Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Funding Opportunity Title	Intellectual and Developmental Disabilities Research Centers 2011 (P30)
Activity Code	P30 Center Core Grants
Announcement Type	Reissue of RFA-HD-09-012
Related Notices	January 16, 2013 - This RFA has been reissued as RFA-HD-13-002.
Funding Opportunity Announcement (FOA) Number	RFA-HD-10-022
Companion FOA	None
Number of Applications	An institution may submit only one application in response to this FOA. Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865
FOA Purpose	The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites applications for Center Core Grants designed to advance the diagnosis, prevention, treatment, and amelioration of intellectual and developmental disabilities (IDD). This Funding Opportunity Announcement (FOA) seeks applications from institutions that meet the qualifications for a program of IDD research. The grants fund core resources to support interdisciplinary research and research training. Funds for the research projects using these core facilities come from independent sources including Federal, State, and private organizations.

Posted Date	January 10, 2011
Letter of Intent Due Date	February 22, 2011
Application Due Date(s)	March 22, 2011
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July 2011
Advisory Council Review	August 2011
Earliest Start Date(s)	September 2011
Expiration Date	March 23, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), through the Intellectual and Developmental Disabilities (IDD) Branch (formerly Mental Retardation and Developmental Disabilities Branch), Center for Developmental Biology and Perinatal Medicine (CDBPM), invites Center Core Grant (P30) applications to advance the diagnosis, prevention, treatment, and amelioration of intellectual and developmental disabilities. This Funding Opportunity Announcement (FOA) seeks applications from institutions that meet the qualifications for a program of IDD research. The primary objective of the NICHD Intellectual and Developmental Disabilities Research Centers (IDDRC) Program is to provide core support and facilities for cohesive, interdisciplinary research and research training. Funds for the research projects using these core facilities come from independent sources including Federal, State, and private organizations.

For more than 40 years, NICHD has provided support for IDDRCs through Center Core (P30) grants that facilitate program coordination and support central research facilities, administration, and development of a limited number of new development projects. The degree of impairment associated with IDD varies with the cause. Moderate and more severe IDD often results from problems that produce profound alterations in brain development and/or function. Defective genes, teratogenic agents, toxic substances, infections, nutritional deficits, accidents, maternal conditions, and other factors causing brain damage may lead to diminished intellectual and adaptive capacity. A larger proportion of cases of IDD relate to environmental or social conditions and disorders of unknown etiology. Each IDD syndrome requires fundamental research into the underlying processes, as well as studies designed to meet the unique needs of the affected children. Therefore, one of the missions of the IDD Branch is to support research on the etiology, pathophysiology, epidemiology, diagnosis and evaluation, prevention, and treatment or amelioration of IDD. Research conducted in the IDDRCs covers a broad spectrum of scientific approaches ranging from laboratory research on fundamental processes of normal and abnormal development to clinical and behavioral research that studies persons with IDD. Major solutions to the problems associated with IDD may emerge from multidisciplinary, collaborative, and integrated approaches involving biomedical, behavioral, and biobehavioral research conducted in the IDDRCs. Thus, NICHD encourages cooperation among the Centers, including their integration into a network that may facilitate infrastructure necessary for the conduct of larger research programs or clinical trials. NICHD encourages the Centers to apply for clinical trials grants (R34, R01, and U01). Administrative and scientific organization within a Center and across the network of IDDRCs should enhance opportunities for breakthroughs. Scientific knowledge achieved through research supported by this special program will help prevent, diagnose, and ameliorate or treat IDD.

A major goal of the NICHD IDDRC Program is to support research that leads to the prevention and/or amelioration of IDD. The intent of IDDRC Center Core Grants is to bring together scientists from a variety of disciplines to work within a Center on the common problems of IDD. NICHD strongly encourages translation of basic research observations into patient-oriented protocols whose ultimate aims are to validate the mechanistic basis of IDD in humans, and to develop new approaches for the prevention, diagnosis and treatment of IDD. Consequently, applications for IDDRC Core Grants (P30) should include investigators studying a range of topics in basic and clinical or applied research. NICHD encourages, but does not require, applicants to include both biomedical and behavioral/biobehavioral components among the topics addressed within their Center. Applications responding to this FOA must include at least five topics relevant to the research mission of IDD. Support of postdoctoral trainees, junior investigators, and investigators new to the IDD field is also encouraged, as one of the goals of the IDDRC program is to attract scientists to IDD research.

Examples of topics include, but are not limited to:

• Developmental and neurobiological studies to define the molecular and cellular bases of IDD and to facilitate development of specific hypotheses about basic abnormalities that underlie these conditions.
• Studies of cellular and molecular aspects of brain development: differentiation, synapse formation and modification, plasticity, trophic factors, and neurotransmitter function and modulation as possible mechanistic substrates for IDD.
• Applied clinical and experimental studies of inborn errors of metabolism relevant to IDD that involve pathophysiology of cellular and subcellular organelles.
• Development of novel and innovative technologies for pre- and post-natal diagnosis of common and rare causes of IDD; investigation and therapy of conditions associated with IDD.
• Studies of the genetic and epigenetic basis of IDD by molecular genetic, epigenetic, genomic, and proteomic approaches.
• Studies of the pathways by which genotype affects the development, function, and dysfunction of the nervous system, particularly with respect to cognition and behavior.
• Creation and characterization of animals that, through genetic alteration, model specific important aspects of IDD by clear neurodevelopmental, pathophysiological, genetic, and/or functional homology, and their use to test existing drugs and to develop new drugs that are safe and effective for individuals with IDD.
• Prenatal therapy of genetic and structural defects using nutritional, pharmacological, surgical, and other techniques.
• Genetic, molecular, behavioral, and biobehavioral research and therapeutic approaches to neurodevelopmental syndromes, such as Down, Fragile X and Rett.
• Studies of physical environmental factors in the etiology, treatment, and prevention of IDD, such as heavy metals (e.g., lead and mercury) and toxic wastes (e.g., hydrocarbons and polycarbonates or PCBs) and their effects on morphogenesis and function that contribute to IDD. Areas of interest include developmental and behavioral teratology, neuroimmunological toxicology, and conditions such as fetal alcohol syndrome.
• Studies of the effects of malnutrition (protein, caloric, micronutrient) on intellectual, behavioral, social, and physical development; intergenerational effects of malnutrition.
• Studies of psychopharmacology, including medication use and development; cellular and molecular mechanisms, pharmacokinetics, behavioral effects; rational drug development (e.g., combinatorial chemistry, pharmacogenomics); medication use and treatment efficacy in different subpopulations of IDD and in those with dual diagnoses.
• Clinical trials for the treatment, amelioration, and/or prevention of IDD. NICHD encourages the Centers to apply for clinical trials grants (R34, R01, and U01).
• Studies of infectious diseases in the etiology, treatment, and prevention of IDD; neuropathological, neurological, behavioral, and intellectual consequences of AIDS in children.
• Studies that develop and test novel methods and measures for screening and diagnosis, and/or identify children and infants at risk; validation of emerging technologies (e.g., microarrays, proteomics, microanalysis of analytes, biomolecule detection, mass spectrometry, functional imaging) for screening and diagnosis.
• Studies that develop methods to better define clinical phenotypes, including sources of variability, in IDD, with particular focus on characteristic components of behavior and cognition; measurement tools to assess cognitive and behavioral development; tests that highlight abilities and disabilities, including tests for specific subpopulations (e.g., specific inborn errors of metabolism and syndromes such as Down, Fragile X, Prader-Willi, and Williams).
• Studies involving early interventions (biological, behavioral, educational, environmental) for infants born at risk for IDD; research into strategies for early intervention; follow-up of high-risk infants and children whose risk is due to biomedical conditions such as low birthweight and/or conditions of environmental deprivation; studies of intergenerational effects and outcomes for children whose parents have conditions associated with IDD; effects of teen pregnancy on at-risk infant outcome.
• Predictive and developmental studies of perinatal problems associated with IDD; developmental studies of low birthweight, including infants who are small for gestational age, preterm, medically fragile, and neonatally sick (such as those who experience hypoxic or ischemic insults).
• Neurodevelopmental and longitudinal studies that characterize the neuropathogenesis and inherent variability in IDD to develop specific hypotheses about the initial (primary) abnormality, and to address the degree to which phenotypic variation impacts upon postnatal brain development.
• Studies to follow the developmental trajectories of different brain functions and their influence on developing cognitive and motor skills; such studies might use techniques of imaging, electrophysiology, pharmacology, molecular biology, and behavioral science.
• Studies of psychological processes in IDD, including attention, cognition, information processing, perception, motor development, neuropsychology, and affective, social, motivational, and personality factors.
• Studies of autism spectrum disorders: screening and diagnosis, etiology, neurobiology, genetics, pathophysiology, and developmental course, using medical, biological, and pharmacological approaches; behavioral and pharmacological interventions.
• Studies involving manipulations of interaction between behavior and environment of individuals with IDD throughout the life-span to reduce behavior problems or to facilitate vocational training, social and self-help skills, and learning; use of social support networks; parent-child, sibling, peers, and family interactions over the life-span.
• Studies that examine and evaluate residential, educational, and vocational settings of individuals with IDD throughout the life span.
• Studies of learning disabilities, dyslexia, and attention deficit hyperactivity disorder.
• Studies of language and communication in IDD populations.
• Studies of socio-ecological processes: individuals with IDD from various cultural and ethnic groups in multiple settings (naturalistic observation); ethnographic research, life history reporting, and systematic observation of specific activities.
• Studies of hyperaggressive, destructive, and self-injurious behavior in humans and animal models, including pharmacological and behavioral treatments; stereotypic behaviors; lack of adherence associated with IDD in family and educational settings.
• Studies of the epidemiology of IDD: analytic and case-control studies of etiology; incidence and prevalence; follow-up over the life span for outcomes.
• Studies that examine and evaluate behavior, life styles, health needs, and health disparities of affected individuals that could affect mortality and morbidity throughout the life span.
• Studies that develop and utilize assistive devices (e.g., computer software, hand-held devices, and touch screen computers) to help individuals with IDD to learn and communicate.

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission of applications from RFA HD-09-012 Revision of applications from RFA HD-09-012 The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The total amount of funding that the NICHD expect(s) to award in FY 2011 is $6.79 million and the anticipated number of awards is five. Future year amounts will depend on annual appropriations. An applicant for a new grant may request a budget for direct costs of $750,000 the first year..
Award Budget	A new application may request up to $750,000 in direct costs. A Renewal application may request up to $750,000 or up to 1 percent above the direct costs awarded in the final noncompeting (Type 5) year. Budget increments for subsequent years will have a three percent limit. Budgets for New and Renewal applications will undergo stringent review within these guidelines. Applications with budgets that exceed these guidelines will be deemed by NICHD to be non-responsive to this FOA and will be returned without review. The cost of a proposed Center will be a material consideration in the selection of applications for funding..
Award Project Period	The total project period for an application submitted in response to this funding opportunity may not exceed five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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 support.

The IDDRC Director should be a scientist or science administrator who can provide effective scientific and administrative leadership. The Director will be responsible for the organization and operation of the IDDRC and for communication with the NICHD on scientific and operational matters. She/he should be able to integrate and synthesize the proposed research and, thereby, serve as an example to other investigators.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

An institution may submit only one application in response to this FOA.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

For the purpose of this FOA, the NICHD will support no more than one IDDRC grant (P30) per institution. Applications for P30 IDDRC grants must propose a program consisting of cores to be accessed by grants that propose research addressing at least five topics relevant to the research mission of IDD. A list of examples is outlined above (in Section I.1. Research Objectives ). This list of topics is not comprehensive, nor are the examples exhaustive.

The program should consist of at least 10 externally funded research projects grouped according to relevant topics. The specific research projects must be (1) relevant to the mission of NICHD's IDD Center programs; (2) of a quality acceptable to NICHD; and (3) funded when the P30 award (initial or renewal) begins. These projects must be of high quality and provide a multidisciplinary approach to the problem(s) under investigation. Projects funded under initiatives unrelated to this FOA (such as Fragile X Research Centers, Autism Centers of Excellence, Rare Disease Cooperative Research Centers, and traditional P01s) may be counted in the 10 externally funded research projects. (Individual research components of a P01 program project may be counted as separate projects to qualify a Center or core.)

An IDDRC must contain an Administrative Core and a minimum of two additional core units. A minimum of three federally funded research projects must utilize each core unit. These projects must relate to IDD and at least one must be funded by NICHD, exclusive of research contracts, training grants, interagency agreements, and supplemental projects funded by other agencies.

When determining core support, subprojects within a Program Project (P01) will be considered as individual projects comparable to an R01. Projects located at institutions that do not already have an IDDRC must receive NICHD prior approval to access core facilities.

Core units must fulfill the following requirements:

• Pprovide essential facilities or services for at least three federally funded research projects, at least one of which is NIH-funded;
• Have satisfactory quality-control systems documented for its services or facilities;
• Be cost-effective, i.e., the centralization should result in a lower cost than would be incurred if the same facilities or services were supported by the individual research grant budgets; and
• Increase the quality and productivity of research projects receiving core support.
• In general, contract-supported projects may not be counted to qualify a core. In cases where the funding agency primarily uses the contract mechanism to support investigator-initiated projects rather than the grant/assistance mechanism, the aforementioned restrictions may not apply. In any case, NICHD staff should be consulted. Use of core facilities by projects funded by research and development contracts will be evaluated on an individual basis. Any use of core facilities by contracts must be paid for in full from contract funds, not from NICHD Center Core Grant funds.
• Use of core facilities by projects located at other institutions is allowable with NICHD prior approval. The sharing of unique core resources between P30 IDDRCs is permitted and encouraged, provided that an appropriate cost-recovery mechanism is developed.
• Use of core facilities by individual trainees supported by Institutional National Research Service Awards (T32) is allowable, with NICHD approval.
• The cost-effectiveness of the core units must be demonstrated in the application. Mechanisms such as fee-for-service, in-kind, or other means are acceptable.

Scientific personnel and institutional resources capable of providing a strong research base in the field specified must be available. There also must be a strong institutional commitment. The commitment may take the form of faculty appointments for investigators, purchase of research equipment, or assignment of research space to facilitate collaborative research and interdisciplinary interaction. Scientists may have access to the Center's centralized facilities and participate in its activities while retaining independent control of their respective research projects. However, all activities using NICHD Center funds must be relevant to the mission of NICHD's Center programs.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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.

By the date listed in Part 1. Overview Information, 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 PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Melissa A. Parisi, M.D., Ph.D.
Intellectual and Developmental Disabilities Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard
Room 4B09, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6880
FAX: (301) 496-3791
Email: [email protected]

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Sherry Dupere, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-1485
FAX: 301-402-4104
Email: [email protected]

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

• For P30 applications, page limits are as follows:
• Specific Aims for Overall P30 1 page
• Overview of the Program Project (for overall P30) 12 pages
• Core Descriptions (each Core) 12 pages
• Research Project Descriptions (each project) 1 page
• New Program Development Projects-Optional (each project) 6 pages
• For Resubmission or Revision applications, also include the following:
  • Introduction (required for a resubmission or revision application)
  • For overall P30 1 page
  • For each Core Unit 1 page
  • For each New Program Development Project 1 page

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide

In keeping with the goals of the IDDRC Program enunciated in the Guidelines and in Other

Submission Requirements, above, the applicants should highlight potentially unique core

resources and how they plan to share them with other IDDRCs. A cost-sharing plan to allow

other IDDRCs access to such unique resources is acceptable and encouraged, if appropriate.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applications are submitted on Form PHS 398. All instructions and guidelines accompanying the PHS 398 are to be followed, with the exception of the sections modified by the specific instructions described below:

• In lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 398, a table of contents should be prepared listing all of the major sections described below and paginated to enable reviewers to find specific information readily.

The applicant must provide a detailed description of each Core unit proposed as part of the Center, with detailed budget and budget justification. The applicant must name a scientist to be responsible for each Core unit proposed. The description of each Core unit proposed should include a rationale, indicating how the Core will support the research effort in an efficient and cost-effective manner. Cores should integrate with or buy into existing institutional resources rather than duplicate them. Core support to individual investigators should not overlap with support already available to them from other sources.

The applicant institution and pertinent departments must show a strong commitment to the Center's support. Dedicated space and/or equipment, staff recruitment, investigators' salaries, or other financial support for the proposed Center exemplify such commitment. The facilities should require no more than modest alteration and/or renovation. NICHD provides no funds for new construction. Scientific personnel and institutional resources must be available to provide a strong research base in the specified fields.

As a major goal, the IDDRC Program promotes 1) interdisciplinary collaboration among Centers investigators, 2) data/information sharing and integration, 3) synthesis of knowledge about IDD, and 4) translational research that will lead to amelioration and prevention. Each Center application should present a specific plan for achieving this major goal.

A major goal of the NICHD is to promote active collaboration among IDDRCs. To accomplish this goal, successful applicants will participate in the collaborative efforts of established Centers' programs. In planning the program, applicants should consider potential collaborative studies and projects that they may propose for the IDDRC network. The Administrative Core should budget for the maintenance of the IDDRC Network Web-Portal and for the development of common protocols, databases, and communications and informatics technologies.

Allowable costs in NIH grants are governed by rules set forth in the National Institutes of Health Grants Policy Statement and the NIH Guide for Grants and Contracts, unless otherwise stated in the FOA and/or the Notice of Grant Award. Under these rules, the director of a P30 Center may exercise flexibility to meet unexpected Center requirements by rebudgeting or requesting approval to rebudget between cores, consistent with NIH policy.

Administrative Core Unit:

• Salaries and support for a limited number of administrative and clerical personnel, such as the Center Director, Center Administrator, secretaries, and clerical support staff. The criteria defined under revised OMB Circular A-21 will be used by NICHD staff to determine allowability of direct charging of administrative and clerical support staff.
• Administrative support services, including supplies, duplication, telephone, and maintenance contracts for equipment when not covered by institutional Facilities and Administrative (F&A) charges; and
• Travel to 1-2 Center Directors' and administrators' meetings annually to confer with other NICHD Center Directors and/or program staff to promote scientific interaction among the Centers, or to visit other Center facilities pursuant to the administration of the Center.

Research-Related Core Units:

• Salaries and support for core staff;
• Supplies (including animals);
• Scientific equipment;
• Computer facilities and services;
• Travel for technical or administrative staff for technical training or to maintain operation of the core unit;
• Minor renovation or alteration of existing facilities;
• Consultant services.

New Program Development Projects:

A goal of the IDDRC Program is to attract scientists to IDD research. Where appropriate, the applicant may request up to five years' support for "New Program Development" for direct research support of one or more projects or investigators. This support should not exceed a total of $100,000 direct costs per year, or 10 percent of total direct costs, whichever is less. Applicants may use such funds to attract new investigators to the Center, to develop a new area or program of research, to facilitate the development of new research programs of newly trained investigators or investigators new to IDD research, or to facilitate use of a Core at one Center by investigators affiliated with another Center that lacks that kind of Core. Description of New Program Development projects should be comparable to R03 research grant applications in detail and development. Each New Program Development project may provide support for no more than two years to any one investigator. Other investigators may be supported in subsequent years with approval of program staff. In addition, support for postdoctoral trainees engaged in IDD-related research is permissible within this category of support, after review by a Center’s advisory committee based on selection criteria to be described in the application, and after approval of such candidates by program staff. Access to Cores by trainees or junior investigators participating in IDD research who have not yet secured independent funding or do not have a mentor with affiliate status may be allowed upon formal request of the PI and with approval of program staff.

Other Costs:

• Costs related to dissemination of research results to the scientific community and lay public;
• Costs related to seminars or meetings designed to promote interdisciplinary interaction, education, or center cohesiveness; and
• Costs related to advisory committee meetings.

Items not fundable under an NICHD P30 grant:

• Direct support of individual research projects (except New Program Development projects);
• Salary and support for central institutional administrative personnel usually paid from institutional F&A charges, such as budget officers, grant assistants, and building maintenance personnel;
• Salary and support for administrative activities such as public relations, health or educational services unrelated to the research;
• Travel of investigators, other than the Center Director or designee, to scientific meetings;
• Support of unfunded research projects by core units generally is not allowable, except in rare situations requiring approval by NICHD staff.

A. FACE PAGE

• Complete all items on the application's face page. This is Form Page 1 of the application; number succeeding pages consecutively.
• On line 2, enter the appropriate Request for Applications (RFA) number and title, and mark the YES box.

B. Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells

• On Form Page 2, describe briefly the research program which will be served by the proposed Center grant and the proposed cores.
• List key scientific and technical personnel participating in the Center Core Grant (including principal investigators of projects accessing cores). Use continuation pages as necessary, numbering consecutively.

C. TABLE OF CONTENTS

• Prepare the Table of Contents as noted above. The major areas to be listed are enumerated in these instructions.

D. BUDGET ESTIMATES

• This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
• For the P30 Center application, prepare a series of composite budget tables as requested below. A separate detailed budget is required for each core unit and each New Program Development project.

1. Composite Budget

• Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of the PHS-398 to present the total budget for all requested support for the first year. For each category, such as "PERSONNEL," "EQUIPMENT," etc., list the amount requested for each core unit and for each New Program Development project.
• If consortium arrangements have been made involving other institutions or organizations, include total costs (direct and F & A) associated with such third party participation in the "CONSORTIUM/CONTRACTUAL COSTS" category. Costs for purchased services should be itemized under "OTHER EXPENSES."
• Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of the PHS-398 to prepare a budget, by category, that provides totals for each year of requested support.

2. Individual Core and New Program Development Budgets

• First year (use Form Page 4 of the PHS-398 for each)
  Consortium Budgets (if applicable) should be presented as described in Item 1 (Composite Budget), including budget for the entire proposed project period. Total Direct and F & A Costs of sub-awardee are to be shown under "CONSORTIUM/CONTRACTUAL COSTS" on individual core budget and a detailed consortium budget is to be inserted following the appropriate core budget.
• Total project period (use Form Page 5 of the PHS-398 for each)

Budget Justifications: Describe the specific functions of key scientific and technical personnel, consultants, collaborators and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For additional years of support requested, justify any significant increases in any category over the first 12-month budget period. Identify such significant increases with asterisks against the appropriate amounts. If a recurring annual increase in "PERSONNEL" or "OTHER EXPENSES" is anticipated, give the percentage. However, current NIH practice limits escalation to three percent. In addition, for Competing Continuation applications, justify any significant increases in any category over the current level of support.

E. BIOGRAPHICAL SKETCH

• Biographical sketches are required for all senior/key scientific and technical personnel participating in the core units and New Program Development projects as listed on Form Page 2.
• Beginning with Center Director, and following in alphabetical order, submit biographical sketches as described in the "Instruction Sheet for Form PHS-398," using the sample format on the Biographical Sketch Format Page. Do not exceed four pages for each person.

F. RESOURCES

• As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II. Identify each core unit by title, and assign each core unit a capital letter (A,B,C) that reflects the order in which the core units are presented in the application research plan. For each core unit, provide the name of the Core Director and biographical sketches for personnel not identified previously.

A. SPECIFIC AIMS FOR OVERALL P30 CENTER (1 Page)

• Follow the instructions in the PHS398 Application Guide

B. OVERVIEW OF P30 CENTER

The Overview shall not exceed 12 pages in total.

• History, Purpose, and Objectives of the Center; Discuss the philosophy and objectives of the Center and general plans for the proposed grant period. For an existing IDDRC, the history information can be shortened to emphasize information that confirms the Center’s past success in realizing its objectives.
• Administration, Organization, and Operation of the Center: Include information on the support and commitment of the parent institution for the Center, the authority of the Center Director, the use of advisory or user committees, and the method of determining core access and space assignment. Describe organizational framework and provide an organizational chart.
• Cost-Effectiveness and Quality Control: Describe procedures used to lower costs and assure quality of Center administrative and research activities.
• Progress Report Overview (If applicable): For renewal applications, a general progress report should be included as described in the PHS 398 Instructions. A more detailed progress report for each core may be included in the Core Descriptions below.
• Accomplishments of Center not previously cited:
  • Use of administrative funds by Center Director for activities such as consultant services, scientific seminars, renovations, or travel.
  • Training activities external to the center (not including the P30 core grant that contributes to the center environment): Previous trainees, preceptors, present positions; Current trainees, preceptors, research topics.
  • Investigators attracted to the field by this center core grant and its facilities: New investigators; Visiting investigators.
  • Impact on institution and community.
  • Role of center in facilitating research, assisting young investigators, attracting other research funds, and enhancing collaboration and interdisciplinary research.
  • Other

C. CORE DESCRIPTIONS

For each Core Unit, include a single cover page listing the title of the Core, the name of the Core Director, and names of any other investigators (with titles and affiliations). Identify each proposed Core unit by a letter (A, B, C ) and a title (Administrative Core, Molecular/Cellular Core, etc.).

The description of each core is limited to 12 pages, with no more than 8 cores total per application.

1. Administrative Core Unit

• Objective
• Organizational Chart
• Staffing: Description of key professional and support staff functions
• Resources: Description of space and physical resources
• Services Provided: Description of current and projected services to other Core units and research projects, as well as the process for prioritizing requests for use of Core facilities by the various research projects;
• Cost effectiveness and plans for quality control
• Progress Report: For competing renewal applications, include a description of progress during the past funding period, including services performed, new technologies developed, changes in protocols or Core administration, and any other significant developments.

2. Research Core Units

• Objective
• Staffing: Brief description of scientific, technical, as well as support staff functions
• Resources: Description of space and physical resources
• Administration: Description of overall management of the research Core unit
• Justification: Description of services provided and their bearing on productivity and quality, as well as documentation of cost-effectiveness and quality control
• Utilization of Core: Provide a summary of projected usage of Core services (e.g., assays performed, animals supplied, etc.) by affiliated research projects.
• Cost effectiveness and plans for quality control
• Progress Report: For competing continuation (renewal) applications, include a description of progress during the past funding period, including services performed, new technologies developed, changes in protocols or core administration, and any other significant developments.
• Human Subjects: If Core service involves human subjects, (e.g., recruitment; screening), discuss the inclusion of women, minorities and their subgroups, and children as research subjects, following relevant policy announcements.

D. RESEARCH PROJECTS PROPOSED FOR CORE USAGE

Research projects proposed for Core usage will be evaluated with respect to the appropriateness of the projects' use of core services. These projects should be listed in numerical order. The following information is to be given for each research project that is currently funded or pending award (status = to be paid in eRA Commons or IMPACII).

Do not exceed one page per project.

• Principal Investigator and percent effort
• Title of project
• Source of support (including complete designation and grant number, such as 5 P01 HG 12345 (P.I. - Smith), Project III (P.I.- Jones)
• Indication of funding status (funded or pending)
• Period of support
• Budget:
  • Total first year or current 12-month budget
  • Total project period
• Brief description of project
• Relevance of the project to P30 center mission as specified in the FOA
• Core(s) to be accessed with brief justification statement

E. NEW PROGRAM DEVELOPMENT PROJECTS (Optional)

For each New Program Development Project, include a single cover page listing the title of the project and the name of the investigators (with titles and affiliations). New Program Development Projects will be peer reviewed for scientific and technical merit, as well as for the appropriateness of the projects' use of Core services. These projects must be described in sufficient detail to permit evaluation through the competitive, peer-review process.

The description of each New Program Development project is limited to 6 pages, and should include the following information:

• Abstract
• Specific Aims
• Background and Significance
• Progress Report/Preliminary Studies
• Research Design and Methods
• Core(s) to be accessed with brief justification statement
• Human Subjects (including consideration of policies on inclusion of women, minorities and their subgroups, and children) and Vertebrate Animals
• Literature Cited

F. PROGRESS REPORT PUBLICATION LIST (For competing renewal applications only)

• List publications prepared during current grant period (or the past five-year period) which report results of research supported by the grant.

G. USE OF CORES IN PRIOR PROJECT PERIOD (For competing renewal applications only)

• Provide a summary of usage of each core by research projects over the past year, presented in a table or other format. Include the name of the project investigator, title of project, funding source, grant number, project period, and percent usage of each core by the project.

H. LETTERS OF ASSURANCE/AGREEMENT

• Any arrangements for collaborative and cooperative endeavors or subcontracts should be highlighted. Include letters of agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For P30 applications, peer review of scientific and technical merit focuses on: (1) review of the individual Core units; (2) review of the New Program Development Projects (if applicable); and (3) review of the P30 program as an integrated collection of projects and Cores oriented around a set of research themes, and the overall merit of the program. Review criteria for these elements are listed in the sections below.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the overall P30 Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Integration of the Overall P30 Center

A major emphasis in evaluating the P30 Center is the integration or centeredness of the overall program. The P30 Center will be evaluated as an integrated collection of cores and research projects oriented around a set of research themes. The review will evaluate the following:

• Does the program function as a true Center rather than a collection of unrelated support services with the sum of the parts being greater than the individual components?
• Is there coordination and integration between the proposed Cores that reflects a cohesive research support program?
• Is there value added by having the proposed Cores comprise a Center that allows the Center to leverage additional resources that would not have been possible without an integrated P30 structure?

The review will also evaluate the following:

• Does the program involve the participation of a suitable number of responsible, experienced investigators with adequate time commitment for the cores and Center to succeed?
• Does the Center Director have leadership ability and scientific stature, an ability to meet the program's demands of time and effort, and an ability to promote the Center mission among participants?
• Is the Center able to provide adequate infrastructure to support novel approaches to IDD research and has it anticipated current and future needs of the research community?
• Are the scope, breadth, and overall quality of the Center's program, the core units, and the research projects adequate?
• Is the program multidisciplinary in scope and does it have the ability to coordinate the research projects and core units?
• Are the arrangements for internal quality control of ongoing research, allocation of funds, day-to-day management, contractual agreements, internal communication, and cooperation among the investigators in the program well delineated and appropriate?
• Is the administrative and organizational structure conducive to attaining the objective of the proposed program?
• If New Program Development Projects are proposed, are the research projects consistent with the goals of the Center, the IDDRC program, and likely to lead to independent or additional funding for the investigator?
• Is the institutional commitment to the requirements of the program adequate?
• Is the academic and physical environment as it bears on research subjects, space, and equipment, and on the potential for interaction with scientists from other departments and institutions sufficient and conducive for the project?
• Is there adequate justification for adding or deleting new Research Projects and/or Cores?
• Has adequate progress been made since the previous competitive review (renewal applications only)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Reviewers will assign an impact score based on the assessment of each Core unit in terms of the following review criteria. Separate criterion scores will not be assigned for Cores.

For each individual Core, the review will evaluate the following:

• Qualifications, experience, and commitment of the Core Director and other Core personnel;
• The quality of the services provided;
• The cost effectiveness and quality control of the Core;
• The utility of the Core to the program;
• Progress during the past funding period (if applicable), including services performed, new technologies developed, changes in protocols or Core administration, and any other significant developments.

For the Administrative Core, the review will also evaluate the following:

• The Core Director’s experience in research administration;
• The appropriateness of administrative structures and day-to-day management of the program.
• The decision-making process within the proposed center for the evaluation of research productivity, allocation of funds, and management of resources;
• The process for prioritizing use of Core facilities by the various research projects;
• The process for selecting additional New Program Development Projects (if applicable);
• The mechanisms proposed for regular communication and coordination among investigators in the program;
• The plan for program evaluation, including the use of any internal or external advisory groups;
• Progress during the past funding period (if applicable), including services performed, new technologies developed, changes in protocols or Core administration, and any other significant developments.

Review Criteria for New Program Development Projects (if applicable)

Reviewers will assign an impact score based on the likelihood of each new program development project to develop new areas of research, or to facilitate the development of newly trained investigators or investigators new to IDD research.

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NICHD (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Cost-effectiveness of the core facilities
• Cost of the Center (e.g., Compliance with resource sharing policies)

NIH considers the following in evaluating Center grant applications:

• The scientific and technical merit of the proposed program;
• The qualifications and experience of the center director and other key personnel;
• The statutory and program purposes to be accomplished;
• The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the center;
• The extent to which the center's activities would be coordinated with similar efforts by other organizations;
• The administrative and managerial capability of the applicant; and
• Other factors which the NICHD considers appropriate in light of its particular statutory mission.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.

Not Applicable

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Melissa A. Parisi, M.D., Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6880
Email: [email protected]

Sherry Dupere, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Blvd, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-1485
Email: [email protected]

Bryan S. Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Parts 74 and 92.