Understanding and Promoting Health Literacy (R21)

Understanding and Promoting Health Literacy (R21) is sponsored by National Institutes of Health (NIH). This program encourages methodological, intervention, and dissemination research for understanding and promoting health literacy, defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make …

Expired PAR-07-018: Understanding and Promoting Health Literacy(R21) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Participating Organizations National Institutes of Health (NIH) ( http://www.

nih. gov ) Agency for Healthcare Research and Quality (AHRQ) ( http://www. ahrq.

gov/ ) Components of Participating Organizations National Cancer Institute (NCI) ( http://www. nci. nih.

gov/ ) Lung, and Blood Institute (NHLBI) ( http://www. nhlbi. nih.

gov/ ) National Institute on Aging (NIA) ( http://www. nia. nih.

gov ) Institute for Biomedical Imaging and Bioengineering (NIBIB) ( http://www. nibib. nih.

gov/ ) Institute of Dental and Craniofacial Research (NIDCR) ( http://www. nidcr. nih.

gov ) National Institute of Environmental Health Sciences (NIEHS) ( http://www. niehs. nih.

gov/ ) Institute of Mental Health (NIMH) ( http://www. nimh. nih.

gov/ ) National Institute of Nursing Research (NINR) ( http://www. ninr. nih.

gov/ ) Office of Behavioral and Social Sciences Research (OBSSR) ( http://obssr. od. nih.

gov/ ) Title: Understanding and Promoting Health Literacy(R21) Update: The following updates relating to this announcement have been issued: March 12, 2010 - This PAR has been reissued as (PAR-10-135). This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond.

If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.

May 28, 2009 - See Notice NOT-OD-09-103 Error Correction Window Extended for Electronic Submission of NIH Opportunities with Due Dates Between May 25 and May 28, 2009. October 24, 2008 - See Notice (NOT-AG-09-001) Notice of NIA Participation. August 29, 2008 - See Notice (NOT-OD-08-108) Notice of Change in Agency Contact for Letters of Intent.

March 20, 2008 - See Notice (NOT-OD-08-046) The purpose of this notice is to clarify the research data sharing policy. April 18, 2007 - See Notice (NOT-OD-07-061) The purpose of this notice is to change an Agency Contacts and a Letter of Intent receipt date. NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.

gov ( http://www. grants. gov ) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants. gov/Apply for Grants (hereafter called Grants. gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV . Domestic Assistance Number(s) 93.

113, 93. 121, 93. 242, 93.

286, 93. 393, 93. 837, 93.

226 , 93. 361 Release/Posted Date: October 27, 2006 Opening Date: March 23, 2007 (Earliest date an application may be of Intent Receipt Date(s): April 24, 2007; December 24, 2007; August 22, 2008; April 24, 2009; December 24 , 2009 NOTE: On time submission requires that applications be successfully submitted to Grants. gov no later than 5:00 p.

m. local time (of the applicant institution/organization).

Application Submission/Receipt Date(s): May 24, 2007 ; January 24, 2008; September 24, 200 8 ; May 25, 2009; January 25, 2010 Peer Review Date(s): October November 2007; June July 2008; January February 2009; October November 2009; June July 2010 Council Review Date(s): January 2008 ; October 2008 ; May 2009 ; January Earliest Anticipated Start Date(s): February 2008; November 2008; June 2009; February 2010; November 2010 Additional Information To Be Available Date (URL Activation Date): Not Applicable Expiration Date: January 26, 2010 Purpose .

The ultimate goal of this program announcement is to encourage empirical research on health literacy concepts, theory and interventions as these relate to the U.S. Department of He alth and Human Services public health priorities that are outlined in its HealthierUS and Healthy People 2010 initiatives.

Health literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand basic health inf ormation and services needed to make appropriate of Support.

This FOA will utilize the R 2 1 grant mechanism and runs in parallel with FOAs of identical scientific scope, PAR- 0 7 - 020 , that solicits applications under the R0 1 grant mechanism , which will be issued at a later date , and PAR- 07 - 019 , that solicits applications under the R 03 grant mechanism. Available and Anticipated Number of Awards.

Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received. Budget and Project Period: The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.

The R21 is Eligible Organizations: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Small Business; For-Profit Organization (Other than Small Business); State Government; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Non-domestic (non-U.S.) Entity (Foreign Organization); Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Regional Organization; Other(s): Eligible agencies of the Federal government; Faith-based or community based organizations.

Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution 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.

Application and Submission Information : Applicants may submit more than one application, provided each application is scientifically distinct. Application Materials . See Section IV.

1 for application materials. Information . For general information on SF424 (R&R) Application and Electronic Submission, see these Application and Electronic Submission Information: http://grants.

nih. gov/grants/funding/424/index. htm on Electronic Submission of Grant Applications: http://era.

nih. gov/ElectronicReceipt/ Hearing Impaired . Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Part II Full Text of Announcement Section I. Funding Opportunity Section II. Award Information 2.

Cost Sharing or Matching 3. Other - Special Eligibility Criteria Section IV. Application and 1.

Request Application Information 2. Content and Form of Application Submission 3. Submission Dates and Times A.

Submission, Review, and B. Submitting an Application Electronically to the NIH C. Application Processing 4.

Intergovernmental Review 6. Other Submission Requirements Section V. Application Review 2.

Review and Selection Process A. Additional Review Criteria B. Additional Review Considerations D.

Sharing Research Resources 3. Anticipated Announcement and Award Dates Section VI. Award Administration 2.

Administrative and National Policy Requirements Section VII. Agency Contact(s) 1. Scientific/Research Contact(s) 2.

Peer Review Contact(s) 3. Financial/Grants Management Contact(s) Section VIII. Other Information - Required Federal Citations - Full Text of Announcement Section I.

Funding Opportunity Description of Health and Human Services, in its Healthy People 2010 initiative, defines health literacy as, the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. (Please see: http://www. healthypeople.

gov/document/HTML/Volume1/11HealthCom. htm ) Low health literacy is a wide spread problem, affecting more than 90 million adults in the United States (Institute of Medicine, 2004), where 43% of adults demonstrate only the most basic or below-basic levels of prose literacy (U.S. Department of Education, 2005).

Low health literacy results in patients inadequate engagement in, and benefit from, health care advances as well as medical errors. Low health literacy is likely to be a major contributor of adverse health outcomes (Agency for Healthcare Research and Quality, 2004; AMA, 1999; Baker, Gazmararian, Williams, Scott, Parker, Green, Ren, & Peel, 2002; Baker, Parker, Williams, & Clark, 1998).

Research has linked low or limited health literacy with such adverse outcomes as poorer self-management of chronic diseases, less healthy behaviors, higher rates of hospitalizations, and overall poorer health (Gazmararian, Baker, Williams, Parker, Scott, Green, Fehrenbach, Ren, & Koplan, 1999; Schillinger, Grumbach, Piette, Wang, Osmond, Daher, Palacios, Sullivan, & Bindman, 2002; Williams, Parker, Baker, Pitkin, Coates, & Nurss, 1995).

Health literacy is a complex phenomenon that involves individuals, families, communities and systems.

For instance, consumers, patients, caregivers, or other laypersons may vary with respect to: Access (e.g., to audience-appropriate information, media or professionals); Skills (e.g., to gather and comprehend health information; to speak and share personal information about health history and symptoms; to act on information by initiating appropriate follow-up visits and conveying understanding back to the information source; to make decisions about basic healthy behaviors, such as healthy eating and exercise; to engage in self-care and chronic disease Knowledge (e.g., of health and medical vocabulary, concepts such as risk, the organization and functioning of healthcare systems); Abilities (e.g., sensory, communication, cognitive or physical challenges or limitations); Features of health care providers and public health systems (e.g., the communication skills of health professionals, platforms employed for patient education, built environments and signage); Demographics (e.g., developmental or life stage, cultural, linguistic or educational differences that affect health beliefs, knowledge and communication) Too often people with the greatest health burdens have limited access to relevant health information.

In part, this is due to individuals limited abilities to fully interpret and understand complex health terminology and instructions. Limited numeracy can also impede the ability to make personal decisions related to risk, risk avoidance, and risk reduction.

For instance, to follow health care instructions, patients need to be able to comprehend written and oral prescription instructions, directions for self-care, and plans for follow-up tests and appointments. The complex and cumbersome ways health information often is presented also contribute to the problem. Health care professionals may not communicate effectively with individuals with limited levels of literacy.

For instance, achieving informed consent for treatment is difficult when health care personnel cannot explain biological processes or treatment procedures in simplified language and patients cannot interpret health information. These situations hamper the effectiveness of health professionals efforts to prevent, diagnose and treat medical conditions, and limit many health care consumers abilities to make important health care decisions.

Several institutes and offices within AHRQ, CDC and NIH have joined together to support this initiative. Applications should be relevant to both the general objectives of the FOA and to the specific research interests of at least one of the participating organizations.

Applications that address generic health literacy issues, but do not delineate clear relationships to the specific interests of at least one of the sponsoring organizations may not secure funding. Researchers are strongly encouraged to review the general illustrative examples of topics relevant to health literacy provided below, as well as the specific research interests of the participating organizations supporting this announcement.

Applications should address health promotion, injury or disease prevention, treatment or management of injuries, diseases or health conditions, and/or the improvement of health or health care outcomes within specific populations (e.g., children, the elderly, low income or vulnerable or underserved populations).

Prospective applicants are strongly encouraged to contact the relevant program administrator for this health literacy FOA as listed in Section VII, the Agency Contacts section of this announcement prior to preparing an The research must involve at least one Health literacy, or one of its many components, as a key outcome; Health literacy as a key explanatory variable for some other outcome; Methodological or technological improvement to strengthen research on health literacy; and/or Prevention and/or intervention strategies that focus on health-literacy Studies to develop, or evaluate, the readability or utility of specific materials that are intended for single uses or single audiences are not responsive to this program announcement unless these investigations are integral to testing a significant research hypothesis related to health literacy.

A wide variety of research approaches are encouraged under this Program Announcement: Basic research that investigates or describes the nature of health literacy and the magnitude of health literacy problems Applied research addressing issues pertinent to health literacy practices (e.g., systems level interventions) and research-in-practice (e.g., active potential end users participate as supportive research partners); models, refine research constructs, improve methods and measurements, and establish causal relationships (e.g., between low health literacy and lack of effective health promotion); Evaluation research that develops and tests the effectiveness of interventions, or adapts and tests existing programs (including those that are implemented by health care systems and systems outside of health care), to reduce low health literacy and its adverse consequences.

Secondary analyses of existing datasets as well as meta-analytic studies Multilevel, multidisciplinary, interdisciplinary, and transdisciplinary research is encouraged, especially studies that incorporate individual, family, community and societal mediators of health literacy in childhood and adulthood, or state-of-the-art health communication theory and knowledge.

Researchers are encouraged to address health literacy as it pertains to prevention, healthy living, chronic disease management, patient-based health care, cultural competence, and health disparities. Research questions can focus on consumers, patients, clients, providers, educators, and organizations or systems.

This Funding Opportunity Announcement (FOA) invites applications to develop research on health literacy in general areas that include, but are not limited to, the following: Identify the nature of the mix of abilities and skills required to be functionally health literate (e.g., including media and health care system navigation skills, etc.), and the roles of basic literacy (i.e., reading, writing, speaking, listening, visual interpretation skills) and mathematics abilities (e.g., graphical interpretation and other quantitative skills) in Examine the problems and factors involved in the presentation and interpretation of quantitative, qualitative and graphical information (e.g., graphic interpretation, risk or probability statistics, the influence of information context and information formats, etc.) from either the provider or user perspective, or investigate how specific health referents, such as basic genetics and/or environmental risk concepts, are best Create a conceptual model of health literacy or the skill sets that influence the comprehension of relevant health information (e.g., visual information comprehension skills that permit understanding of such visual messages as color-coding, representation of risk, or disease processes).

Evaluate the different strategies and channels available, including the role of information technologies, that enable consumers to seek, access, and interpret relevant health information effectively, and how these may differ by cultural and health literacy backgrounds (e.g., research on the information seeking or service utilization characteristics among health consumers with different levels of health literacy). 2.

Lifespan and Cultural Differences Explore the developmental precursors of low health literacy and the age-related changes in reading and other cognitive skills throughout the life course that may contribute Identify the reading and oral language comprehension skills crucial for the satisfactory acquisition and understanding of basic health information by children, adolescents, and Examine the role of social and cultural factors in the development of health literacy.

For example, how do children acquire health-related knowledge (e.g., through the media, family socialization) as they age, especially those children in households where their parents speak limited English and the children serve Explore whether the nature of limited health literacy among the elderly differs from younger populations and test whether interventions are equally effective for the Determine how intuitive or everyday notions of germs, contagions, environmental exposures, disease, drugs, bodily processes and other health-related concepts influence health literacy and consequent illness-prevention behaviors across the life-course, and identify age-appropriate intervention techniques that can be used to mitigate these problems.

Examine the nature and impact of irrational health beliefs that resist scientific evidence, identify social and cultural factors that reinforce or refute those beliefs, and explore strategies to influence those beliefs and/or mitigate 3.

Mediators and Moderators of Health Literacy: Protective and Risk Factors Examine how patients information seeking abilities and health information interpretation mediates or moderates the effects of provider practices on health literacy (e.g., how does patients use of print and electronic health information mediate or moderate their communication with providers?)

Examine how health care providers nonverbal communication influences patients comprehension and implementation of health-related information. Examine the influence of social, contextual, and environmental factors (e.g., urban versus rural, housing types, workplace features, social support and social network members, etc.) on health literacy outcomes.

Examine how media (including TV, radio, movies, newspapers, the Internet, and interactive systems) affect health literacy. How can different media be used to target communications most effectively with specific sub-groups of consumers varying in health literacy levels, age, race, ethnicity, disease, etc.?

Examine the factors that influence the desire for, or processing of, health literacy information (e.g., self-efficacy in decision making and/or financial planning, ease of cognitive access via intuitive and reasoning processes, coping and anxiety Examine how the design and structure of a health care system can support the information needs of consumers with different levels of health literacy.

Study the effects of technological innovations (e.g., simulations, interactive assessment tools, animations, virtual reality) on the understanding and retention of health information. Examine compensatory mechanisms of persons with limited health literacy (e.g., How do persons with limited health literacy make sure they are taking their medications correctly? Are these mechanisms harmful or fallacious, and if so, can they be corrected?

How might such mechanisms inform development 4. Impacts and Consequences of Low Examine the relationship between health literacy and health disparities. Analyze the role of health literacy in the prevention and treatment of chronic diseases.

Identify the relationship between health literacy variation and the ability to engage in informed decision making for a variety of health issues, such as chronic disease management, consumer-directed healthcare, or participation in clinical trials.

Evaluate the magnitude of the problems caused by low levels of health literacy, or by professionals lack of effective communication skills for adapting to the communication needs of consumers with differing levels of literacy.

Assess the role of health literacy as a mediator or moderator of health-care access across Assess the impact of low health literacy on issues such as patient safety, medication errors, emergency preparedness, quality of care improvement. Calculate the cost of low health literacy from social and organizational perspectives 5.

Education and Training Explore the role of K-12 education systems in increasing levels of health literacy and improving health Examine skill-based training programs that will impart skills and knowledge to the health care provider to be able to improve health literacy.

Evaluate undergraduate, graduate and in-service training curricula, including innovative approaches that aim that to adequately prepare provider groups (e.g., pharmacists, social workers, nurses, dentists, etc.) in communications with low literate patient populations (e.g., How does cultural competence effect provider communication skills?)

Determine which policies and technologies support the development, implementation and effectiveness of provider training experiences. Evaluate approaches to increasing health literacy through adult education programs. 6.

Health Systems Interventions Evaluate the effectiveness of health literacy interventions, directed at the general public, different audience segments, patients, providers, or the health care or public health systems, that seek to improve health literacy and patient outcomes (e.g., What health care systems designs support the information needs of consumers with different levels of health literacy?

How effective are interventions intended to increase the access of intended audiences to relevant health information and appropriate materials, such as print or audiovisual materials, Internet-based information, interpreters and translated materials, library information resources and services, and patient advocates?)

Determine the best methods of developing and disseminating effective information sources and materials for audiences with different levels of health literacy and from difference cultural backgrounds (e.g., How should prevention campaigns be designed to communicate with audiences with differing levels of health literacy effectively?)

Design and evaluate health literacy diagnostic and/or communication tools to help health care professionals identify, and communicate more effectively with, consumers with different levels of health literacy (e.g., Develop and assess tools and/or strategies to help make complex quantitative health information more understandable, such as technology tools for automatically converting health information to a variety of Identify effective strategies, practices and policies currently in use that can be disseminated immediately to promote health literacy across the various participants in Conduct cost/effectiveness analyses of various health literacy interventions.

Evaluate adaptation strategies used by providers and consumers to minimize health literacy problems, including systemic and cultural barriers, during provider-patient communications. Test methods for spreading effective health literacy interventions to new locations. 7.

Methodology and Research Technology Assess the efficacy of current methods of health literacy assessment; develop, as needed, audience-appropriate methodologies to understand the prevalence of low health literacy in different populations, the interaction of low health literacy with other demographic and social factors, and the contribution of low health literacy to healthcare costs and health outcomes.

Identify effective approaches of combining qualitative and quantitative methods to further knowledge of health Identify a core set of constructs, variables, and quantitative measures for conducting health literacy research.

Develop and pilot new tools and technologies to identify and overcome health literacy barriers (e.g., an assessment to distinguish, among persons with low literacy skills, those who have learning disabilities or communication disorders such as auditory processing, aphasia, or hearing loss).

In the context of understanding and promoting health literacy: develop technologies related to data reduction, data mining, and knowledge extraction; develop tools for meta-databases and integrative services to enhance the utility of existing databases; develop new methods or technologies for timely, appropriate communication of pertinent health information and knowledge at the point of care (e.g., as seen through the development of new telehealth technologies, or to enhance patient, doctor, or administrator decision-making regarding health literacy, etc.) Federally Qualified Health Centers (FQHCs) may provide a valuable resource to applicants interested in responding to this PA, particularly those that have an active collaboration with colleges and universities.

These FQHCs include Community Health Centers and Migrant Health Centers across the country. Information may be found at the DHHS Health Resources and Services Administration website for the Bureau of Primary Health Care: http://pubs. niaaa.

nih. gov/publications/datasys. htm The Indian Health Service (IHS) through its direct federal programs, Tribal programs and urban programs serves more than 1.

6 million American Indian and Alaska Native people. These programs may also be of interest to applicants. Information can be found at the IHS website at: http://www.

ihs. gov The Institute of Medicine s recent report, Health Literacy: A Prescription to End Confusion (2004), and the report, Literacy and Health Outcomes (2004), sponsored by the Agency for Healthcare Research and Quality, review the current body of knowledge about health literacy, and identify actions for the promotion of health literacy in society.

Potential applicants are encouraged to consult these reports as general references: Health Literacy: A Prescription to End Confusion (2004) Nielsen-Bohlman L, Panzer AM, Kindig DA (eds). Committee on Health Literacy, Board on Neuroscience and Behavioral Health, Institute of Medicine. (Available at: http://www.

iom. edu/report. asp?

id=19723 ) Liter acy and Health Outcomes (2004) Berkman ND, DeWalt DA, Pignone MP, Sheridan SL, Lohr KN, Lux L, Sutton SF, Swinson T, Bonito AJ. Agency for Healthcare Research and Quality. (Available at: http://www.

ahrq. gov/clinic/tp/littp. htm ) See Section VIII, Other Information - Required Federal Citations , for policies related to this This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism .

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data.

By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research. R21 mechanism is intended to encourage new exploratory and developmental research projects.

For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area.

These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism.

For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism. Information on the R03 program can be found at http://grants. nih.

gov/grants/funding/r03. htm . This FOA uses Just-in-Time information concepts.

It also uses the modular as well as the non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement .

Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 3.

4, Modular Budget Component, of the Application applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096 . Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) applications will not be accepted.

Applicants may submit a resubmission, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement) . Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. total project period for an application submitted in response to this funding opportunity may not exceed 2 years.

Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.

Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. 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. costs requested by consortium participants are not included in the direct cost limitation.

See NOT-OD-05-004 , November 2, 2004 . III. Eligibility Information 1.

A.

Eligible Institutions application(s) if your institution/organization has any of the following Controlled Institution of Higher Education 501(c)(3) IRS Status (Other than Institution of Higher Education) 501(c)(3) IRS Status (Other than Institution of Higher Organization (Other than Small Business) U.S. Territory or Possession American Tribal Government (Federally Recognized) American Tribal Government (Other than Federally Recognized) American Tribally Designated Organization (non-U.S.) Entity (Foreign Organization) Colleges and Universities (HBCUs) Colleges and Universities (TCCUs) A laska Native and Native Hawaiian Serving Institutions agencies of the Federal government or community based organizations Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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. This program does not require cost sharing as defined in the current NIH Grants Policy Statement . Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www. grants.

gov/Apply/ and follow the directions provided on that Web site. A one-time registration is required for institutions/organizations at both: Grants. gov ( http://www.

grants. gov/GetStarted ) Commons ( http://era. nih.

gov/ElectronicReceipt/preparing. htm ) PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons. Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as 1) Organizational/Institutional Registration in Grants.

gov/Get will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants. gov registration process. does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time.

A valid TIN or EIN is necessary for CCR validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days. regarding Grants. gov registration to: Grants.

gov Customer Support Business Hours: M-F 7:00 a. m. - 9:00 p.

m. Eastern Time 2) Organizational/Institutional Registration in the eRA Commons organization is already Commons-registered, see the " List of Grantee Organizations Registered in NIH eRA Commons. regarding the Commons registration to: Phone: 301-402-7469 or 866-504-9552 (Toll Free) Business hours M-F 7:00 a.

m. 8:00 p. m.

Eastern Time 3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants. gov. PD/PI account in the Commons and must be affiliated with the applicant organization.

This account cannot have any other