Full Text HD-97-003
 
MENTAL RETARDATION RESEARCH CENTERS
 
NIH GUIDE, Volume 26, Number 9, March 21, 1997
 
RFA:  HD-97-003
 
P.T. 04

Keywords: 
  Mental Retardation 
  Disease Prevention+ 
  Treatment, Medical+ 
  Biomedical Research, Multidiscipl 

 
National Institute of Child Health and Human Development
 
Letter of Intent Receipt Date:  May 16, 1997
Application Receipt Date:  July 18, 1997
 
PURPOSE
 
The National Institute of Child Health and Human Development (NICHD),
through the Mental Retardation and Developmental Disabilities Branch
(MRDD), Center for Research for Mothers and Children (CRMC), invites
research center core grant applications (P30) as part of the
Institute's Mental Retardation Research Program to develop new
knowledge in the field of diagnosis, prevention, treatment, and
amelioration of mental retardation and developmental disabilities.
Four centers may be supported in response to this announcement.
 
A Mental Retardation Research Center (MRRC) is a center to
facilitate, through organization and operation, a program of
biomedical and/or behavioral research related to mental retardation.
Mental Retardation Research Center core grants support
multidisciplinary research in areas which may lead to diagnosis,
prevention, treatment, and/or amelioration of mental retardation and
developmental disabilities.  These grants fund core support services,
administration, and development of a limited number of new research
programs.
 
The primary objective of the NICHD MRRCs is to provide support and
facilities for a cohesive, interdisciplinary program of research and
research training in mental retardation and related aspects of human
development. Public Law 88-164, Title I, Part A authorized
construction of mental retardation research centers.  NICHD has
provided partial support for a limited number of these centers
through the provision of core grants (P30) which facilitate program
coordination and support central research facilities.  Funds for the
research projects using these core facilities come from independent
sources including Federal, State and private organizations.  This
announcement seeks applications not only from these constructed
centers but also from other comparable institutions that meet the
qualifications for a program of mental retardation research.
 
A major goal of the MRDD Branch's Mental Retardation Research Centers
is to prevent and/or ameliorate mental retardation.  The degree of
impairment associated with mental retardation varies in relation to
the cause. Moderate and more severe mental retardation often results
from problems that produce profound alterations in brain development
and/or function.  Diminished intellectual and adaptive capacity can
often be traced to defective genes, teratogenic agents, toxic
substances, infections, nutritional deficits, accidents, diseases and
other disorders causing brain damage.  A larger proportion of cases
of mental retardation is related to environmental conditions and
disorders of unknown etiology.  These complex problems require
integrated, multidisciplinary approaches involving biomedical and
behavioral sciences in a variety of settings.  Several mental
retardation syndromes have been identified, and new ones are being
discovered.  Each requires fundamental research into the underlying
processes, as well as studies designed to meet the unique needs of
the afflicted children.  Therefore, one of the missions of the MRDD
Branch is to support research on the etiology, pathophysiology,
epidemiology, diagnosis and evaluation, prevention, and treatment or
amelioration of mental retardation.
 
The purpose of a Mental Retardation Research Center is to provide a
research environment which facilitates interdisciplinary
collaboration among investigators who are working in areas of
relevance to the prevention and amelioration of mental retardation.
Such research will cover a broad spectrum of scientific approaches
ranging from laboratory research on fundamental processes of normal
and abnormal development, to clinical and behavioral research in
which persons with mental retardation are studied.  It is thought
that major solutions to the problems of mental retardation may be
found as a result of multidisciplinary collaboration involving a
variety of approaches in the MRRCs.  As a result of the
administrative and scientific organization within a Center and across
the network of MRRCs, opportunities for breakthroughs will be
enhanced.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Application (RFA), Mental Retardation Research Centers, is
related to several priority areas including nutrition, alcohol and
other drugs, mental health and mental disorders, environmental
health, maternal and fetal health, HIV infection, immunization and
infectious diseases.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-011-00474-0 or
Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, and units of State or local governments.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.  For
the purpose of this RFA, the NICHD will not support more than one
center grant (P30 ) in a given university or other applicant
institution.
 
MECHANISM OF SUPPORT
 
Mental Retardation Research Center grants will be supported through
the customary grant-in-aid mechanism.  The application should be
prepared in a manner consistent with the general guidelines presented
in the publication titled P30 CENTER CORE GRANT GUIDELINES which are
available from the MRDD Branch office listed below.
 
Awards will be made for a period of five years.  To be eligible for
an award the Center must provide core support for a minimum of 10
projects funded from non-university sources.
 
The cost of a center will be a material consideration in the
selection of applications for funding.  The total direct costs
requested for the first year of a new Center Core Grant (P30) should
not exceed $500,000.  Renewal applications from existing P30 Centers
may request initial year direct costs up to, but not exceeding, 120
percent of the Council recommended level of direct costs for the
final year of the preceding project period, or $500,000 direct costs,
whichever is greater.  Budget increments for subsequent years
generally will be limited to 4%.  Budgets of new and renewal
applications will be stringently reviewed within these guidelines.
Applications with budget request exceeding these guidelines will be
administratively withdrawn by NICHD and returned to the applicant.
 
FUNDS AVAILABLE
 
This is the ninth in a series of annual announcements. Plans are to
make four awards in fiscal year 1998.  The estimated funds available
for the first year of support for the entire program is $4.7 million
total costs.
 
This level of support is dependent on the receipt of a sufficient
number of applications of high scientific merit. Although this
program is provided for in the financial plans of the Institute,
awards pursuant to this RFA are also contingent upon the availability
of funds for this purpose.
 
RESEARCH OBJECTIVES
 
Mental Retardation Research Center Core Grants are intended to bring
together in a Center scientists from a variety of disciplines to work
on the common problems of mental retardation.  Consequently,
applications for Mental Retardation Center Core Grants (P30) should
include investigators studying a range of topics in basic and
clinical or applied research.  Applicants are encouraged, but are not
required, to include both biomedical and behavioral components among
the topics addressed within their Center.  Center grant applications
must include among these topics at least 5 of the following that are
focused specifically on mental retardation and developmental
disabilities:
 
1.  Developmental neurobiological studies relevant to MRDD:
neurophysiology, neuroanatomy, neurochemistry, neuropharmacology,
neuroplasticity.
 
2.  Inborn errors of metabolism relevant to MRDD, including
mitochondrial disorders:  pathophysiology, recombinant DNA
technology, screening, applied clinical and experimental studies,
including treatment.
 
3.  Genetic/cytogenetic disorders associated with MRDD: research on
prenatal diagnosis, particularly non-invasive methods during the
early stages of pregnancy on prevalent genetic causes of mental
retardation such as Down syndrome or Fragile X syndrome; research on
rare genetic disorders associated with mental retardation; genomic
imprinting.
 
4.  Molecular biology:  gene localization, structure, function and
organization; gene mapping; gene therapy; and development of animal
models.
 
5.  Toxicology and physical environmental factors in the etiology,
treatment and prevention of MRDD including lead, mercury, and
alcohol; developmental and behavioral teratology; subclinical levels
of toxic agents and their effects on morphological and behavioral
changes associated with mental retardation.
 
6.  Effects of malnutrition (protein, calorie, micronutrients) on
intellectual, behavioral, social and physical development and the
intergenerational effects of malnutrition.
 
7.  Developmental pharmacology and psychopharmacology: medication
used with MRDD populations.
 
8.  Infectious diseases in the etiology, prevention and treatment of
MRDD; neurological, neuropathological, behavioral and intellectual
consequences of AIDS in children.
 
9.  Diagnosis:  development and application of biomedical and
behavioral methods and measures; identification of children and
infants at risk for MRDD.
 
10.  Early interventions for infants at risk to develop MRDD:
research into the process of early intervention strategies.
 
11.  Predictive and developmental studies of perinatal problems
associated with MRDD:  developmental studies of low birth weight,
small for gestational age, preterm and neonatally sick infants;
hypoxic or ischemic insults.
 
12.  Psychobiological processes in MRDD of conditions such as autism
and Rett syndrome using methods of behavioral genetics, embryology
and teratology, developmental neuroscience and psychophysiology.
 
13.  Psychological processes in MRDD:  studies of cognitive and
information processing; attention and perception; sensory and motor
development; family, social and affective behavior; and, motivation
and personality.
 
14.  Behavioral analyses:  manipulations of interaction between
behavior and environments of individuals with MRDD to reduce problem
behaviors, facilitate vocational training, improve social and self-
help skills, and increase acquisition of adaptive behaviors.
 
15 .  Family and community studies:  parent-child and family
interactions; sexual behaviors; family structure and demographic
variables, including ethnic minority families with members with MRDD;
family and community factors influencing developmental outcomes and
adjustment; community resources; care giver behavior; and social
support networks.
 
16.  Language and communication of MRDD populations: studies on
development of alternative communication systems; ontogeny of
linguistic processes.
 
17.  Learning disabilities, dyslexia, and attention deficit disorder.
 
18.  Residential, educational, and occupational settings throughout
the life- span:  effects on behavior and adjustment of individuals
with MRDD; learning and social behavior in educational settings;
adaptation to residential environments; aberrant behavior, including
stereotypies, destructive behavior, and self-injury.
 
19.  Socioeconomic status, ethnicity, and ecological processes:
interaction of MRDD individuals in multiple settings (naturalistic
observation); ethnographic research; life history reporting;
systematic observation of specific activities.
 
20.  Epidemiology of MRDD:  analytic and case-control studies of
etiology; prevalence; follow-up of outcomes.
 
21.  Behavior and life-styles that could affect mortality and
morbidity.
 
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 subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
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 "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH
Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994.
 
Because P30 funds in general do not directly support research
projects, the issue of minority/gender representation will need to be
addressed at the individual project level (i.e., R01 level).
However, the application will specifically need to address these
issues for any New Program Development projects or core units that
focus on subject recruitment.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by May 16, 1997, a letter
of intent that includes descriptive title of the proposed research,
the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.  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
Institute staff to estimate the potential review workload and avoid
conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Felix F. de la Cruz, M.D., M.P.H.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B-09
Bethesda, MD  20892
Telephone:  (301) 496-1383
FAX:  (301) 496-3791
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications 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:
ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed
under INQUIRIES.  Applicants for P30 Mental Retardation Research
Center grants must propose a program with a theme relevant to the
mission of the MRDD Branch as outlined above.  The program should
consist of at least 10 externally funded research projects grouped
according to relevant topics.  These projects must be of high
quality, providing a multidisciplinary approach to the problem(s)
being investigated.  Each project is to be summarized in accordance
with the NICHD P30 Center Core Grant Guidelines.
 
SPECIAL REQUIREMENTS
 
The MRRC Director should be a scientist or science administrator who
can provide effective administrative and scientific leadership.  The
Director will be responsible for the organization and operation of
the MRRC and for communication with the NICHD on scientific and
operational matters.  Scientific personnel and institutional
resources capable of providing a strong research base in the fields
specified must be available.  In addition, the institution and
pertinent departments have to show a strong commitment to the
Center's support.  Such commitment may be provided as dedicated
space, salary support for investigators, dedicated equipment, or
other financial support for the proposed Center.
 
Each core unit proposed for funding under the MRRC grant must be
utilized by a minimum of three federally funded research projects, at
least one of which is funded by the MRDD Branch of NICHD, exclusive
of research contracts, training grants, interagency agreements, and
NIH-supplemental projects funded by other agencies.  Program staff
will make exceptions to this requirement in instances where research
relevant to MRDD is assigned elsewhere within NICHD.  Subprojects
within a program project (P01) will be considered as individual
projects comparable to an R01.  A detailed description of each core
unit proposed as part of the center must be provided with detailed
budget and budget justification.  A scientist must be named as
responsible for each core unit proposed.  The description of the core
units proposed should include a rationale to show how they will
support the research effort in a cost effective manner. Facilities
must be available for the primary needs of the MRRC Program and
require no more than modest alteration and/or renovation.  Funds for
new construction will not be provided.  Promoting interdisciplinary
collaboration among scientists working within a Center is a major
goal of the MRRC Program.  Each Center applicant should submit a
plan, as part of the application, to assure continuing interaction
among participating scientists from different disciplines.
 
Another goal of the MRRC Program is to attract scientists to the
field of mental retardation research.  Therefore, where appropriate,
the applicant may request "New Program Development" funds for direct
research support of one or more projects, not to exceed a total of
$50,000 per year or 10% of total direct cost, whichever is less.
Such funds might serve to attract new investigators to the Center, to
develop a new area or program of research, or to facilitate the
development of newly trained investigators' research programs.  New
Program Development projects should be comparable to R01 research
applications in their detail and development.  Each such project can
provide support for only two years for any one investigator.
 
It is a major goal of the NICHD to promote active collaboration among
MRRCs.  To accomplish this goal, the successful applicants will be
encouraged to participate in the collaborative efforts of established
Centers' programs. Some consideration should be given, in planning
the program, to potential collaborative studies and projects which
might be proposed for the MRRCs network.
The RFA label available in the PHS 398 (rev.  5/95) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Director, Division of Scientific Review
National Institute of Child Health and Human Development
Building 6100, Room 5E-03 6100
Executive Boulevard, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-1485
 
Applications must be received by July 18, 1997.  If an application is
received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by Institute 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
the NICHD Mental Retardation Research Committee at its March 1998
meeting in accordance with the review criteria stated below.
 
As part of the initial merit review, a process may be used by the
initial review group in which applications will be determined to be
competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.  The second-level review will be made
by the National Advisory Child Health and Human Development Council
at its June 1998 meeting.  The anticipated date of award is August 1,
1998.
 
Review Criteria
 
In addition to the specific criteria listed in the NICHD P30
Guidelines, reviewers will evaluate:
 
o scientific, technical, or medical significance and originality of
proposed research;
 
o qualifications and research experience of the Principal
Investigator and scientific collaborators;
 
o scientific and administrative leadership of the Principal
Investigator;
 
o quality of proposed core facilities;
 
o availability and quality of resources and research environment;
 
o quality of research projects that will be using the core
facilities;
 
o plans for interdisciplinary/multidisciplinary collaboration;
 
o institutional commitment;
 
o appropriateness of the proposed budget;
 
o inclusion of women and minority subjects in research.
 
The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.
 
AWARD CRITERIA
 
In addition to the scientific and technical merit of the application,
other factors will be considered in making the awards.  Among these
are:
 
o centers addressing research areas of high programmatic interest to
the MRDD Branch, the CRMC, and NICHD; and research areas targeted by
Congress;
 
o relevance of research projects accessing the core facilities to
mental retardation and related developmental disabilities.
 
o availability and quality of resources, especially institutional
commitment and support;
 
o access to unique populations;
 
o potential to increase productivity and quality of research within
the Center, and stimulate interdisciplinary/multidisciplinary
collaborations;
 
o providing unique resources for the use of other Centers, and the
greater research community; and
 
o cost-effectiveness of the core facilities.
 
INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Felix F. de la Cruz, M.D., M.P.H.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B-09
Bethesda, MD  20892
Telephone:  (301) 496-1383
FAX:  (301) 496-3791
Email:  CRUZF@HD01.NICHD.NIH.GOV
 
Direct inquiries regarding fiscal matters to:
 
Mr. Edgar D. Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A-17
Bethesda, MD  20892
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
E-mail:  SHAWVERD@HD01.NICHD.NIH.GOV
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.865 Research for Mothers and Children. Awards are
made under the authority of the Public Health Service Act, Title IV,
Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC
241 and 285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.
 
The PHS 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.
 
.

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