RFA-HD-98-016: NICHD STUDY OF EARLY CHILD CARE: MIDDLE CHILDHOOD PHASE

Department of Health
and Human Services (HHS)

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NICHD STUDY OF EARLY CHILD CARE: MIDDLE CHILDHOOD PHASE Release Date: August 25, 1998 RFA: HD-98-016 P.T. National Institute of Child Health and Human Development Letter of Intent Receipt Date: September 14, 1998 Application Receipt Date: October 28, 1998 PURPOSE The goal of this Request for Applications (RFA) is to recruit six to ten investigators who are experts in middle childhood development to join as full partners in the Steering Committee of the National Institute of Child Health and Human Development (NICHD) Study of Early Child Care. These investigators are expected to augment the expertise of the current team of investigators and broaden the focus of the study from the effects of child care on child development. The broadened study will investigate when and how variations in the physical and social environment affect variation in the development of children. Additional expertise is called for in domains not previously studied by the current investigators as well as in domains that were studied in the first seven years of life, but where middle childhood expertise is needed. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, NICHD Study of Early Child Care: Middle Childhood Phase, is related to the priority area of maternal and child health, and education and community based programs. The solicitation is also related to the age related objectives for children. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202 512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for profit and non-profit organizations, public and private such as universities and research organizations. The need for continuous and active communication among investigators dictates that only institutions in the United States are eligible to apply. Racial/ethnic minority individuals, women and persons with disabilities are especially encouraged to apply as principal investigators. MECHANISM OF SUPPORT This program will use the National Institutes of Health (NIH) cooperative agreement (U10) mechanism of support. The major difference between a cooperative agreement and a research project grant is that there is a substantial programmatic involvement of the NICHD Project Scientist/ Scientific Coordinator above and beyond the levels required for traditional program management of grants. Cooperative agreement is an "assistance" mechanism (rather than an acquisition mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients activity by involvement in the activity and otherwise working jointly with award recipients in a partner role. NIH staff involvement must reflect the expectation that the dominant role and prime responsibility for the activity reside in the awardees for the project as a whole, but not necessarily for each task. All parties will agree to accept the participatory and cooperative nature of the group process. FUNDS AVAILABLE The estimated combined total cost (direct + F&A) for the first year of the grants is $ 1,180,000. It is anticipated that six to ten awards will be made as a result of this RFA, depending on the scientific merit of applications and the availability of funds. RESEARCH OBJECTIVES Background and Overview The National Institute of Child Health and Human Development (NICHD) has an interest in the support of research on the long-term development of children who have been placed in child care arrangement during their infancy. In 1988, NICHD issued an RFA titled "Effects of Nonparental Infant Daycare on Child Development." The data collection for Phase I of the study terminated in the end of 1994. In 1994, NICHD issued a letter of invitation to the investigators of the study and affiliated experts to extend the study through 1999 (Phase II). NICHD intends to extend this study again for an additional five years (Phase III) so as to allow the initiation and execution of a follow-up study, starting when the children are in second grade and following their development through fifth grade. The NICHD Study of Early Child Care is a longitudinal "natural history" study guided by ecological conceptualizations of child development. It examines the relations between the rearing environments and the developmental outcomes of children born in the U.S. in the early 1990s. The sample of more than 1,000 children is diverse along economic, ethnic, parent education and other demographic and geographical dimensions. It is also diverse in terms of the children’s rearing experiences. The development of the children has been followed up from the time they were six months of age through first grade, using methods including questionnaires, interviews, observations and psychological testing. Specifically, the children’s social, emotional, cognitive, linguistic and health development were assessed repeatedly over their first seven years of life. The NICHD intends for the extension of the study to be conceptualized and carried out by an enlarged team including the investigators who are affiliated with the 10 data collection sites, new investigators to be recruited through this open competition and the NICHD project scientist/scientific coordinator. To accomplish this goal, NICHD invites submissions of competitive cooperative agreement (U10) applications from experts in the assessment of development in middle childhood and/or in the assessment of the pertinent contexts of development. Scope The Phase III follow-up study will continue to investigate contexts of development and their impact on children’s development. The contexts of development studied in earlier phases were the family, child care (including after school care), school and poverty. It is expected that in Phase III, the continuing and new investigators will together focus on the family, school, and after-school environments as well as on contexts such as the neighborhood, ethnic culture, peer culture, and electronic technology. The changes in contexts of development over time and their influence on children’s development continue to be an important focus of the study. The planned research on the contexts of development will allow for the study of conditions that foster resiliency. It will also allow for "life course" research that considers historical, economic and political influences on child development. The developmental domains and constructs to be investigated in Phase III are those studied in the earlier two phases, as well as others that require special attention due to the age of the children during the third phase of the study. Information about specific developmental processes and outcomes in diverse domains of development will allow the combined team of continuing and new investigators to answer questions pertaining to the relationships among these domains as well as questions about the ways in which contexts affect developmental processes and outcomes in the different domains. The developmental domains to be studied in Phase III include: Cognitive competencies, social competencies, language development, academic achievement, moral development, intimacy, independence, and conflict resolution, friendship formation, intergroup relationships, puberty, physical appearance, physical health, and risk taking behavior and its environmental and psychological predictors. The new investigators are expected to collaborate with the current investigators to consider and possibly implement revisions or augmentation of the protocols proposed by the current investigators for the first cycle of data collection (second and third grade). Time constraints associated with the fact that the majority of the children will be in second grade in 1999 and in third grade in the year 2000, will surely limit the amount of revision and augmentation possible. The new investigators are expected to participate fully in the process of designing the second cycle data collection (fourth and fifth grade). Because the final protocols that make up the comprehensive Phase III follow-up protocol will not be known before the current and new investigators meet and agree, each new protocol will be reviewed by scientific advisors prior to its implementation. Protocols presented in the competing continuation grant applications of the current investigators and found to be of high scientific and technical merit will be exempt from further review, if they have not been modified by the augmented team of investigators. Organizational Structure and Function The new investigators are expected to join and contribute to an ongoing study through participation in the organizational structures that were designed to facilitate collaboration among many individuals. Below is a description of the structures and their functions. The NICHD Study of Early Child Care is conducted by a network of investigators, the NICHD Early Child Care Research Network. The Network is led and managed by a Steering Committee which includes an independent chairperson, one representative from each of the grantee sites, one representative from the data center and one representative from NICHD. The Steering Committee has established internal policies and procedures that govern the operations of the network, including its publication procedures. These policies and procedures undergo periodic review and may be amended and supplemented at the discretion of the Steering Committee. The Steering Committee meets several times a year. Other communications occur by telephone and in correspondence (electronic and otherwise). It is expected that when planning for Phase III is initiated, the Steering Committee will meet once a month for the first six months and every other month in the following six months. Later, the Steering Committee will meet five or six times per year, based on need. The Steering Committee has many subcommittees. Some are administrative and most are scientific. These subcommittees report to the Steering Committee. Decisions of the Steering Committee are usually reached by consensus, with formal voting for the record. Each member of the Steering Committee has one vote. The chairperson votes in a case of a tie. The progress of the study is monitored by NICHD and by the Steering Committee with guidance from an Advisory Board that reports to the Director, NICHD. The Advisory Board is expected to meet with the Steering Committee twice a year, during Steering Committee meetings. It communicates its recommendations in writing to the Director of the NICHD and to the Steering Committee. Decisions of the Steering Committee regarding the research protocol are guided by scientific considerations as well as by feedback from the site coordinators. The research protocol is implemented at the various sites by the coordinators and their teams. The teams are carefully trained and data collectors are all certified. The site coordinators communicate regularly over e-mail. They meet twice a year to discuss the implementation of protocols and to make joint recommendations to the Steering Committee. All data are transmitted to the data coordinating center where it is checked and monitored. The data center staff works closely and collaboratively with the investigators who make plans for data reduction and for data analyses. Subgroups of investigators (pods) make the plans for data reduction and other subgroups (task forces) make plans for data analyses. The task forces also write scientific papers with guidance from the Steering Committee. The NICHD Early Child Care Research Network is a complex system which allows for productive collaboration and includes multiple checks and balances. The network is characterized by a high level of commitment to the overall goals of the study and, in addition, members have developed close working relations. Phase III is planned as a collaboration between current and new investigators. After consultation with the current and new investigators, NICHD will put in place conditions that will facilitate fruitful collaboration. SPECIAL REQUIREMENTS Scientific and Collaborative Plans Applications in response to this RFA must contain the following information: 1. A description of the applicant’s scientific area of expertise as it pertains to middle childhood and/or the assessment of pertinent environments, 2. A rationale for including a sub-study in the area of the applicant’s expertise as part of the common protocol of Phase III of the NICHD Study of Early Child Care, 3. A detailed proposal for a specific sub-study that the applicant plans to submit to the Steering Committee of the NICHD Study of Early Child Care for inclusion in the common research protocol of the study. The proposal will not necessarily be implemented. It is meant to provide the reviewers of the proposal with an example of the scientific interests and capabilities of the applicant. The proposal should include the methods and planned analyses and should follow the format for an R01 application as described in the instructions accompanying the PHS 398 application form, 4. A commitment to collaborate with other investigators. The commitment should describe the intent to collaborate with (a) the current investigators from the 10 data collection sites, (b) investigators from the data center, and (c) the NICHD project scientist/ scientific coordinator, and 5. An acknowledgment of the fact that actual data collection will take place at the existing data collection sites for the NICHD Study of Early Child Care. Budget Guidelines The total project period for applications submitted in response to the RFA should be five years. The requested resources for the first year should be limited to funds to pay for (a) up to 25% of the PI’s time, (b) up to 50% of a research associate, (c) office supplies, (d) communication costs, (e) travel and accommodation for nine Steering Committee meetings in Bethesda in 1999 and for six meetings in each of the following years. It is understood that in future years grantees may be eligible for supplements for additional staff, depending on responsibilities they assume in the study. TERMS AND CONDITIONS 1. The cooperative agreement is an "assistance" mechanism (rather than an acquisition mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients activity by involvement in the activity and otherwise working jointly with the award recipients in a partner role. NIH staff involvement must reflect the expectation that the dominant role and prime responsibility for the activity reside in the awardees for the project as a whole, but not necessarily for each task. 2. The purpose of this solicitation is to establish a research network to continue the NICHD Study of Early Child Care into the middle childhood years (Phase III). The studies to be carried out as a result of this solicitation will represent a common research protocol that will be the same across the funded data collection sites. 3. Planning and implementation of the study is the responsibility of a Steering Committee consisting of the principal investigators of all the funded grants under the cooperative agreement, an independent chairperson, the director of the Data Acquisition and Analysis Center (funded as a result of an independent solicitation through a U01 grant) and the NICHD project scientist/ scientific coordinator for the study. A member of the NICHD grants management staff serves as an advisor to the committee. o This Steering Committee is the corporate Principal Investigator for the study and oversees all the scientific work associated with the NICHD Study of Early Child Care. Awardees will be required to implement the common protocol and procedures approved by the Steering Committee. o The Steering Committee may establish subcommittees as it deems appropriate and the NICHD partner serves on established subcommittees as she deems appropriate. o The Steering Committee conducts data acquisition and analyses in full participation with the Data Acquisition and Analysis Center. The data center collaborates with the awardees in the following ways: It contributes to deliberations of the Steering Committee. It provides assistance in the development of research protocols. It participates in the design of data collection instruments and manuals. It prepares the final forms for data collection instruments and produces the final versions of the manuals of operation. It provides consultation and assistance in the implementation of the studies planned by the Steering Committee of which it is a voting member. It monitors the sites to ensure standardization of procedures and integrity of the data. It designs and implements efficient research data management systems. It provides easy to use data archives with appropriate documentation of procedures, problems, and analyses performed. It assembles, checks for quality, and documents all the data collected at the collaborating sites in line with the objectives set by the Steering Committee. It carries out data reduction and analysis in line with requests from the Steering Committee or subcommittee requests. It assists the Steering Committee in the publication and dissemination of results. o The individual data collection sites retain the rights to the data they collect and each may publish in accordance with the publication policy developed by the Steering Committee. The Steering Committee has access to the combined, common data set. For the duration of the cooperative agreement, the Steering Committee is the coordinator of the publications emanating from the study. 4. Awardees have authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusion of the NICHD Study of Early Child Care. More specifically, awardees o Collaborate with all other grantees of this cooperative agreement, including continuing and new grantees, grantees of the data center and the NICHD Project Scientist/Scientific Coordinator. o Contribute to the development of the various research protocols that make up the comprehensive follow-up protocol of the NICHD Study of Early Child Care. o Contribute to the selection, design and preparation of Phase III data collection instruments. o Contribute to the preparation of Phase III manuals describing data collection methods. o Contribute to the training and certification of Phase III data collectors. o Contribute to plans for data reduction, data analyses and paper writing based on results from Phase I, Phase II and Phase III of the study. o Contribute to written responses to recommendations made by the Advisory Board for the study. o Participate as member of various subcommittees. o Assure that additional data collection from target families and children at a given site (i.e., site specific research) does not in any way jeopardize the integrity of the common protocol. o Participate with the Data Center and the NICHD project scientist/scientific coordinator in the monitoring of the progress of ongoing studies, including field data collection, standardization of methods across study sites, adherence to protocol and quality control procedures. o Disseminate information about the study for the public through popular writing and through the media. The above responsibilities will be carried out in compliance with Steering Committee policies for distribution of responsibilities and for authorship. 5. The NICHD staff member (the project scientist/scientific coordinator) on the Steering Committee will be involved as follows: o Serves as the liaison between the team of investigators and (a) the Director for the Center for Research for Mothers and Children, (b) the Director, NICHD, (c) other NICHD staff and (d) the Advisory Board for the study. o Serves as the Scientific Coordinator of the NICHD Study of Early Child Care. This role includes the following activities, all in participation with other members of the Steering Committee: -- Providing logistical support and attending all Steering Committee meetings and regularly scheduled conference calls of the Executive Subcommittee. -- Facilitating the preparation of extensive archival minutes of Steering Committee meetings. -- Attending meetings of the Site Coordinators and all training meetings of data collectors. -- Responding to requests for information pertaining to the NICHD Study of Early Child Care. Requests come from investigators in the study, members of the scientific community, government agencies, and the media. -- Helping detect and overcome problems with the design or implementation of the study. o Informs the Director, NICHD, the Director for the Center for Research for Mothers and Children, and staff of the Grants Management Branch about the following: -- The scientific progress of the study. -- Performance of the data collection sites. -- The level of cooperation among sites and investigators. -- Fiscal issues as they arise. o Collaborates with awardees of this cooperative agreement and of the cooperative agreement for the data center. o Contributes to the development of the various research protocols that make up the comprehensive follow-up protocol of the NICHD Study of Early Child Care. o Contributes to the selection, design and preparation of Phase III data collection instruments. o Contributes to the preparation of Phase III manuals describing data collection methods. o Contributes to the training and certification of Phase III data collectors. o Contributes to plans for data reduction, data analyses and publication based on results from Phase I, Phase II and Phase III of the study. o Contributes to written responses to recommendations made by the Advisory Board for the study. o Participates as member of subcommittees. o Assure that additional data collection from target families and children at a given site (i.e., site specific research) does not in any way jeopardize the integrity of the common protocol. o Participate with the Steering Committee and the Data Center in the monitoring of the progress of ongoing studies, including field data collection, standardization of methods across study sites, adherence to protocol and quality control procedures. o Disseminates information about the study to the public through popular writing and through the media. Of the above responsibilities, those pertaining to all members of the Steering Committee will be carried out in compliance with Steering Committee policies for distribution of responsibilities and for authorship. 6. Programmatic responsibility for review and oversight of the cooperative agreement will reside with the Director of the Center for Research for Mothers and Children (the fiscal coordinator). The role will include the following: o Option to withhold support to a participating institution if technical performance requirements such as complying with the protocol are not met. o Continuous review of all activities to ensure objectives are being met. o Redirecting activities or improving the cooperation and performance of participating institutions. o Ensuring that the scientific progress of the cooperative agreement is commensurate with the funds provided to each of the sites. o Reviewing, analyzing and approving, in collaboration with grants management staff, all requests for initial funds and supplemental funds. 7. The scientific conduct and progress of the study are evaluated biannually by an independent Advisory Board consisting of members appointed by the Director, NICHD. The advisory Board will consist of members with particular expertise to review the research being conducted by the institutions involved with this cooperative agreement. Members of the Steering Committee and other individuals from their institutions may not serve as members of the Advisory Board. 8. When agreement between awardee and the NICHD staff cannot be reached on scientific/programmatic issues that may arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the principal investigators, one person selected by the NICHD staff and a third person selected by these two individuals. The decision of the arbitration panel, by majority vote, will be binding. 9. Cooperative agreements are subject to the same administrative requirements as grants. All pertinent DHHS, PHS and NIH grant regulations, policies and procedures are applicable. Business management aspects will be administered by the NICHD Grants Management Branch. The above Terms of Award are in addition to, not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 74, and other HHS, PHS and NIH grant administration policies. The special arbitration procedures in no way affect the right of a recipient of a cooperative agreement assistance grant to appeal an adverse determination in accordance with PHS regulations at 42 CFR Part 50, subpart D, and HHS regulations at 45 CFR Part 16 and 75. Business management aspects of these awards will be administered by the NICHD Grants Management Branch in accordance with HHS, PHS, and NIH grant administration requirements. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that women and members of minority groups and their subpopulations 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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which has been published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Since the cohort for the study is already in place, the composition of the cohort must be described in terms of gender and racial/ethnic groups. This information can be received from NICHD. In addition, gender and racial/ethnic issues must be addressed by the research design and mentioned in the application. NIH POLICY AND GUIDELINES ON THE 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 subject 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 I) 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 LETTER OF INTENT Prospective applicants are asked to submit by September 14, 1998, a letter that includes a descriptive title of the proposed research, the name, address, e-mail and telephone number of the principal investigator, the identities of other personnel and participating institutions, and the number and title of the RFA in response to which the application is being 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 program and review staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Sarah L. Friedman, Ph.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Building 61E, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5097 FAX: (301) 480-7773 Email: FriedmaS@exchange.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/59) is to be used in applying for this 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 PHS 398 may also be obtained from the Internet at http://grants.nih.gov/grants/funding/funding.htm The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. 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. 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 services) At the time of submission, two additional copies of the application must be sent under separate cover to: Scott Andres, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E 03H, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier services) Applications must be received by October 28, 1998. 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 previously 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 Center for Scientific Review (CSR) and for responsiveness to the terms of this RFA by NICHD staff. Incomplete applications will be returned to the applicant without further consideration. Complete and responsive applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD in accordance with the review criteria listed below. As part of the initial merit review, all applications will receive a priority score and a written critique. In addition, applications will receive a second level of review by the NICHD Advisory Council. The earliest expected start date for the grants is February 1999. Review Criteria The goals of NIH supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of the criteria below will be addressed and considered by the reviewers in assigning the overall score weighing 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 a 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 the field forward. o Significance: Does the proposed study address an important problem in the context of the NICHD Study of Early Child Care? If the aims of the proposed research are achieved, as part of the total NICHD Study, how will scientific knowledge be advanced? What will be the effects of these studies on the concepts or methods that drive the field? o Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the NICHD Study of Early Child Care? Does the applicant acknowledge potential problem areas and consider alternative tactics? o 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? o Investigator: Is the investigator appropriately trained and well suited to carry out the proposed work? Is the work proposed appropriate to the experience level of the principal investigator? Does the investigator have a demonstrated ability to collaborate effectively with others? Does the applicant have a commitment to collaborate within the existing network of the NICHD Study of Early Child Care and to abide by all Terms and Conditions? o 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 as appropriate for the scientific goals of the research. o The adequacy of the proposed protection for humans, animals and the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will be selected for funding based on their scientific merit, the fit between the proposed research and the scientific needs of the NICHD Study of Early Child Care, the commitment of the applicant to collaboration and to meeting the Terms and Conditions of the Award, and the availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. To the extent that potential applicants are interested in papers describing the NICHD Study of Early Child Care, its procedures and its findings to date, these materials will be made available. Direct inquiries regarding programmatic issues to: Sarah L. Friedman, Ph.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Building 61E, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5097 FAX: (301) 480-7773 Email: FriedmaS@exchange.nih.gov Direct inquiries regarding fiscal matters to: Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development Building 61E, Room 8A17 MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: mc113b@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health System Agency Review. The PHS strongly encourages all grant and contract 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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