MENTAL RETARDATION RESEARCH CENTERS

Release Date:  April 15, 1999

RFA:  HD-99-004

P.T.

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  May 15, 1999
Application Receipt Date:  July 15, 1999

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 Request for Applications (RFA).

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, support
central research facilities, administration, and development of a limited number
of new research programs.  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.

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" at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State or local governments and eligible agencies of the
Federal government.  Foreign institutions are not eligible for these P30 grants. 
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

This RFA will use the National Institutes of Health (NIH) center core grant (P30)
award mechanism.  Responsibility for the planning, direction, and execution of
the proposed work will be solely that of the applicant. 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 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.

FUNDS AVAILABLE

The NICHD intends to commit $4.1 million in FY 2000 to fund up to four new and/or
competing continuation grants in response to this RFA.  This level of support is
dependent on the receipt of a sufficient number of applications of outstanding
scientific merit.  Although this program is provided for in the financial plans
of the NICHD, awards pursuant to this RFA are also contingent upon the
availability of funds for this purpose.

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.  Competing
continuation applications from existing P30 Centers may request initial year
direct costs no greater than 20 percent 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 3 percent.  Budgets
of new and renewal applications will be stringently reviewed within these
guidelines.  Applications with budget requests exceeding these guidelines will
be administratively withdrawn by NICHD and returned to the applicant.

RESEARCH OBJECTIVES

Background

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 or social 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.  Research conducted in the
MRRCs 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.

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 five 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 behavior genetics, embryology and teratology,
developmental neuroscience and psychophysiology.

14.  Psychological processes in MRDD:  studies of cognition and information
processing; attention and perception; sensory and motor development; family,
social and affective behavior; and, motivation and personality.

15.  Behavioral analysis:  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.

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.

Applications 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.

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 percent of total direct
costs, 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.  Description of
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.

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 are 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, available on the web at: 
https://grants.nih.gov/grants/guide/notice-files/not94-100.html.

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:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

Because P30 funds, in general, do not directly support research projects, the
issue of minority/gender representation, and inclusion of children as
participants in research involving human subjects, will need to be addressed at
the individual project level (i.e., R01 level).  However, the application must
specifically address these issues for any New Program Development projects or
core units that involve subject recruitment.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed center, 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 this RFA.  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 the program staff listed under INQUIRIES
by May 15, 1999.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants.  These forms are available at most institutional offices of
sponsored research and 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.

The RFA label available in the PHS 398 (rev. 4/98) 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) 435-6911

Applications must be received by July 15, 1999.  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 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 the NICHD.  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
2000 meeting in accordance with the review criteria stated below.  As part of the
initial merit review, all applications will receive a written critique and
undergo a process in which only those applicatons deemed to have the highest
scientific merit, generally the top half of the applications under review, will
be discussed, assigned a priority score, and receive a second level review by the
National Advisory Child Health and Human Development Council at its June 2000
meeting.  The anticipated date of award is August 1, 2000.

Review Criteria

The review criteria can be found on pages 10 - 11 of the NICHD P30 Center Core
Grant Guidelines.  In addition, for those Center grant applications that include
New Program Development, the following criteria will be used in order to judge
the likelihood that the proposed research will have substantial impact on the
pursuit of the research goals.

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In the
written comments reviewers will be asked to discuss the following aspects of the
application in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application.  Note that the application does not need to be
strong in all categories to be judged likely to have major scientific impact and
thus deserve a high priority score.  For example, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move a field forward.

(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?

(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?

(4) Investigator: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level of
the principal investigator and other researchers (if any)?

(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?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research.  Plans for
the recruitment and retention of subjects will also be evaluated.

o The reasonableness of the proposed budget and duration in relation to the
proposed research.

o The adequacy of the proposed protection for humans, animals or the environment,
to the extent they may be adversely affected by the project proposed in the
application.

o Availability and quality of resources, especially institutional commitment and
support.

Schedule

Letter of Intent Receipt Date:    May 15, 1999
Application Receipt Date:         July 15, 1999
Peer Review Date:                 March 2000
Council Review:                   June 6, 2000
Earliest Anticipated Start Date:  August 1, 2000

AWARD CRITERIA

In addition to the scientific and technical merit of the application, as
determined by peer review, and the availability of funds, 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 access to unique populations;

o potential to increase productivity and quality of research within the Center,
and to stimulate interdisciplinary/multidisciplinary collaborations;

o providing unique resources for use by other Centers and the greater research
community;

o cost of the Center; 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: FD14A@NIH.GOV

Direct inquiries regarding fiscal matters to:

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:  ds117g@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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