and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
Title: Intellectual
and Developmental Disabilities Research Centers 2009 (P30)
Announcement Type
This is a reissue of RFA-HD-07-012.
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-HD-08-016
Catalog of Federal Domestic Assistance Number(s)
93.865
Key Dates
Release Date: October 3, 2008
Letters of Intent
Receipt Date: November 21, 2008
Application Receipt Date: December 22, 2008
Peer Review Date(s): March/April 2009
Council Review Date: May
2009
Earliest Anticipated Start Date: July
1, 2009
Additional Information to Be
Available Date (Url Activation Date): Not applicable
Expiration Date: December
23, 2008
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, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), through the Intellectual and Developmental Disabilities (IDD); formerly Mental Retardation and Developmental Disabilities Branch, Center for Developmental Biology and Perinatal Medicine (CDBPM), invites Center Core Grant (P30) applications to advance the diagnosis, prevention, treatment, and amelioration of intellectual and developmental disabilities. This Funding Opportunity Announcement (FOA) seeks applications from institutions that meet the qualifications for a program of IDD research. The primary objective of the NICHD Intellectual and Developmental Disabilities Research Centers (IDDRC) Program is to provide core support and facilities for cohesive, interdisciplinary research and research training. Funds for the research projects using these core facilities come from independent sources including Federal, State, and private organizations.
Background
For more than 40 years, NICHD has provided support for IDDRCs through Center Core (P30) grants that facilitate program coordination and support central research facilities, administration, and development of a limited number of new research programs. The degree of impairment associated with IDD varies with the cause. Moderate and more severe IDD often results from problems that produce profound alterations in brain development and/or function. Defective genes, teratogenic agents, toxic substances, infections, nutritional deficits, accidents, maternal conditions, and other factors causing brain damage may lead to diminished intellectual and adaptive capacity. A larger proportion of cases of IDD relate to environmental or social conditions and disorders of unknown etiology. Each IDD syndrome identified requires fundamental research into the underlying processes, as well as studies designed to meet the unique needs of the affected children. Therefore, one of the missions of the IDD Branch is to support research on the etiology, pathophysiology, epidemiology, diagnosis and evaluation, prevention, and treatment or amelioration of IDD. Research conducted in the IDDRCs covers a broad spectrum of scientific approaches ranging from laboratory research on fundamental processes of normal and abnormal development to clinical and behavioral research that studies persons with IDD. Scientific knowledge to be achieved through research supported by the special program: Major solutions to the problems associated with IDD may emerge from multidisciplinary, collaborative, and integrated approaches involving biomedical, behavioral, and biobehavioral research conducted in the IDDRCs. Thus, NICHD encourages cooperation among the Centers, including their integration into a network that may facilitate infrastructure necessary for conduct of clinical trials. NICHD encourages the Centers to apply for clinical trials grants (R34, R01, and U01). Administrative and scientific organization within a Center and across the network of IDDRCs should enhance opportunities for breakthroughs. Scientific knowledge achieved through research supported by this special program will help prevent, diagnose, and ameliorate or treat IDD.
Objectives
A major goal of the NICHD IDDRC Program is to support research that leads to prevention and/or amelioration of IDD. The intent of IDDRC Center Core Grants is to bring together scientists from a variety of disciplines to work within a Center on the common problems of IDD. NICHD strongly encourages translation of basic research observations into patient-oriented protocols whose ultimate aims are to validate the mechanistic basis of IDD in humans, and to develop new approaches for the prevention, diagnosis and treatment of IDD. Consequently, applications for IDDRC Core Grants (P30) should include investigators studying a range of topics in basic and clinical or applied research. NICHD encourages, but does not require, applicants to include both biomedical and behavioral/biobehavioral components among the topics addressed within their Center. Applications responding to this FOA must include at least five topics relevant to the research mission of IDD.
Examples of topics include, but are not limited to:
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding opportunity will use the NIH Core Grant (P30) award mechanism. The Project Director/Principal Investigator (PD/PI) 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 FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 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
The estimated amount of funds available for support of three Centers awarded as a result of this announcement is $4.2 million for fiscal year 2009. Future year amounts will depend on annual appropriations. 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 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 or the amount representing an increase of up to 1 percent above the direct costs awarded in the final noncompeting (Type 5) year, whichever is greater. 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 IC(s) provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation; see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1. A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1. B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
The IDDRC Director should be a scientist or science administrator who can provide effective scientific and administrative leadership. The Director will be responsible for the organization and operation of the IDDRC and for communication with the NICHD on scientific and operational matters. She/he should be able to integrate and synthesize the proposed research and, thereby, serve as an example to other investigators.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
An institution may submit one application in response to this FOA.
Resubmission applications will be accepted; however, such applications must include an Introduction addressing the previous peer review critiques (Summary Statement)
Renewal applications are permitted in response to this FOA.
For the purpose of this FOA, the NICHD will support no more than one IDDRC 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.
Applications for P30 IDDRC grants must propose a program consisting of cores to be accessed by grants that propose research addressing at least five topics relevant to the research mission of IDD. A list of examples is outlined above (in Section I.1. Research Objectives ). This list of topics is not comprehensive, nor are the examples exhaustive.
The program should consist of at least 10 externally funded research projects grouped according to relevant topics. 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 IDDRC must contain an Administrative Core and a minimum of two additional core units. A minimum of three federally funded research projects must utilize each core unit. These projects must relate to IDD and at least one must be funded by NICHD, exclusive of research contracts, training grants, interagency agreements, and supplemental projects funded by other agencies.
When determining core support, subprojects within a Program Project (P01) will be considered as individual projects comparable to an R01. Projects located at institutions that do not already have an IDDRC must receive NICHD prior approval to access core facilities.
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)
710-0267, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System (DUNS)
number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and
number of this funding opportunity must be typed in item (box) 2 only of the
face page of the application form and the YES box must be checked.
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 N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters
of Intent Receipt Date: November 21, 2008
Application Receipt Date: December 22, 2008
Peer Review Date(s): March/April 2009
Council Review Date: May
2009
Earliest Anticipated Start Date: July
1, 2009
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
in Section IV.3.A.
The letter of intent should be sent to:
Ljubisa Vitkovic, Ph.D.
Intellectual
and Developmental Disabilities Branch
Eunice Kennedy Shriver National Institute
of Child Health and Human Development (NICHD)
6100
Executive Boulevard
Room
4B09E, MSC 7510
Bethesda,
MD 20892
Rockville,
MD 20852 (for express/courier 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 forms found in the PHS 398 instructions for
preparing a research grant application. Submit a signed, typewritten original
of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the
application and all copies of the appendix material must be sent to:
Robert
Stretch, Ph.D.
Director,
Division of Scientific Review
The
Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
6100
Executive Boulevard, Room 5B01D, MSC 7510
Bethesda,
MD 20892
Rockville,
MD 20852 (for express/courier service)
Telephone:
(301) 496-1485
Fax:
(301) 402-4104
Email: stretchr@mail.nih.gov
3.C. Application
Processing
Applications must be received on or before the
application receipt date) described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Institute Incomplete and/or non-responsive
applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at NIH Grants
Policy Statement.
Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or renewal award if such costs: 1) are
necessary to conduct the project, and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or renewal award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the grantee
to be fully aware that pre-award costs result in borrowing against future
support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements and Information
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 IDDRC Program promotes 1) interdisciplinary collaboration among Centers investigators, 2) data/information sharing and integration, 3) synthesis of knowledge about IDD, and 4) translational research that will lead to amelioration and prevention. Each Center application should present a specific plan for achieving this major goal.
Another goal of the IDDRC Program is to attract scientists to IDD research. Where appropriate, the applicant may request up to five years' support for "New Program Development" for direct research support of one or more projects. This support should not exceed a total of $100,000 direct costs per year, or 10 percent of total direct costs, whichever is less. Applicants may use such funds to attract new investigators to the Center, to develop a new area or program of research, to facilitate the development of new research programs of newly trained investigators or investigators new to IDD research, or to facilitate use of a Core at one Center by investigators affiliated with another Center that lacks that kind of Core. Description of New Program Development projects should 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 IDDRCs. To accomplish this goal, successful
applicants will participate in the collaborative efforts of established
Centers' programs. In planning the program, applicants should consider
potential collaborative studies and projects that they may propose for the
IDDRCs network. The Administrative Core should budget for the maintenance of
the IDDRC Network Web-Portal and for the development of common protocols,
databases, and communications and informatics technologies.
Research Plan Page
Limitations
Not applicable
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only.I Include five identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Keeping with the goals of the IDDRC Program enunciated in the Guidelines and in Other Submission Requirements, above, the applicants should highlight potentially unique core resources and how they plan to share them with other IDDRCs.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
that are complete and responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NICHD and in accordance with NIH peer
review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
Scientific and technical merit of the proposed project as determined by peer review
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 meritorious 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?
NIH considers the following in evaluating Center grant applications:
Review of renewal (competing continuation) applications (type 2) will evaluate the progress made by a Center in the previous funding period in addition to the review criteria applied to new applications. The reviewers will evaluate productivity of investigators affiliated with a Center by the number, impact and relevance to IDD of the publications that acknowledge support by the Center grant.
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 rating:
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate? Remove if not applicable
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 on Human
Subjects in the PHS 398 instructions).
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 on Human Subjects in the
PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five points described in the Vertebrate Animals
section of the Research Plan 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. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award
Dates
Not applicable
Section VI. Award Administration Information
1. Award Notices
After the peer review
of the application is completed, the PD/PI will be able to access his or her Summary
Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (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 Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
The Non-Competing Grant Progress Reports must explicitly describe the progress in achieving the goals of the IDDRC Program that are articulated in this document and should follow the guidelines presented in the "NICHD P30 CENTER CORE GRANT GUIDELINES" (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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.
Intellectual
and Developmental Disabilities Branch
Eunice
Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
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
Eunice
Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
6100 Executive
Boulevard, Room 5B01D, MSC 7510
Bethesda,
MD 20892
Rockville,
MD 20852 (for express/courier service)
Telephone:
(301) 496-1485
Fax:
(301) 402-4104
Email: stretchr@mail.nih.gov
3. Financial or Grants Management Contacts:
Bryan
S. Clark, M.B.A.
Chief
Grant Managements Officer
Eunice
Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
6100
Executive Boulevard, Room 8A01, MSC 7510
Bethesda,
MD 20892-7510
Rockville,
MD 20852 (for express/courier service)
Telephone:
(301) 435-6975
FAX:
(301) 402-0915
Email: clarkb1@mail.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of
PHS support for activities involving live, vertebrate animals must comply with
PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human
Subjects Protection:
Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and
Safety Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing
Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators
proposing research involving human subjects should read the "NIH Policy
and Guidelines" on the inclusion of children as participants in research
involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education
on the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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 Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
Standards
for Privacy of Individually Identifiable Health Information:
The Department
of Health and Human Services (DHHS) issued final modification to the "Standards
for Privacy of Individually Identifiable Health Information", the
"Privacy Rule", on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable health
information, and is administered and enforced by the DHHS Office for Civil
Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH
Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
Healthy
People 2010:
The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. 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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