www2.niddk.nih.gov/Research/ScientificAreas/default.htm. NIDDK's Strategic Plan to reduce and ultimately eliminate minority health disparities includes initiatives aimed at reducing the human and economic costs resulting from inequities in health care and health outcomes.

The Healthy People initiative has provided 10-year national objectives for improving the health of all Americans over the past three-decades. Each Healthy People initiative has set benchmarks and monitored the progress towards the achievement of these 10-year objectives. On December 2, 2010, the Department of Health and Human Services released the Healthy People 2020 initiative, with the overarching goal of promoting a "society in which all people live long, healthy lives" (see: http://www.healthypeople.gov/2020/about/default.aspx).

The overarching goals of Healthy People 2020 are:

• "Attain high-quality, longer lives free of preventable disease, disability, injury and premature death.
• Achieve health equity, eliminate disparities, and improve the health of all groups.
• Create social and physical environments that promote good health for all.
• Promote quality of life, healthy development, and healthy behaviors across all life stages."

As noted previously, the second goal of Healthy People 2020 is to "Achieve health equity, eliminate disparities, and improve the health of all groups." Healthy People 2020 defines a health disparity as a particular type of health difference that is closely linked with social, economic, and/or environmental disadvantage. Health disparities adversely affect groups of people who have systematically experienced greater obstacles to health based on their racial or ethnic group; religion; socioeconomic status; gender; age; mental health; cognitive, sensory, or physical disability; sexual orientation or gender identity; geographic location; or other characteristics historically linked to discrimination or exclusion. Additionally, Healthy People 2020 defines health equity as the attainment of the highest level of health for all people. Achieving health equity requires valuing everyone equally with focused and ongoing societal efforts to address avoidable inequalities, historical and contemporary injustices, and the elimination of health and health care disparities.

The overall objective of this Funding Opportunity Announcement (FOA) is to understand and mitigate health disparities in the development, diagnosis, and treatment of diseases of high priority to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institutes of Health (NIH). It is recognized that both biologic and non-biologic factors may be operating in these underrepresented populations.

Research approaches may include metabolic, genetic, clinical, behavioral, and/or epidemiologic studies in representative populations. Advantage might be taken of extant cohort studies that have been established for investigation of diabetes or other diseases. Collaboration among investigators of these established cohorts would be desirable, so that these studies might jointly develop protocols and evaluate findings. Alternatively, investigators may propose to start a new cohort, appropriately powered, to capture the current risks and outcomes in the era of new medications for some of the diseases. Such studies of current risks might appropriately be based in large HMOs or clinical practices with structure and data management practices conducive to efficient and cost-effective analyses.

Appropriate topics for investigation in NIDDK diseases would include but are not limited to:

• Testing approaches that influence healthcare delivery to reduce disparities in prevention and treatment;
• Better understanding of the racial and ethnic differences in screening, diagnosis, incidence, and prevalence of NIDDK diseases and whether there are differences among sub-groups in the rates of progression; with an emphasis on identifying factors that help inform treatment development, practice, or policy designed to reduce or eliminate disparities;
• State-of-the-art, hypothesis-driven mechanistic studies to determine whether there are biological differences that might influence disease outcomes;
• Studies to investigate environmental or behavioral factors, such as medical care, lifestyle, and socioeconomic status that may contribute to risk for development and progression of NIDDK diseases and related complications; and
• Studies of effects of medications or other therapies for prevention or treatment of NIDDK diseases in racial or ethnic minority populations, including differences across the lifespan in these populations.

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 Renewal Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited, but need to reflect the actual needs of the proposed project.
Award Project Period	The maximum project period is 5 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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are 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 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.

Additionally, eligible individuals to serve as the PD/PI for this research program grant should demonstrate their clinical and research abilities to provide "cultural and linguistic competent" care. The definition of "cultural and linguistic competence" has been established by the Office of Minority Health as "a set of congruent behaviors, attitudes, and policies that come together in a system, agency or among professionals that enables effective work in cross-cultural situations. "Culture"' refers to integrated patterns of human behavior that include the language, thoughts, communications, actions, customs, beliefs, values, and institutions of racial, ethnic, religious, or social groups. "Competence" implies having the capacity to function effectively as an individual and an organization within the context of the cultural beliefs, behaviors, and needs presented by consumers and their communities." (From "National Standards for Culturally and Linguistically Appropriate Services in Health Care - Final Report," available at: http://minorityhealth.hhs.gov/assets/pdf/checked/finalreport.pdf).

Eligible PD/PIs should document training in cultural competence their NIH biosketch as described below in " SF424(R&R) Senior/Key Person Profile." Online training is acceptable, as is in-person training. An example of such training is the "Think Cultural Health" website developed by the HHS OMH available at: https://www.thinkculturalhealth.hhs.gov/Content/ContinuingEd.asp.

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.

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, with the following additional instructions:

Facilities and Other Resources: For research applications involving Human Research Subjects, the standards for culturally and linguistically appropriate service (CLAS) are considered the "best practices" for providing culturally and linguistically accessible resources to patients from underserved racial and ethnic populations. In the context of the research environment, the NIDDK also believes that these "best practices" aid in providing culturally and linguistically accessible resources to human research subjects from the same underserved populations. The standards for CLAS are provided in the "National Standards for Culturally and Linguistically Appropriate Services in Health Care (Final Report)," issued by the U.S. Department of Health and Human Services' (HHS) Office of Minority Health (OMH) (available at: http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=2&lvlID=15

Therefore, conformance with the CLAS Standards regarding Language Access Service (Standards 4 through 7) may be interpreted as evidence that the scientific environment will contribute to both the overall success of the research and demonstrate unique and innovative features of the research facility(ies) to conduct health disparities research with underserved racial and ethnic populations. Similarly, the Culturally Competent Care (Standards 1 through 3) demonstrates the commitment of the research environment and the research team to the importance of accessible cultural and linguistic services to underserved research populations. The specific standards are:

Culturally Competent Care:

• Standard 1: "Health care organizations should ensure that patients/consumers receive from all staff members effective, understandable, and respectful care that is provided in a manner compatible with their cultural health beliefs and practices and preferred language."
  
  
• Standard 2: "Health care organizations should implement strategies to recruit, retain, and promote at all levels of the organization a diverse staff and leadership that are representative of the demographic characteristics of the service area."
  
  
• Standard 3: "Health care organizations should ensure that staff at all levels and across all disciplines receive ongoing education and training in culturally and linguistically appropriate service delivery."

Language Access Service:

• Standard 4: "Health care organizations must offer and provide language assistance services, including bilingual staff and interpreter services, at no cost to each patient/consumer with limited English proficiency at all points of contact, in a timely manner during all hours of operation."
  
  
• Standard 5: "Health care organizations must provide to patients/consumers in their preferred language both verbal offers and written notices informing them of their right to receive language assistance services."
  
  
• Standard 6: "Health care organizations must assure the competence of language assistance provided to limited English proficient patients/consumers by interpreters and bilingual staff. Family and friends should not be used to provide interpretative services (except on request by the patient/consumer)."
  
• Standard 7: "Health care organizations must make available easily understood patient-related materials and post signage in the languages of the commonly encountered groups and/or groups represented in the service areas."

The documentation should include details regarding how the Applicant Organization and all involved facilities meet each of the aforementioned Standards. Failure to document any of the four Language Access Service standards will not make an Organization ineligibile to participate in this FOA, but may be considered in the review criteria of the scientific environment during peer review.

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

Biographical Sketch: Include biographical sketches of all senior/key personnel and Other Significant Contributors. The Biographical Sketch may not exceed four pages per person including the table at the top of the first page.

Following the educational block, complete sections A, B and C as described in the SF424 (R&R) instructions. However, complete section D as described below.

D. Training in Cultural Competence:

The PD/PI, all senior/key personnel and Other Significant Contributors shall provide documentation of their formalized training in cultural competence. If no formal training in cultural competence has been received, then please state "None" under section D and please provide a justification for the absence of such formalized training.

If formal training in cultural competence has been received, then please provide information as to the provider of the training, the location of the training, the dates of training, and a synopsis of the training received (including format, duration of training, certification, recertification, etc.). Online training is acceptable, as is in-person training. An example of such training is the "Think Cultural Health" website developed by the HHS OMH available at: https://www.thinkculturalhealth.hhs.gov/Content/ContinuingEd.asp.

Current & Pending Support: As the normal section D of the Biosketch is replaced with information documenting the training of the PD/PI, all senior/key personnel and Other Significant Contributors, please submit the "Research Support" for all of the applicable persons as an attachment in the "Attach Current & Pending Support" field. Please use the instructions described in the SF424 (R&R) instructions, including using the format on the Biographical Sketch Format Page to prepare this section.

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:
Definitions:

For the purposes of this FOA, the following definitions are to be utilized by all applicants:

• Health Disparity: as defined by Healthy People 2020, is a particular type of health difference that is closely linked with social, economic, and/or environmental disadvantage. Health disparities adversely affect groups of people who have systematically experienced greater obstacles to health based on their racial or ethnic group; religion; socioeconomic status; gender; age; mental health; cognitive, sensory, or physical disability; sexual orientation or gender identity; geographic location; or other characteristics historically linked to discrimination or exclusion.
  
  
• Health Equity: as defined by Healthy People 2020, is the attainment of the highest level of health for all people. Achieving health equity requires valuing everyone equally with focused and ongoing societal efforts to address avoidable inequalities, historical and contemporary injustices, and the elimination of health and health care disparities.

Health Disparities Associated with Racial or Ethnic Minority:
As defined by the Office of Management and Budget's "Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity (available at: http://www.gpo.gov/fdsys/pkg/FR-1997-10-30/pdf/97-28653.pdf), the following are the minimum categories for data on race:

• American Indian or Alaska Native: A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment.
  
  
• Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
  
  
• Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American."
  
  
• Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
  
  
• White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

The following are the minimum categories for data on ethnicity:

• Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term, "Spanish origin," can be used in addition to "Hispanic or Latino."
  
  
• Not Hispanic or Latino

Health Disparities Associated with Physical Disabilities:

As defined by the "Americans with Disabilities Act of 1990, As Amended (P.L. 110-325, available at: http://www.ada.gov/pubs/adastatute08.pdf), a disability means, with respect to an individual.

• A physical or mental impairment that substantially limits one or more major life activities of such individual;
• A record of such an impairment; or
• Being regarded as having such an impairment (as described in paragraph (3)).

Health Disparities Associated with Socioeconomic Status:

Poverty, as manifested by low income, may be defined as one of the following:

1. For the purposes of defining health disparities based upon low socioeconomic status, one definition of poverty is based upon the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. 9902(2). Individuals or families with an annual income below these published poverty guidelines may be defined as "low socioeconomic status" or in "poverty." These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels in the Federal Register, most recently on January 24, 2013 (available at: http://www.gpo.gov/fdsys/pkg/FR-2013-01-24/pdf/2013-01422.pdf).

2. Alternatively, poverty may be defined using the United States Census Bureau's poverty threshold, which varies by family size and composition. If a family's total income based upon the number of family members is below the poverty threshold, then that family and every individual in it is considered to be in "poverty." The most recent poverty threshold data may be found in Appendix B of "Income, Poverty, and Health Insurance Coverage in the United States: 2011" (available at http://www.census.gov/prod/2012pubs/p60-243.pdf).

Health Disparities Associated with Geographic Location:

For the purposes of this FOA, the definition of "rural" includes the following Federal Government definitions and any one definition is acceptable:
U.S. Census Bureau:

The U.S. Census Bureau defines "urbanized areas" as a continuously built-up area with a population of 50,000 or more. Outside of "urbanized areas," an "urban place" is any incorporated place or census designated place with at least 2,500 inhabitants. Thus, the U.S. Census definition of a "rural" place is one of exclusion, being any territory, population, and housing units that that the Census Bureau does not classify as urban. Therefore, a "rural place" is any incorporated place or census designated place with fewer than 2,500 inhabitants and is located outside of an "urbanized area." Under this definition, 19.3% of the U.S. population in the 2010 Census was considered rural while over 95% of the land area was classified as rural.

Office of Management and Budget:

Similar to the U.S. Census Bureau, the Office of Management and Budget (OMB) defines "rural" by what it is not. The OMB defines a "metropolitan statistical area" as at least one urbanized area (as defined by the U.S. Census Bureau) that has a population of at least 50,000.The OMB defines a "micropolitan statistical area" as at least one urban cluster (i.e., an "urban place," as defined by the U.S. Census Bureau) that has a population of at least 10,000 but less than 50,000 (definitions available at: http://www.whitehouse.gov/sites/default/files/omb/assets/fedreg_2010/06282010_metro_standards-Complete.pdf). Thus, all counties that do not meet the definition of a "metropolitan statistical area" or are not classified as either "metropolitan" or "micropolitan" are classified as "rural." Under this definition about 17% of the population in 2000 was considered Non-Metro while 74% of the land area was contained in Non-Metro counties

Office of Rural Health Policy:

The Office of Rural Health Policy (ORHP) accepts all non-metropolitan areas as rural. Additionally, ORHP uses an additional method for the determination of rurality, called the "Rural-Urban Commuting Area" (RUCA) codes. For more information on RUCAs, please see the following hyperlink: http://www.ers.usda.gov/briefing/Rurality/RuralUrbanCommutingAreas/. ORHP has classified tracts inside metropolitan counties with RUCA codes 4 - 10 as rural, as well as 132 large area census tracts with RUCA codes 2 or 3. Under this definition, approximately 20% of the US population and 91% of the land area are defined as rural.

In order to eliminate health disparities and to promote health equity, all proposals must include a plan for the measurement of health disparities. For the measurement of health disparities, applications should adhere to the methodological issues outlined by Keppel K, et al. 2005 (Keppel K, Pamuk E, Lynch J, et al. Methodological issues in measuring health disparities. National Center for Health Statistics. Vital Health Stat 2(141).2005. Available at: http://www.cdc.gov/nchs/data/series/sr_02/sr02_141.pdf). The Guidelines proposed by Keppel K, et al. are:

1. "When disparities are measured, the reference point should be explicitly identified and the rationale for choosing a particular reference point should be provided.

2. If comparisons are made between two groups, the more favorable group rate should be used as the reference point.

3. Disparities should be measured in both absolute and relative terms in order to understand their magnitude.

4. When relative measures of disparity are employed to compare disparities across different indicators of health, all indicators should be expressed in terms of adverse events.

5. Pair-wise comparisons are called for when the objective is to describe disparities between one or more individual groups and a specific reference point.

6. Summary measures can be used when disparities are measured for a domain of several groups and comparisons are to be made over time or across indicators, geographic areas, or populations.

7. Conclusions based on summary measures always should be interpreted in conjunction with the group-specific rates on which they are based.

8. The choice of whether to weight the component groups when summarizing disparity across a domain should take into consideration the purpose and application of the summary measures. In addition, implications with respect to other types of decisions, such as the choice of a reference point, need to be considered.

9. The size of the groups and the number of persons affected in each group should be taken into account when assessing the impact of disparities.

10. When the primary interest is in how health varies with the amount of the characteristic defining the domain, rather than with the groups themselves, summary measures of disparity that take into account the order of groups should be considered.

11. Whenever possible, a confidence interval should accompany each measure of disparity."

Research Strategy

As part of the Research Strategy for applications involving Human Research Subjects, the PD/PI must submit an evaluation plan for assessing the cultural competency and the quality of the intervention plan(s) of the PD/PI, all senior/key personnel and Other Significant Contributors from the target population's perspective. As described by The Commonwealth Fund's Cultural Competency and Quality of Care: Obtaining the Patient's Perspective" (available at: http://www.commonwealthfund.org/usr_doc/Ngo-Metzger_cultcompqualitycareobtainpatientperspect_963.pdf), the evaluation must address the five (5) domains:

1. Subject-Research communication.

2. Respect for subject preferences and shared decision-making.

3. Experiences leading to trust or distrust.

4. Experiences of discrimination.

5. Linguistic competency.

Finally, the PD/PI must state how the results of the target population's perspective of the cultural competency and the quality of the intervention plan(s) will be used to enhance the intervention so as to improve the cultural competency and, ultimately, to increase the living and deceased donor organ donations from the target population.

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:

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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.

Use the appendix to include the evaluation instruments as a single document entitled "Evaluation-Instrument.PDF."

If certification is earned by the PD/PI, all senior/key personnel and Other Significant Contributors as a result of training in cultural competence, please provide a copy of the certification in the Appendix as a single document entitled "Cultural Competence.pdf."

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout 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, NIH. Applications that are incomplete will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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?

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?

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?

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?

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

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.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 the Center for Scientific Review, 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. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. 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 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)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Lawrence Agodoa, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-1932
Email: agodoal@mail.nih.gov

Frank A. Hamilton, M.D.
Chief, Digestive Disease Programs Branch
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301- 594-8877
Email: hamiltonf@mail.nih.gov

Christine M. Hunter, Ph.D.
Director of Behavioral Research
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4728
Email: hunterchristine@mail.nih.gov

Marva M. Moxey-Mims, M.D.
Deputy Director, KUH Clinical Research
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7717
Email: moxeymimsm@mail.nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Carolyn S. Kofa
Grants Management Specialist
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7687
Email: kofac@mail.nih.gov

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.