RELEASE DATE:  June 18, 2004

PA NUMBER:  PA-04-113

December 13, 2006 - The R01 portion of this funding opportunity has been 
replaced by PA-07-149, which now uses the electronic SF424 (R&R) 
application for February 5, 2007 submission dates and beyond.

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. 
A replacement R03 (PA-06-345) funding opportunity announcement has been issued 
for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter.

EXPIRATION DATE for R03 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 AIDS and AIDS-Related Applications: May 2, 2006 
Expiration Date for R01 Non-AIDS Applications: November 2, 2006 
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Child Health and Human Development (NICHD) ( National Institute on Drug Abuse (NIDA) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865, 93.279 This Program Announcement (PA) replaces PAS-00-108, which was published in the NIH Guide on June 22, 2000. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This Program Announcement (PA), jointly issued by the Demographic and Behavioral Sciences Branch (DBSB) and the Child Development and Behavior Branch (CDBB) of the National Institute of Child Health and Human Development (NICHD) and the National Institute on Drug Abuse (NIDA), invites research grant applications that seek to develop a comprehensive program of research focused on the mechanisms through which social, economic, cultural, and community-level factors, and their interactions, impact the early cognitive, neurobiological, socio-emotional, and physical development of children. Understanding the influence of these mechanisms is especially important for understanding the impact of public policies on the development of children at whom (or at whose families) these policies are often specifically targeted, notably children living in poverty or near the federal poverty line. Arenas of particular relevance within public policy include childcare, early childhood education, welfare reform, tax, social services, and family/work policies, as all of these shape the life experiences of children in poverty. Thus, a goal is for the research to develop data that would bear directly on these arenas and might thereby inform policies that impact child development, whether or not child development is the explicit focus of those policies. This PA extends the Science and Ecology of Early Development (SEED) initiative. RESEARCH OBJECTIVES Background Children's cognitive, socio-emotional, and physical development is unquestionably influenced by social, economic, cultural, and community-level factors, or the ecological context in which they grow up. However, at present, there is limited knowledge as to how these broader factors impact children's development. Research examining the link between child development and these factors is critical because this understanding is needed to inform policy development, including policies regarding childcare, welfare reform, early childhood education, and social services; these policies in particular have a large impact on poor families and their children. This program announcement is part of a larger collaborative effort among the following agencies: (1) U.S. Department of Health and Human Services [NICHD, NIMH, NIDA, Administration on Children and Families (ACF), Office of the Assistant Secretary for Planning and Evaluation (ASPE), and the Centers for Disease Control and Prevention (CDC)], and (2) the Department of Education (National Center for Education Statistics and National Center for Education Research in the Institute of Education Sciences; Office of Special Education Programs). The SEED program was launched by NICHD in 1997. In October 1998, the NICHD convened a planning conference for SEED that included scientists in developmental psychology, economics, education, evolutionary biology, medicine, and sociology. The purpose of this workshop was to discuss the issues involved in crafting a research agenda to examine ecological contextual factors in relation to children's development. The main themes that emerged included defining poverty across ethnic/cultural groups, unpacking the "poverty" box (i.e., focusing on mechanisms through which poverty affects child outcomes, developing better measures for poverty, separating out family characteristics that are often confounded with poverty (such as race/ethnicity and educational attainment), and developing theoretical models that incorporate the dynamic interaction between the various contexts (home, school, and neighborhood) in which children's developmental trajectories are shaped. Although there is now an expanding body of research on examining these ecological contextual factors in relation to children's development, there are still significant gaps in knowledge. These gaps are in part a reflection of the fact that much of this research remains discipline-specific and not well integrated across fields. Encouraging multidisciplinary and interdisciplinary research was a primary theme of the original SEED program. Thus, while much progress has been made in understanding the ecological context that influences children's development, there are still significant research questions that need to be answered. In general, there is a need to understand multiple outcomes of child development (cognitive, physical, social, and emotional) within the context of multiple factors (social, economic, cultural, and community-level), and understand how these factors interact across levels of family income, including those families living in poverty, at or near the federal poverty line, and those above the poverty line. A significant body of research has accumulated regarding children's cognitive, social, emotional, and physical development, and therefore the process of children's typical development in each of these areas, is fairly well understood. In each area the developmental course and appropriate milestones are relatively well established, and deviations from a normal course of development can be documented. Nonetheless, although much is known about child development, much of this research is limited in that it has been conducted without examining the influence of the ecological context in which children grow up. Specifically, in the bioecological model developed over the past 35 years by Bronfenbrenner and his colleagues, the mechanisms of development, called proximal processes, are known to be influenced by the elements of the child's proximal and distal environments. However, studying multiple levels of influence, developmental processes, and child developmental outcomes has proven to be a daunting task. To this end, there is a need for an understanding of the social, economic, cultural, and community-level factors, which alone and, more importantly, in combination, influence both the processes of development and child developmental outcomes. Relevant Contexts and Levels The social context in which children grow up, including family structure and relationships and peer networks, has long been thought to influence children's development. For example, a large body of research documents poorer developmental outcomes in children growing up with single parents. Considering the social context in which children develop is particularly important because major socio-demographic changes in community and family structure and population composition have taken place in the last two decades. For example, the increase in the rate of maternal labor force participation, the parallel increase in the enrollment of children in non-parental care, and the rapid decline in the proportion of married two-parent families have created different challenges and opportunities for families. Today's families are likely to have complex and shifting family structures, highly diverse ethnic and linguistic backgrounds, and often have uneven education and employment. These issues are even more complex for poor families as, for example, the majority of poor children live in one-parent households and the poverty rate for one-parent families is higher than for two-parent households. Economic factors, such as family resources and income, parental education, availability of public assistance, and employment, also appear to shape the context in which children develop. These factors are increasingly important to consider in child development, as changes in welfare reform, health care, and child welfare have taken place in the last decade. Communities also have undergone drastic changes. In this era of globalization and the emergence of the "network society," concentrated urban poverty and related dimensions of economic disadvantage, such as racial and ethnic exclusion, have affected child development in ways that are not fully documented. Families living in rural communities face a different set of complex economic challenges due to shifts in the economy, especially farming and migrant workers. Parental drug abuse is an example of the importance of considering the joint effects of social and economic context. Research suggests long-term associations between parent drug abuse and deleterious developmental outcomes (e.g., insecure attachments, failure to resolve developmental tasks, psychological dysregulation, affiliation with deviant peers, suicide, and homelessness). Substance-abusing parents are likely to live in poverty and likely to have a chaotic lifestyle organized around drug-related activities. This lifestyle can put the parents and their families in dangerous situations and may lead to forced parent-child separations due to incarceration, drug- related illness, or death. There are also numerous community-level issues that affect children's lives and development, including available neighborhood and community resources, neighborhood crime (such as drug-related activities), and the quality of schools. For example, the quality of preschool programs influences children's school readiness and the quality of public schools affects early academic outcomes across content areas. Racial segregation at the community level, particularly when coupled with economic disadvantage, also is likely to play an important role in influencing development. The cultural contexts in which children develop also influence developmental outcomes. Ethnic and cultural beliefs and attitudes, religion and spirituality, and cultural norms and expectations (including those about family structure and roles) play a role in children's lives that is not well understood. In addition, there have been major shifts in the cultural context in which children grow up. The influence of the media in shaping cultural context, and its implications for child development, are poorly understood. Very little research has been conducted on the role of religion and family religious participation in child development. Increasing racial and ethnic diversity and income inequality in the US population add further complexity to the cultural environment that enfolds children growing up in the US today. Public policies may impact child development, whether or not they are actually aimed at children. While some public policies have a direct impact on the child's immediate environment (e.g., legislating class size, adult-to-child ratios in child care, healthcare, etc.) other policies are likely to affect children through their impact on more distal elements of the child's world (e.g., policies concerning workplace leave, TANF, drug-related incarceration, etc.). During the 1990s, welfare reform experiments and policy shifts sought to reduce welfare caseloads by increasing child-support payments from non- custodial parents and increasing employment for poor single mothers. Research suggests that these changes have led to higher employment rates among women leaving welfare dependency and stabilized the level of child-support payments, which otherwise would have been significantly less. Other research has examined the effects of these policies on children and has found, for example, mixed outcomes for children related to parental welfare transitions, either on or off welfare and into or out of paid work. Additional research has shown that court-awarded child support encourages increased contact between non- resident fathers and their children. Schooling policies are another important context for child development. Children, particularly minority students, assigned to smaller classrooms perform better academically than those who in larger classes. In terms of social development, children are less likely to have racially segregated friendship networks when structured settings such as classrooms and extracurricular activities are integrated. However, integration policies at levels higher than that of the classroom or activity do not always have the intended effect. Racially based busing is associated with greater segregation, suggesting that negative family and community reaction to policies at the level of the school district may impact student relations and require that busing be accompanied by within-school integration activities. Interactive Nature of Contexts and Cross-Level Interactions Understanding the influence of these social, economic, cultural, and community-level factors, and their interactions, on child development is critical for determining effective means of improving child development outcomes. This is particularly critical to consider for children who are growing up in poverty, as these children are especially at risk for problems in physical health and cognitive and socio-emotional development. Poverty among children is associated with an array of problems, including low birth weight, infant mortality, contagious diseases, and childhood injury and death. Poor children are at risk for developmental delays in intellectual development and school achievement. Compared to non-poor peers, poor children tend to have lower average levels of school-related skills and their progress through school is slower and more subject to termination from dropout. Poor children also have relatively high rates of social, emotional, and behavioral problems, including anxiety, social withdrawal, aggression, and delinquency; lack of self-esteem and self-efficacy; and psychological distress. Nevertheless, not all poor children develop these problems, as many are healthy, intellectually productive, and socially well adjusted. This variation in outcomes suggests the existence of social, economic, cultural, and community-level influences that serve as protective or risk factors for children in poverty. In summary, there is a need to establish a body of research that examines the ecological contexts in which children grow up and the factors that either positively or negatively influence child development outcomes. While these issues are important for all children, they bear directly on children in poverty, as development and/or implementation of policies can often drastically change the environment in which poor children live. Research on these topics involves significant scientific challenges. Ecological factors thought to influence child development tend to be interrelated and also correlated strongly with individual-level characteristics of families and children. Correlations between parental circumstances and behaviors and child outcomes may reflect common biological endowments as well as social influences. Moving from correlation to cause and effect requires innovative theory and data, the development of creative study designs and methodologies, utilization of complex data analytic strategies, and the accumulation of knowledge across different approaches. However, advances in research methodology and data analyses, often in diverse disciplines, provide promise in disentangling the effects of interrelated, often hierarchically structured, contextual variables. Objectives and Scope This initiative solicits studies that focus specifically on research on the social, economic, cultural, and community-level factors that affect developmental processes and outcomes for children living in poverty, and that draw on current theoretical and methodological advances in social, behavioral, and biobehavioral research. Specifically, this initiative encourages research that: (1) is multidisciplinary or interdisciplinary; (2) uses existing sources of data and/or justifies new data collection efforts; (3) uses longitudinal, experimental, or comparative designs; and (4) has relevance for public policy, particularly in the areas of childcare, early childhood and primary/secondary education, welfare reform, tax reform, social services, and family/work policies. Populations of interest include diverse children of all ages, with a focus on understanding how the ecological context in which children in poverty grow up influences early development in the short term, or long-term trajectories stemming from early development. Outcomes of interest include cognitive, socio-emotional (e.g., temperament, behavior, character development, interpersonal relations), and physical development and trajectories. Research Priorities and Examples of Research Questions The following research priorities and examples of research questions are offered to illuminate areas of particular interest to the NICHD and NIDA. In general, these institutes seek studies that are intended to identify, describe, and potentially inform and launch interventions based upon the processes underlying the relationships between poverty status and child outcomes. Examples of research questions that address the objectives of this PA include, but are not limited to: o What are the effects of welfare reform on childcare, social services, and family structure, and how does this have an impact on child development? o What are the emotional and behavioral problems and disorders experienced by children living in poverty? o How does access to health insurance impact child development and do different sources of insurance have different impacts? o How do parents' relationships with each other influence child development? o How does drug abuse by family members, particularly parents, affect children's developmental outcomes? o How do parent drug use, child maltreatment, and subsequent unhealthy attachments between parent and child shape developmental outcomes? o How do housing policies affect child development and/or risk for emotional and behavioral disorders in poor children via housing quality, quality of life, and residential stability? o In what ways do educational institutions affect peer influences that shape developmental, behavioral, and educational outcomes? o How do parent drug abuse and poverty impact developmental outcomes that may be risk factors for later drug abuse (e.g., cognitive, emotional, and behavioral dysregulation, particularly conduct disorder and post-traumatic stress disorder)? o How does ethnic/racial homogeneity in neighborhoods affect cultural and economic processes relevant to child development and does this vary by nativity and race/ethnicity? o How does family/parental stress mediate the impact of ecological factors (e.g., policy, crime, poverty) on child development outcomes? o To what extent do neighborhood characteristics (cohesion, "collective efficacy," poverty, family composition) affect child development outcomes once individual family effects are taken into account? o How does access to public assistance funds for childcare and social services interact with family factors, such as employment and childcare decision- making, and how do these forces act directly or indirectly on child development outcomes? o What qualitative aspects of parental work impact child development, and can community factors moderate these relationships? o How do religion and family religious participation affect child development, behavior, or health, and can they offset the negative impact of other deficits in the child's environment? o How does the context of poverty interact with biological factors in development, and do selected aspects of that context differentially impact neural and psychophysical developmental systems? o What are the mutual influences of physical health, genetics, and nutrition on child outcomes and how do conditions of poverty interact with these factors? How do children's age, gender, and temperament interact with parents' characteristics to influence parenting patterns that affect child development? o What are the child characteristics (e.g., temperament) and family factors (e.g., sibling bonds) that put children at greater risk or protect them from the effects of harmful ecological factors, such as poverty combined with parent psychopathology and/or drug abuse? Across these and other research questions, this PA is intended to support investigations that examine the processes underlying relationships between living in poverty and child outcomes. An understanding of the relevant pathways and mechanisms will lead to improvements in interventions aiming to reduce the risks associated with poverty and promote positive developmental outcomes for children in disadvantaged contexts. MECHANISM OF SUPPORT This PA will use the NIH Research Project Grant (R01) and Small Grant (R03) award mechanisms. Please follow the guidelines for the R03 as described in the NIH Small Grant Program Announcement ( As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her 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. SPECIAL REQUIREMENTS It is the intention of the SEED program to support projects that will accumulate information that not only furthers the scientific understanding of child development from an ecological perspective, but also informs public policy. Therefore, Principal Investigators from projects funded under the SEED initiative will be expected to engage in an interactive, collaborative process; each participating Principal Investigator will be expected to participate in workshops and conferences designed to further the research/public policy dialogue. The co-sponsors of the SEED program encourage the participation in these activities of junior scholars who might develop links with researchers to explore training opportunities. Annual Meeting for Investigators Principal Investigators will be expected to attend an annual SEED Investigators Meeting to share findings, research approaches, and core instruments or data elements. Applicants should include in the application’s budget request, sufficient funds to support travel for the Principal Investigator to one two-day meeting in Washington, DC, in each of the requested years of support. NIH SEED investigators will interact with staff from SEED agencies and their contractors and grantees at these events. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Rosalind King, Ph.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6986 FAX: (301) 496-0962 Email: Kyle Snow, Ph.D. Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-2307 FAX: (301) 480-0230 Email: Jessica J. Campbell, Ph.D. Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Suite 5174, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 402-1850 FAX: (301) 480-2543 Email: o Direct your questions about financial or grants management matters to: Rashawn L. Farrior Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-7010 FAX: (301) 402-0915 Email: Christine A. Kidd Grants Management Branch National Institute on Drug Abuse 6101 Executive Boulevard, Room 270, MSC 8403 Bethesda, MD 20892-8403 Telephone: (301) 435-1372 FAX: (301) 594-6849 Email: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). 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 DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS: Applicants for the NIH Small Grant (R03) should follow the guidelines described in the NIH Small Grant Program Announcement ( APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant 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 includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least six 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) Identify, in a cover letter sent with the application, 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 SENDING AN APPLICATION TO THE NIH: 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 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at The CSR 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 CSR 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 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures ( will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o 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 o Receive a written critique o Receive a second level review by the appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The 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 be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator 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 (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will 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 criteria included in the section on Federal Citations, below.) 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 Inclusion Criteria in the sections on Federal Citations, below.) ADDITIONAL CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their 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 priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS 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 ( 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 - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (; a complete copy of the updated Guidelines is available at 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 RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects 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 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 proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at 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 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. 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at 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 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.

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