Developing Outcome Measures for Young Children

RFA Number: RFA-HD-04-026

Part I Overview Information

Participating Organizations:
National Institutes of Health (NIH), (http://www.nih.gov/)
Administration for Children and Families (ACF), (http://www.acf.hhs.gov/)
U. S. Department of Education (ED), (http://www.ed.gov/)

Components of Participating Organizations:
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
Administration for Children and Families (ACF), (http://www.acf.hhs.gov/)
Office of Special Education Programs, Office of Special Education and Rehabilitative Services (OSEP/OSERS), (http://www.ed.gov/about/offices/list/osers/osep/)

Announcement Type:
New

Catalog of Federal Domestic Assistance Number(s):
93.865

Key Dates
Release Date: November 26, 2004
Letters Of Intent Receipt Date(s): December 27, 2004
Application Receipt Dates(s): January 25, 2005
Peer Review Date(s): June 2005
Council Review Date(s): September 2005
Earliest Anticipated Start Date: September 2005
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: January 26, 2005

• This initiative will support theory-driven development of new measurement approaches for use with children during their early childhood years. It is critical that they be universally designed for large-scale studies and diverse populations.
• Total funding in the first year is expected to be approximately $5.5 million to support 6-10 awards.
• This initiative uses the NIH Research Project Grant (R01) award mechanism.
• Eligible organizations include for-profit or non-profit organizations, public or private institutions, units of State and local governments, eligible agencies of the Federal government, faith-based organizations, domestic or foreign entities.
• Eligible principal investigators are those with the skills, knowledge, and resources necessary to carry out the proposed research.
• Only one application may be submitted by an individual principal investigator.
• 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.
• Telecommunications for the hearing impaired: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Award Criteria
4. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

There is a persistent unmet need in the developmental community, which is also identified and reported by the policy community: despite years of high quality research, there remains a paucity of measurement tools and strategies that are capable of adequately assessing the developmental competence of young children in areas that are important in understanding early childhood development and readiness for school. This is particularly the case among diverse populations of children and for specific developmental outcomes. Much of the measurement work that has been completed to date has been done within the context of completing specific studies. Thus, many of the measures arising from this work have been limited in their appropriateness for larger-scale studies. Moreover, these measures have frequently been developed within the context of scientific investigations with children of known backgrounds, to be administered by teams of highly trained researchers. A major purpose of this solicitation is to allow for measurement development to move from the laboratory into real world applications.

As scientific knowledge increases with respect to the role of early childhood characteristics in assessing current functioning and predicting future functioning, the lack of measures of early and later outcomes becomes more apparent. For example, only recently has the importance of early social competence been widely recognized as a predictor of school adjustment and success. Unfortunately, there is a relative absence of measures and strategies to assess domains of social competence on a large scale. This is especially true in the area of positive social development.

Additionally, few valid and reliable measures of children's functioning have been developed to inform instruction and interaction with children to enhance their growth in social, emotional, and cognitive development, and to keep parents informed about children's progress. Finally, there is an important policy focus on measuring outcomes for young children being served by federally-funded programs. This has created a need for outcome measures that are appropriate for use in large, diverse samples or populations of children.

In June 2002, the NICHD, the Administration for Children and Families, and the Office of the Assistant Secretary for Planning and Evaluation sponsored a workshop entitled Children's Early Learning, Development, and School Readiness: Conceptual Frameworks, Constructs, and Measures (see summary at http://www.nichd.nih.gov/crmc/cdb/Kyle-workshop.pdf). This meeting brought together a number of national experts in child development to develop an overview of the state of the art in early childhood assessment, as well as to make recommendations to inform the future direction of research and development activities in the area. These recommendations form the foundation of this solicitation.

At this meeting, participants examined a number of current measures of early childhood outcomes associated with school readiness and concluded that, although there are many such measures available, most are not appropriate for large scale applications with diverse populations, and that the most promising approaches were those that were still under development. Of particular concern were measures that enjoy popularity even though they may lack appropriateness for the purposes for which they are often used, which may produce floor or ceiling effects, and which show little sensitivity to intervention effects. A compilation of early childhood measures was undertaken in conjunction with this workshop, including psychometric data from the most commonly used measures (see (aspe.hhs.gov/hsp/ECMeasures04/index.htm).

The need for research and development of child outcome measures is also highlighted by a number of federal investments in advisory boards and outcomes assessment systems. The largest, most well-known of these is the Head Start National Reporting System (HSNRS). Launched in Fall 2003, the HSNRS relies upon a brief child assessment battery compiled and field tested under the guidance of a Technical Working Group composed of experts in a number of areas of child development and assessment (see http://www.headstartinfo.org/nrs_i&r.htm for more information). The assessment battery used in 2003 and to be used in the Fall of 2004 was limited by decisions to include only instrumentation that meets rigorous psychometric criteria and measures that had already been successfully used with Head Start populations. The application of these criteria revealed the scope of work necessary to develop measures that are psychometrically sound and provide reliable and valid data on child competence in a number of cognitive and socioemotional domains.

The Office of Special Education Programs (OSEP) in the US Department of Education has funded an Early Childhood Outcomes Center to promote development and implementation of child outcome measures for young children with disabilities (as defined by the Individuals with Disabilities Education Act (IDEA)) that can be used for accountability and program improvement purposes. One of the many challenges to this work is the lack of psychometrically sound tools for large-scale measurement of outcomes for young children with disabilities.

This initiative will support projects to develop new tools and/or strategies to measure outcomes in specific areas of young children's development for which appropriate measurement tools and/or strategies do not currently exist. Particularly important are projects to develop tools and strategies appropriate for diverse populations, to measure critical constructs. Measures should also be appropriate for large-scale utilization and able to assess change over time. Projects should develop tools and/or strategies from a theoretical base, validate the approach, and establish basic psychometric data on the tool/strategy during the award period. The expectations for projects funded under the solicitation are drawn largely from recommendations emanating from the previously described workshop on conceptual frameworks, constructs, and measures. This solicitation is intended to support only those projects which propose to develop new early childhood outcome measures, as described below. Projects that intend to refine, revise, or modify existing, published measures are not appropriate for this solicitation; such projects may be submitted as investigator-initiated grant applications. Once funded, it is expected that the grantees will form an informal network of researchers who will meet annually to present their conceptual and empirical work, and to cooperatively address arising concerns.

Domains of Early Childhood:

While measurement development is encouraged for all domains of early childhood functioning, there are several specific areas of interest where measurement work is particularly needed. The list of broad domains below, with a limited number of specific examples in parentheses, provides a general overview of areas of need:

Cognitive outcomes include, but are not limited to:

• General cognition (including broad batteries, general knowledge, etc.)
• Literacy (including phonemic awareness, letter knowledge, print awareness, decoding, reading, etc.)
• Oral language (including receptive and expressive vocabulary, semantics, pragmatics, etc.)
• Mathematics (including number, shape, size, basic operations, etc.)
• Science (including scientific reasoning)

• Social competence (including general sociability, social skills, etc.)
• Adult-child relationships (including attachment, compliance, cooperation, etc.)
• Peer-relationships (including friendships, aggression, etc.)
• Behavioral regulation (including executive functioning, behavioral control, inhibition, delay of gratification, etc.)
• Affect regulation (including mood, emotionality, etc.)
• Attentional regulation (including sustained attention, attentional release, orienting response, etc.)
• Approaches to learning (including task persistence, motivation to learn, etc.)

Although high quality work is welcomed that addresses measure development in any of the domains above, there is particular need for work in areas where the development of measures has lagged. Therefore, in identifying areas of work to be completed, investigators should provide an overview of currently available measures for the domains of interest, and identify how the proposed measure or measures would contribute to the field. Additionally, there is a need for the development of measures that adequately assess child outcomes along several key constructs within the larger domain, or measures that cross domains to provide a broader measure of early childhood developmental outcomes. Finally, to the extent possible, investigators should plan to develop measures consistent with state- and/or federally-mandated indicators of early childhood outcomes to enable the possible adoption of the developed measure by states to meet reporting needs associated with some federally-funded programs.

Ground Measures in Child Development Theory:

Projects funded under this solicitation will be expected to pursue a theory-driven, data-informed research and development process. Identification of constructs to be measured, a review of relevant theoretical literature, and identification of current approaches and their limitations are all necessary to set the context for the proposed work. To be considered universally designed, this context must include a consideration of the linguistic and cultural diversity of children; consideration of any special demands and needs relevant to children with disabilities; consideration of the range and diversity of the skill sets and training of individuals who would use the developed measure, including individuals with limited or no specific training in child assessment; and an expectation that the measure will be used at large scales. Proposed projects should also include plans for the inclusion of multiple conceptual frameworks (where possible) and move toward or achieve consensus regarding key constructs and how to measure them. It is expected that projects will present a clear conceptual framework and, during the early months of the award period, allow for scientific debate with colleagues in the field to refine this conceptualization.

Develop Measures with Practical Relevance:

Measures proposed under this solicitation are expected to be developed and tested in applied settings that frequently include large numbers of children from diverse linguistic and cultural backgrounds, children with disabilities, and children from across the socioeconomic spectrum. Additionally, in real world applications, the individuals performing the assessments may not be trained in the assessment of young children, and may lack expertise and/or experience in the importance of standardized assessment procedures, reporting accuracy, etc. Finally, in these applications, the time allotted for assessments may be limited. Therefore, consideration should be given to training and the development of documentation to aid in administering the developed measure and interpreting its results, as well as plans for providing for brief versions, even if these are drawn from a longer version of the measure developed.

Provide Evidence of Sound Psychometric Properties:

Measures developed under this initiative should achieve the highest possible levels of psychometric soundness. Proposals should include plans for both validation and reliability studies. Validation studies should include both concurrent and predictive validation. For studies using factor analysis, Item-Response Theory (IRT) modeling, or other advanced statistical techniques to derive subscales, plans to validate the subscales and document stability of the structure should be incorporated into the study. Because a key goal of this solicitation is the development of measures appropriate to diverse populations of children, plans should be included to examine the psychometric properties of the measures within and across important subgroups of children. Plans for norming the measure should be presented. Additionally, the measures developed under this solicitation would be expected to be used in intervention and/or evaluation studies involving children from diverse backgrounds. Therefore, plans for identifying floor and ceiling effects should be presented, as well as plans for addressing these effects if they occur in the data, and the measures should be designed to be sensitive to intervention effects.

This solicitation is specifically intended to support the development of measures appropriate for children during early childhood, typically between the ages of three and five years. Measures that are appropriate for multiple ages, or include plans for standardization at different ages, are encouraged, but projects that are designed to develop measures with wide age-range applicability must include children aged three to five years, and must include a plan for standardization and/or norming as appropriate.

Although measures developed under this solicitation may use either direct assessment, parent/teacher/caregiver report, or even self-report, applicants are encouraged to consider the various uses of the measure under development, and make plans to complete such development using the most appropriate approach given the nature of the construct being measured, and in consideration of the practical applications called for above. For projects developing measures other than direct assessments, plans must be included for interrater reliability and validation against existing, preferably direct-assessment, measures with strong psychometric properties.

Applications that propose to deconstruct, rescale, or otherwise draw heavily from a currently copyright-protected measure or measures, even if the application includes all relevant permissions to use such measures, will be considered nonresponsive to this RFA. Such projects may be appropriate as investigator-initiated applications, but will not be accepted under this solicitation. Likewise, applications that propose to revise or otherwise modify a currently published, copyright-protected measure or measures will be considered nonresponsive to this solicitation.

Section II. Award Information

2. Funds Available

The participating agencies intend to commit approximately $5.5 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2005 to fund six to 10 new and/or competing continuation grants in response to this RFA. NICHD plans to contribute $2 million, ACF $3 million, and OSERS $500,000 in FY 2005.

An applicant may request a project period of up to five years and budget for direct cost of up to $350,000 in the first year and up to $500,000 in years 02 through 05. A justification and detailed budgets must be provided for all years, with particular attention to justification of costs for years 02 through 05 when requested direct costs increase over the standard NIH three percent escalation rate. 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. See: http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html

Although the financial plans of the participating agencies 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.

Section III. Eligibility Information

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Eligible agencies of the Federal government
• Domestic institutions/organizations
• Foreign institutions/organizations
• Faith-based or community-based organizations

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing

No cost sharing is required.

3. Other-Special Eligibility Criteria

Annual PI Meetings

Investigators should plan and budget for annual investigator meetings to occur in the metropolitan Washington, D.C. area. The schedule for these meetings will be determined collaboratively between the PIs and Federal Program staff upon funding; however, the first meeting will be scheduled during Fall 2005.

Applicants may submit only 1 application as principal investigator.

Section IV. Application and Submission Information

3. Submission Dates

Applications must be received by the receipt date.

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date(s): December 27, 2004
Application Receipt Dates(s): January 25, 2005
Peer Review Date(s): June 2005
Council Review Date(s): September 2005
Earliest Anticipated Start Date: September 2005

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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 IC 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:

Kyle Snow PhD
Child Development and Behavior Branch
National Institute of Child Health And Human Development
6100 Executive Boulevard, 4B05B, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-2307
FAX: (301) 480-0230
Email: snowk@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Using the RFA Label: The RFA label available in the PHS 398 application instructions 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/labels.pdf.

3.C. Application Processing

Applications must be received by the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. Incomplete and/or nonresponsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Award Criteria).

6. Other Submission Requirements

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the data sharing plan and the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section V. Application Review Information

Applications will be evaluated according to the standard criteria for scientific merit (Section V.3 below).

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the (NICHD). Incomplete and/or non-responsive applications will not be reviewed.

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 NIH Center for Scientific Review in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score
• Receive a written critique
• Receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council.

3. Merit Review Criteria

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Are the proposed measures conceptually important in understanding early childhood and school readiness? Do the intended measures address gaps in our current measurement and assessment capacity? Are the intended measures likely to be useful at scale?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are there clear plans for the conceptualization of the content of the measure(s) to be developed? Does the project include plans to conduct both concurrent and predictive studies of reliability and validity for the developed measure? Is there a clear plan for the revision and/or modification of the measure while in development to accommodate diverse populations of children and/or diverse backgrounds and skills of assessors? Does the approach include use of the most current psychometric and analytic approaches?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does the proposal effectively reconcile conceptual differences in the domains of interest?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Does the team have necessary expertise in early childhood development as well as psychometric analyses?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? ? Is there already in place an infrastructure to support research in early childhood, including access to research participants?

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

3.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing

3.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section VI. Award Administration Information

Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via e-mail notification from the awarding component, NICHD, to the grantee business official (designated in Item 14 on the Application Face Page). If a grantee is not e-mail enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

2. Administrative Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm.

3. Award Criteria

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

Once the availability of funds is confirmed, and scientific merit of each application established by peer review, federal program staff will consider the most suitable applications to comprise the network funded by this solicitation to ensure that a breadth of projects, outcome measures, and populations addressed, are included.

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually:
http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts:

Kyle Snow, Ph.D.
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B05B, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-2307
FAX: (301) 480-0230
Email: snowk@mail.nih.gov

2. Peer Review Contacts:

Gayle M. Boyd, Ph.D.
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1014-3
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 451-9956
FAX: (301) 594-6363
Email: gboyd@csr.nih.gov

3. Financial or Grants Management Contacts:

Fran Petti
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-7191
FAX: (301) 451-5510
Email: fp9k@nih.gov

Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at 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 applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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 PA 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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