Additional Overview Content

• The National Institutes of Health (NIH), through the participating Institutes, Centers, and Offices listed above, invite applications in support of research on mind-body interactions and health. "Mind-body interactions and health" refers to the relationships among cognitions, emotions, personality, social relationships, and health. A central goal of this program is to encourage interdisciplinary collaboration and innovation towards understanding the processes underlying mind-body interactions and health as well as towards the application of such basic knowledge to interventions and clinical practice in the promotion of health and the prevention or treatment of disease and disabilities.
• The total amount to be awarded depends on the scientific merit of applications and the funds available at the participating NIH Institutes/Centers.
• The anticipated number of awards is contingent on their scientific merit and the funds available in the general funding pool of the participating NIH Institutes/Centers.
• The type of mechanism is the Research (R01) Award. NIH Institutes and Centers may also accept applications for other mechanisms.
• Eligible organizations include for-profit and not-for-profit, public or private organizations, units of state and local governments, eligible agencies of the Federal Government, domestic or foreign institutions/organizations, faith-based or community-based organizations, and Native American tribal organizations.
• Eligible principal investigators are any individuals with the skills, knowledge, and resources necessary to carry out the proposed research.
• The number of applications each applicant may submit is unrestricted.
• The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone 301-710-0267, E-mail: [email protected].

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and 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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
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

1. Research Objectives

The Public Health Service has documented that many of the leading causes of morbidity and mortality in the U.S. are attributable to social, behavioral, and lifestyle factors (e.g., tobacco use, lack of exercise, poor diet, and drug and alcohol abuse). Numerous studies have also documented that psychological stress is linked to a variety of health outcomes, and researchers and public health officials are becoming increasingly interested in understanding the nature of this relationship. Research has shown, for example, that psychological stress can contribute to increased heart disease, decreased immune system functioning, and premature aging. Other research has demonstrated that cognitions (attitudes, beliefs values), social support, prayer, and meditation can reduce psychological stress and contribute to positive health outcomes. Consequently, over the past decade the National Institutes of Health have increased efforts to encourage and support health and behavior research (e.g., Innovative Approaches to Disease Prevention through Behavior Change, NIH Guide to Grants and Contracts, October 24, 1997; Maintenance of Behavioral Change, NIH Guide to Grants and Contracts, January 15, 2003). Mind-body research is viewed as one component of health and behavior research. In 1999, using funds especially appropriated by Congress to the OBSSR, the NIH issued a Request for Applications (RFA) for Centers for Mind-Body Interactions and Health (OD-99-005) and subsequently awarded five P50 Center Grants (http://obssr.od.nih.gov/Content/Research/Request_for_Applications_(RFAs)/mbpage.htm). On January 9 2003, NIH issued two related RFAs on Mind-Body Interactions and Health: Research Infrastructure Program (OB-03-004; see http://grants.nih.gov/grants/guide/rfa-files/RFA-OB-03-004.html) and Mind-Body Interactions and Health: Exploratory/developmental Research Program (OB-03-005; http://grants.nih.gov/grants/guide/rfa-files/RFA-OB-03-005.html). NIH issued a RFA on July 14, 2003 for research project grants (OD-03-008; http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-03-008.html). The current program announcement is based upon the July 2003 RFA.

During approximately the same time period, the NIH has commissioned a series of reports from the National Research Council and the Institute of Medicine, such as "New Horizons in Health: An Integrative Approach" (National Academy Press, 2001) and "Health and Behavior: The Interplay of Biological, Behavioral, and Societal Influences (National Academy Press, 2001). These reports include calls for expansion of interdisciplinary health research on mind-body topics. (See summary of recommendations at http://obssr.od.nih.gov/Publications/NRC-Reports.htm.)

Research Topics

Three areas of research are emphasized. In addition, special importance is given to mind-body research in diverse racial/ethnic and socioeconomic status populations (e.g., cultural beliefs regarding health and choice of treatments, such standard care vs. alternative or folk treatments; perceived racism and health; distrust of health care systems and health care utilization). The formation of multidisciplinary teams to perform the research of this initiative is viewed as essential.

1) The first area of emphasis is the effect of cognitions or personality (e.g., beliefs, attitudes, and values; modes of thinking) and of emotions on physical health. Included is research on social, psychological, behavioral, affective, and biological factors mediating these effects. What are the physiological, behavioral, and social pathways by which beliefs, attitudes, and values or particular stress- management interventions affect health? How do emotions, personality, and cognitions interact to affect health?

2) The second emphasis is on determinants or antecedents of health-related cognitions (beliefs, attitudes, or values; modes of thinking; decision-making styles). That is, given that some beliefs and attitudes have been shown to affect health, how are these beliefs, attitudes, and values developed, maintained, or changed?

Specifically, this program announcement encourages research that addresses issues such as: What contributes to individual differences in the beliefs, attitudes, and values that affect health and biological processes? How are health-related beliefs, attitudes, and values formed, maintained, and changed? How do social class, family, culture, disability, age, gender, or ethnicity influence health-related beliefs, attitudes, values, or cognitive styles?

3) The third is on how stress influences health, including: (a) basic research investigating how affect, attitudes, beliefs, and values influence perceived stress, individual differences in the biology of stress, and interactions between stress and behavioral risk factors for disease; (b) behavioral, affective, and biological mediators of the relationship between stress and health or disease, (c) the evaluation of mind-body interventions (e.g., relaxation-based, cognitive therapy, or support group) for physical illness and/or biological functioning, and (d) the translation of successful interventions into programs deliverable in clinical settings. These interventions may be examined alone or in conjunction with other stress management techniques.

Issues such as the following would be appropriate here: Through which psychological or physiological pathways do stress management approaches affect health? What are the effective components in successful stress- management practices? Does the combination of various stress management techniques improve outcome? Are particular stress- management interventions more effective for certain individuals, populations, or health outcomes? Can successful stress-management practices be effectively implemented in natural settings? What are the possible economic implications of utilizing stress management interventions? What are the factors that lead to individual differences in how stress is experienced and managed as well as in the health consequences of stress?

Examples of topics of interest specific to the Institutes that have joined with OBSSR in supporting this initiative are:

• National Cancer Institute
  NCI is interested in research that examines how interactions among environmental, psychosocial, immune, neuroendocrine, genetic, and other biological factors affect the disease, its treatment and side- effects, and/or outcome. Research may involve cancer detection, prevention, treatment, or survivorship. Examples of relevant topics include host differences, sickness behaviors (e.g., nausea, fatigue, depression), and biological factors impacting tumor growth or metastasis (e.g., DNA damage and repair, apoptosis, angiogenesis). Interdisciplinary research and research that includes integrative conceptual models are encouraged.

• National Center for Complementary and Alternative Medicine
  Mind-body medicine represents one of the major domains of complementary and alternative medicine (CAM). This domain includes CAM practices that intend to facilitate the mind's capacity to affect bodily functions, lessen symptoms of disease, and impact disease processes. These diverse practices are of interest to NCCAM and include, but are not limited to, certain lifestyle behaviors, such as tai chi chaun exercise; meditative strategies such as yoga and mindfulness meditation; psychological strategies such as stress management approaches; and spiritual practices such as prayer and related practices. In addition, many traditional medical systems, such as Traditional Chinese, Native American, and Ayurvedic Medicine, utilize mind-body CAM techniques. NCCAM is also interested in research on the placebo effect, expectancy, resilience, coping, and studies on practitioner-patient interactions. Specifically related to this PA, NCCAM is interested in research involving various CAM mind-body strategies that can help elucidate the mechanisms by which personality, cognitions, behaviors, emotions, beliefs and attitudes can affect physical health; and how and whether CAM mind-body interventions can enhance healing and reduce the physical manifestations of illness. Investigations of certain mind-body interventions, such as cognitive behavioral therapy and stress management techniques, may be of interest to NCCAM when such investigations incorporate particularly innovative aspects or when applied to unique populations or questions. NCCAM encourages CAM-related mind-body research that draws upon contemporary tools of neurobiology, neuroimmunology, and neuroendocrinology using state-of-the-art imaging, cellular, biochemical and molecular approaches. Details of NCCAM's 5-year strategic plan can be found at http://nccam.nih.gov/about/plans/2005/index.htm.

• National Heart, Lung, and Blood Institute
  The NHLBI supports behavioral research designed to investigate the relationship between psychosocial factors (e.g., depression, social support, hostility, stress, emotions) and diseases and disorders of the circulation, respiratory system, blood, and sleep, including the mechanisms that mediate these associations. Other areas include motivational, (e.g., beliefs, attitudes and values), emotional and cognitive processes involved in the formation, change, or maintenance of health related behaviors. The interactions of these processes with sociocultural and socioeconomic factors are also important. Finally, the study of gene /environment interactions is important. This includes not only the influence of genes on behavior, but also the neurohormonal pathways through which psychosocial factors influence gene expression. In all of these areas, translation of basic research into clinical applications is also encouraged.

• National Institute of Alcohol Abuse and Alcoholism
  The NIAAA is particularly interested in mind-body interactions as they may impact the prevalence and incidence of alcohol abuse and alcoholism; as they may be disrupted by alcohol use; and as they may play a critical role in recovery from alcoholism. Mind-body interactions of importance include, spirituality, motivation, and craving, as well as the effects of stress, alienation or stigmatization. For example, the role of spirituality in achieving and maintaining sobriety is widely acknowledged, but well-designed research is needed to determine the underlying mechanisms. Such studies may lead to new strategies to improve alcoholism treatment or enhance relapse prevention. We need to understand how mind-body interactions may influence the risk for harmful drinking or contribute to protective factors. Mind-body interactions may also influence progress through stages of change, help-seeking behavior, or readiness for cognitive- behavioral therapy. It is anticipated that such knowledge could be incorporated into more effective means of preventing and treating alcohol disorders among adolescents as well as adult populations. In addition, the NIAAA is committed to reducing alcohol-related health disparities in vulnerable populations. The mind-body interaction may enhance understanding of how reactions to stress, stigma, racism, and discrimination may influence the incidence of alcohol abuse and alcoholism.

• National Institute of Dental and Craniofacial Research
  NIDCR encourages studies that investigate mind-body interactions with regard to oral and craniofacial diseases and disorders or dental treatments. Examples include, but are not limited to, studies of the effects of beliefs, affective states, or stress on the immune system as related to the onset, progression, or treatment of oral diseases or conditions such as the periodontal diseases, caries, head and neck cancers, temporomandibular joint and/or muscle disorders, herpetic and apthous lesions, oral manifestations of HIV infection, or oral mucosal wound healing following oral surgery. Studies identifying linkages between changes in orofacial appearance or function and psychosocial outcomes are also of interest, as are studies of the psychosocial impacts of acquired or congenital craniofacial conditions (e.g., cleft lip/palate) or studies of the range of psychosocial impacts associated with head/neck cancers and ablative or other treatments. The NIDCR also encourages studies that integrate oral biomarkers into the evaluation of effects of stress-management or other therapeutic interventions. Changes in salivary composition and flow are examples of oral biomarkers shown to be relevant to stress and its physiological impact. The relative accessibility of the oral cavity provides unique opportunities for non-invasive studies of psychophysiological responses associated with positive or negative life events, acute or chronic stress-inducing conditions, and psychological characteristics or psychiatric conditions.

• National Institute of Environmental Health Sciences
  NIEHS is particularly interested in stimulating interdisciplinary research that seeks to prevent and reduce morbidity and mortality of environmentally induced diseases. In order to better understand the linkage between exposures to environmental agents and human disease, consideration should be given to behaviors that place individuals at risk of these exposures. NIEHS is interested in better understanding beliefs, knowledge, and attitudes associated with these exposures which will help elucidate the sources of body burden and allow scientists to design appropriate and effective strategies to reduce or eliminate exposure from one's environment. With regards to housing and the built environment where there are multiple environmental stressors (social, chemical, physical and biological), NIEHS is interested in exploring how these stressors impact health. New programs that seek to understand how health promotion activities (i.e. healthier nutritional choices, physical activity) and behavior change to reduce exposures can mitigate some of the untoward health outcomes in these environments are of particular interest. In general NIEHS is interested in exploring further the impact of social and economic factors on the health of the community and the individual, especially issues related to minority and immigrant communities who generally work in high injury and high stress jobs and live in substandard housing and environments. It is also important to NIEHS that these projects are able to communicate and disseminate their findings to have public health and policy impacts.

• National Institute of Mental Health
  The NIMH supports mind-body research that has central and explicit relevance to mental disorders or related disability. Intervention studies--including prevention, treatment, and rehabilitation--submitted to the NIMH under this announcement should primarily target mental disorder outcomes that are co-morbid with other physical disorders (e.g., heart disease, diabetes, cancer, asthma, etc.). Examples include preventing or treating mood or anxiety disorders in people with another physical disorder. Interventions may be pharmacological, behavioral, psychosocial, environmental, or a combination of these approaches. The NIMH also supports mind-body research to improve function and reduce disability in people with mental disorders, especially research on health behavior change in people with mental disorders.

• National Institute of Child Health and Human Development
  NICHD is particularly interested in interdisciplinary research projects examining mind/body interactions that influence child health and development, population processes and reproduction, and disability and rehabilitation in children and young adults. Studies are encouraged that: A) would focus on the interactions of the social context with family structure, relationships and support to influence the health, development and well-being of the population, especially children, adolescents and adults of reproductive age. Race, ethnicity, nativity, religious involvement, and socio-economic status are of particular interest as elements of the social context; B) would focus on the effects of mind/body interactions on male and female reproductive health in particular, menstrual cyclicity, ovulation, egg health and quality, semen quality, gonadal function, uterine environment, chronic pelvic pain, infertility and success of assisted reproduction; C) would focus on the influences on child health behavior and development such as: studies of stress, sleep, and pain in context of the immune system and illness; risk behaviors and health in terms of children's understanding of health, illness, religiosity, and spirituality; and childhood illnesses and complementary medicines; or D) would focus on the interactions of physical disability on the health of children and adults. Mind-body interactions such as: severity of disability and health status; severity of disability and family structure; beliefs and attitudes of health and physical disability; and, physical disability and stress in interacting with the environment.

• National Institute on Aging
  The NIA's mission is to improve the health and well-being of older Americans through research. The NIA is interested in a developmental life-course perspective of aging and mind-body effects on acute and chronic health, quality of life, functional capacity, and life expectancy/mortality. Research linking cognitive, affective, and/or perceived events (past, present or ongoing) to maintenance of health, function, and quality of life in older adults is desired. How diseases common in late-life (e.g. hypertension, Type II diabetes, osteoarthritis, Alzheimer's disease) are modulated by the interactions of (a) physiological and neurological mechanisms with (b) cognitive, affective, perceptual, and social factors experienced by the older individual is of high interest. Research on how mind-body processes affect health disparities is especially encouraged, as is multilevel, multi-system and interdisciplinary research. Illustrative examples include: mind-body effects on longevity; early life experiences mediated via mind-body interactions and their effects on late-life health; the pathways and mechanisms through which mind-body interactions modulate behavior and cognitive functions in older individuals; the modulatory effects of age upon mind-body process, especially in relation to stress and cognitive processes; mind-body effects that are predictive of adherence to and benefit from an intervention; the cumulative effects of stress on the health of the elderly; the impact of optimism, happiness, or a positive attitude on well-being and health; the cognitive impact of social exclusion and disruptions to social functioning on health; the percepts and affective responses to one's socioeconomic and occupational environment and their effects on health; and the cumulative impact of extreme stress on health in low resource/low income and in-transition countries.

• National Institute on Drug Abuse
  Behavioral and social sciences research plays an important role in the NIDA's search for solutions to the complex social and public health problems posed by drug abuse and addiction. These scientific disciplines provide NIDA with the knowledge necessary to better predict, prevent, and treat drug abuse and addiction problems. NIDA is interested in supporting research that investigates the role of cognitive and/or emotional variables mediating or moderating the development of drug abuse and addiction from the initiation of drug abuse ("chipping" or occasional drug use), the maintenance or continuation of drug taking behaviors (chronic abuse, including escalation to compulsive abuse and its associated negative consequences), relapse, and characteristics of sustained abstinence. The study of cognitive and/or emotional factors (e.g., self-regulation, beliefs, self-attributes, perceived risks or benefit), that influence vulnerability or resilience to drug abuse, is also of interest. Investigators may study responsivity to acute drug challenge, including the examination of how physiological, motivational or subjective responses to drugs of abuse are influenced by cognitive and emotional variables (e.g., expectancy, affective state, emotional context, etc.). Also appropriate would be studies examining cognitive and emotional variables (e.g., coping, emotional regulation, self-efficacy) in the context of treatment or preventive interventions (e.g., role in adherence or compliance). The study of decisions and other cognitive processes, and their associated neural substrates, which give rise to sexual risk behavior, is also an area of research interest. Studies on the influence of physiological indicators of stress, stress perception or stress reactivity on drug abuse vulnerability or clinical outcome, may be included in proposed investigations. NIDA has an interest in supporting research that investigates the epidemiology, prevention, and treatment of medical, behavioral, health, and other consequences of drug abuse, including but not limited to HIV/AIDS, hepatitis B, and STD's. Research of interest includes, for example, identifying how drug use affects the sensory perceptual system and cognitive abilities such as planning and organizing in terms of risk behaviors. Given that drug users and their sex partners account for a substantial proportion of new HIV infections in the US each year, studies to improve under- standing of the behavioral, social, and environmental mechanisms that facilitate HIV transmission and other infectious diseases among drug users are welcome. NIDA's focus on health promotion and disease prevention encourages researchers to investigate strategies for tailoring interventions to optimize their beneficial effects to determine which interventions work, for whom, and under what conditions.

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

1. Mechanism of Support

This funding opportunity will use the NIH Research (R01) award mechanism. The NIH ICs may accept applications for other mechanisms as well. Contact IC staff for specific information (Section VII.1). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

Applications received in response to this program announcement will compete for funds in the general funding pool of the participating NIH ICs. No specific funds have been set aside for this announcement. The number and size of the awards will depend on the number of applications received, their relative scientific merit, and the general availability of funds for investigator-initiated research at the participating ICs.

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 receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-04-040.

This section addresses considerations or factors that make an applicant or application eligible or ineligible for consideration. Applicants' failure to meet an eligibility criterion by the time of an application deadline will result in the return of the application without review. Applications for renewal or supplementation of existing projects are eligible to compete with applications for new awards.

1. Eligible Applicants

1.A. Eligible Institutions

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

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local governments
• Eligible agencies of the Federal government
• Domestic institutions/organizations
• Foreign institutions/organizations
• Native-American tribal organizations
• Faith-based or community-based organizations

Applications from foreign institutions must conform to the NIH's policy for foreign grants. See http://grants2.nih.gov/grants/policy/nihgps/part_iii_5.htm.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing or Matching
Not applicable.

3. Other-Special Eligibility Criteria
Not applicable.

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone 301-710-0267, E-mail: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms. Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See Section VI.2 Administrative Requirements for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times
Applications must be mailed on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): Not applicable
Application Receipt Dates(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

The NIH will not accept any application in response to this PA that is essentially the same as one currently pending initial 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. (See also Section VI.3. Reporting)

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 or competing continuation 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 or competing continuation 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Specific Instructions for Modular Grant Applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More Per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

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.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

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.

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. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources 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.

1. Criteria
Applications will be evaluated according to the standard criteria for scientific merit.

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:

• 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 priority score
• Receive a written critique
• Receive a second level of review by the appropriate national advisory council or board.

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

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.

1. 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?

2. 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?

3. 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

4. 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 principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable).

5. 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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 will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. 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

Announcements and awards will follow the standard schedule that is posted at http://grants.nih.gov/grants/funding/submissionschedule.htm. See Review and Award Schedule.

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm.

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

NGAs are sent via e-mail to the office of the Administrative Official named in item 12 on the Face Page of the PHS 398 (rev. 5/2001) application form.

2. Administrative and National Policy Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually: http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

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:

General Inquiries regarding the scope and content of this program announcement should be directed to:

Ronald P. Abeles, Ph.D.
Special Assistant to the Director
Office of Behavioral and Social Sciences Research
National Institutes of Health
Gateway Building, Room 2C234, MSC 9205
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: 301-496-7859
Fax: 301-435-8779
E-mail: [email protected]

Direct inquiries regarding research interests and topics of Specific Institutes and Centers to:

National Cancer Institute
Paige A. McDonald, Ph.D.
Basic Biobehavioral Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, Room 4062, MSC 7363
Bethesda, MD 20892-7363
Phone: 301-496-8776
Fax: 301-435-7547
E-mail: [email protected]

National Center for Complementary and Altnernative Medicine

Deborah Hayes, MS
Program Officer
Division of Extramural Research
National Center for Complementary & Alternative Medicine
National Institutes of Health (NCCAM/NIH)
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Ph: (301) 496-2583
Fx: (301) 480-1587
www.nccam.nih.gov

National Heart, Lung and Blood Institute
Jared Jobe, Ph.D.
Behavioral Medicine Research Group
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive - MSC 7936
Bethesda, MD 20892-7936
Phone: 301-435-0407
E-mail: [email protected]

National Institute of Dental and Craniofacial Research
Patricia S. Bryant, Ph.D.
Clinical, Epidemiology, and Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
45 Center Drive, Rm 4AS.43A
Bethesda, MD 20892-6402
Phone: 301-594-2095
Fax: 301-480-8322
E-mail [email protected]

National Institute of Mental Health
Donna Mayo, PhD
Program Chief
Functional Assessment in Mental Disorders
Program Chief
Behavior Change Research Program
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
Phone: 301-594-9483
Fax: 301-443-6000
E-mail: [email protected]

National Institute on Aging
Jeffrey W. Elias, Ph.D.
Individual Behavioral Processes Branch
Behavioral & Social Research Program
National Institute on Aging
Gateway Bldg., Suite 533
Bethesda, MD 20892
Phone: 301-402-4156
Fax: 301-402-0051
E-mail: [email protected]

National Institute on Alcohol Abuse and Alcoholism
Peggy Murray, MSW
Chief, Health Sciences Education Branch
Office of Research Translation and Communications
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3105, MSC 9304
Bethesda, MD 20892-9304
Phone: 301-443-2594
Fax: 301-480-1726
E-mail: [email protected]

National Institute on Drug Abuse
Ro Nemeth-Coslett, PhD
National Institute on Drug Abuse
Division of Treatment Research and Development
Clinical Neurobiology Branch
Neuroscience Center, Rm 4234 MSC 9551
6001 Executive Blvd,
Bethesda, MD 20892-9551
Phone: 301-402-1746
Fax: 301-443-6814
E-mail: [email protected]

National Institute of Environmental Health Sciences
Shobha Srinivasan, Ph.D.
Susceptibility and Population Health Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-21
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Phone: 919-541-2506
Fax: 919-316-4606
E-mail: [email protected]

National Institute of Child Health and Human Development
V. Jeffrey Evans, Ph.D., J.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8B07
Bethesda, MD 20892
Phone: 301-496-1176
Fax: 301-496-0962
E-mail: [email protected]

2. Peer Review Contact(s):
Not applicable.

3. Financial or Grants Management Contacts:

National Cancer Institute
Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, Maryland 20892
Phone: 301-496-8634
E-mail: [email protected]

National Center for Complementary and Altnernative Medicine
George Tucker
Grants Management Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Room 401, MSC 5475
Bethesda, MD 20892-5475
Phone: 301-594-9102
E-mail: [email protected]

National Heart Lung and Blood Institute
Tanya McCoy
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive - MSC 7926
Bethesda, MD 20892-7926
Phone: 301-435-0171
E-mail: [email protected]

National Institute of Dental and Craniofacial Research
Mary E. Daley
National Institute of Dental and Craniofacial Research
45 Center Dr MSC 6402
Bethesda, MD 20892-6402
Phone: 301-594-4800
Fax: 301-480-8303
E-mail: [email protected]

National Institute of Mental Health
Brian Albertini
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd, Room 6115, Mail Stop 9605
Bethesda, MD 20892
Phone: 301/443/0004
E-mail: [email protected]

National Institute on Aging
Traci Lafferty
Grants Management Specialist
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Phone: 301-496-8987
Fax: 301-402-3672
E-mail: [email protected]

National Institute on Alcohol Abuse and Alcoholism
Judy Fox
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Phone: 301-443-4704
Fax: 301-443-3891
E-mail: [email protected]

National Institute on Drug Abuse
Gary Fleming, J.D., M.A.
National Institute on Drug Abuse
Office of Planning and Resource Management
Grants Management Branch
6001 Executive Boulevard, Room 3131 MSC 9541
Bethesda, MD 20892-9541
Phone: 301-443-6710
Fax: 301-594-6847
E-mail: [email protected]

National Institute of Environmental Health Sciences
Susan Ricci
Grants Management Office
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-21
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Phone: 919-316-4666
Fax: 919-541-2860
E-mail: [email protected]

National Institute of Child Health and Human Development

Victoria Connors
Grants Management Team Leader
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8A17P
Bethesda, MD 20892-7510
Phone: 301-496-5482
Fax: 301-480-3780
E-mail: [email protected]

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 (45CFR46) 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, June 12, 1998: 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, 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.

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/guide/notice-files/NOT-OD-04-042.html). 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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal beginning with the October 1, 2004 receipt date, 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 new PHS Form 398; 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 that is available at 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 (see 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.

Public 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 public 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 PA 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.

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 PA 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 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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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NIH Funding Opportunities and Notices

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