and Human Services (HHS)
EXPIRED
DEVELOPMENTAL GRANTS FOR AUTISM CENTERS OF EXCELLENCE
Release Date: April 25, 2001
RFA NUMBER: RFA-MH-01-013
(also see Notice NOT-OD-01-039)
National Institute of Mental Health
(http://www.nimh.nih.gov/)
National Institute of Child Health and Human Development
(http://www.nichd.nih.gov/)
National Institute of Neurological Disorders and Stroke
(http://www.ninds.nih.gov/)
National Institute on Deafness and Other Communication Disorders
(http://www.nidcd.nih.gov/)
National Institute of Environmental Health Sciences
(http://www.niehs.nih.gov/)
Letter of Intent Receipt Date: June 12, 2001
Application Receipt Date: July 12, 2001
THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS RFA INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA.
PURPOSE
The National Institutes of Health Autism Coordinating Committee (NIH/ACC) is
implementing the aspects of the Children"s Health Act of 2000 that relate to
autism. An important component of the Act is the establishment of Centers of
Excellence in Autism Research by NIH. As a first stage in implementing this
centers program, the NIH/ACC institutes are releasing this Request for
Applications (RFA) to support teams of investigators in planning and
developmental activities aimed at maximizing the probability that they will
become highly qualified applicants for future Centers of Excellence in Autism
Research support. Support under this RFA is intended to facilitate planning
and developmental processes so that highly competitive applications for
center support can be developed quickly. However, participation in this RFA
or the review outcome of this participation, will not itself be a factor in
the review of a subsequent Center application. Accordingly, teams with
current autism research support, for example, may decide to submit a Center
application without first having participated in this developmental RFA.
Investigators interested in applying for support of autism research using
mechanisms other than this RFA should see NIH PA-01-051
(http://grants.nih.gov/grants/guide/pa-files/PA-01-051.html) for a
description of NIH"s broad support of research dealing with this disorder.
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 Request for
Applications (RFA), Developmental Grants for Autism Centers of Excellence, is
related to one or more of the focus areas. Potential applicants may obtain a
copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic for-profit and non-profit
organizations, public and private institutions, such as universities,
colleges, hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government. Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to apply as
Principal Investigators.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH)
Exploratory/Developmental Grant R21 award mechanism. Responsibility for the
planning, direction, and execution of the proposed project will be solely
that of the applicant. Funding under this developmental RFA will be for one
year at a maximum of $100,000 direct costs. For those applications that
include more than one institution, direct costs of up to $125,000 for the
year may be requested to allow for F&A costs on consortium arrangements.
Awards are not renewable and supplements are not allowed. This RFA is a one-
time solicitation. The earliest anticipated award date is September 30,
2001.
Specific application instructions have been provided under "Application
Procedures" (below) to reflect the purpose and nature of this mechanism and
this RFA, as well as to accommodate the "Modular Grant" and "Just-In-Time"
streamlining efforts being implemented by the NIH.
FUNDS AVAILABLE
The estimated total funds (direct and Facilities and Administrative (F&A)
costs) available for support for all awards made under this RFA will be $1.7
million. Thus, up to 10 awards may be made if meritorious grant applications
are received and funds are available.
Allowable Costs
Funds provided under this RFA are intended to support activities such as
travel for group meetings, partial support for administrative personnel to
facilitate the logistics of intensive interaction among investigative teams,
support for critical ongoing pilot projects that could demonstrate
feasibility in a Centers of Excellence proposal, development of resource
cores, and/or other expenses that are reasonably incurred in activities that
are crucial to developing a quality proposal for Centers of Excellence
support.
The usual NIH policies governing grants administration and management will
apply. Although this program is provided for in the financial plans of the
participating institutes, awards pursuant to this RFA are contingent upon the
availability of funds for this purpose and the receipt of a sufficient number
of applications of high scientific merit.
RESEARCH OBJECTIVES
Background
In the few years since the NIH/ACC was established, there has been
considerable expansion and enhanced coordination of autism research efforts
at NIH. The members of the NIH/ACC have been and are committed to the broad
intensification of autism research efforts called for in the Children"s
Health Act of 2000. This RFA represents one component of that commitment.
Even given the promising growth of the clinical and basic research fields
relevant to autism, and the interaction among investigators in the field
cultivated by sustained NIH support of the Collaborative Programs of
Excellence in Autism (CPEA) program, the Centers of Excellence in Autism
Research program will represent a quantum increase in the organization and
scope of the scientific enterprise related to autism. The present RFA is
intended to increase the number and quality of teams and/or sites fully
prepared to organize the scientific and infrastructure resources necessary to
generate outstanding applications to become Centers of Excellence for Autism
Research. Developmental grants are a proven method of facilitating
collaborations among teams of researchers who need to interact intensively in
order to formulate integrative strategies. Following such focused
preparation, researchers are in a far better position to apply for
comprehensive center support, and the resulting centers are better
conceptualized and more effective.
Therefore, the primary goal of the present initiative is to support early and
mid-stage development of interdisciplinary teams of accomplished
investigators focused on basic and clinical issues related to autism. This
support will provide them the opportunity to define common goals and
objectives, prove the feasibility of their working as a cohesive, interactive
research team, and aid in the acquisition of resources, equipment, or
administrative support needed to operate an interdisciplinary center. This
type of multidisciplinary, multi-faceted research is of paramount importance
in better understanding the etiology, pathophysiology, and insightful
treatment of autism. Demonstrating the planning and development interaction
of such teams to produce innovative, potentially high-impact approaches to
important research problems would position these teams well to apply for
support as Centers of Excellence in Autism Research. The present RFA is also
intended to support activities that will attract into this effort outstanding
investigators who have not have been part of the autism field. Such
investigators may need initial support to establish appropriate
collaborations with investigators with autism expertise and to demonstrate
and document the feasibility of their new collaborations.
Characteristics of Responsive Applications
Critical elements of any application submitted in response to this RFA will
include (1) an overview of the proposed team, (2) an explanation of how it
could eventually constitute the backbone of a center, (3) a description of
the potential center’s central theme and goals. The applicants should
describe how the team can achieve its major development objectives during the
1-year period of support provided under this RFA, and the team’s vision of
how a center created by them could develop over a period of several years.
This would involve explaining the proposed contribution of each team member
and how that investigator is synergistic with other members and their
probable research programs.
Only applications that include both basic and clinical research components
will be considered responsive to this RFA. The Act stipulates that each
Center of Excellence should include investigations into the cause, diagnosis,
early detection, prevention, control, and treatment of autism. However,
applications for the present RFA will be expected to propose developmental
activities only in some substantial subset of these topics. It is also
stipulated in the Act that the centers, as a group, shall conduct research
including the fields of developmental neurobiology, genetics, and
psychopharmacology. Thus, strengths in these areas will be desirable for the
present RFA.
It is expected that most of the teams that compete for support under this RFA
will submit applications for the Centers of Excellence Program. However,
some teams may be successful in the present competition and decide that their
research programs are more suitable for support by R01 or other NIH
mechanisms and proceed accordingly. Other teams may decide that they are
prepared to apply for full center support without responding to this RFA.
These developmental grants will provide institutions with the resources to
set in place detailed plans for all of the components that would potentially
make them competitive for Center of Excellence support. An appropriate
developmental PI with expertise in basic or clinical research relevant to
autism must be selected, as well as a Co-Director with expertise in a
complementary field. The PI should have a demonstrated capability to
organize, administer and direct the team. It is expected that the PI will
have a substantial investment in this developmental effort, with the goal of
assembling and organizing an outstanding center application. Investigators
with the qualifications to be members of the research team, and to contribute
to such a unique enterprise, may be located in different geographic
locations. Therefore, collaborations among different institutions are
encouraged, if scientifically appropriate. The proposed team will be
responsible for the definition of the research goals and objectives of the
developmental enterprise, as well as ongoing activities. The lead
investigators should represent major scientific components that will be
involved in the relevant proposed Center of Excellence, and each must have
demonstrated scientific accomplishment, but they do not need to demonstrate
prior interactive research amongst themselves. Since the organization and
submission of applications in response to this RFA is time-limited, it is
expected that modifications to the membership of the team may occur during
the developmental funding period. For example, to provide the most effective
combination of scientific skills, the team may well recruit new members
during the funding period.
Since the duration and total amount of support provided under the present
mechanism are limited, it is not anticipated that totally new or substantial
research projects will be entirely funded from this support. However,
support for new pilot projects of limited scope, or pivotal funding of
partially completed projects critical to a future Centers of Excellence
application would be appropriate. Thus, the application for this RFA may
contain descriptions of the Developmental Projects selected or examples of
possible Developmental Projects. These projects will not be reviewed as
traditional research projects. Rather, the proposed Developmental Projects
will serve as an indication of the priorities to be focused on by the group,
a reflection of the decision-making abilities of the scientific leadership,
the ability to stimulate mutually beneficial collaborations between members
of the team, and the initial ability of the group to interact productively
and scientifically.
Applications in response to this RFA should provide a description of the
clinical populations, tissue resources, genetics resources, and other
resources that will be involved as part of the team"s clinical research
component.
Activities During Funding Period
During the course of the developmental award, the leadership team will be
responsible for the design and implementation of planning activities that
will lead to a well-developed, conceptually sound application for a Center of
Excellence in Autism. This will include a proposed plan through which
scientific synergy can occur on a stable and continuing basis that will
incorporate: 1) an organizational structure specifically designed to
facilitate intellectual cross-fertilization among team members, 2) a detailed
description of core facilities that would support research activities, 3) a
plan for the distribution and management of developmental funds for
feasibility testing of new projects, 4) a strategy for providing career
development opportunities for new and established investigators, and 5) a
broad range of educational activities, from formal undergraduate and graduate
programs to courses and seminars for students and researchers, visiting
scientists program or other types of training or educational approaches.
The planning activities should emphasize the interface between clinical and
basic research and should be structured to meet the needs and level of
maturity of the ongoing efforts. Planning activities should address the
following elements:
o Establishment of an Organizational Structure - Organizational activities
must occur, during which the group will be expected to define:
- The organization and operational structure of the team. This will include
planning for leadership by senior investigators, who will be responsible for
the overall scientific direction of the Program. This will also involve
delineating mechanisms for involving a dynamic group of investigators at all
levels of experience.
- A plan for interactive activities that will occur regularly over the
entire course of the developmental award. These interactions will be
determined by the applicants, and emphasis will be placed on establishing
creative, productive interactions. In addition the interactive activities
should be geared towards promoting the cross-fertilization between
subdisciplines of research relevant to autism.
- A description of the core facilities necessary to support the scientific
goals of the program. Access to equipment and resources is often a problem,
especially for multi-disciplinary programs. The establishment of core
resources dedicated to team-related Developmental Projects will provide this
access. Initially, core resources may simply be extensions of existing
laboratories or facilities, and the definition of a core resource would vary
considerably depending on the Developmental projects to be selected, existing
facilities, and the scientific focus of the team.
- A model of the process for the selection, monitoring, funding and, if
necessary, termination of Developmental Projects to be implemented.
- A plan for developing a full range of educational activities, from formal
undergraduate and graduate programs to courses and seminars for student and
researchers, visiting scientists program or other types of training, cross-
training, or educational approaches.
o Initiation or Expansion of Developmental Projects Applicants may select
two to three highly interactive Developmental Projects for research support.
These projects can be geared toward determining project feasibility, proof of
principle, and/or acquisition of preliminary data. Developmental Projects
may demonstrate newly established collaborative efforts between two or more
groups of investigators or may be significant extensions of ongoing
collaborations.
When funded teams submit their Centers of Excellence application, it is not
expected that the Developmental Projects will necessarily have generated
sufficient data for meaningful interpretation, since the term of the
developmental grants is quite limited. The progress made during this phase,
however, will be an important indication of how successfully the
developmental team functioned to implement innovative research.
Centers of Excellence in Autism Research
Because of the explosive growth of basic and clinical research into the
biological and behavioral aspects of complex disorders, there exist rapidly
expanding opportunities to speed the progress of biomedical research into
disorders such as autism. The Autism Centers of Excellence specified in the
Children"s" Health Act of 2000 are intended to support outstanding scientific
projects, and also to create an infrastructure of excellence in basic and
clinical science relevant to autism that will support and promote
multidisciplinary research and provide an environment in which to train a new
generation of autism researchers.
The Act contains other provisions that will apply to Centers of Excellence.
Some of these will primarily be relevant to the review of the Centers
applications themselves, but are relevant to the present RFA mostly because
applicants should be aware that they will need to address these issues in any
future application they submit for Centers support. The text of the Act
pertaining to Centers of Excellence is as follows:
(1) IN GENERAL. The Director [of NIH] shall under subsection (a)(1)
make awards of grants and contracts to public or nonprofit private entities
to pay all or part of the cost of planning, establishing, improving, and
providing basic operating support for centers of excellence regarding
research on autism.
(2) RESEARCH. Each center under paragraph (1) shall conduct basic and
clinical research into autism. Such research should include investigations
into the cause, diagnosis, early detection, prevention, control, and
treatment of autism. The centers, as a group, shall conduct research
including the fields of developmental neurobiology, genetics, and
psychopharmacology.
(3) SERVICES FOR PATIENTS.-
(A) IN GENERAL. A center under paragraph (1) may expend
amounts provided under such paragraph to carry out a program to make
individuals aware of opportunities to participate as subjects in
research conducted by the centers.
(B) REFERRALS AND COSTS. A program under subparagraph (A) may,
in accordance with such criteria as the Director may establish, provide
to the subjects described in such subparagraph, referrals for health
and other services, and such patient care costs as are required for
research.
(C) AVAILABILITY AND ACCESS. The extent to which a center can
demonstrate availability and access to clinical services shall be
considered by the Director in decisions about awarding grants to
applicants which meet the scientific criteria for funding under this
section.
(4) COORDINATION OF CENTERS, REPORTS.- The Director shall, as
appropriate, provide for the coordination of information among centers under
paragraph (1) and ensure regular communication between such centers, and may
require the periodic preparation of reports on the activities of the centers
and the submission of the reports to the Director.
(5) ORGANIZATION OF CENTERS.- Each center under paragraph (1) shall
use the facilities of a single institution, or be formed from a consortium of
cooperating institutions, meeting such requirements as may be prescribed by
the Director.
(6) NUMBER OF CENTERS, DURATION OF SUPPORT.-
(A) IN GENERAL.- The Director shall provide for the
establishment of not less than 5 centers under paragraph (1).
(B) DURATION.- Support for a center established under paragraph
(1) may be provided under this section for a period of not to exceed 5
years. Such period may be extended for 1 or more additional periods
not exceeding 5 years if the operations of such center have been
reviewed by an appropriate technical and scientific peer review group
established by the Director and if such group has recommended to the
Director that such period should be extended.
Future Plans
This initial RFA will be followed by another in FY2002 that will solicit
proposals for Centers of Excellence, with anticipated funding of the first
round of successful applications in FY2003. The Act calls for NIH to fund no
fewer than 5 Centers, which may require subsequent rounds of competition.
The participating institutes intend to create a funding pool for the Centers
that would be approximately $8 million per year to fund the total costs of a
complement of 5 centers. The participating institutes will fund the Centers
in a collaborative way so that they will become an interactive network of
high-quality research enterprises covering a spectrum of interests in this
disorder. The scope of NIH support was specified to include planning (as in
this RFA), establishing, improving, and providing basic operating support for
such Centers. Each Center will conduct basic and clinical research into
autism, and such research should include investigations into the cause,
diagnosis, early detection, prevention, control, and treatment of autism.
Furthermore, the Centers, as a group, will conduct research including the
fields of developmental neurobiology, genetics, and psychopharmacology.
While the Centers of Excellence program will encompass this broad spectrum of
research endeavors, individual initial applications under this RFA will not
be required to include all these elements.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
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 biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are 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 research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The
revisions relate to NIH defined Phase III clinical trials and require: a)
all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
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" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of the policy from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
DATA AND SAFETY MONITORING
It is the policy of NIH that provision be made for the oversight and
monitoring of all intervention studies to ensure the safety of participants
and the validity and integrity of the data. The NIH policy was published in
the NIH Guide to Grants and Contracts, June 10, 1998 and is available at:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html. NIMH
guidance on data safety and monitoring is available at:
http://www.NIMH.nih.gov/research/safetymonitoring.cfm.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should read the
policy that was published in the NIH Guide for Grants and Contracts, June 5,
2000 (Revised August 25, 2000), available at the following URL address
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH GRANTS POLICY STATEMENT
The NIH Grants Policy Statement (NIHGPS) has been revised and reissued. The
provisions of the revised NIHGPS are effective for all funded NIH grants and
cooperative agreements with budget periods beginning on or after March 1,
2001. The revised NIHGPS is available at:
http://grants.nih.gov/grants/policy/nihgps_2001.
LETTER OF INTENT
Prospective applicants are asked to submit, by June 12, 2001, a Letter of
Intent that includes a descriptive title of the overall proposed research,
the name, address and telephone number of the Principal Investigator, and the
number and title of this RFA. Although this letter is not required, is not
binding, and does not enter into the review of subsequent applications, the
information that it contains allows NIMH staff to estimate the potential
review workload to plan the review. The letter of intent is to be sent to
Dr. Steve Foote at the address listed under INQUIRIES.
APPLICATION PROCEDURES
Applicants are strongly encouraged to call one of the NIH program staff
listed at the end of this document with any questions regarding the
responsiveness of their proposed project to the goals of this RFA.
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the deadline indicated at the beginning of this
document. Application kits are available at most institutional offices of
sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email: GrantsInfo@nih.gov. In addition, the application kits can be found on
the following URL: http://grants.nih.gov/grants/forms.htm.
There are special application instructions for this RFA: The Research Plan
is limited to 10 pages. Appendix material is limited to 5 items.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
BUDGET INSTRUCTIONS
All applications submitted in response to this RFA must provide a modular
budget, that is, they will request direct costs in $25,000 modules. The
total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments up to a maximum of $100,000, or up to $125,000 for
applications with more than one institution, to allow for F&A costs for
consortium arrangements) and Total Costs [Modular Total Direct plus
Facilities and Administrative (F&A) costs] for the initial budget period
Items 8a and 8b should be completed indicating the Direct and Total Costs for
the entire proposed period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page
4 of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. [See sample pages at:
http://grants.nih.gov/grants/funding/modular/modular.htm.]
At the top of the page, enter the total direct costs requested for each year.
This is not a Form page.
o Under Personnel, list all project personnel, including their names,
percent of effort, and roles on the project. No individual salary
information should be provided. However, the applicant should use the NIH
appropriation language, salary cap and the NIH policy for graduate student
compensation in developing the budget request.
For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the
nearest $1,000. List the individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort of all personnel,
and the role on the project. Indicate whether the collaborating institution
is foreign or domestic. The total cost for a consortium/contractual
arrangement is included in the overall requested modular direct cost amount.
Include the Letter of Intent (LOI) to establish a consortium.
Provide an additional narrative budget justification for any variation in the
number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual"s qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, following the instructions below. No more than three
pages may be used for each person. A sample biographical sketch may be
viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm.
- Complete the educational block at the top of the form page,
- List position(s) and any honors,
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years,
- List selected peer-reviewed publications, with full citations.
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied in
the calculation of the F&A costs for the initial budget period and all future
budget years.
o The applicant should provide the name and phone number of the individual
to contact concerning fiscal and administrative issues if additional
information is necessary following the initial review.
For purposes of identification and processing, item 2a on the face page of
the application must be marked "YES" and the RFA number "MH-01-13" and the
words "DEVELOPMENTAL GRANTS FOR AUTISM CENTERS OF EXCELLENCE" must be entered
on the face page.
Applications must be received by July 12, 2001. Applications not received as
a single package on the receipt date or not conforming to the instructions
contained in PHS 398 (rev. 4/98) Application Kit (as modified in, and
superseded by, the special instructions below, for the purposes of this RFA),
will be judged non-responsive and will be returned to the applicant.
The RFA label and line 2 of the application should both indicate the RFA
number. The RFA label must be affixed to the bottom of the face page.
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.
The sample RFA label, available at the following URL
[http://grants.nih.gov/grants/funding/phs398/label-bk.pdf] has been modified
to allow for this change. Please note this is in Portable Document Format
(PDF).
If the application submitted in response to this RFA is substantially similar
to a grant application already submitted to the NIH for review, but that has
not yet been reviewed, the applicant will be asked to withdraw either the
pending application or the new one. Simultaneous submission of identical
applications will not be allowed, nor will essentially identical applications
be reviewed by different review committees. Therefore, an application that
is essentially identical to one that has already been reviewed cannot be
submitted in response to this RFA. This does not preclude the submission of
substantial revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.
Submit a signed, typewritten original of the application, including the
checklist, and 3 signed, exact, single-sided photocopies, in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (For express mail or courier service)
At the time of submission, 2 additional copies of the application, including
all appendix material, must be sent to:
Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9663
Bethesda, MD 20817 (for courier/express service)
Applications must be received by July 12, 2001. If an application is
received after this date, it will be returned to the applicant without
review.
Applicants from institutions that have a General Clinical Research Center
(GCRC) funded by the NIH National Center for Research Resources may wish to
identify the GCRC as a resource for conducting the proposed research. If so,
a letter of agreement from either the GCRC Program Director or Principal
Investigator should be included with the application.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by program staff. Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration.
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 NIMH in accordance with the review criteria stated below. As
part of the initial merit review, all applications will receive a written
critique and will be discussed, assigned a priority score, and receive a
second level review by the respective Institute’s National Advisory Council.
Review Criteria
The criteria to be used in the evaluation of grant applications are listed
below. To put those criteria in context, the following information is
contained in instructions to the peer reviewers.
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. The
reviewers will comment on the following aspects of the application in their
written critiques 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 by the reviewers in assigning the
overall score weighting them as appropriate for each application. Note that
the application does not need to be strong in all categories to be judged
likely to have a 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.
1. Significance. Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
2. Approach. Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? What is the likelihood that support of the proposed
developmental activities will improve the quality of a subsequent Center of
Excellence in Autism Research application, and increase the likelihood of
success.
3. Innovation. Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies? Special
emphasis will be placed on integration of basic and clinical research
components relevant to autism into promising synergistic proposals. The
review will not emphasize detailed protocols or methods.
4. Investigator. Are the investigators appropriately trained and well
suited to carry out this work? The quality of the research team will be
given special emphasis in this review. The inclusion of outstanding
investigators who have not previously engaged in or have been associated with
NIH-supported research directly relevant to autism, is encouraged, especially
when there is autism expertise among some other members of the research team.
5. Environment. Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support? Are there strong potential resources available at the performance
site(s)?
The initial review group will also examine: The appropriateness of proposed
project budget and duration, the adequacy of plans to include children and
both genders and minorities and their subgroups as appropriate for the
scientific goals of the research and plans for the recruitment and retention
of subjects, the provisions for the protection of human and animal subjects,
and the safety of the research environment.
Schedule
Letter of Intent Receipt Date: June 12, 2001
Application Receipt Date: July 12, 2001
Scientific Review Date: August, 2001
Advisory Council Date: September, 2001
Earliest Date of Award: September 30, 2001
AWARD CRITERIA
Funding decisions will be made on the basis of scientific and technical merit
as determined by peer review, program balance, and the availability of funds.
The earliest anticipated date of award is September 30, 2001.
INQUIRIES
Written and telephone inquiries concerning this RFA are encouraged. The
opportunity to clarify any issues or questions from potential applicants is
welcome.
Direct inquiries regarding programmatic (research scope and eligibility)
issues to:
Stephen L. Foote, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
Neuroscience Center, Room 7204, MSC-9645
6001 Executive Boulevard
Bethesda MD 20892-9645
For express/overnight services: Rockville, MD 20852
Telephone: (301) 443-3563
Fax: (301) 443-1731
Email: sfoote@mail.nih.gov
Deborah Hirtz M.D.
Clinical Trials, Division of Extramural Research
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2212, MSC 9523
Bethesda, MD 20892-9523
Telephone: (301) 496-5821
Fax: (301) 480-1080
Email: dh83f@nih.gov
Marie Bristol-Power, Ph.D.
National Institute of Child Health and Human Development
6100 Executive Blvd, Room 4B09, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6862
Fax: (301) 480-7773
Email: db171s@nih.gov
Judith A. Cooper, Ph.D.
Scientific Programs Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400C, MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 496-5061
Fax: (301) 402-6251
Email: Judith_Cooper@nih.gov
Cindy P. Lawler, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-23
Research Triangle Park, NC 27709
Telephone: (919) 316-4671
FAX: (919) 541-5064
Email: lawler@niehs.nih.gov
Direct inquiries regarding fiscal matters to one of the following:
Diana S. Trunnell
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health, NIH
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
Fax: (301) 443-6885
Email: Diana_Trunnell@nih.gov
Gladys Melendez-Bohler, M.S.
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3290, MSC 9537
Bethesda, Maryland 20892-9537
Telephone: (301) 496-3929
Fax: (301) 402-0219
Email: gb13y@nih.gov
Mary E. Daley
Lead Grants Management Specialist, Grants Management Branch
National Institute of Child Health and Human Development
Buidling 6100, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1305
Fax: (301) 402-0915
Email: md74u@nih.gov
Sara Stone
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400B, MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
Fax: (301) 402-1758
Email: Sara_Stone@nih.gov
Laura Williams-Boyd
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-23
Research Triangle Park, NC 27709
Telephone: (919) 541-7629
FAX: (919) 541-2860
Email: willia27@niehs.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalogue of Federal Domestic Assistance
Nos: 93.242 (NIMH), 93.865 (NICHD), 93.853 (NINDS), 93.173 (NIDCD), and
93.113 (NIEHS). Awards are made under authorization of Sections 301 and 405
of the Public Health Service Act as amended (42 USC 241 and 284) and
administered under NIH grants policies and Federal Regulations 42 CFR 52 and
45 CFR Parts 74 and 92. This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
The Public Health Service strongly encourages all grant and contract
recipients to provide a smoke-free workplace and promote the non-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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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