RFA-DA-01-008: HEALTH DISPARITIES: DRUG USE AND ITS ADVERSE BEHAVIORAL, SOCIAL, MEDICAL, AND MENTAL HEALTH CONSEQUENCES

Department of Health
and Human Services (HHS)

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HEALTH DISPARITIES: DRUG USE AND ITS ADVERSE BEHAVIORAL, SOCIAL, MEDICAL, AND MENTAL HEALTH CONSEQUENCES Release Date: January 15, 2001 RFA: RFA-DA-01-008 National Institute on Drug Abuse (http://www.nida.nih.gov) Letter of Intent Receipt Date: March 16, 2001 Application Receipt Date: April 16, 2001 THIS REQUEST FOR APPLICATIONS (RFA) USES THE "MODULAR GRANT" AND "JUST-IN- TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICAITONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE This RFA is a part of the National Institutes of Health-wide initiative to eliminate health disparities in racial and ethnic minority populations. It builds on the National Institute on Drug Abuse’s (NIDA) efforts over the past several years to understand better and address drug abuse and addiction among and across racial and ethnic minority populations. It is designed to stimulate epidemiological, prevention, treatment, and services research that addresses issues relating to the differential drug use patterns and/or their associated behavioral, social, medical, and mental health consequences within and across racial and ethnic minority populations. For purposes of this announcement, health disparities research is defined as research that addresses differential incidence and prevalence rates of drug use and its adverse behavioral, social, and health consequences among and across racial and ethnic minority populations. This RFA encourages multidisciplinary research that expands scientific understanding of the etiology of drug use and progression to addiction in racial and ethnic minority populations and the relationship between drug use and its adverse behavioral, social, and health consequences. The overall intent of this announcement is four-fold: 1) to build a theoretical framework to further understand the phenomenon of disparities in drug use and its associated adverse behavioral, social, and health outcomes within and across racial and ethnic minority populations, 2) to develop an understanding of within and across group drug related health disparities, 3) to develop and evaluate prevention and intervention strategies aimed at reducing and eliminating drug-related health disparities across and within racial and ethnic populations, and 4) to understand how the management of resources and organization of community, public and private health systems impacts upon the access to and utilization and retention of racial and ethnic minority populations in drug abuse prevention treatment services. 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 RFA, "Health Disparities: Differential Drug Use and Its Adverse Behavioral, Social, and Health Consequences," 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project (R01), small grant (R03), and exploratory/developmental (R21) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one- time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2001. The small grant (R03) is limited to 2 years, the exploratory/developmental grant (R21) is limited to 3 years, and the R01 is limited to 5 years. The R03 and R21 are non-renewable and limited in direct cost amount per year (R03, $50,000, R21, $100,000). The R03 mechanism gives funding priority to newer, less experienced investigators, or investigators at institutions without well-developed research traditions and resources, or experienced investigators wishing to change research directions or test new methods or techniques. The R21 mechanism is intended to encourage exploratory research projects with sound methodology and strong rationales in underdeveloped research areas of drug abuse, such as the areas covered in this RFA. Investigators may also choose to include methods development as one component within any of the other mechanisms. Specific information on individual research mechanisms can be obtained from the NIDA home page at http://www.nida.nih.gov/Funding.html. FUNDS AVAILABLE NIDA intends to commit approximately $2,000,000 in FY 2001 to fund 7-9 new and/or competitive continuation awards in response to this RFA. Because the nature and scope of the research proposed under this announcement may vary, it is anticipated that the size of each award will also vary. Awards made under this RFA are dependent upon the availability of funds. Only applications of high scientific and technical merit will be considered for funding. RESEARCH OBJECTIVES Background: Drug addiction poses unique challenges to researchers, scientists, health practitioners, and public health officials in search of effective intervention strategies. Addiction is a stigmatized disease, which disproportionately affects racial and ethnic minority populations and makes it difficult to access preventive and treatment services. Studies indicate, for example, that despite reports of lower drug use rates, racial and ethnic minority groups tend to be over-represented among those who suffer from adverse health, behavioral, and social consequences related to drug use (e.g., HIV/AIDS, premature births, low birth-weight, intentional and unintentional injuries, violence, crime, arrest, incarceration, educational attainment, premature death, and other co-morbid conditions [includes co- morbidity associated with mental health conditions and physical illnesses/conditions]). African Americans and Hispanics continue to be heavily affected by the HIV/AIDS epidemic. In 1999, more than three fourth (i.e., 79%) of the new drug-related AIDS cases reported to the Centers for Disease Control and Prevention were from members of minority ethnic groups. Moreover, African American and Hispanic women comprised more than two thirds (i.e., (67%) of the reported cumulative drug-related AIDS cases among women through 1999. Drug-related behavioral adverse outcomes have also been found to be disproportionately distributed across racial and ethnic minority groups. For example, youth violence continues to be a major public health concern. While homicide rates among 15-19 year olds have been declining since their record levels in the early 1990s, they remain unacceptably high. Homicide is the leading cause of death among African American youth between the ages of 15-24 and the second cause of death among Hispanics in this age group. Achieving a better understanding of the causal mechanisms underlying the violence-drug nexus among and across racial and ethnic minority youth presents a great challenge for scientists. There are disparities in risks for chronic disease and injury among racial and ethnic minorities. These risks include access to health care, health status, health risk behaviors, and use of clinical preventive services among others. Racial differences have been reported in patterns of clinical psychiatric diagnoses as well as the distribution of mental health services resources. For example, African American patients were more likely to be diagnosed with schizophrenia and substance abuse than similar White patients, and were significantly more likely to be hospitalized, particularly at a public hospital. A recent volume of the Morbidity and Mortality Weekly Report indicate that African American and Hispanics have a higher prevalence of hepatitis C (HCV) infections than do Whites. There are disparities in cigarette smoking among racial and ethnic minority groups, yet they do not mirror the observed racial and ethnic disparities in mortality related to cigarette smoking. The role of tobacco use in the etiology of diseases that are disproportionately prevalent among minorities needs to be examined. Social adverse outcomes such as poverty, income inequity, and neighborhood crime rates have been demonstrated to be associated with drug use as well as higher rates of morbidity and mortality. Although the poor have always suffered higher rates of premature mortality and morbidity, the socioeconomic status/health relationship occurs as a gradient across all social classes. Furthermore, racial differences often persist even at equivalent levels of socioeconomic status. What is not well understood is the extent to which drug use mediates or moderates these relationships. For this reason, this announcement will support research that examines the interrelationships among socioeconomic status, educational attainment, environmental influences, cultural factors (religiosity, attitudes, knowledge about disease, etc.) and other behavioral and lifestyle factors to clarify the role of drug abuse in the manifestation of disparate health outcomes across racial and ethnic minority populations. Because subpopulations within racial and ethnic minority populations are not equally affected by the drug epidemic, studies of disparities within racial and ethnic minority groups are also encouraged. Scientists are, therefore, encouraged to investigate the variability in drug use and its effects within and across different racial and ethnic minority groups. Also encouraged is research on effective preventive interventions that focus on improving outcomes among racial and ethnic minority populations. For example, research on school-based interventions has identified differences in the circumstances within which drugs are offered for different racial/ethnic populations. This would suggest different types of intervention approaches might be needed to address those different circumstances. Cultural differences in family structure and relationships need to be examined in terms of developing and testing family-based preventive interventions. Moreover, to decrease barriers to access, research is needed on the organization and financing of prevention and treatment services as well as on the utilization of drug treatment and other health services. Areas of Research Focus: Illustrative examples of research areas within the scope of this RFA are outlined below. The following examples serve as a guide and are not meant to subsume all research topics that would be appropriate to the study of health disparities within and across racial and ethnic minority populations under this RFA. o conduct comparative epidemiologic and etiologic studies to determine the nature and source of differences in rates and patterns of drug use and abuse in different racial and ethnic minority groups and delineate the variations in the pathways and risk and protective factors associated with the development of drug abuse in the respective groups, o identify and delineate the underlying dynamic causal mechanisms associated with differential rates of adverse drug-related health outcomes within and across racial and ethnic groups by integrating individual level (i.e., biological and behavioral) and environmental level (i.e., physical, social and cultural) factors, o identify the pathways by which drug use influences health by examining social (e.g., SES), psychological, behavioral, biological mechanisms, o develop and evaluate the effectiveness of intervention strategies that target both community level and individual level risk factors to prevent drug use and drug use-related health consequences, o identify causes of health disparities across racial and ethnic minority groups and how patterns of drug use interact with individual, social, and community factors to facilitate such disproportionate social, medical, and mental health consequences among racial and ethnic minority groups, o identify differential factors relating to access to and utilization of health care and health services, including maternal health care and services across racial and ethnic populations, o identify and specify the causal mechanisms by which host factors, viral factors, co-infections and co-factors may influence drug-related diseases (e.g., HIV, HCV) progression, o investigate how the dynamic status of the individual membership in different social networks influences drug use and disparities across racial and ethnic groups at different stages of development, o investigate differential trajectories and pathways to drug use and addiction within and across racial and ethnic populations, o investigate differential effect of financing, organizational structure and process, administration and management of health care systems leading to barriers access and utilization issues, o investigate health and developmental disparities across racial and ethnic groups for children and adolescents who have experienced prenatal drug exposure and/or early initiation to drug use, o investigate differential effectiveness of universal, selective and indicated preventive interventions that target racial/ethnic minorities in the school, family, and community, and o develop and test new or existing tailored preventive interventions that strengthen protective factors and prevent drug abuse among racial/ethnic minority populations. SPECIAL REQUIREMENTS Meeting The Principal Investigators of awards resulting from this RFA will be asked to participate in 2 meetings to be convened during the second and third (if applicable) funding years to report progress, discuss problems and share information on emerging and current trends related to the conduct of their grants. Funds to support attendance at these meetings, to be held in the Washington DC area, should be included as a part of the budget proposal. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS - UPDATED AUGUST 2, 2000 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning these policies. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review the recommendations of the Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA"s Home Page at http://www.nida.nih.gov/ under Funding or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows the Institute staff to estimate the potential review workload and plan the review. Send the letter of intent (by receipt date listed above) to: Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, and - List selected peer-reviewed publications with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application must be sent to: Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (express/courier service) Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by NIDA"s National Advisory Council. 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that 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. (1) 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? (2) 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? (3) 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? (4) 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)? (5) 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o The adequacy of the proposed plan to share data. Schedule Letter of Intent Receipt Date: March 16, 2001 Application Receipt Date: April 16, 2001 Peer Review Date: June/July 2001 Council Review: September 2001 Earliest Anticipated Start Date: September 30, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include: scientific merit (as determined by peer review), availability of funds, and programmatic priorities INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquires regarding programmatic issues to: Arnold R. Mills, M.S.W. Division of Epidemiology, Services & Prevention Research or Dionne Jones, Ph.D. Center on AIDS and Other Medical Consequences National Institute on Drug Abuse 6001 Executive Boulevard, Room 5160, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 443-6720 or (301) 443-1801 FAX: (301) 480-4544 or (301) 443-4100 Email: amills@nida.nih.gov or djones1@nida.nih.gov Direct inquiries regarding fiscal matters to: Jack Manischewitz, Ph.D. Grants Management Branch, OPRM National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: jm198m@nih.gov Direct inquiries regarding review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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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