Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)

Title: Intellectual and Developmental Disabilities Research Centers 2010 (P30)

Announcement Type
This is a reissue of RFA-HD-08-016

Update: The following update relating to this announcement has been issued:

• January 10, 2011 - This RFA has been reissued as RFA-HD-10-022.

Request for Applications (RFA) Number: RFA-HD-09-012

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: December 3, 2009
Letters of Intent Receipt Date: December 11, 2009
Application Receipt Date: January 24, 2010
Peer Review Date(s): February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010
Additional Information to Be Available Date (Url Activation Date): Not applicable
Expiration Date: January 25, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• 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.
• Mechanism of Support. This FOA will utilize the NIH Core Center research (P30) grant mechanism.
• Funds Available and Anticipated Number of Awards. The total amount of funding that the NICHD expect(s) to award in FY 2010 is $3.23 million; the anticipated number of awards is three.
• Budget and Project Period. A new application may request up to $750,000 in direct costs. A renewal application may request up to $750,000 OR an increase of up to 1 percent above the direct costs awarded in the final noncompeting (Type 5) year, whichever is greater. The total project period for an application submitted in response to this funding opportunity may not exceed five years. Budget increments for subsequent years will have a three percent limit.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
• Number of Applications. An institution may submit one application in response to this FOA.
• Resubmissions. Applicants may submit a resubmission application, but such an application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Renewal applications are permitted in response to this FOA.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: 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 or Matching
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 and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. 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

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

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.

Background

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 research programs. 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 identified 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. Scientific knowledge to be achieved through research supported by the special program: 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 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.

Objectives

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.
• 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.
  

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Core Center research (P30) grant award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

The estimated amount of funds available for support of three Centers awarded as a result of this announcement is $3.23 million for fiscal year 2010. 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. An applicant for a renewal grant may request a budget for initial year direct costs of $750,000 or the amount representing an increase of up to 1 percent above the direct costs awarded in the final noncompeting (Type 5) year, whichever is greater. The total project period for an application submitted in response to this funding opportunity may not exceed five years. 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. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation see NOT-OD-05-004.

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• 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 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 (Other than Small Businesses)
• State Governments
• U.S. Territory or Possession
• Regional Organizations
• Eligible Agencies of the Federal Government

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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 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.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. An institution may submit one application in response to this FOA.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Renewal applications are permitted in response to this FOA.

Eligibility Requirements

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 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.

Each core unit must:

• provide 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.

The following additional requirements apply:

• 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.

Allowable Budgetary Items and Supportable Activities

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 relevant 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.

The following NICHD guidelines also affect cost allowability.

Items fundable under an NICHD P30 grant include:

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;
• Travel to one Center Directors' meeting annually to discuss scientific advances in the Centers and promote scientific interaction among the Centers; and
• At the discretion of the relevant NICHD Center program, and as described in the relevant FOA, travel to one Center Directors' and administrators' meeting annually to confer with other NICHD Center Directors 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 of technical or administrative staff for technical training that would enhance the quality of core unit operation or travel required to maintain the operation of a core unit;
• Minor renovation or alteration of existing facilities; and
• Consultant services.

New Program Development Projects

Funds may be requested to provide initial support of new research projects relevant to the center's goals. Plans for seeking subsequent grant support through other funding mechanisms or sources should be indicated. (NICHD encourages these alternatives as a first option.)

Support for individual New Program Development projects is limited to a two-year period. Funding may not exceed 10 percent of the center grant's total annual direct costs awarded, inclusive of the portion budgeted for New Program Development projects, or $100,000 per year, whichever amount is smaller. With NICHD staff approval, the period of support may be extended one additional year.

When support for a New Program Development project is requested in a new or competing continuation Center grant application, the proposed research plan must be described in sufficient detail, comparable to a small research grant application (R03), to permit evaluation of the project through the competitive peer review process.

Supplemental applications (Type 3) requesting additional funds for a New Program Development project are discouraged. Any such applications should be discussed with NICHD staff before submission.

If New Program Development is approved for an initial two-year period, funds may be included each year for the full five years, or may be rebudgeted for support of cores in Years 03-05. Funds for New Program Development in Years 03-05 will be contingent upon identification of project(s) that are within scope . Funding levels for New Program Development in Years 03-05 will be based on the approved level in Years 01 and 02.

Other Research Projects

Support of unfunded research projects by core units generally is not allowable, except in rare situations, and requires approval by NICHD 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 include:

• 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; and
• Travel of investigators, other than the Center Director or designee, to scientific meetings.

Section IV. Application and Submission Information

1. Address to Request Application Information

The most current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

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.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: December 11, 2009
Application Receipt Date: January 24, 2010
Peer Review Date(s): February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010

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 in Section IV.3.A.

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: parisima@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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

Robert Stretch, 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: stretchr@mail.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive 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. Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH 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 NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

The applicant must provide a detailed description of each Core unit proposed as part of the Center, with detailed budget and budget justification.

Budgetary items allowable for Administrative Core Units include salaries and support for a limited number of administrative and clerical personnel; administrative support services, when not covered by institutional Facilities and Administrative (F & A) charges; travel to one Center Directors' meeting to discuss scientific advancements of the Centers annually; and travel to one Center Directors' and administrators' meeting annually to confer with other NICHD Center Directors and program staff.

Budgetary items allowable for other Cores include 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; and consultant services .

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 in to 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.

Another 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 whom do not have a mentor with affiliate status may be allowed upon formal request of the PI and with approval of program staff.

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. Include any supplementary application instructions not stated elsewhere in the announcement.

SECTION I - GENERAL INFORMATION

1. 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.

2. 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.

3. TABLE OF CONTENTS

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

4. BUDGET ESTIMATES

Prepare a series of composite budget tables for the Center Core Grant 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
1. 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.
2. 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.

5. 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, including principal investigators of projects accessing cores.

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.

6. SUMMARY TABLE OF CENTER RESEARCH SUPPORT

Present a summary table of current research support such as shown below:

7. SUMMARY OF INDIVIDUAL RESEARCH SUPPORT

Information regarding active and pending research support of all key scientific and technical personnel named on Form Page 2 (except consultants) should be presented in a format such as that suggested in Table I, below, beginning with Center Director and listed thereafter in alphabetical order. Identify other support in the following categories:

1. Current Active Support; and
2. Applications Pending Review or Funding.

Place an asterisk next to those projects proposed to access cores.

8. 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.

SECTION II - RESEARCH PLAN

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.

1. OVERVIEW

The Overview and Progress Report (if applicable) shall not exceed 20 pages in total.

1. 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, since aspects of its history are likely to be included in the Progress Report (section B described below).
2. 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.
3. Center Publications. List publications prepared during the past five-year period or, for competing continuations, during the current grant period.
4. Assurances and Collaborative Agreements. Any arrangements for collaborative and cooperative endeavors or subcontracting should be highlighted. Letters of Intent to Collaborate and Letters of Agreement from consultants should be referenced here and included at the end of the appropriate core unit.
5. Cost-Effectiveness and Quality Control. Describe procedures used to lower costs and assure quality of Center administrative and research activities.
6. Quantitative Use Table. A summary table should be submitted for the first year of the proposed Center grant, showing quantitative use (percent) of each core by research projects, presented in a format such as that suggested in Table II, below.
7. Accomplishments of Center not previously cited
1. Results of completed research projects not previously included (competing continuation only).
2. Use of administrative funds by Center Director for activities such as consultant services, scientific seminars, renovations, or travel (competing continuation only).
3. 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
4. Investigators attracted to the field by this center core grant and its facilities: New investigators; Visiting investigators
5. Impact on institution and community
6. Role of center in facilitating research, assisting young investigators, attracting other research funds, and enhancing collaboration and interdisciplinary research
7. Other
1. PROGRESS REPORT - if applicable (renewal applications only).

For Type 2 applications, a progress report should be included, as described in the PHS 398 Instructions.

3. CORE DESCRIPTION

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

Identify each proposed core unit by a letter (A, B, C ) and a title (Administrative, Molecular/Cellular, ).

For each proposed core, address cost effectiveness and plans for quality control, as appropriate.

1. Administrative Core Unit
1. Objective
2. Organizational Chart
3. Staffing: Description of key professional and support staff functions
4. Resources: Description of space and physical resources
5. Services Provided: Description of current and projected services to other core units and research projects

2. Research Core Units
1. Objective
2. Staffing: Brief description of scientific, technical, as well as support staff functions
3. Resources: Description of space and physical resources
4. Administration: Description of overall management of the research core unit
5. Justification: Description of services provided and their bearing on productivity and quality, as well as documentation of cost-effectiveness and quality control
6. Utilization: Indicate past and/or current usage (e.g., assays performed, animals supplied, etc.) and list projects proposed for core usage, identified by full title, such as displayed in sample format shown in Table II.
7. 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 (see FOA for references).

4. NEW PROGRAM DEVELOPMENT PROJECTS (Not to exceed 6 pages)

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 following sections should be included in the presentation of each New Program Development project proposed.

1. Abstract
2. Specific Aims
3. Background and Significance
4. Progress Report/Preliminary Studies
5. Research Design and Methods
6. Human Subjects (including consideration of policies on inclusion of women, minorities and their subgroups, and children) and Vertebrate Animals
7. Literature Cited

5. 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. The scientific and technical merit of projects funded by NIH and NSF generally will not be assessed because such projects already have been peer reviewed. These projects should be listed in numerical order. The following information is to be given for each funded and pending research project from NIH and NSF proposed for core usage. Do not exceed one page per project.

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

All projects with funding sources other than NIH and NSF, as well as 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 following tables provide sample formats for the requested Research Support and Core Usage information, which may be included in the Appendix:

TABLE I

ALL CURRENT AND PENDING RESEARCH SUPPORT OF PROFESSIONAL PERSONNEL

(SAMPLE FORMAT)

* Accessing cores.

TABLE II

QUANTITATIVE USE (PERCENT) OF CORE UNITS BY RESEARCH PROJECTS

(SAMPLE FORMAT)

Research Strategy Page Limitations

Page limits for each section are addressed above in submission instructions.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

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.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

• 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 impact/priority score.
• Receive a written critique.
• Receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council.

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

Core Review Criteria. 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?

• Is the research program significant to the mission of the NICHD IDDRC Program?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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?

• Does the program involve the participation of a suitable number of responsible, experienced investigators?
• 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?

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?

• 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 a New Program Development project or support of trainees is proposed, is the research project consistent with the goals of the Center, the IDDRC program, and likely to lead to independent or additional funding for the investigator?

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?

• 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?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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.

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.

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.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period. Review of renewal (competing continuation) applications (type 2) will evaluate the progress made by a Center in the previous funding period in addition to the review criteria applied to new applications. The reviewers will evaluate productivity of investigators affiliated with a Center by the number, impact and relevance to IDD of the publications that acknowledge support by the Center grant.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), 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 recommended for 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.

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.

Additional Review Considerations

As applicable for the project proposed, reviewers will address 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.

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

Select Agents 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).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Selection Process

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by 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 NICHD considers appropriate in light of its particular statutory mission

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

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 (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. Reporting

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.

The Non-Competing Grant Progress Reports must explicitly describe the progress in achieving the goals of the IDDRC Program that are articulated in this document.

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.

Section VII. Agency Contacts

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:

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: parisima@mail.nih.gov

2. Peer Review Contacts:

Robert Stretch, 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: stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Bryan S. Clark, M.B.A.
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard
Room 8A01, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6975
FAX: (301) 402-0915
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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 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 funding opportunity 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 (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.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.