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
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)  

Title: Mental Retardation and Developmental Disabilities Research Centers 2008 (P30)

Announcement Type
This is a reissue of RFA-HD-05-030 which was previously released on September 29, 2005.  

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

Request For Applications (RFA) Number: RFA-HD-07-012

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: August 10, 2007
Letters of Intent Receipt Date: November 21, 2007
Application Receipt Date: December 21, 2007
Peer Review Date: March/April, 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 2008
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: December 22, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The 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 mental retardation and developmental disabilities (MRDD). This Request for Applications (RFA) seeks applications from institutions that meet the qualifications for a program of MRDD research as specified at: http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm. 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.

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 and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

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

1. Developmental and neurobiological studies to define the molecular and cellular bases of MRDD and to facilitate development of specific hypotheses about basic abnormalities that underlie these conditions.

2. Studies of cellular and molecular aspects of brain development: differentiation, synapse formation and modification, plasticity, trophic factors, and neurotransmitter function and modulation.

3. Applied clinical and experimental studies of inborn errors of metabolism relevant to MRDD that involve pathophysiology of cellular and subcellular organelles.

4. Development of novel and innovative technologies for pre- and post-natal diagnosis of common and rare causes of MRDD; investigation and therapy of conditions associated with MRDD.

5. Studies of the genetic and epigenetic basis of MRDD by molecular genetic, genomic, and proteomic approaches.

6. Studies of the pathways by which genotype affects the development, function, and dysfunction of the nervous system, particularly with respect to cognition and behavior.

7. Creation and characterization of animals that, through genetic alteration, model specific important aspects of MRDD by clear neurodevelopmental, pathophysiological, genetic, and/or functional homology, and their use to test existing and to develop new medications that are safe and effective for individuals with MRDD.

8. Prenatal therapy of genetic and structural defects using nutritional, pharmacological, surgical, and other techniques.

9. Genetic, molecular, behavioral, and biobehavioral research and therapeutic approaches to the MR syndromes, such as Down, Fragile X and Rett.

10. Studies of physical environmental factors in the etiology, treatment, and prevention of MRDD, 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 MRDD. Areas of interest include developmental and behavioral teratology, neuroimmunological toxicology, and conditions such as fetal alcohol syndrome.

11. Studies of the effects of malnutrition (protein, caloric, micronutrient) on intellectual, behavioral, social, and physical development; intergenerational effects of malnutrition.

12. 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 MRDD; dual diagnoses.

13. Clinical trials for the treatment, amelioration, and/or prevention of MRDD. NICHD encourages the Centers to apply for clinical trials grants (R34, R01, and U01).

14. Studies of infectious diseases in the etiology, treatment, and prevention of MRDD; neuropathological, neurological, behavioral, and intellectual consequences of AIDS in children.

15. 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 analyates, biomolecule sensing, mass spectrometry, functional imaging) for screening and diagnosis.

16. Studies that develop methods to better define clinical phenotypes, including sources of variability, in MRDD, 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).

17. Studies involving early interventions (biological, behavioral, educational, environmental) for infants born at risk for MRDD; research into the strategies for early intervention; follow-up of high-risk infants and children whose risk is due to biomedical conditions such as low birth weight and/or conditions of environmental deprivation; studies of intergenerational effects and outcomes for children whose parents have conditions associated with MRDD; effects of teen pregnancy on at-risk infant outcome. 

18. Predictive and developmental studies of perinatal problems associated with MRDD; developmental studies of low birth weight, including infants who are small for gestational age, preterm, medically fragile, and neonatally sick (such as those who experience hypoxic or ischemic insults).

19. Neurodevelopmental and longitudinal studies that characterize the neuropathogenesis and inherent variability in MRDD to develop specific hypotheses about the initial (primary) abnormality, and to address the degree to which phenotypic variation impacts upon postnatal brain development.

20. 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.

21. Studies of psychological processes in MRDD, including attention, cognition, information processing, perception, motor development, neuropsychology, and affective, social, motivational, and personality factors.

22. Studies of autism spectrum disorders: screening and diagnosis, etiology, neurobiology, genetics, pathophysiology, developmental course, using medical, biological, and pharmacological approaches; behavioral and pharmacological interventions.

23. Studies involving manipulations of interaction between behavior and environment of individuals with MRDD 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.

24. Studies that examine and evaluate residential, educational, and vocational settings of individuals with MRDD throughout the life span.

25. Studies of learning disabilities, dyslexia, and attention deficit hyperactivity disorder.

26. Studies of language and communication in MRDD populations.

27. Studies of socio-ecological processes: individuals with MRDD from various cultural and ethnic groups in multiple settings (naturalistic observation); ethnographic research, life history reporting, and systematic observation of specific activities.

28. 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 MRDD in family and educational settings.

29. Studies of the epidemiology of MRDD: analytic and case-control studies of etiology; incidence and prevalence; follow-up over the life span for outcomes.

30. 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.

31. Studies that develop and utilize assistive devices (e.g., computer software, hand-held devices, and touch screen computers) to help individuals with MRDD to learn and communicate.

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

Section II. Award Information


1. Mechanism(s) of Support
 
This funding opportunity will use the NIH Center Core Grant (P30) award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

Applicants must prepare the application in a manner consistent with the guidelines presented in the "NICHD P30 CENTER CORE GRANT GUIDELINES" (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

NICHD intends to commit approximately 4.5 million dollars in FY 2008 to fund up to three new and/or  renewal (competing continuation) applications in response to this RFA. An applicant for a new grant may request a project period of up to five years and a budget for direct costs up to 750,000 dollars per year. An applicant for a renewal (competing continuation) grant may request a project period of up to five years and a budget for initial year direct costs of 750,000 dollars or the amount representing an increase of up to 3 percent above the direct costs awarded in the final noncompeting (Type 5) year, whichever is greater. 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.

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 NICHD 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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

For the purpose of this RFA, the NICHD will support no more than one MRDDRC grant (P30) per institution. To be eligible for an award, the proposed Center must provide core support for a minimum of 10 projects funded from non-university sources. Additional eligibility criteria for the P30 are listed in the NICHD P30 CENTER CORE GRANT GUIDELINES at: http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm.

1.B. Eligible Individuals

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

The MRDDRC 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 MRDDRC 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

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Applications for P30 MRDDRC 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 MRDD. 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. These projects must be of high quality and provide a multidisciplinary approach to the problem(s) under investigation. Each project is to be summarized in accordance with the NICHD P30 CENTER CORE GRANT GUIDELINES (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). Projects funded under initiatives unrelated to this RFA (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.

An MRDDRC 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 MRDD 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 MRDDRC must receive NICHD prior approval to access core facilities.   

Section IV. Application and Submission Information


1. Address to Request Application Information

The 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) 435-0714, 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 on line 2 of the face page of the application form and the YES box must be checked.

Instructions for application preparation can be found in the NICHD P30 CENTER CORE GRANT GUIDELINES (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).  

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times not applicable.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: November 21, 2007
Application Receipt Date: December 21, 2007
Peer Review Date: March/April, 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 2008  

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Ljubisa Vitkovic, Ph.D. 
Mental Retardation and Developmental Disabilities Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 4B09E, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier/non-USPS service )  
Telephone: (301) 402-1822
FAX: (301) 496-3791
Email: vitkovil@mail.nih.gov  

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications 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/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
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 5B01, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier/non-USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov  

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NICHD. Incomplete and non-responsive applications will not be reviewed.

Upon receipt in NICHD, an administrative review of the application is performed by NICHD staff for conformance to NIH policy and NICHD guidelines, responsiveness to the RFA, as well as for its relevance to NICHD program interests. If the application fails to comply with NIH policy and guidelines or is determined to be non-responsive to the RFA, it will be returned to the applicant without review.

Budgets for new and renewal applications will undergo stringent review within the guidelines described in Section II.2 (above). Applications with budget requests exceeding these guidelines will be considered non-responsive to this FOA and will be returned to the applicants without review.

Research projects proposed for core use that are of questionable relevance or are not thematically related may be also be considered non-responsive.

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 http://grants.nih.gov/grants/policy/policy.htm.

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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation 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.

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 MRDDRC Program promotes 1) interdisciplinary collaboration among Centers’ investigators, 2) data/information sharing and integration, 3) synthesis of knowledge about MRDD, 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 MRDDRC Program is to attract scientists to MRDD 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. 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 MRDD 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 compare to R01 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.

A major goal of the NICHD is to promote active collaboration among MRDDRCs. 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 MRDDRCs network. The Administrative Core should budget for the maintenance of the MRDDRC Network Web-Portal and for the development of common protocols, databases, and communications and informatics technologies.  

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
 
Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

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

Sharing Research Resources

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

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Keeping with the goals of the MRDDRC 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 MRDDRCs.

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD in accordance with the review criteria stated below.

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

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

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

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

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? 

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

In their considerations, the reviewers will also be guided by the following criteria:

NICHD will evaluate all applications responding to this RFA according to the review criteria for Core units, New Program Development projects, and the overall center as outlined in the NICHD P30 CENTER CORE GRANT GUIDELINES (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).

Review of competing continuation (renewal) 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 MRDD of the publications that acknowledge support by the Center grant.

A site visit is not a prerequisite for consideration of any application by an NICHD review committee. Site visits will not be conducted for applications responding to this RFA. The applicant should not rely on a site visit to supplement or improve an incompletely written application.

A five-year total project period is required.

Core units may be recommended for a minimum of three years. This would not preclude requests for support of core units for less than three years. However, a minimum of three core units is required in each of the five years of the Center grant.

2.A. Additional Review Criteria:
 
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

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

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

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

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

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The reviewers will be asked to assess the adequacy of the plan.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the 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 PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

The Non-Competing Grant Progress Reports must explicitly describe the progress in achieving the goals of the MRDDRC Program that are articulated in this document and should follow the guidelines presented in the "NICHD P30 CENTER CORE GRANT GUIDELINES" (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).

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:

Ljubisa Vitkovic, Ph.D. 
Mental Retardation and Developmental Disabilities Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 4B09E, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-1822
Email: vitkovil@mail.nih.gov  

2. Peer Review Contacts:

Robert Stretch, Ph.D 
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 5B01, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Email: stretchr@mail.nih.gov  

3. Financial or Grants Management Contacts:

Bryan S. Clark, M.B.A
Chief Grants Management Officer
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 8A01, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Phone: (301) 435-6975
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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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-02-005.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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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 RFA 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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