MENTAL RETARDATION AND DEVELOPMENTAL DISABILITIES RESEARCH CENTERS RELEASE DATE: May 7, 2002 RFA: HD-02-014 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) LETTER OF INTENT RECEIPT DATE: August 19, 2002 APPLICATION RECEIPT DATE: September 17, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Child Health and Human Development (NICHD), through the Mental Retardation and Developmental Disabilities Branch (MRDD), Center for Research for Mothers and Children (CRMC), invites research center core grant applications (P30) as part of the Institute"s Mental Retardation Research Program to develop new knowledge in the field of diagnosis, prevention, treatment, and amelioration of mental retardation and developmental disabilities. Three centers may be supported in response to this announcement. The primary objective of the NICHD Mental Retardation and Developmental Disabilities Research Centers (MRDDRC) Program is to provide support and facilities for a cohesive, interdisciplinary program of research and research training in mental retardation and related aspects of human development. For more than 35 years, NICHD has provided support for MRDDRCs through core grants (P30) that facilitate program coordination and support central research facilities, administration, and development of a limited number of new research programs. Funds for the research projects using these core facilities come from independent sources including Federal, State, and private organizations. This Request for Applications (RFA) seeks applications from institutions that meet the qualifications for a program of mental retardation and developmental disabilities research. RESEARCH OBJECTIVES Background A major goal of the NICHD MRDDRC Program is to prevent and/or ameliorate mental retardation. The degree of impairment associated with mental retardation varies in relation to the cause. Moderate and more severe mental retardation often results from problems that produce profound alterations in brain development and/or function. Diminished intellectual and adaptive capacity often can be traced to defective genes, teratogenic agents, toxic substances, infections, nutritional deficits, accidents, diseases, and other disorders causing brain damage. A larger proportion of cases of mental retardation is related to environmental or social conditions and disorders of unknown etiology. These complex problems require integrated, multidisciplinary approaches involving biomedical and behavioral sciences in a variety of settings. Several mental retardation syndromes have been identified, and new ones are being discovered. Each requires fundamental research into the underlying processes, as well as studies designed to meet the unique needs of the affected children. Therefore, one of the missions of the MRDD Branch is to support research on the etiology, pathophysiology, epidemiology, diagnosis and evaluation, prevention, and treatment or amelioration of mental retardation. Research conducted in the MRDDRCs will cover a broad spectrum of scientific approaches ranging from laboratory research on fundamental processes of normal and abnormal development, to clinical and behavioral research in which persons with mental retardation are studied. It is thought that major solutions to the problems of mental retardation may emerge from multidisciplinary collaboration involving a variety of approaches in the MRDDRCs. As a result of the administrative and scientific organization within a Center and across the network of MRDDRCs, opportunities for breakthroughs will be enhanced. Research Scope MRDDRC Core Grants are intended to bring together scientists from a variety of disciplines to work within a Center on the common problems of mental retardation. Consequently, applications for MRDDRC Core Grants (P30) should include investigators studying a range of topics in basic and clinical or applied research. Applicants are encouraged, but not required, to include both biomedical and behavioral components among the topics addressed within their Center. Center grant applications must include among these topics at least five of the following, focused specifically on mental retardation and developmental disabilities (MRDD): 1. Developmental and neurobiological studies relevant to MRDD: physiology, anatomy, chemistry, pharmacology, electrophysiology, molecular biology, plasticity, and structural and functional imaging, as well as behavioral science techniques employed to define the molecular, cellular, and/or biochemical bases of disorders associated with MRDD and to facilitate development of specific hypotheses about basic abnormalities that underlie these conditions. 2. Studies of cellular and molecular aspects of brain development: differentiation, synapse formation and modification, plasticity, trophic factors, and neurotransmitter function and modulation. 3. Studies of inborn errors of metabolism relevant to MRDD, including mitochondrial, lysosomal and peroxisomal disorders as well as other disorders including, but not limited to, amino acid, organic acid, carbohydrate, cholesterol, nitrogen, catecholamine, and indolamine metabolism, molecular biology, pathophysiology, recombinant DNA technology, screening, applied clinical and experimental studies. 4. Studies of genetic/cytogenetic disorders associated with MRDD: research on prenatal diagnosis, particularly non-invasive methods during the early stages of pregnancy on prevalent genetic causes of mental retardation such as Down syndrome or Fragile X syndrome, research on isolation and characterization of fetal cells recovered from maternal circulation, research on rare genetic disorders associated with mental retardation. 5. Studies of the molecular genetics of MRDD, including gene mapping, genomic imprinting, gene transfer, and gene localization, structure, function, regulation, and organization, genomics and proteomics. 6. Studies examining the mechanism by which genetic status affects the development, function, and dysfunction of the nervous system, particularly with respect to cognition and behavior. 7. Studies that develop and characterize animal models relevant to MRDD, e.g., gene knockout, gene repair, transgenesis, and homologous recombination, creation of conditional tissue-specific targeted knockout animal models, development and use of animal models that have specific relevance to disorders associated with MRDD based on clear neurodevelopmental, pathophysiological, genetic and/or functional homology, development and use of animal models to test existing medications and develop new psychopharmacologic medications that are safe and effective for patients with MRDD. 8. Prenatal therapy of genetic and structural defects using metabolic, pharmacologic, nutritional, surgical, and other techniques. 9. Genetic, molecular, behavioral, and biobehavioral research and therapeutic approaches to Fragile X syndrome and Rett syndrome. 10. Studies of toxicology and physical environmental factors in the etiology, treatment, and prevention of MRDD, including lead, mercury, and other heavy metals, and toxic wastes, such as hydrocarbons and polycarbonates (PCBs), developmental and behavioral teratology, fetal alcohol syndrome, neuroimmunological toxicology, subclinical levels of toxic agents and their effects on morphological and behavioral changes associated with MRDD. 11. Studies of the effects of malnutrition (protein, calorie, micronutrients) on intellectual, behavioral, social, and physical development, intergenerational effects of malnutrition. 12. Studies of psychopharmacology: cellular and molecular mechanisms, pharmacokinetics, behavioral effects, medications used and treatment efficacies in different subpopulations of MRDD, dual diagnoses, rational drug development, combinatorial chemistry. 13. Clinical trials for the treatment, amelioration, and/or prevention of MRDD. 14. Studies of infectious diseases in the etiology, prevention, and treatment of MRDD, neurological, neuropathological, behavioral, and intellectual consequences of AIDS in children. 15. Studies that develop and apply methods and measures for screening and diagnosis, and/or identify children and infants at risk. 16. Studies that develop methods to better refine the definition of clinical phenotype in disorders associated with MRDD, with particular focus on characteristic component behavioral and cognitive features. 17. Studies involving early interventions (biological, behavioral, educational, environmental) for infants born at risk for MRDD, research into the process of early intervention strategies, follow-up of high-risk infants and children who are at risk due to biomedical conditions such as low birth weight and/or conditions of environmental deprivation, studies of intergenerational effects and outcomes for children whose parents have conditions associated with MRDD, effects of teen pregnancy on at-risk infant outcome. 18. Predictive and developmental studies of perinatal problems associated with MRDD: developmental studies of low birth weight, small for gestational age, preterm and neonatally sick infants, hypoxic or ischemic insults. 19. Neurodevelopmental and longitudinal studies that characterize the neuropathological progress and inherent variability in conditions associated with MRDD in order to develop specific hypotheses about the initial (primary) abnormality, and to address the degree to which phenotypic variation relates to postnatal brain development. 20. Studies applying imaging, electrophysiology, pharmacology, molecular biology, and behavioral science techniques to follow the developmental trajectories of different brain functions and their influence on developing cognitive and motor skills. 21. Studies of psychobiological processes in MRDD of conditions such as autism and Rett syndrome using methods of behavioral genetics, embryology and teratology, developmental neuroscience and psychophysiology, developmental psychopharmacology. 22. Studies of psychological processes in MRDD, including attention, cognition, information processing, perception, motor development, neuropsychology, affective, social, motivational, and personality factors. 23. Studies of autism and autism spectrum disorders: screening and diagnosis, etiology, neurobiology, genetics, pathophysiology, developmental course, medical, biological and pharmacological approaches, behavioral intervention. 24. Studies involving behavioral analysis: manipulations of interaction between behavior and environments of individuals with MRDD in infancy, childhood, adolescence, and adulthood to effect reduction in behavior problems, or to facilitate vocational training, social and self-help skills, and learning curves, use of social support networks, parent-child, sibling, peers, and family interactions over the life span. 25. Studies that develop and utilize measurement tools to assess cognitive and behavioral development: tests that highlight abilities and disabilities, including tests for specific subpopulations, such as Fragile X, inborn errors of metabolism, and Williams syndrome. 26. Studies that examine and evaluate residential, educational, and vocational settings throughout the life span: effects of behavior and adjustment of individuals with MRDD, learning and social behavior in these settings, adaptation to residential environments. 27. Studies of learning disabilities, dyslexia, and attention deficit hyperactivity disorder. 28. Studies of language and communication in MRDD populations. 29. Studies of socio-ecological processes: individuals with MRDD from various cultural and ethnic groups in multiple settings (naturalistic observation), ethnographic research, life history reporting, and systematic observation of specific activities. 30. Studies of hyperaggressive, destructive, and self-injurious behavior in human and animal models, including pharmacologic treatment, stereotypic behaviors, lack of compliance of mentally retarded children in family and educational settings. 31. Studies of the epidemiology of MRDD: analytic and case-control studies of etiology, incidence and prevalence, follow-up over the life span (infancy to adulthood) for outcomes. 32. Studies that examine and evaluate behavior and life styles that could affect mortality and morbidity. 33. Studies that develop and utilize assistive devices (e.g., computer software) to help individuals with MRDD to learn and communicate. MECHANISM OF SUPPORT This RFA will use NIH Center Core Grant (P30) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. Applications should be prepared in a manner consistent with the guidelines presented in the "NICHD P30 CENTER CORE GRANT GUIDELINES"(http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). The anticipated award date is July 1, 2003. FUNDS AVAILABLE The NICHD intends to commit approximately $3.5 million in FY 2003 to fund up to three new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years. 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 NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. The cost of a proposed Center will be a material consideration in the selection of applications for funding. The total direct costs requested for the first year of a new Center should not exceed $750,000. Competing continuation applications from existing P30 Centers may request initial year direct costs no greater than 20 percent above the level of the last year of the Type 5 award, or $750,000 direct costs, whichever is greater. Budget increments for subsequent years generally will be limited to three percent. Budgets for new and renewal applications will be stringently reviewed within these guidelines. Applications with budget requests exceeding these guidelines will be administratively withdrawn by NICHD and returned to the applicant. 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 For the purpose of this RFA, the NICHD will not support more than one MRDDRC center grant (P30) in a given university or other applicant institution. To be eligible for an award, the proposed Center must provide core support for a minimum of 10 projects funded from non-university sources. Additional eligibility criteria for the P30 are listed in the "NICHD P30 CENTER CORE GRANT GUIDELINES," available from the program contact listed under WHERE TO SEND INQUIRIES, below, and on the Internet at: http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm. 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 their institution to ddevelop 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 o The MRDDRC Director should be a scientist or science administrator who can provide effective administrative and scientific leadership. The Director will be responsible for the organization and operation of the MRDDRC and for communication with the NICHD on scientific and operational matters. Scientific personnel and institutional resources capable of providing a strong research base in the fields specified must be available. In addition, the institution and pertinent departments must show a strong commitment to the Center"s support. Such commitment may be provided as dedicated space, staff recruitment, salary support for investigators, dedicated equipment, or other financial support for the proposed Center. o Applications for P30 MRDDRC grants must propose a program with a theme relevant to the mission of the MRDD Branch as outlined above. The program should consist of at least 10 externally funded research projects grouped according to relevant topics. These projects must be of high quality, providing a multidisciplinary approach to the problem(s) being investigated. Each project is to be summarized in accordance with the NICHD P30 CENTER CORE GRANT GUIDELINES (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). o Each core unit proposed for funding under the MRDDRC grant must be utilized by a minimum of three federally funded research projects, at least one of which is funded by the MRDD Branch of NICHD, exclusive of research contracts, training grants, interagency agreements, and NIH-supplemental projects funded by other agencies. Program staff will make exceptions to this requirement in instances where research relevant to MRDD is assigned elsewhere within NICHD. Subprojects within a Program Project (P01) will be considered as individual projects comparable to an R01. A detailed description of each core unit proposed as part of the Center must be provided, with detailed budget and budget justification. A scientist must be named as responsible for each core unit proposed. The description of each core unit proposed should include a rationale, indicating how it will support the research effort in a cost-effective manner. Facilities must be available for the primary needs of the MRDDRC Program and require no more than modest alteration and/or renovation. Funds for new construction will not be provided. o Promoting interdisciplinary collaboration among scientists working within a Center is a major goal of the MRDDRC Program. Each Center applicant should submit a plan, as part of the application, to assure continuing interaction among participating scientists from different disciplines. o Another goal of the MRDDRC Program is to attract scientists to the field of mental retardation and developmental disabilities research. Therefore, where appropriate, the applicant may request "New Program Development" funds for direct research support of one or more projects, not to exceed a total of $75,000 per year or 10 percent of total direct costs, whichever is less. Such funds might serve to attract new investigators to the Center, to develop a new area or program of research, or to facilitate the development of newly trained investigators" research programs. Description of New Program Development projects should be comparable to R01 research grant applications in their detail and development. Each such project may provide support for only two years for any one investigator. o It is a major goal of the NICHD to promote active collaboration among MRDDRCs. To accomplish this goal, the successful applicants will be encouraged to participate in the collaborative efforts of established Centers" programs. In planning the program, some consideration should be given to potential collaborative studies and projects that might be proposed for the MRDDRCs network. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: o Direct your questions about scientific/research issues to: L. R. Stanford, Ph.D. Mental Retardation and Developmental Disabilities Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1385 FAX: (301) 496-3791 Email: lstanfor@mail.nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: rstretch@nih.gov o Direct your questions about financial or grants management matters to: Ms. Mary E. Daley Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1305 FAX: 301) 480-4783 Email: md74u@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: L. R. Stanford Mental Retardation and Developmental Disabilities Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1385 FAX: (301) 496-3791 Email: lstanfor@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Supplemental instructions for application preparation can be found in the NICHD P30 Center Core Grant Guidelines (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 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 RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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: Robert Stretch, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-1485 APPLICATION PROCESSING: 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. 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 the NICHD in accordance with the review criteria stated below. No site visits are planned in the review of these applications, all information required for evaluation must be contained in the application. As part of the initial merit review, all applications will: o Receive a written critique o 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 and assigned a priority score o Receive a second level review by the National Advisory Child Health and Human Development Council. REVIEW CRITERIA All applications responding to this RFA will be evaluated according to the review criteria for core units, New Program Development projects, and the overall center as outlined in the NICHD P30 Center Core Grant Guidelines (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: August 19, 2002 Application Receipt Date: September 17, 2002 Peer Review Date: March 2003 Council Review: June 2003 Earliest Anticipated Start Date: July 1, 2003 AWARD CRITERIA In addition to the scientific and technical merit of the application, as determined by peer review, factors that will be considered in making the awards include: o relevance to research areas of high programmatic interest to the MRDD Branch, the CRMC, and NICHD, and research areas targeted by Congress, o relevance of research projects accessing the core facilities to mental retardation and related developmental disabilities, o access to unique populations, o potential to increase productivity and quality of research within the Center, and to stimulate interdisciplinary/multidisciplinary collaborations, o providing unique resources for use by other Centers and the greater research community, o cost-effectiveness of the core facilities. o cost of the Center, and o availability of funds. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998). 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-sponsored 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 AMENDMENT "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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are 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 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. 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 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 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 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://grants.nih.gov/grants/stem_cells.htm 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 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 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. Because P30 funds, in general, do not directly support research projects, the issues of minority/gender representation, inclusion of children as participants in research involving human subjects, required education on the protection of human subject participants and the use of human embryonic stem cells will need to be addressed at the individual project level (i.e., R01 level). However, the application must specifically address these issues for any New Program Development projects or core units as appropriate. 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 RFA 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 RFA 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 No. 93.865 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 administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR 74 and 92. The Public Health Service 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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