MENTAL RETARDATION RESEARCH CENTERS

Release Date:  April 30, 1998

RFA:  HD-98-010

P.T.

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  June 12, 1998
Application Receipt Date:  July 30, 1998

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.  Two centers may be supported in response to this
Request for Applications (RFA).

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 RFA 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 that 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 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 center
core grants (P30) mechanism.  The application must 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 program staff
listed under INQUIRIES.

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) may not exceed $500,000.  Renewal
applications from existing P30 Centers may request initial year direct costs
no greater than 20% over what is stated for the last year of the type 5 award,
or $500,000 direct costs, whichever is greater.  Budget increments for
subsequent years generally will be limited to four percent.  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

The estimated funds available for the first year of support for the entire
program is $2.6 million total costs.  Plans are to make two awards in fiscal
year 1999.  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, structural
and functional neuroimaging.

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.  Fetal therapy: surgical, medical (metabolic, pharmacologic).

6.  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.

7.  Effects of malnutrition (protein, calorie, micronutrients) on
intellectual, behavioral, social and physical development and the
intergenerational effects of malnutrition.

8.  Developmental pharmacology and psychopharmacology: medication used with
MRDD populations.

9.  Infectious diseases in the etiology, prevention and treatment of MRDD;
neurological, neuropathological, behavioral and intellectual consequences of
AIDS in children.

10.  Diagnosis:  development and application of biomedical and behavioral
methods and measures; identification of children and infants at risk for MRDD.

11.  Early interventions for infants at risk to develop MRDD:  research into
the process of early intervention strategies.

12.  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.

13.  Psychobiological processes in MRDD of conditions such as autism and Rett
syndrome using methods of behavioral genetics, embryology and teratology,
developmental neuroscience and psychophysiology.

14.  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.

15.  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.

16 .  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.

17.  Language and communication of MRDD populations: studies on development of
alternative communication systems; ontogeny of linguistic processes; speech
intelligibility; literacy development.

18.  Learning disabilities, dyslexia, and attention deficit disorder.

19.  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.

20.  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.

21.  Epidemiology of MRDD:  analytic and case-control studies of etiology;
prevalence; follow-up of outcomes.

22.  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.

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, staff
recruitment, 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 that might be proposed for the MRRCs
network.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 12, 1998, 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
NICHD 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@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.

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 2 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:

CENTER FOR SCIENTIFIC REVIEW
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:

Scott Andres, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E-03, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-1485

Applications must be received by July 30, 1998.  If an application is received
after that date, it will be returned to the applicant without review.  The
Center for Scientific Review (CSR) 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 CSR 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 CSR and
responsiveness by NICHD 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 1999 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 1999 meeting.  The
anticipated date of award is August 1, 1999.

Review Criteria

In addition to the specific criteria listed in the NICHD P30 Guidelines,
reviewers will evaluate:

o  scientific, technical, or medical significance of proposed research;

o  originality and innovativeness of proposed research and core facilities;

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 and support;

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, the
following factors will be considered in making the awards:

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 and requests for the P30
guidelines 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:  FD14A@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
Email:  ES65o@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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