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: Limited Competition for Fragile X Research Center Revision Applications (P30)
 
Announcement Type 
New

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

Request For Applications (RFA) Number: RFA-HD-07-013

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: March 23, 2007
Letters of Intent Receipt Date(s): April 23, 2007
Application Receipt Date(s): June 29, 2007
Peer Review Date(s): November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): April 1, 2008
Additional Information to be Available Date (Url Activation Date): Not applicable
Expiration Date: June 30, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

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

Purpose

The National Institute of Child Health and Human Development (NICHD) invites Principal Investigators of Mental Retardation and Developmental Disabilities Research Center (MRDDRC) Core Grants to submit grant applications for competing revisions (formerly called supplements) to develop new or continue existing Fragile X Research Centers.  This limited competition RFA will continue the “Centers-within-Centers” structure for this program. This “Centers-within-Centers” structure prompts the sharing of both the infrastructure and resources of the MRDDRC in a manner that is beneficial to both “Centers.”

The original RFA, Neurobiology and Genetics of Fragile X syndrome, was developed in response to the Children's Health Act of 2000 (H. R. 4365) Section 452E which called for the funding of three Fragile X syndrome Research Centers.  The funded Centers have produced numerous findings that have propelled the field of Fragile X syndrome research forward at a rapid pace.  It is the purpose of this RFA to maintain the momentum of discovery and further develop research relevant to Fragile X syndrome and associated disorders.  The Fragile X Research Centers are intended to stimulate the formation of multidisciplinary, multi-institutional teams with a goal of facilitating the translation of basic research findings related to Fragile X syndrome from “bench-to-bedside-to-community.” 

Background

Fragile X syndrome is one of the most common causes of inherited mental retardation.  It occurs as a result of the expansion of CGG trinucleotide repeat in the 5' untranslated region of the FMR1 gene preventing the expression of fragile X mental retardation protein (FMRP).  FMRP is vital to the development and maturation of dendritic spines and synaptic connections and is considered to be responsible for many of the phenotypic characteristics of the syndrome. In the absence of FMRP, dendritic spines are long and immature in appearance.

Fragile X syndrome has a broad spectrum of phenotypic involvement.  Full mutations (more than 200 repeats) generally result in hypermethylation of the CGG repeat and the adjacent promoter region, transcriptional silencing, and the loss of FMRP.  This leads to a severely disabling neurodevelopmental disorder involving physical, neurocognitive, and emotional characteristics.  Full mutations and mental retardation (MR) have been estimated to occur in approximately 1 in 4,000 males and in 1 in 6,000 females and have been found across race and ethnic groups.

Distinct phenotypes are also evident in individuals with pre-mutations (55-200 repeats).  Individuals with permutations are at risk of developing physical, neurocognitive, and emotional characteristics unique to the condition throughout their lifespan.  These include anxiety and autism in young children, symptoms of ADHD, academic learning disabilities during adolescence, premature ovarian failure in women, and the appearance of a neurological syndrome, Fragile X Tremor/Ataxia Syndrome, at older ages. It has been estimated that approximately 1 in 259 females and 1 in 810 males carry the pre-mutation.  

The NICHD has supported research related to Fragile X since the late 1960s and is committed to continuing this tradition by maintaining support for Fragile X Research Centers.

Research Scope

This RFA is designed to create and/or continue Fragile X Research Centers whose participating investigators would direct research efforts in developmental neurobiology, pathophysiology, genetics, proteomics, epidemiology, structure-function correlations, and clinical, behavioral and biobehavioral studies directly relevant to Fragile X syndrome (FXS) and associated disorders.    

Projects should have a well-defined central research focus related to improving the diagnosis and treatment of FXS and associated disorders or leading to an eventual cure. The application should provide a multi-disciplinary, yet unified approach to the problems being investigated by the Fragile X Research Center. Examples of the types of studies addressing Fragile X syndrome that may be proposed in response to this RFA include, but are not limited to, the following:

Research proposed for inclusion in the Fragile X Research Center must represent new research projects.  Projects relevant to Fragile X syndrome research that are currently supported by the R01, P01 or other funding mechanisms may not apply for supplemental funds that extend or modify their scope under this RFA.  Projects that represent competing continuations of existing R01 and P01 project components, however, are eligible to be incorporated into a Fragile X Research Center application as "new" research projects, provided that they withdraw any overlapping applications currently funded or under review.  The budgets of individual research projects may not exceed $250,000 in total costs per year.

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

Section II. Award Information


1. Mechanism(s) of Support

This limited competition RFA will use the NIH Center Core Grant (P30) funding mechanism.  Awards will be made for “Centers-within-Centers” as revisions (formerly called supplements) to existing Mental Retardation and Developmental Disabilities Research Center (MRDDRC) Core Grants (P30).

The “Centers-within-Centers” approach is designed to encourage and support broadly based multidisciplinary research programs that have a well-defined central research focus or objective in Fragile X syndrome research.  Careful attention must be paid by applicants to the requirements contained in this RFA.  Applications failing to adhere to these instructions will be returned to the applicant without review.  

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

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 (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The NICHD intends to commit approximately $4 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2008 to fund at least three Fragile X Research Centers as "Center within a Center" components of existing MRDDRC P30 Centers in response to this RFA.  An applicant for a Fragile X Research Center grant may request a project period of up to five years and a budget for total costs of up to $1.33 million in the first year, provided that the total budget period requested in the revision application does not exceed the time remaining on the original parent grant. 

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.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Any currently funded NICHD MRDDRC with scientific personnel and institutional resources capable of providing a strong research base in Fragile X is eligible.   Individual MRDDRCs may submit one application, but a given application may involve multiple sites, including other MRDDRCs and partners that may be domestic or foreign non-profit and for-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State or local government; and eligible agencies of the Federal government.

1.B. Eligible Individuals

The application is to be submitted by a team consisting of:  (1) The Principal Investigator of the MRDDRC, who also shall serve as the Associate Director of the MRDDRC for Fragile X Research and; (2) the designated Director of the Fragile X Research Center.  The Principal Investigator of the MRDDRC may also serve as the Director of the Fragile X Research Center. Both the Principal Investigator of the MRDDRC and the Fragile X Research Center Director will assume responsibility and accountability to the applicant institution and to the NICHD for the performance and proper conduct of the Fragile X Research Center in accordance with the requirements specified in this RFA. 

The applicant(s) will be solely responsible for planning, directing, and executing the proposed project.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

None

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.

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(s): April 23, 2007
Application Receipt Date(s): May 23, 2007
Peer Review Date(s): November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): April 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:

Tiina K. Urv, Ph.D.
Mental Retardation and Developmental Disabilities Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B09D, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or express service)
Telephone: (301) 402-7015
Fax: (301) 496-3791
Email: urvtiin@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 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 H. 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 20892-7510
(Rockville, MD 20852 for courier or express service)
Telephone:   (301) 496-1485
FAX:   (301) 402-4104
Email: stretch@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.

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

Collaborative Arrangements

A strong institutional commitment at any partnering institution involved must be demonstrated.  Evidence of prior collaboration and/or a plan for proposed collaborations between the investigators and proposed access of the partner to at least one Core facility at the affiliated MRDDRC should be cited. 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.  Affiliation with and utilization of at least one Core within an existing MRDDRC is required for a Fragile X Research Center application to be responsive to this RFA.

The application must provide details of agreements regarding sub-contracting arrangements and the approach to conducting the team science effort, through its description of: the roles and areas of responsibility of participating scientists, the process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, procedures for resolving conflicts, and other information related to the management of the proposed project in order to demonstrate the potential effectiveness of such collaboration for the ongoing work of the Fragile X Research Center.

Center Structure and Requirements

An existing MRDDRC may submit only one "Center within a Center" Fragile X Research Center application.  Individual Directors of Fragile X Research Center Projects or Cores may affiliate with more than one MRDDRC for the purpose of establishing a Fragile X Research Center.  However, Research Project Directors must apply for support of unique, distinct, and non-overlapping research projects at each MRDDRC/Fragile X Research Center with which they affiliate.  Core Directors may provide Core services for more than one Fragile X Research Center. However, with the exception of the Administrative Core, these Core services must not duplicate MRDDRC Core services at the affiliated MRDDRC.   An important feature of the “Center within a Center” concept is that the interrelationships among the individual projects and Cores proposed for the Fragile X Research Center will result in a greater contribution to the overall MRDDRC goals than if each project was pursued independently.

The application may consist (a) entirely of research projects and cores within the home institution of the MRDDRC; or (b) partly of research projects and/or cores from an MRDDRC home institution and partly of projects and cores to be located at partnering institutions that together form a collaborative affiliation with the MRDDRC for the purposes of forming a Fragile X Research Center.  In the latter case, at least one core proposed for use by the Fragile X Research Center must be among the existing Cores of the MRDDRC.  

An application for a competitive revision (formerly called supplement) to an existing grant must be submitted by the Principal Investigator of the existing grant.  In order to offer maximum flexibility and scientific expertise in leadership of the Fragile X Research Center, an individual other than the Principal Investigator of the MRDDRC may be identified as the Director of the Fragile X Research Center of the MRDDRC.  An institution other than the parent institution of the MRDDRC may employ this individual.  In this instance, the Director of the Fragile X Research Center shall be listed as a Co-Investigator, and shall also be designated as the Associate Director of the MRDDRC for Fragile X Research.

It is the intent of the NICHD that the Fragile X Research Center shall be an identifiable entity as a "Center within a Center" in the organizational structure of the MRDDRC.  Applicants must indicate how they intend to meet this requirement.  Applicants must present a plan that identifies clearly how the Fragile X Research Center will enhance the affiliated MRDDRC mission, increase its diversity, and meet existing requirements for Core access. Similarly, the MRDDRC must indicate how each component of the Fragile X Research Center will benefit from its affiliation with the MRDDRC.  NICHD also expects that the Directors of the Fragile X Research Centers will attend the annual meetings of the MRDDRC Directors with NICHD staff. 

Required Application Components

For Fragile X Research Centers that extend beyond an existing MRDDRC, at least one of the Support Cores to be accessed by Fragile X Research Center investigators must be an existing Core at the MRDDRC with which the Fragile X Research Center has established an affiliation.  Applications submitted in response to this RFA must contain descriptions of three components:  (1) An Administrative Core unit, directed by the Fragile X Research Center Director.(2) At least three independent Research Projects, one of which must be clinical research, directed by Research Project Leaders. (3) Support Cores, as needed, directed by Support Core Leaders. 

One or more of these components may be located at collaborating institution or at the affiliated MRDDRC (see below).

(1) Administrative Core.  The designated Fragile X Research Center Director is responsible for the Administrative Core.  The Administrative Core is a separately budgeted administrative unit that manages daily operations of the Fragile X Research Center.  The Administrative Core will ensure that the aims of the Research Projects are carried out by the Research Project Leaders and that Support Cores provide the necessary services to further the research aims.

The Administrative Core may propose to provide salaries and support for a limited number of administrative and clerical personnel, such as the Fragile X Research Center Director, secretaries, and clerical support staff.  Staff will use criteria defined under revised OMB Circular A-21 to determine whether direct charging for administrative and clerical staff will be allowed.  The Administrative Core, particularly if it is located at an institution other than that of the affiliated MRDDRC, may propose administrative support services, including supplies, duplication, telephone, and maintenance contracts for equipment when not covered by institutional Facilities and Administrative charges or by the Administrative Core of the affiliated MRDDRC.  Travel by the Director of the Fragile X Research Center to meetings of the MRDDRC Directors should be included in the application, as well as a statement of agreement to participate in these meetings.

The Administrative Core must provide for an advisory board consisting of three or more persons who have interest and experience relevant to Fragile X research.  Members should include, but are not limited to: 1) Public Representative; 2) Scientific/Health Care Expert; 3) Policy Maker; and 4) Other relevant stakeholder groups.  It is the function of the advisory board to evaluate ongoing activities annually and make recommendations related to the direction of the Fragile X center as a whole.  Funds should be sufficient to support one annual meeting for all members and for the travel of one board member to one Fragile X Center Directors meeting.

Other costs that may be proposed by the Administrative Core of the Fragile X Research Center include costs related to dissemination of research results to the scientific community and lay public, and costs of research-related seminars or meetings designed to promote interdisciplinary interaction, education, or center cohesiveness.  Costs may NOT be requested for salary and support of central administrative personnel usually paid from institutional Facilities and Administrative (overhead) charges, such as budget officers, grant assistants, and building maintenance personnel; for administrative activities such as public relations, health or educational services unrelated to the research; and travel of investigators, other than the Fragile X Research Center Director, to scientific meetings. 

(2) Research Projects.  The application requires a minimum of three related, integrated, and high-quality research projects that provide a multi-disciplinary, yet unified approach to the problems being investigated by the Fragile X Research Center.  The application must include at least one clinical research project. 

Funds requested for individual research projects to be supported by the Cores of the Fragile X Research Center should conform to PHS 398 instructions and requirements http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Research proposed for inclusion in the Fragile X Research Center must represent new research projects.  Projects relevant to Fragile X syndrome research that are currently supported by the R01, P01 or other funding mechanisms may not apply for funds that extend or modify their scope under this RFA.  Projects that represent competing continuations of existing R01 and P01 project components, however, are eligible to be incorporated into a Fragile X Research Center application as "new" research projects, provided that they do not duplicate projects that are currently funded or under review. 

For each research project, a budget for total costs of up to $250,000 per year may be requested.  However, for the purpose of this RFA, the budget for individual research projects should NOT be presented in modular grant format.   Support for the research projects proposed for the Fragile X Research Center may be requested for a period of up to five years, provided that the total budget period requested in the revision application does not exceed the time remaining on the original parent grant..

Research Project Leader:  The individual responsible for directing one or more of the Research Projects of the Fragile X Research Center.  The Research Project Leader may or may not be the Fragile X Research Center Director.

Clinical Research:  At least one research project must meet the criteria for the NIH-defined clinical research:

(3) Support Core(s).  At least one separately budgeted component(s) that provide(s) support for the research programs must be proposed.  For the purposes of this RFA, use of core facilities located at other institutions is allowed and use of at least one Core at an existing, affiliated MRDDRC is required.  Applicants for the Fragile X Research Center must provide evidence of accomplishment and progress to date of the Core unit(s) in the existing MRDDRC, and anticipated accomplishments and progress that will be made by projects proposed for the Fragile X Research Center.

Except for the Administrative Core, the Fragile X Research Center Cores may not duplicate the particular services of existing Cores of the affiliated MRDDRC.  Examples of Cores at existing MRDDRCs that investigators at the Fragile X Research Center might propose to access include, but are not limited to:  Genetics or Molecular Genetics Core, Behavioral Science Core, Information Technology Core, Design and Statistical Computing Core, Human Subjects Core, Data Management and Analysis Core, Participant Services Core, Quantitative and Observational Methodology Core, Genomics Core, Transgenic Mouse Core, Database and Biostatistics Core, and/or Longitudinal Studies and Statistical Modeling Core.  Applicants are encouraged to contact NICHD Program Staff prior to submission of the application to determine whether the Core services proposed for the Fragile X Research Center may represent duplication of Core services available at the proposed or affiliated MRDDRC.

For the purposes of this RFA, each Core must provide essential facilities and services to at least TWO component projects of the Fragile X Research Center at all times during the period of award.  This is an exception to the NICHD P30 Guidelines stating that each core should be utilized by three or more component projects.  If only one of the component projects requires proposed Core support, then the required expertise, technology, and/or infrastructure should be integrated into the relevant component project and the Core eliminated as a separate entity.

The application should provide:

(1) A plan for implementation of satisfactory quality-control systems for services and facilities for each new core proposed;

(2) Documentation of quality-control systems already in place for Cores being accessed at the MRRDRC;

(3) Evidence of cost-effectiveness through mechanisms such as fee-for-service, in-kind, or other means.  Centralization should lower the costs that would be incurred if the individual research projects proposed had to provide the same facilities and services;

(4) Evidence that the proposed cores will increase the quality and productivity of the research projects receiving core support. 

Budgets for Core units may include salaries for support core staff, supplies (including animals), scientific equipment, computer facilities and services, travel of technical and administrative staff for technical training that would enhance the quality of core unit operation or travel required to maintain the operation of the core unit, minor renovation of alteration of existing facilities, and consultation services.

Support Core Leader(s): The individual responsible for directing a support Core facility. There may be one or more support Cores.  These Cores would provide services to achieve the research goals.  At least one of these individuals must be the Core Director of an existing and affiliated MRDDRC.

Annual Meetings

In coordination with the biannual MRDDRC Center Director’s meeting, the Fragile X Research Center Directors, Associate Directors, and invited participants (e.g., constituency representatives, interested researchers from outside the Research Centers) will meet with the purpose of establishing collaborative projects among the Fragile X Research Centers that may be funded by appropriate competitive mechanisms.  An advisory board member from each center will attend the meeting once a year.

Plan for Sharing Research Data

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will 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.

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 addition, reviewers will evaluate the individual cores and the overall center, using the following criteria:

For all Cores:

For the Administrative Core:

Criteria for Overall Critique of the Center:

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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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

3. Anticipated Announcement and Award Dates

N/A

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.

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:

Tiina K. Urv, Ph.D.
Mental Retardation and Developmental Disabilities Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B09D MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for express/courier, non-USPS service)
Telephone: (301) 402-7015
FAX: (301) 496-3791
Email: urvtiin@mail.nih.gov

2. Peer Review Contacts:

Robert H. 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 20892-7510
(Rockville, MD 20852 for express/courier, non-USPS service)
Telephone:   (301) 496-1485
FAX:   (301) 402-4104
Email:   stretch@nih.gov

3. Financial or Grants Management Contacts:

Margaret Young
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17K,  MSC 7510
Bethesda, MD 20892-7510 (for express/courier service; non-USPS service
(Rockville, MD 20852 for express/courier, non-USPS service)
Telephone: (301) 301-435-7008
Email: youngmar@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 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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