Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov/) (No Longer participating per NOT-HS-12-009)

Components of Participating Organizations
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/)
National Cancer Institute (NCI) (http://www.nci.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
National Institute on Aging (NIA) (http://www.nia.nih.gov/)
National Institute for Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
National Library of Medicine (NLM) (http://www.nlm.nih.gov/)

Title: Understanding and Promoting Health Literacy (R21)

Announcement Type

This Funding Opportunity Announcement (FOA) is a reissue of PAR-07-018.

Update: The following updates relating to this announcement have been issued:

• March 1, 2013 - This PAR has been reissued as PAR-13-132.
• April 20, 2012 - See Notice NOT-HS-12-009. AHRQ Will No Longer Participate in the NIH Parent Funding Opportunity Announcements related to Understanding and Promoting Health Literacy.
  
• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
• September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.
• June 24, 2010 - See Notice NOT-TW-10-008 Notice to Highlight Current NIH Funding Opportunities that Promote Research on the Human Health Effects of Climate Change.

Program Announcement (PA) Number: PAR 10-135

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) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in http://www.grants.gov/applicants/apply_for_grants.jsp

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.226, 93.399, 93.837, 93.866, 93.286, 93.865, 93.173, 93.121, 93.113, 93.242, 93.361, 93.879

Key Dates
Release/Posted Date: March 12, 2010
Opening Date: May 16, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Due 30 days before application due date.
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 Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: May 8, 2013

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• 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 Health and Human Services public health priorities that are outlined in its HealthierUS and Healthy People initiative. Health literacy is defined 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.
• Mechanism of Support. This FOA will utilize the NIH Exploratory/Developmental (R21) grant mechanism and runs in parallel with FOAs of identical scientific scope, PAR-10-133 that encourages applications under the R01 grant mechanism, and PAR-10-134, that encourages applications under the R03 grant mechanism.
• Funds 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.
• Application Research Strategy Length: The R21 application Research Strategy section of the PHS398 may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Limits.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors Eligible Project 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/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.
• Number of PDs/PIs. More than one PD/PI, or multiple PDs/PIs, may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
• Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted.
• Application Materials. See Section IV.1 for application materials
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
• SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
• General information 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.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Background

The Department 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) Limited health literacy is a wide spread problem. Over a third of adults in the United States 77 million people would have difficulty with common health tasks, such as following directions on a prescription drug label or adhering to a childhood immunization schedule using a standard chart (U.S. Department of Health and Human Services 2009). Limited health literacy results in patients inadequate engagement in, and benefit from, health care advances as well as medical errors. Limited 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 emergency department use, higher prostate-specific antigen levels, higher mortality, and overall poorer health (Gazmararian, Baker, Williams, Parker, Scott, Green, Fehrenbach, Ren, & Koplan, 1999; Schillinger, Grumbach, Piette, Wang, Osmond, Daher, Palacios, Sullivan, & Bindman, 2002; Baker, Gazmararian, Williams, Scott, Parker,Green Wren, & Peel 2004; Wolf, Knight, Lyons, Durazo-Arvizu, Packard, Arseven, Arozullah, Colella, Ray, Bennet 2006; Baker, Wolf, Fineglass, Thompson, Gazmarian, & Huang 2007).

Health literacy is a complex phenomenon that involves individuals, families, health professionals, 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 management);
• 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, professionals 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 medical 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. . In addition, community residents need to be able to understand public health messages to take action to reduce potentially harmful exposures.

The Institute of Medicine has described health literacy as the result of multiple, complex social and individual factors (2004). These include complicated, cumbersome and unfamiliar ways health information often is presented to different audiences. Health care professionals may not communicate effectively with individuals with limited health literacy. For instance, achieving informed consent for treatment is difficult when health care personnel cannot explain biological processes or treatment procedures in clear language and patients are unfamiliar with medical terminology. The public may find it difficult to follow public health recommendations if they have not been provided with clear, actionable information. These situations hamper the effectiveness of medical and public health interventions and impede limit many health care consumers opportunities to make important and appropriate health care decisions.

Specific Objectives

Several institutes and offices within AHRQ 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, environmental exposure reduction, 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 application.

The research must involve at least one of the following:

• 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 improving 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 appropriate for this program announcement unless these investigations are integral to testing a significant research hypothesis related to health literacy. Studies with a sole focus of describing the association between health literacy and other factors (i.e., purely descriptive studies) will not be considered appropriate for this program announcement unless they also include one or more of the research approaches listed below.

Approaches:

A wide variety of research approaches are encouraged under this Program Announcement:

• Basic research to elucidate the mechanisms underlying health literacy and to determine the causal pathways that link health literacy to a behavioral outcome or to tease out the underlying components of health literacy, such as cognitive ability or other underlying constructs/skills integral to health literacy;
• 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);
• Methodological and measurement research to test theoretical models, refine research design and constructs and to develop, validate and improve methods and measures of health literacy including numeracy;
• Intervention research that develops and tests the effectiveness of strategies to improve informed decision making, health care, and/or heath outcomes for individuals with limited health literacy;
• Public health research to improve population health literacy and elucidate and measure the role of health literacy as a determinant of population health disparities;
• Implementation and dissemination that adapts and tests evidence-based practices and interventions in real world settings (health care systems, communities, etc.) and diverse populations.
• Secondary analyses of existing datasets as well as meta-analytic studies if addressing one or more research approaches listed above (e.g., meta-analysis evaluating intervention approaches);

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.

Priority Program Areas

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, communities and organizations or systems.

This Program Announcement invites applications to develop research on health literacy in general areas that include, but are not limited to, the following:

1. Nature and Scope

• Analyze and measure the mix of abilities and skills required to be functionally health literate (e.g., including 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 health literacy.
• 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 understood and conveyed.
• 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) and agency.
• 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).
• Analyze and evaluate alternate approaches to the design of medical and public health systems to facilitate consumer and patient access to and use of health information and services.

2. Lifespan and Cultural Differences

• Explore the developmental precursors of limited health literacy and the age-related changes in reading and other cognitive skills throughout the life course that may contribute to these difficulties.
• Identify the reading and oral language comprehension skills crucial for the satisfactory acquisition and understanding of basic health information by children, adolescents, and adults of various ages.
• 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 as interpreters?
• Explore whether the nature of limited health literacy among older adults differs from younger populations and test whether interventions are equally effective for different groups of older adults with regards to processing health information.
• 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 their impact.
• Explore cross-cultural and international differences in the determinants and consequences of health literacy.

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 verbal and 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 reduction behaviors)
• 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 of an intervention?)
• Examine how community health workers and promoters affect health literacy

4. Impacts and Consequences of Limited Health Literacy

• Examine the mechanisms through which limited health literacy contributes to health disparities.
• Analyze the role of health literacy in the prevention, management and treatment of chronic diseases or the reduction of environmental exposures.
• 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 and community-based participatory research.
• 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 adulthood.
• Assess the impact of limited health literacy on issues such as understanding of and adherence to health recommendations, consumer engagement in health care, use of health technologies, patient safety, medication errors, emergency preparedness, quality of care improvement.
• Calculate the cost of limited health literacy from social and organizational perspectives
• Investigate the role of health literacy in consumer ability to understand and act on decisions regarding the health and economic costs and benefits of different health services or treatment options.

5. Education and Training

• Explore the role of K-12 education systems in increasing levels of health literacy and improving health communication skills.
• Examine skill-based training programs that will impart skills and knowledge to health care providers and public health professionals 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?)
• Evaluate skill-based training programs for community health workers and promoters to improve health literacy.
• Determine which policies and technologies support the development, implementation and effectiveness of provider training experiences.
• Develop or evaluate approaches to increasing health literacy through adult education programs.
• Evaluate training programs that build skills of journalists to build health literacy of community residents.

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 appropriate levels).
• Identify effective strategies, practices and policies currently in use that can be disseminated immediately to promote health literacy across the various participants in the health care systems.
• 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.
• Investigate the ability of consumers to understand and navigate health insurance options and benefits and how this impacts use of health services and health outcomes.
• Test methods for disseminating, adapting and implementing effective health literacy interventions to new locations.

7. Methodology and Research Technology Development

• Assess the efficacy of current methods of health literacy assessment; develop, as needed, audience-appropriate methodologies to understand the prevalence of limited health literacy in different populations, the interaction of limited health literacy with other demographic and social factors, and the contribution of limited health literacy to healthcare costs and health outcomes.
• Identify effective approaches of combining qualitative and quantitative methods to further knowledge of health literacy.
• 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.)
• Identify patterns of how populations with varying health literacy access and use health information technology.

Examples of Research Topics

Several NIH components and the Agency for Healthcare Research and Quality (AHRQ) have joined together to support this Funding Opportunity Announcement (FOA). Applications should be relevant to both the objectives of the FOA and to at least one of the participating organization's research interests. Researchers are strongly encouraged to review the general research interests of the participating organizations and the examples of topics of interest specific to health/disabilities disparities, which are posted at http://obssr.od.nih.gov/scientific_areas/social_culture_factors_in_health/health_literacy/r21.aspx.

Additional Resources:

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

Reference Report:

The Institute of Medicine’s 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)

Literacy 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 announcement.

Section II. Award Information

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1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the Exploratory/Developmental Research Grant (R21) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts see SF424 (R&R) Application Guide). It also uses modular as well as 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 5.4, Modular Budget Component, of the Application Guide).

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The 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

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NO-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• 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
• 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)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Other(s):
  • Eligible Agencies of the Federal Government
  • Faith-based or Community based Organizations
  • Foreign Organizations (Non-domestic (non-U.S.) Entity

Note: Unlike NIH, AHRQ s authorizing legislation does not allow it to fund applications from for-profit organizations submitted under this Funding Opportunity Announcement

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted.

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.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA 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 follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

• Your organization 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.
• If your organization 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 registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual 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.
• The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
• This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons.
• Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY: 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.) PHS398 Research & Related Budget, for Non-domestic (non-U.S.) Entities (Foreign Organizations) only

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

• Request budgets in U.S. dollars;
• Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component). See NOT-OD-06-096;
• Not include any charge back of customs and import fees;
• Comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF;
• If appropriate, request funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment) (see NOT-OD-01-028, March 29, 2001);
• Comply with Federal/NIH policies on human subjects, animals, and biohazards; and Comply with Federal/NIH biosafety and biosecurity regulations (see Section VI.2., Administrative and National Policy Requirements. )

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: May 16, 2010 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): 30 days before application due date
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Helen Meissner, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
31 Center Drive
Building 31, Room B1C19
Bethesda MD 20892
Telephone: 301-402-1146
Fax: 301-402-1150
Email: [email protected]

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:

• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 6 pages. See Table of Page Limits.
• Preliminary data are not required but may be included if available.

Budget Component

U.S. applicants submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

R21 applications will use the modular as well as non-modular budget formats and "Just-in-Time" information concepts, with direct costs requested in $25,000 modules, up to the total direct costs limitation of $275,000 over an R21 two-year period. No more than $200,000 in direct costs will be allowed in any single year.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Not Applicable The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Foreign Applications (Non-domestic [non-U.S.] Entities)

Indicate how the proposed project has specific relevance to the mission and objectives of the IC and has the potential for significantly advancing the health sciences in the United States.

Inclusion of Estimated Travel Expenses in Budget

Application budgets must include funds for two investigators from each site to attend one meeting of grantees annually, to be held in the Washington, DC area.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a rating;
• Receive a written critique; and
• Receive a second level of review by the appropriate national advisory council or board.

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

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority 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 five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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/PIs, 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?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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.

Renewal Applications. Renewal applications are not permitted for this FOA.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), 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.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority 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 Agents 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 (Not applicable); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. 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.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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 NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

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.

3. Reporting

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

A final progress report, intervention statement, and Financial Status Report are required when an award is relinquished when a receipt changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Cindy Brach
Agency for Healthcare Research and Quality
540 Gaither Rd.
Rockville, MD 20850
Phone: 301-427-1444
Fax: 301-427-1430
Email: [email protected] (preferred)

Wen-ying Sylvia Chou, PhD, MPH
Health Communication and Informatics Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd. EPN 4046
Bethesda, MD 20892
Tel: (301)435-2842
Email: [email protected]

Peter Kaufmann, Ph.D.
Division of Epidemiology and Clinical Applications, Clinical Applications and
Prevention Program
National Heart, Lung, and Blood Institute
Building RK2, Room 8118
Bethesda, MD 20817
Telephone: 301-435-0404
Email: [email protected]

Jonathan W. King, PhD
National Institute on Aging
National Institutes of Health
Division of Behavioral and Social Research
7201 Wisconsin Ave., # 533
Bethesda, MD 20892-9205
Phone: (301) 402-4156
Fax: (301) 402-0051
Email: [email protected]

Brenda Korte, Ph.D.
National Institute of Biomedical Imaging & Bioengineering
6707 Democracy Blvd., Suite 200, MSC 5469
Bethesda, MD 20892
Telephone: 301-402-1231
Fax: 301-480-1614
Email: [email protected]

Lynne Haverkos, MD, MPH
Program Director, Pediatric Behavior and Health Promotion
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd., Room 4805G
Bethesda, MD 20892-7510
Telephone: (301) 435-6881
Fax: (301) 480-
Email: [email protected]

Amy Donahue, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communications Disorders
6120 Executive Blvd, EPS 400C MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
Fax: (301) 402-6251
Email: [email protected]

Ruth Nowjack-Raymer, MPH, PhD
Director, Health Disparities Research Program
Center for Clinical Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS-43F
Bethesda, Maryland 20892-6401
Telephone: (301) 594-5394
FAX: (301) 480-8322
Email: [email protected]

Liam R. O Fallon
National Institute of Environmental Health Sciences
KEYSTN/3067
MSC K3-12
530 Davis Dr.
Durham, N.C. 27713
Telephone: (919) 541-7733
Email: [email protected]

David M. Stoff, Ph.D.
Center for Mental Health Research on AIDS
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Blvd, Room 6210, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-4625
FAX: (301) 443-9719
Email: [email protected]

(Note: Appropriate NIMH contact for applicants interesting in promoting health literacy as it relates to HIV/AIDS)

David Chambers, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7133, MSC 9631
Bethesda, MD 20892-9631
Telephone: 301-443-3747
Email: [email protected]

(Note: Appropriate NIMH contact for applicants interested in promoting health literacy in the context of mental health services.)

Paul A Cotton, PhD, RD
Program Director, Office of Extramural Activities
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 402-6423
Fax: 301-451-5647
Email: [email protected]

Hua-Chuan Sim, MD
Program Officer
Division of Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Telephone: 301.594.4882
FAX: 301.402.2952
Email: [email protected]

2. Peer Review Contact(s):

Michael Micklin, Ph.D. Chief
Risk, Prevention, & Health Behavior Integrated Review Group
Division of AIDS, Behavioral and Population Sciences
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Rm. 3100 MSC 7808
Bethesda, MD 20892 (20817 for overnight delivery)
Tel: 301-435-1258
FAX: 301-594-6363
Email: [email protected]

3. Financial/Grants Management Contact(s):

Carol Harris
Grants Management Specialist
Division of Grants Managment
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1448
Fax: (301) 427-1462
Email: [email protected]

Crystal Wolfrey
Branch Chief
Cancer Control and Population Sciences Branch
Office of Grants Administration
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., Suite 243
Bethesda, MD 20892 (for regular mail)
Rockville, MD 20852 (for hand delivered mail)
Phone: (301) 496-8634
Email: [email protected]

Lesa McQueen, M.Sc.
Senior Grants Management Specialist
Grants & Contracts Management Branch
National Institute on Aging
7201 Wisconsin Avenue, Room 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: [email protected]

Florence Turska
Lead Grants Management Specialist
Office of Grants Management
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd. MSC 5469
Suite 900, Democracy II
Bethesda, MD 20892-5469
Phone: (301) 451-4782
FAX: (301) 451-5735
E-mail:[email protected]

Bryan S. Clark, MBA
Chief Grants Management Officer
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8A01A, MSC 7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Phone: 301-435-6975
Fax: 301-451-5510
Email: [email protected]

Christopher Myers
Division of Extramural Activities
National Institute on Deafness and Other Communications Disorders
6120 Executive Blvd, EPS 400B MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
Fax: (301) 402-1758
Email: [email protected]

Mary Daley Greenwood
Chief, Grants Management Officer
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd., Room 658 Mail Stop 4878
Bethesda, Maryland 20892-4878
Telephone: (301) 594-4808
FAX: (301) 480-3562
Email: [email protected]

Donald Ellis
Grants Management Specialist
NIEHS Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-11
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-7733
Fax: (919) 541-1874
Email: [email protected]

Rita Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd., Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: [email protected]

Mr. Andrew Diggs
Division of Extramural Programs
National Library of Medicine/NIH
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892-7968
Telephone: 301-496-4221
Fax: 301-402-0421
Email: [email protected]

Randi Freundlich
Office of Grants and Contracts Management
National Institute of Nursing Research, NIH
6701 Democracy Blvd, Room 710
One Democracy Plaza
Bethesda, MD 20892-4870 (courier use 20817)
Telephone : (301) 594-5974
Fax : (301) 402-4502
Email: [email protected]

Section VIII. Other Information

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Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance athttp://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.