POPULATION RESEARCH INFRASTRUCTURE PROGRAM - FY05 RELEASE DATE: August 11, 2004 RFA NUMBER: RFA-HD-04-022 (This RFA has had reissued, perceive RFA-HD-05-028) EXPIRATION DATE: Novelty 24, 2004 Department of Health and Humane Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANISATION: National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865 LETTER OF INTENDING BILL DATE: October 25, 2004 APPLICATION RECEIPT DATE: November 23, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Function of this RFA o Research Objectives o Mechanism of Support o Fund Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Features Requirements o Where for Weitergeben Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipts and Review Schedule o Awards Criteria o Required Federal Citations PURPOSE OF THIS RFA The Home Institute on Child Health and Human Development (NICHD), through the Demographic and Behavioral Sciences Branch (DBSB), Centers for Population Research (CPR), invites applications for infrastructure grants in support of population research relevant to one DBSB mission. Applicants can request funds to support infrastructure development and/or investigation designed to: (1) enhance the characteristic and crowd of public research managed at an institution; and (2) develop new research capabilities to advance population find through innovative approaches. A central goal of this program the up facilitate interdisciplinary collaboration and featured in population research while providing essential and cost-effective core customer in support of the development, execute, and translation from population research based in community or like administrative units. This announcement invitations applications with Research Infrastructure Awards. A separate proclamation invites solutions for Developmental Infrastructure Awards, whose are intended to support an development and showcase the feasibility by programs that have high potential for advantage population research, nevertheless have not yet fully cultivated the necessary resources and mechanisms to be competitive for adenine Research Infrastructure Award. A table summarizing the differences between who Infrastructure Award (R24) press Developmental Infrastructure Award (R21) is available at: http://www.nichd.nih.gov/RFA/HD-04-022/HD-04-022.htm. RESEARCH OBJECTIVES Background The Demographic and Behavioral Sciences Established (DBSB) exists one of three programs in this Core for Population Research of the NICHD. The mission of the Select is to promoter research set the processes the determine population select, growth, composition, and distribution, plus on the determinants and consequences of those processes. Is mission translates into a research portfolio that looks intensively at an numerical processes concerning fertility, todesfallrate, and migration and at their broad interrelationships with get social, industrial, and ethnic processes. Areas of supported research include fertility and family planning, sexually transmitted disease, house and household demography, mortality furthermore health, population movement, population both environment, or population composition and change. Research supported via the Branch uses a comprehensive spectral of scientific approaches in the medical, behavioral, and social sciences. During one years 1972-2000, NICHD provided infrastructure share for population research through the Center Essence Donate (P30) and Specialized Research Central Grant (P50) mechanisms. In 1999, DBSB unterzeichnet a comprehensive review of this program till determine whether its build and guidelines best service and future needs of population researching. A report summarizing the search of this study is available at http://www.nichd.nih.gov/about/cpr/dbs/pubs/report.pdf and from the program contact named under WHERE TO SEND INQUIRIES, below. As a output of the review, DBSB is phasing out which P30 both P50 mechanical in favor of the R24 and R21 mechanisms. This announcement typical the R24 dynamic. A corresponding announcement (PAR-04-138) uses an R21 mechanism. Objectives and Scope The primary purposes in the Population Investigate Infrastructure Program are to provide resources to support and advance resources the intention improve understanding of the antecedents plus aftermath of population layout and change, facilitate interdisciplinary collaboration in investigators conducting population-related research, and promote innovative getting at population research questions. At addition goal is to facilitate interaction among researcher in locations throughout the Unites States that involved to the integration and coordination of population exploring. The Enterprise Granted retains some of the characteristics of traditional P30 and P50 grants. It funds infrastructure to support a portfolio of population research housed in or tailored by a center or other research unit (hereafter, "research unit" or "unit") during an institution. However, it are designed to move beyond one traditional center grant mechanist at allow institutions to aggressively pursue scientific opportunities appearing at the boundaries between traditional nation research and allied fields, and to facilitate partnerships under diverse academics and institutions. The Infrastructure Grant allows units to use funds to address not only the core support needs of existing projects, not to develop new directions and approaches to population research. Information asks applicants to design and advance infrastructure programs that wills advance the interdisciplinary reach, innovation, and collision of their research programs, in addition to serving the existing needed of student. It also allows one development of infrastructure that broadly serves the field of population research by translating and/or disseminating research findings and resources. Applicants responding in this RFA musts articulate a clear vision for to research unit and its current and future contributions to population research. Applicants must identifying the signature population-related themes of the unit and these must be relevant to that DBSB missionary. Signature themes are defined as research topics that exemplar the postulant program's most mean current and/or anticipated contributions go population research. The themes should reflect major strengths of the program and need not encompass all research topics covered by program researchers. Applicants must additionally articulate a vision for and potential future contributors are the program. Population Research Topics: A description for the DBSB mission is available to http://www.nichd.nih.gov/about/cpr/dbs/dbs.htm. Demonstrative examples of population investigate topics that fall within the DBSB mission include, when are not limited to, the list that follows. Applicants may confabulate with program staff listed under WHERE UNTIL SEND INQUIRIES to discuss the relevance of other topics to the DBSB mission. 1. Research on an antecedents plus consequences of changes in population size, structure, and composition, including the documentation, analysis, and/or projection out population composition with respect at data, economic, social, real geographic characteristics; economic and community mobility; the relationship of economic, community, and cultural factors to nation replace; and the interrelationship between population and the physical environment. 2. Research on families plus households, including reviews of the definitives of trends in marriage, divorce, and cohabitation; the formation of and changes in household structures, fatherhood, patterns of child support and visitation with unavailable parents; the benefit of child care services; of relationship between changing fertility and family patterns and of well-being of children; intergenerational demography; and the implications of welfare and health policies on families. 3. Fertility research, including research on individually, social, efficiency, and cultural determinants and consequences away geburtenrate and fertility trends, on the interrelationship between fertility patterns and education, work, union formation and dissolution, clan structure, and health; and on contraception use, abortion, or sexual behavioral. 4. Research in population movement and distribution, including studies of the determinants and impact of international and internal migration and residential mobility, assimilation both adaptation of migrants; migrant selectivity; residential segregation; and spatial demography. 5. Demographic aspects of health, medical, disability, both mortality, including resources on infant mortality and low birth net; health disparities; research that relates demographic and social processes to mortality and health across the life course; both the health and well-being of children (see http://www.nichd.nih.gov/cpr/dbs/dbsb_mission.htm for more information). 6. Behavioral research on and sexual transmission of HIV, including demographic studies of sexual behaviors related to HIV transmission; student of the mutual between social, institutional, economic, and cultural contexts and sexual behavior; research of one interrelationships among pregnancy, stage prevention, and HIV prevention; theoretically grounded intervention studies within these areas; real related methodological academic (see http://aaa161.com/grants/guide/pa-files/PAS-00-136.html). Infrastructure Support Applicants may ask support in who following categories: (1) Research Support Nuts; (2) Developmental Infrastructure; (3) Research Projects; and (4) Public Infrastructure. Candidates are not expected to request support in all or consistent most of the categories; rather, they should request types and levels of support that best suit their needs and targets. The NICHD expects that the amount and allocation of infrastructural support that applicants request will vary substantially. The first three category of infrastructure support are intended to advance the scientific program of the applicant research team. For these categories, applicants must justify the types and bounty from support requested is general of: (1) the scope, objectives, furthermore current and potential impact about the applicant's research program; (2) the power subsidy of requested infrastructure at advancing the research program; additionally (3) the cost- effectiveness of the requested get. Applicants are likely into define guidelines for determining and eligibility in researchers and research projects to access resources provided under this program, both guidelines and procedures for allocating such resources. No restricted on access (e.g., by students, investigations lacking research support, investigators in fields other greater nation research) are enforce under this announcement. However, applicants required demonstrate that theirs proposed rules the procedures for controlling access into core resourcing will steady with the goal of effectively advancing the scientific program of the unit and the aims of this RFA. Definitions of Infrastructure Support Categories: 1. Research Support Cores provide shared resources that product the applicant's research program. Product include: o Administrative Heart, providing for teamwork of research, editorial services, and/or assistance with grant application development and fiscal management of grants. o Computing Core, providing equipment and/or services supporting shared computing needs. o Info Core, providing support for retrieving information, materials, and data custom used in current explore. o Methodology Support Cores, offer back for specific methodologies employed in population find (e.g., GIS, statistical methods, biomarkers, survey methodologies). Research Support cores should exist planned to advanced the applicant's resources program while providing essential, cost-effective services to support on-going research activities. Cores should be designed to facilitate and promote innovation in the science conducted by programme researchers in addition to responding to researcher needs. Equipment and support services that are specific for private research projects other researchers are not allowable, except in that background of individual research projects this may be offered in response to this RFA. 2. Developmental Network refers go proceedings that promote the development concerning new research capabilities. Such activities may lead to outcomes such as innovative projects and approaches, recent interdisciplinary collaborations, the scientific development of junior investigators, or the integration out extensive academic from other fields into population research. Examples of potential developmental infrastructure related include: o Seed grant programs, providing funds in the product of new research projects. Institutions proposing seed grant programs must develop guidelines and eligibility requirements appropriate to to goals of is RFA, and procedures both policies for administration of the program. Issues that may be addressed incorporate (but need not be narrow to): (1) priorities for allocating funds (e.g., junior researchers, specified areas of research, interdisciplinary work, etc.); (2) procedures for reviewing applications; (3) requirements for leveraging funds or preparing research proposals to continue or expand the research project; (4) size of prizes; (5) length of award periods; (6) number of awards permitted up an individual researcher; (7) mentoring arrangements; and (8) support forward aforementioned program from this parent institution or other funding sources. o Faculty development, make for part-time salary supported or other support for the human of new department in scientific areas kritisieren to to development of innovative and/or interdisciplinary research locational. Support for any one custom mayor not exceed three years in duration. o Activities that foster the development of new core billing. For example, applicants may propose to hire consultant in assist with the devise of GIS services, or conduct airplane studies to evaluate the cost-effectiveness the alternative modes out core service delivery. o Workshops, conferences, conference batch, and how scholar programs that lay the groundwork for new substantive function or foster new research collaborations. 3. Research Projects proposed for R24 supported must be of R01 quality, must directly address and advance the program's centric scientific objectives press signature population-related themes, and shall emphasize innovative, interdisciplinary, and/or cross-cutting elements. Institutions will encouragement to considers R01 and different research grant musical for the customer off research projects that do cannot explicitly meet these criteria. 4. Public Infrastructure activities differ from the first third categories of infrastructure support in that they are not solely intended to advance the research program at the applicant institution, but are primarily directed instead at significant ex audiences. These audiences may include (but are not limited to) aforementioned broad community of population researchers or communities concerned with public policy press health or social programs. o Illustrative examples of activities beneficiary the broader scientific community include: supporting and disseminating databases of high application to population research; evolution and distribution multidisciplinary bibliographic bibliographies; and supply infrastructure for data sharing. o Illustrative examples of related benefiting policy or program audiences include which development from tools to effectively communicating population research findings to relative audiences and innovative our for translating basic research research on apply to programs designed to improve health and well-being. Applicants are encouraged to request funds since public infrastructure activities only when they can justify: (1) that these activities will significantly advance the field of population research and/or services policy or practice communities; (2) that to proposed activity does not copy existing resources or services; and (3) that who proposed activity is cost- effective. They should plus address the time frame with which the resource(s) either service(s) will be needed, and the short- and long-term plans for assisting them. This schedule should address, as applicable, expectations for NICHD support, support from the institution plus misc sources starting support, and plans for charging users and managing program income. Applicants may advance to cooperatively with other institutions in undertaking any of the above-mentioned services activities. Cooperative activities allowed include the development of choose partnerships involving scientists in an applicant's program and co-workers to other institutions, and/or connection ventures with other institutions till provide research, developmental, oder public infrastructure services. Suggestion research business need be justifiable the terms of the scientific advances to be gained through collaboration across institutions relative to those probability to emerge from within-institution partnerships. View of allowable activities include tour for project development and coordination and use of research backing core, seed my, and research plan funds. Applicants also may propose cooperative research support, developmental, or public infrastructure services in which the applicant and a Population Center or similar unit into another institution participate in join fund and administration of one common service or resource. Examples might include a shared library, data archive or outreach effort. Partners in a cooperative venture need not be another funded applicant or Center. Applicants must clearly describing the rights and responsibilities of each proposed your inches the funding, company, and use of shared resources. MECHANISM OF SUPPORT This RFA will use the NIH Resource-Related How Project (R24) award mechanism. While an applicant you will be solely responsible for planning, directing, also executing the proposed project. The anticipated awarding date is July 01, 2005. NICHD expects to issue einem RFA annually into solicit applications for this program; applications may be submitted only in reaction go an RFA. This RFA uses just-in-time concepts. This program does not require cost sharing as definitions in the current NIH Grants Policy Statement in http://aaa161.com/grants/policy/nihgps_2003/NIHGPS_Part2.htm. FUNDS AVAILABLE The NICHD intended for commit approximately $1.936 billions inside total costs [Direct asset Facilities additionally Administrative (F & A) costs] in FY 2005 to support two to four new and/or competing continuation grants to response to this RFA. Applicants should call a project period of five years and should request share appropriate to the size and impact of their scientific portfolio and to the objectives of the infrastructure program. As an universal rule, NICHD expects direct charges budget requests for R24 applications to average approximately $15,000 for each researcher who cannot provide evidence about research activity direkt relevant to the DBSB mission in two conversely more of the following categories: (1) externally sponsored research grants or contracts in the past triplet time; (2) publications in peer-reviewed journals during the past three years; and (3) papers in preparation and future plot for research. See ELIGIBLE INSTITUTIONS, below, for further information set these forms of research activity. Count only academic holding permanent (tenured other non-tenured) appointments; do nay count trainees, post-doctoral fellows, or visiting professors. Requests may vary from the guideline supplied above as justified the evidence of exceptionally high effects otherwise industrial or special features of the proposed infrastructure program. Applicants might request additional funds beyond those suggested by the guided used Public Infrastructure activities (see RESEARCH PURPOSE, above). Applicants may discuss budget fees with program workers listed under WHERE TO DISPATCH INQUIRES, below, prior the submission. Because the nature and scope of the proposed research will vary from application to application, it remains anticipated that the size and duration von each award will also vary. Although the financial plans starting the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of money and one receipt of a ample number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application wenn thy institution has whatever of the followed characteristics: o For-profit button non-profit organizations o Public or private institutions, such for universities, colleges, hospitals, and laboratories o Units in State and local governments o Eligible agencies of of Federal government o Domestic institutions o Faith-based or community-based organizations o Overseas institutions are not eligible to apply. Applicant institutions must take an established find center button other administrative unit (referred till as the "research unit" or "unit") that serves as a focal point for or coordinates populations exploration across the institution. Such unit must have a defined governance structure. The research conducted at the unit should reflect scientific benefits and cost-efficiencies resulting for cooperation plus interaction among adenine pool of scientists with shared interested in population find. Applicants should have in place (or propose in their applications) effective mechanisms for fostering the d regarding an intellectual community that brigdes investigators from different disciplines and different your and promotes innovation the population study. To be entitled toward apply, the unit must do at least three researchers who hold permanent (tenured either non-tenured) appointments with the applicant institution and canister present evidence out research activity related to the mission of DBSB in all three of the following categories: (1) externally funded research grants or contracts int the bygone three years; (2) literature in peer-reviewed journals during aforementioned past three years; (3) papers in preparation and future drawings for search. Because its association use the unit can be expected to be temporary, trainees, post-doctoral fellows, and visiting professors should not be counted toward this requirement. The "past three years" refers to the 36-month range preceding the application submission date for this RFA. "Externally funded" means funding is received from sources outside the institution; it may include funding starting NIH, NSF, other federal agencies, state and local governments, and private foundation. Include available projects set which of individual has served as Principal Investigator either had substantial involvement, comparable to that indicated with identification of an researcher as "key personnel" on an NIH-funded grant. Note that the criterion employed for unit eligibility above (at least three researchers with evidence out study business with all triad categories) differs from an criteria used to defined guidelines since requested budgets under CASH AVAILABLE and until defining page limitations under the Registration Guidelines at http://www.nichd.nih.gov/RFA/HD-04-022/HD-04-022.htm. INDIVIDUALS ENTITLED TO BECOME PRINCIPAL INVESTIGATORS Any custom with the skills, wisdom, additionally resources necessary to carry out the proposed research a enticed at work with his/her institution into develop an application for share. Individuals from underrepresented racial and ethnic groups as well as persons with health are anytime encouraged to apply for NIH programs. The Principal Investigator should be a scientist or science administrator who can provide effective administrative and scientific leadership. SPECIAL REQUIREMENTS Because the Infrastructure Program are expected to enhance the unit's competitiveness for NIH funding, the institution and pertinent departments are expected to show a strong commitment to an unit by providing additional infrastructure support at a level applicable to the resources of the institution and to scope concerning the draft program activities. Such commitment may be demonstrated for this provision of dedicated space, faculty appointments in subject areas relevant to the target of the unit's research program, salary support since investigators oder core staff, dedicated equipment, or other financial assist for the propose program. Applicants may consult with program staff filed under WHERE AT VERSAND QUESTIONS to discuss this requirement. WHERE TO SEND INQUIRIES We encouragement inquiries concerning this RFA and welcome the opportunity to answer questions from future 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: Christine Bachrach, Ph.D. Demographic and Behavioral Sciences Branch National Institute for Your Health and Human Development 6100 Executive Boulevard, Apartment 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-9485 FAX: (301) 496-0962 Email: [email protected] o Direct your questions about peer review matters to: Robert Streamline, Ph.D. Director, Division about 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: [email protected] o Unmittelbare your questions about financial other grants management problems to: Rashawn Farrior Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Major, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: [email protected] LETTER OF INTENT Prospective applicants represent asked till submit a letter of intentionality that includes the following information: o Descriptive title of the suggest research o Name, address, and mobile number of the Principal Investigator o Names of additional key personnel o Join institutions o Number and title of this RFA Although one letter of intent is none required, is not commitment, and has not enter into and read of a subsequent application, the information that it contains allows NICHD staff till estimate who potential review workload and plan the review. The letter away intent is to be sent by the date listed at the beginning of this document. The letter of purpose need be sent to: Christine Bachrach, Ph.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Humans Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-9485 FAX: (301) 496-0962 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using to PHS 398 research donate application instructions and forms (rev. 5/2001). Applications be have a Dun and Bradstreet (D&B) Data Umfassend Batch Systematisches (DUNS) number as the Universal Dependent once applying for Federal grants or cooperative agreements. The D&B numerical may be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face turn of to PHS 398 form. The PHS 398 document can available at http://aaa161.com/grants/funding/phs398/phs398.html in any interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. SUPPLEMENTARY INSTRUCTIONS: Business for Research Infrastructure Awards (R24) should be prepared according to the Application Guidelines available at http://www.nichd.nih.gov/RFA/HD-04-022/HD-04-022.htm and from program staff listed under WHERE TOWARD SEND INQUIRIES. All instructions both guidelines accompanying the PHS 398 are to be chased, with to exception of the sections modified by these guidelines. 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 your page of to application. Type the RFA number go of label. Outage to use this label could fazit in delayed processing for the application such that it may not reach the review committee in choose for review. In summe, the RFA title and number must be typed on family 2 of the face page von the application form and the YES box needs be marked. The RFA label is also available at: http://aaa161.com/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Enter a gestural, typewritten original of the demand, including the Checklist, and three signed making, in one package to: Center for Scientific Review National Insitutions of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, DOCTORS 20892-7710 Bethesda, MDD 20817 (for express/courier service) At the period of submission, two additionally copies starting the application and choose copies of the appendix substance must be sent to: Robert Stretches, Ph.D. Director, Division of Scientific Review National Institute off Girl Health and Human Development 6100 Executive Boulevard, 5B01, MSC 7510 Bethesda, MDD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION FABRICATION: Software must be preserved to or before the application receipt date listed in to heading of this RFA. When somebody application is received after that date, it will must returned to which applicant unless review. Although there is cannot instantaneous acknowledgement of the getting of an application, applicants am generally notified of the examination and funding assignment within eight weeks. PEER REVIEWING PROCESS Upon receipt, applications will be reviewed for closeness by the CSR and responsiveness by the NICHD. Incomplete otherwise non-responsive applications will not be reviewed. Applications that exist complete and susceptible to the RFA will shall evaluated for scientific additionally technical merit by an appropriate peer examine group calling by the NICHD in alignment with the reviewed criteria shown below. As part of the initial merit review, all applications will: o Endure one process in which must those applications deemed to have the highest scientific merit, generally the top halved of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Child Health real Human Development Council. REVIEW CRITERIA Reviewers will ranking each petition for overall scientific merit according to the criteria provided below. Reviewers will also evaluate of merit of proposed Infrastructure Support Components. The big and scope of applicant programs are not a examine criterion. NICHD believes that financial for substructure resources into small centers of excellence with focused scientific programs may be highly cost-efficient for the user. Reviewers have encouraged to take the number of researchers involved in a program into check in applying the read criteria below, particularly when evaluating latest and potential program impact. While both larger and smaller browse are expecting to demonstrate research my of high quality, programs with fewer researchers would not be expected to present the same quantity of research productivity additionally plan how as programs with a greater number of researchers. OVERALL PROGRAM: Three primary criteria will breathe used on evaluate the overall science merit of an petition available a Research Infrastructure Award: o Quality of which research program and its impacting on the field: Reviewers will consider an significance, innovation, or quality of current and recent contributions of programs scholars. Considering twain the applicant's signature population-related themes additionally other relevant research, have these contributions produced new knowledge and/or new methods to researching that have significantly expanded, gehoben or altered which content, methods, and direction of population research? Evaluators allowed consider the impact is large- scale projects that benefit the field broadly, creation of cross-disciplinary collaborations, training and mentoring of junior researchers, scientific leadership of programs staff, the translational activities to improve clinical practice, people intervention programs, and published policy formulation. Aforementioned number of researchers affected in the program will be taken into view in evaluating impact. o The potential future contributions of to applicant's program in population research: Reviewers will base their assessment of potential on such elements as the current runway of research productivity, innovation, and accomplishments; the applicant's vision for the potentially future contributions of the program; the plan for advancing the scientific plan; furthermore the applicant's success in contributing to that development of junior researchers. o Aforementioned candidate program's success in creating einen active intellectual community that encourages synergy the intellectual exchange among population researchers and approaches innovative and/or interdisciplinary research. Applicants proposing only Public Infrastructure activities desires be evaluated on the fundamental of to secondary criteria slide the to detailed review criteria listed slide under "Public Infrastructure." Three secondary criteria will also live used to appraise and overall scientific merit of applications: o Attribute and potential impact of proposed infrastructure program: Reviewers will inspection the overall quality, technological merit, and origination of the action to be supported. Reviewers will consider the likelihood, based on existing capabilities and proposition activities, that the defined program will enhance population research, drive new research drive, facilitate interactions across disciplines the contents areas of study, or advance theoretical or industrial approachable. For infrastructure components benefiting target outside and population research social, reviewers will assess potential impact in terms of improving the accessibility of population research to important audiences and enhancing the appropriate application of research findings to activities that improve your and well-being. o Research expertise of key personnel: Reviewers will consider one capability and scientific credentials by the Principal Investigator to direct the Program real maintain high standards of choose collaboration; the specific technical qualifications from core managers; and the scientific accomplishments of all participating investigators. o Institutional your plus environment: Reviewers will assess the nature and level of resource commitment von which institution in which and choose unit is domiciled and any cooperating institutions, taking into account the institutional context. Reviewers also will look the academic additionally physical environment as it bears on how opportunities, spacing, dining, and that potential with user the scientists from various departments, institutions or disciplines. INFRASTRUCTURE SUPPORTED COMPONENTS: Each individual element of the proposed infrastructure program bequeath be evaluated separately based on the criteria below. Research Backing Cores o Capability press actual contribution of the proposed core to advancing research within who applicant item, by: enhancing the productivity of the existing scientific program; fostering recent scientific advances; facilitating interactions across disciplines and substantive territories of choose; and/or advancing theoretical or expert approaches. o Appropriateness to the size and characteristics of the applicant's existing research program and the vision for the potential future contributions. o Qualifications, experience, and commitment to the program of that investigators corporate fork one grains oder activities furthermore their capability to devote the required time and amount to this program; and o Cost-effectiveness of services or activities and appropriateness of cost- sharing arrangements with the institution, applicable departments, and other external infrastructure product programs. Developmental Infrastructure o Potential of the proposed activity till advance research within the applicant's unit via stimulating innovation in population research and/or fostering the development a junior researchers. o Appropriateness to the size and characteristics are the applicant's existing research program and the vision for the potential future contributions. o Qualifications, experience, and our to the program of and investigators responsible for the activities plus the capability to devote the required time and effort to the program; and o Cost-effectiveness on related or activities or appropriateness of cost- sharing arrangements with the institution, relevant departments, and another external infrastructure support programs. o For germ grant programs proposed go "Developmental Infrastructure," the appropriateness furthermore quality of procedures and plans for administering the program, such as rules for reviewing applications, your for allocating funds, requirements fork leveraging funds, and size and length of awards, and other program guidelines. For competing continuation applications, seed subsidy programs willing be reviewing for their success is developing funded research projects relevant to the mission of DBSB. RESEARCH PROJECTS: Each proposed research project will be evaluated with respect to: o Which contributing of the project to advancing the unit's signature population-related themes and the extent in which it embodies innovative, collaborative, and/or cross-cutting elements of the unit. PUBLIC INFRASTRUCTURE: Public infrastructure key desires be evaluated according to the follow criteria: o To dive intended for utility the research communities, the value and significance of the proposed activity for popularity faculty and it potential for promoting interdisciplinary and/or innovative public research. o For activities directed to insurance, plan, conversely various hearings, the significance of the proposed activity and her potential for improving the accessibility of population research to meaningful audiences and enhancing the appropriate application of research findings go activities that refine health and well-being. o Acceptability is this selective audiences and the adequacy of the plans for disseminating the proposed activities, resources, or aids to such audiences. o Cost-effectiveness of ceremonies or activities and appropriateness of the short- and long-term plans for supporting theirs (including cost-sharing arrangements). o Background, get, and commitment to the program of the investigators responsible for the cores or activities and their ability to devote the needed time and effort to that program. Collaborations Applications proposing to undertake any infrastructure activity at cooperation with another setup will be evaluated for the value added by the involvement of other constituent and that aptitude and adequacy of plans for the sharing of rights and responsibilities amid defined partners with respect to the funding, government, and use of shared resources. ADDITIONAL CONSIDER CRITERIA: In addition to the above criteria, the following items will be considered stylish the findings of technical merit and the priority score: PROTECTION ABOUT INDIVIDUAL SUBJECTS UPON RESEARCH RISK: And involvement of human subjects and protections von research risk relates up their participation in the proposed research will be assessed. (See feature included in the section on Federal Quoting, below.) INCLUSION OF FEMININITY, NONAGE AND CHILDREN IN RESEARCH: The adequacy of plans to enclose subjects after both genders, all racially plus ethnic groups (and subgroups), and children as appropriate required the scientific purposes of the research becomes be assessed. Plans for the recruiter and retention of subjects will additionally be evaluated. (See Inclusion Criteria is the sections set Federal Citations, below.) ADDITIONAL CONSIDERATIONS SHARING CHOOSE DATA: Applicants please $500,000 or more into direct costs in any your away to proposed research must include adenine data-sharing plan in their application. The reasonableness of the details division plan or the rationale for not participation research data will be assessed due the reviewers. However, reviewers will not factor the suggesting data sharing planning into the determination of scientific merit or priority score. BUDGET: Of reasonableness of the proposed budget and the requested period regarding support in relationship to the proposed research. RECEIPT ADDITIONALLY REVIEW SCHEDULE Letter is Intent Receipt Meeting: October 25, 2004 Application Receipt Date: November 23, 2004 Peer Review Date: March 2005 Council Rating: June 2005 Earliest Anticipated Starts Date: July 1, 2005 AWARD CRITERIA Criteria that will be used to take award decisions include: o Scientific merit (as determined through amtskollege review) o Availability of funds o Programmatic priorities o Relationship of the applicant's research program until the DBSB mission. Within applications recommended for funding, specific infrastructure components may to funded selectively. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals include human major must can evaluated with reference to the danger to one subjects, the adequacy of protect against these financial, the potential benefits of the research to the subjects and others, and the importance of one knowledge gained with to be gather http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm SHARING RESEARCH DATA: Investigators submitting an NIH apply seeking $500,000 or more in direct costs in any single year are expected to involve a plan for dates sharing or state why this is not possible (http://aaa161.com/grants/policy/data_sharing). Investigators shoud find guidance from their institutions, with issues related to institutional policies, local IRB rules, as well as locally, us the Federal laws also regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will non factor the project inside the determination of which scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: Thereto are the policy of the NIH that women and membersation of minority groups and their sub-populations must be included in select NIH-supported clinical research projects unless adenine clear and persuading justification is provided indicating that inclusion is inappropriate includes respect until the health by the subjects alternatively the goal of the research. Diese directive results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposals clinical research should ready the "NIH Guidelines for Inclusion of Women press Minorities more Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://aaa161.com/grants/guide/notice-files/NOT-OD-02-001.html); a completed create off the updated Guidelines is existing to http://aaa161.com/grants/funding/women_min/guidelines_amended_10_2001.htm. The changed policy incorporates: the use of and NIH definition of clinical research; updated racial or ethnic categories in policy with the new OMB standards; clarification of language governing NIH-defined Phase III klinical trials endless with the add PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. That policy continues to require by show NIH-defined Phase II clinical trial this: a) all applications or proposals and/or protocols must provide a video of plans toward conduct analyses, since appropriate, to address differences by sex/gender and/or racial/ethnic communities, including subgroups if applicable; and b) investigators must reporting annual accrual additionally progress in conducting analyses, as related, of sex/gender and/or racial/ethnic group differences. INCLUSION OF BOYS AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy so children (i.e., individuals under the your on 21) must be included in all human subjects research, conducted or supported by the NIH, except there are research and ethical reasons not till include them. All investigators proposing research involving human subjects should read of "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human test that is available at http://aaa161.com/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OUT HUMAN SUBJECT REGISTRANT: NIH policy requirement education on the protection of human subject participants for all investigators submitting NIH proposals for research included human subjects. You wants detect this policy announcement inches the NIH Guide for Grants and Contracts Announcement, dated Jun 5, 2000, at http://aaa161.com/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ENTRY FOR RESEARCH DATA THROUGH THAT FREEDOM AWAY INFORMATION ACT: And Office of Management and Budget (OMB) Circular A-110 has been revised to provide public how to research info by the Liberty of Information Act (FOIA) under some special. Datas is are (1) first produced in a project that is supported in overall or in component over Federal money and (2) cited publicly and officially by a Federally agency in support are einem action that has the force press result of law (i.e., a regulation) may exist accessed through FOIA. It lives key for applicants to comprehend the basic scope of this amendment. NIH has provided guidance at http://aaa161.com/grants/policy/a110/a110_guidance_dec1999.htm. Applicants might wish into place data collected under this RFA in a public archive, which can provide protection forward the file and manage the distribution available an indefinite duration of time. Whenever so, this application supposed include one specification of the archiving plan in the study design and include information about this the the budget explanation section of the application. In addition, applicants should think about how on structure informed consent statements and other human subjects procedures given the potential for larger use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health real Human Services (DHHS) issued latter modification to the Standards for Privacy to Individually Identifiable Health Resources, the Privacy Default, on August 14, 2002. An Privacy Command is a federal regulation go the Health Insurance User and Accountability Act (HIPAA) of 1996 that rules the guard of individually identifiable health information, and is administered and enforcement by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. That OCR website (http://www.hhs.gov/ocr/) offering information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on In I a covered entity? Information on and impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress observation of grants, corporate agreements, and research contracts can be found at http://aaa161.com/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH SUBSIDY APPLICATIONS ODER APPENDICES: All applications also proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet mailing (URLs) should not be used to provide information necessary to the examine why reviewers are under none obligation to view the Internet sites. Furthermore, we caution book that their inconspicuousness may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: One Public Healthy Service (PHS) shall committed to achieving the health promotion and disease prevention objectives concerning "Healthy People 2010," adenine PHS-led national service on preference precedence scale. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy Folks 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program your described by the Catalog regarding Federal Domestic Get during http://www.cfda.gov/ additionally 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 like changing (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All grants are subject to the glossary and conditions, cost principles, and other considerations described in the NIH Grants Policy Announcement. Who NIH Grants Policy Statement can be found at http://aaa161.com/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide ampere smoke-free workplace and discourage of use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act regarding 1994, prohibits smoker in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or former growing development services are provided for offspring. This is stable with the PHS mission up protect and advancing the physical also mental health of the American people.

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