Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.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 Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov )
Office of Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov)

Title: Understanding Mechanisms of Health Risk Behavior Change in Children and Adolescents (R21)

Announcement Type
This is a reissue of PA-04-121, which was previously released July 6, 2004.

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this 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 Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

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

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date (see Key Dates below); and

2) Applicants must complete a verification step in the eRA Commons within 2 business days of notification from NIH. Note: Since e-mail can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.

Program Announcement (PA) Number: PA-06-298

Catalog of Federal Domestic Assistance Number(s)
93.865, 93.361, 93.399, 93.837, 93.273, 93.279

Key Dates
Release/Posted Date: March 29, 2006
Opening Date: May 2, 2006
Letters of Intent Receipt Date(s): Not applicable
Application Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
AIDS Application Receipt Dates(s): Not applicable
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (Activation Date): Not applicable
Expiration Date: March 17, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

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. Sending an Application 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 Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Nature of the Research Opportunity

The National Institute of Child Health and Human Development, the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, the Office of Behavioral and Social Sciences Research, and the Office of Dietary Supplements invite research grant applications that will enhance our understanding of the factors and mechanisms that determine changes in health risk behaviors during childhood and adolescence. The concept of health risk behavior change is used in this program announcement to encompass the evolution of specific health impairing behaviors. Of particular interest are factors and processes that influence the initiation, continuation, and/or cessation of one or more of the following health risk behaviors: (1) substance abuse, (2) inadequate exercise and poor dietary practices as they relate to being overweight or obese, and (3) intentional and unintentional injuries. The terms "health risk behaviors" and "risky behaviors" are used interchangeably in this FOA.

The goal of this FOA is to promote optimal physical and mental health in children and adolescents. This may be accomplished by research to enhance our understanding of the origin, evolution, and termination of health risk behaviors and, ultimately, by the development of effective prevention and intervention strategies designed to maintain healthy behaviors and prevent health risk behaviors. Interdisciplinary research is sought to explore the biological, genetic, physiological, psychological, and social/environmental factors and mechanisms that influence health risk behavior change in children and adolescents. A better understanding of theory-driven, causal pathways and recognition of mediators and moderators will aid in the identification of the etiology of health risk behaviors, precursors of health risk behaviors, and associated risk and resilience factors. The research findings will have the potential to inform the development of more comprehensive and effective prevention and intervention strategies in the fields of substance abuse, obesity, and injuries.

Background

Many of the health risk behaviors of the 21st century result from voluntary behaviors such as unhealthy eating habits, the use of tobacco, alcohol or other drugs, and the failure to be physically active, maintain a healthy weight, or use safety equipment. Health risk behaviors, once considered the result of faulty decision-making, impulsive behavior, or characteristic of psychosocial development, are now recognized as dynamic conditions (some with genetic predispositions) evolving across the lifespan. Much research has been done to document various types of health risk behaviors, but little research has focused on understanding the mechanisms and contextual factors responsible for the process of behavior change. A biopsychosocial approach to the investigation of the mechanisms of health risk behavior change will explore the multiple spheres of influence provided by the individual, family, community, and society.

Childhood and adolescence are times of tremendous biological, cognitive, and psychosocial growth and development, taking children on a whirlwind trajectory from early childhood to young adulthood. Childhood and adolescence represent challenging targets for research aimed at understanding how health risk behaviors form; how they differ by individual, by ethnicity, and by gender; and the importance of genotype, phenotype, and the environment. Childhood offers a window of opportunity for the development of health promoting behaviors, but also represents a period of vulnerability for the formation of health risk behaviors. Further, transition points between childhood and adolescence are marked by widespread developmental changes in emotional, social, and cognitive development that may contribute to the development of health related behaviors in important ways. Health risk behaviors involve both genders and all socioeconomic, ethnic, and racial groups.

Limited research exists on isolating process variables and causal pathways involved in the initiation, treatment, and cessation of health risk behaviors. The development of effective prevention and intervention strategies for health risk behaviors should include theory-driven models and hypotheses, and the identification and evaluation of mediators and moderators involved in the behavior change process.

The Healthy People 2010 objectives for the nation relate to improvements in the following leading health indicators: physical inactivity, overweight and obesity, tobacco and other substance abuse, and injury and violence. The goal of Healthy People 2010, with its focus on prevention, is to achieve longer and healthier lives for individuals and the general population. Accomplishing this goal will be facilitated by the development of effective prevention programs based on an understanding of the motivations and determinants of health risk behaviors throughout childhood and adolescence.

Overview of Current Research and Theory

Health risk behaviors such as tobacco, alcohol and other substance use, unhealthy dietary behaviors, and physical inactivity are evident in childhood and have far-reaching implications for individuals, families, and communities. Young people are trying illicit drugs at early ages, with almost one in three individuals having first experimented with alcohol (other than a few sips) before the age of 13 years. Alcohol consumption is a leading contributor to accidents, homicides, and suicides, the three leading causes of teen death.

One in five youths has smoked a whole cigarette and one in ten youths has tried marijuana before turning 13 years of age. Cigarette smoking is the primary preventable cause of death in the United States. The majority of all American adult deaths results from cardiovascular disease and cancer, with many of the associated risk factors being initiated during adolescence. Substance abuse and the other health risk behaviors carry an enormous price tag in terms of the toll on life, quality of life, and economic costs.

Health risk behaviors are monitored by surveys such as the Youth Risk Behavior Survey (YRBS), which in 2001 showed that 10.5 percent of high school students were overweight, 67.8 percent did not attend physical education class daily, 28.5 percent had smoked cigarettes, and 78.6 percent had not eaten five servings of fruits and vegetables daily in the week preceding the survey.

During the 30 days preceding the survey, 14.1 percent of high school students had rarely or never worn a seat belt, 30.7 percent had ridden with a driver who had been drinking alcohol, 13.3 percent of students nationwide had driven a car or other vehicle one or more times after drinking alcohol, 47.1 percent had drunk alcohol, 17.4 percent had carried a weapon, and 23.9 percent had used marijuana. In the 2002 Monitoring the Future Survey, 11.3 percent of 12th graders were reported to have used illicit drugs other than marijuana in the month prior to the survey.

The United States is facing an epidemic of childhood obesity, with poor dietary behaviors and high rates of physical inactivity contributing to this preventable health condition. In 1999 in the United States, 13 percent of children ages six to 11 years and 14 percent of adolescents' ages 12 to 19 years were overweight. The prevalence of overweight has nearly tripled for adolescents in the past two decades. And, though rising rates of overweight and obesity affect all racial, ethnic, socioeconomic, and education-level groups, they have disproportionately affected African Americans, Hispanics, and individuals from lower-income and lower-education brackets.

One potential complication of obesity is type II diabetes mellitus, a condition also increasing by epidemic proportion. Other complications likely to follow the increase in obesity and type II diabetes include increases in cardiovascular disease, kidney failure, and blindness. Besides type II diabetes, overweight and obese children and adolescents are at risk of becoming overweight adults with problems of coronary artery disease, hypertension, stroke, respiratory problems, gallbladder disease, osteoarthritis, sleep apnea, and some forms of cancer. Obese individuals also face decreased productivity, social stigmatization, high health care costs, and premature death. Each year, 300,000 deaths in the U.S. are associated with obesity.

Physically inactive youth with low levels of cardiovascular fitness, high percentage of body fat, and large amounts of visceral adipose tissue have unfavorable cardiovascular risk profiles (e.g., low HDL, insulin resistance, and high triglycerides and LDL) which increase their risks of developing cardiovascular disease later in life.

Although physical activity can help prevent excessive weight gain, more than a third of all middle and high school students do not get the recommended 30 minutes of moderate physical activity on most days of the week. Regular exercise and participation in sports or physical education classes can have positive effects such as building and maintaining strong muscles and bones, controlling weight, and providing positive psychological benefits. Physical activity declines as children transition from childhood through adolescence. Children of lower socioeconomic status are less active than children of higher socioeconomic status and girls are less active than boys during adolescence.

Unintentional injuries are the leading cause of death for individuals from age one to 24 years. Motor vehicle crashes, fires, and poisonings injure and kill thousands of children each year, despite the fact that a number of effective preventive strategies exist. Understanding factors that influence children's decisions to wear seat belts and bike helmets, and identifying motivational aids to enhance their compliance with safety devices, will inform prevention and intervention strategies and subsequently reduce unintentional injuries and deaths.

For years, researchers have been intrigued by health risk behaviors and have expended extensive effort to observe, describe, predict, and prevent risky behaviors. Many health risk behaviors co-occur and co-vary in segments of the population, although the basis of the covariance is frequently unknown. Research is needed that moves beyond measuring variance in search of a comprehensive understanding of the processes and factors responsible for health risk behavior change. Numerous intervention and prevention programs have been implemented for substance abuse, physical inactivity, obesity, violence and injury prevention, yet the effectiveness in many cases has been limited and the results have been short term. It is apparent that providing factual information concerning the dangers and negative consequences associated with health risk behaviors is not sufficient to deter all individuals from participating in high risk health behaviors. Understanding why some individuals are risk takers, the timing of their health risk behaviors, and the factors that influence their decisions and actions are all important in advancing the field of child and adolescent health risk behavior.

Although a number of theories have been developed to explain adult behavior change, few have considered the multiple systems of influence and the complexity of their combined effects on behavior change in children and adolescents. Theoretical models relevant to health and risk behavior include the following: self-regulation theory (Kanfer, 1970), health belief model (Rosenstock, 1974), theory of reasoned action (Fishbein and Ajzen, 1975), subjective culture and interpersonal relations theory (Triandis, 1977), protection motivation theory (Maddux and Rogers, 1983), theory of planned behavior (Ajzen, 1985), self-determination theory (Deci & Ryan, 1985), transtheoretical model of behavior change (Prochaska, DiClemente, and Norcross, 1992), social cognitive theory (Bandura, 1994), and the ecological models (Sallis and Owen, 1999; Marshall and Biddle, 2001).

Behavioral change theorists have identified a number of factors believed to play important roles including attitudes, intentions, skills, emotions, self-standards, self-efficacy, social norms, intrinsic and extrinsic motivation, and environment. Neuroscientists are discovering more about the complex changes in neurobehavioral systems with underpinnings that control behavior and emotion. This Program Announcement welcomes the behavioral, biobehavioral, and neuroscience communities to engage in the search for causal pathways to health risk behaviors.

Research Scope

The health risk behaviors of interest to this FOA include: (1) substance abuse, (2) physical inactivity and poor dietary practices, and (3) intentional and unintentional injury. These topics were selected because each represents a significant risk to the health and well being of youth, with subsequent social and health implications during adulthood. These important health risk behaviors are amenable to short-term change in some cases and, at times, to long-term change. Additionally, these health risk behaviors have a high co-occurrence in individuals; it is important to understand factors that contribute to the development of each risky behavior independently, as well as the possible synergistic, additive, or dynamic interaction of these risk behaviors.

Studies of interest may be observational, epidemiological, interventional, secondary data analyses (i.e., analysis of existing data), and cost/benefit analyses. A multidisciplinary approach is encouraged and research findings from fields such as developmental pediatrics, psychology, behavioral science, neuroscience, neuropsychology, business, education, public policy, and others will be considered.

Health risk behaviors are influenced by a multitude of genetic, social, environmental, psychological, and physiological factors. Intrinsic factors such as genetic makeup, temperament, and memory of prior experiences combine with social and environmental factors to influence the physical, emotional, and intellectual development of an individual. Applicants are encouraged to expand upon current theories of behavior change and to consider techniques, strategies, and other models such as intrinsic and extrinsic motivation, motivational interviewing, feedback interventions, contingency management, social marketing, innovation diffusion, behavioral extinction, behavioral momentum/choice theory, contingency management techniques, behavioral economics, models of decision-making, and goal-directed behaviors. Numerous skills are involved in behavior change and should be considered for applications responding to this FOA. These skills include self-monitoring (self-awareness), goal setting (realistic and specific), cognitive restructuring, stress management, mental imagery, relapse prevention skills, time management, conflict resolution, assertiveness skills, decision making skills, and substituting healthy behaviors for unhealthy behaviors. Identifying skills absent or ineffective in health risk behaviors and also those that are linked to healthy behaviors will be helpful.

Both internal and external (contextual) factors contribute to an individual's propensity to engage in or refrain from health risk behaviors. What these factors are, how they interact, for whom, and when in the developmental trajectory, are all questions of importance in understanding health risk behaviors and behavior change.

Examples of research questions designed to fill gaps in our understanding of mechanisms and factors responsible for substance abuse, physical inactivity and poor dietary practices, and intentional and unintentional injuries include, but are not limited to, the following:

1. Biological Influences on Substance Abuse, Physical Inactivity and Poor Dietary Practices, and Injuries

2. Psychological Influences on Substance Abuse, Physical Inactivity and Poor Dietary Practices, and Injuries

3. Contextual Influences on Substance Abuse, Physical Inactivity and Poor Dietary Practices, and Injuries

4. Co-occurring Health Behaviors

The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism. Information on the R03 program can be found at http://grants.nih.gov/grants/funding/r03.htm.

See Section VIII, Other Information - Required Federal Citations for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. It also uses the 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).

Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.

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 Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The NICHD is not setting aside funds for this initiative. At this time, it is not known if this FOA will be reissued.

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 Program Announcement funding opportunity.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

PD/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 Started

2) Organizational/Institutional Registration in the eRA Commons

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

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

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 in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and 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: GrantsInfo@nih.gov.

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 and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

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 that, 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include 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

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

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the United States.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:May 2, 2006 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): Not Applicable
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s) http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the SO for the organization must verify the submission via Commons within 2 business days of notification of the NIH validation.

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. Information related to the assignment of an application to a Scientific Review Group is also 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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

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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

Renewal (formerly competing continuation or Type 2 ) applications are not permitted.

All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications:

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

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

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

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

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:

The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. 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 goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., Reporting.

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.

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 Contacts:

Lynne Haverkos, M.D., M.P.H.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B05, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6881
FAX: (301) 480-0230
Email: haverkol@mail.nih.gov

Amy L. Yaroch, Ph.D.
Health Promotion Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
National Institutes of Health
6130 Executive Boulevard, EPN Room 4074, MSC 7344
Bethesda, MD 20892-7344 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 402-8425
Fax: (301) 480-2087
E-mail: yarocha@mail.nih.gov

Charlotte Pratt, Ph.D., R.D.
Division of Epidemiology and Clinical Applications
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Room 8134, MSC 7936
Bethesda, MD 20892-7936
Telephone: (301) 435-0382
FAX: (301) 480-1669
Email: prattc@nhlbi.nih.gov

Cherry Lowman, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2051, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-0637
FAX: (301) 443-8774
Email: clowman@niaaa.nih.gov

Kathleen Etz, Ph.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5163, MSC 9589
Rockville, MD 20892-9589
Telephone: (301) 443-1514
FAX: (301) 443-2636
Email: etzk@mail.nih.gov

Yvonne Bryan, Ph.D., R.N.
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-6908
FAX: (301) 480-8260
Email: bryany@mail.nih.gov

2. Peer Review Contacts:

Not applicable

3. Financial or Grants Management Contacts:

Lisa Moeller
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5482
FAX: (301) 402-0915
Email: moellerl2@mail.nih.gov

Aida Vasquez
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243, MSC 7150
Bethesda, MD 20892-7150
Telephone: (301) 496-2736
FAX: (301) 496-8601
Email: vasquez@mail.nih.gov

Kieran Kelley
Senior Grants Management Specialist
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Room 7170, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0154
FAX: (301) 480-3310
Email: kelleyk@nhlbi.nih.gov

William Caputo
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3027, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-2434
FAX: (301) 443-3891
Email: bcaputo@mail.nih.gov

Gary Fleming
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: gf6s@nih.gov

Lawrence Haller
Office of Grants/Contract Management
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 402-1878
FAX: (301) 451-5652
Email: hallerl@mail.nih.gov

Section VIII. Other Information

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 IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 at http://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.

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.

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-02-005.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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) 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 DHHS 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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 or Health Systems Agency review. 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.

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