MENTAL RETARDATION RESEARCH CENTERS

Release Date:  April 13, 2000

RFA:  HD-00-017

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  June 1, 2000
Application Receipt Date:       July 18, 2000

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.

The primary objective of the NICHD Mental Retardation Research Centers (MRRC) 
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.  For more than 30 years   NICHD has provided support for 
MRRCs  through the provision of core grants (P30) that facilitate program 
coordination, and 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 Request for 
Applications (RFA) seeks applications from institutions that meet the 
qualifications for a program of mental retardation research.

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), 
Mental Retardation Research Centers, is related to several priority areas.  
Potential applicants may obtain “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, 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.  To be 
eligible for an award, the proposed Center must provide core support for a 
minimum of 10 projects funded from non-university sources.  Additional 
eligibility criteria for the P30 are listed in the “NICHD P30 CENTER CORE 
GRANT GUIDELINES,” available from the program contact listed under INQUIRIES, 
below, and on the Internet at:  
http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm. 

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.  
Applications should be prepared in a manner consistent with the guidelines 
presented in the “NICHD P30 CENTER CORE GRANT GUIDELINES”  
(http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). 

FUNDS AVAILABLE

The NICHD intends to commit approximately $5 million in total costs (direct 
plus Facilities and Administrative [F & A] costs) in FY 2001 to fund up to 
four new and/or competing continuation grants in response to this RFA.  
Applicants may request a project period of five years.  Because  the nature 
and scope of the programs proposed may vary, it is anticipated that the size 
of awards also will vary.  Although this program is provided for in the 
financial plans of the NICHD, awards pursuant to this RFA are contingent upon 
the availability of funds and the receipt of a sufficient number of 
meritorious applications.

The cost of a proposed 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 should not exceed $500,000.  Competing 
continuation applications from existing P30 Centers may request initial year 
direct costs no greater than 20 percent above the level of 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 three 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 NICHD Mental Retardation Research Centers Program 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 often can 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 emerge from 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.

RESEARCH SCOPE

Mental Retardation Research Center Core Grants are intended to bring together 
scientists from a variety of disciplines to work within a Center 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 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, 
focused specifically on mental retardation and developmental disabilities:

1.  Developmental and neurobiological studies relevant to MRDD:  physiology, 
anatomy, chemistry, pharmacology, plasticity, and structural and functional 
imaging.

2.  Cellular and molecular aspects of brain development:  differentiation, 
synapse formation and modification, plasticity, trophic factors, and 
neurotransmitter function and modulation.

3.  Inborn errors of metabolism relevant to MRDD, including mitochondrial and 
peroxisomal disorders and other disorders including, but not limited to, amino 
acid, organic acid, carbohydrate, cholesterol, nitrogen, catecholamine, and 
indolamine metabolism, molecular biology, pathophysiology, recombinant DNA 
technology, screening, applied clinical and experimental studies.

4.  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.

5. Molecular genetics of MRDD, including gene mapping, genomic imprinting, 
gene therapy, and gene localization, structure, function, regulation, and 
organization.

6.  Development and characterization of animal models relevant to MRDD, e.g., 
gene knockout, gene repair, transgenesis, homologous recombination.

7.  Prenatal therapy of genetic and structural defects using metabolic, 
pharmacologic, nutritional, and surgical techniques.  

8.  Genetic, molecular, behavioral, and biobehavioral research and therapeutic 
approaches to Fragile X syndrome and Rett syndrome.                                        

9.  Toxicology and physical environmental factors in the etiology, treatment, 
and prevention of MRDD, including lead, mercury, and other heavy metals, and 
toxic wastes, such as hydrocarbons and polycarbonates (PCBs), developmental 
and behavioral teratology, fetal alcohol syndrome, neuroimmunological 
toxicology, subclinical levels of toxic agents and their effects on 
morphological and behavioral changes associated with mental retardation.

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

11.  Psychopharmacology, cellular and molecular mechanisms, pharmacokinetics, 
behavioral effects, medications used and treatment efficacies in different 
subpopulations of MRDD, dual diagnoses, rational drug development, 
combinatorial chemistry.

12.  Clinical trials for the treatment, amelioration, and/or prevention of 
MRDD.

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

14.  Diagnosis:  development and application of methods and measures for 
screening and diagnosis, identification of children and infants at risk.

15.  Early interventions (biological, behavioral, environmental) for infants 
born at risk for MRDD, research into the process of early intervention 
strategies, follow-up of high-risk infants and children who are at risk due to 
biomedical conditions such as low birth weight and/or conditions of 
environmental deprivation.

16.  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.

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

18.  Psychological processes in MRDD, including attention, cognition, 
information processing, perception, motor development, neuropsychology, 
affective, social, motivational, and personality factors.

19.  Autism and autism spectrum disorders:  screening and diagnosis, etiology, 
neurobiology, genetics, pathophysiology, developmental course, medical, 
biological and pharmacological approaches, behavioral intervention.

20.  Behavioral analysis:  manipulations of interaction between behavior and 
environments of individuals with MRDD in infancy, childhood, adolescence, and 
adulthood to effect reduction in behavior problems, or to facilitate 
vocational training, social and self-help skills, and learning.

21.  Family and community processes:  effects of family members with MRDD on 
family life, family, community, ethnic, socioeconomic, and cultural factors 
influencing developmental outcomes and use of community resources, use of 
social support networks, parent-child, sibling, peers, and family interactions 
over the life span.

22.  Measurement tools to assess cognitive and behavioral development, tests 
that highlight abilities and disabilities, including tests for specific 
subpopulations, such as Fragile X, inborn errors of metabolism, Williams 
syndrome.

23.  Residential, educational, and vocational settings throughout the life 
span:  effects of behavior and adjustment of individuals with MRDD, learning 
and social behavior in these settings, adaptation to residential environments.

24.  Learning disabilities, dyslexia, and attention deficit hyperactivity 
disorder.

25.  Language and communication in MRDD populations.

26.  Socio-ecological processes:  individuals with MRDD from various cultural 
and ethnic groups in multiple settings (naturalistic observation), 
ethnographic research, life history reporting, and systematic observation of 
specific activities.

27.  Hyperaggressive, destructive, and self-injurious behavior in human and 
animal models, including pharmacologic treatment, stereotypic behaviors, lack 
of compliance of mentally retarded children in family and educational 
settings.

28.  Epidemiology of MRDD:  analytic and case-control studies of etiology, 
incidence and prevalence, follow-up over the life span (infancy to adulthood) 
for outcomes.

29.  Behavior and life styles that could affect mortality and morbidity.

30.  Development of assistive devices (e.g., computer software) to help 
individuals with MRDD to learn and communicate.

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 must 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 
(http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).

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 each core unit proposed should include a 
rationale, indicating how it 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 grant applications in their detail and development.  
Each such project may 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.  In 
planning the program, some consideration should be given to potential 
collaborative studies and projects that 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,” 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, and available on the Internet at: 
http://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/or 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,” published in the NIH Guide for Grants and 
Contracts, March 6, 1998, and available on the Internet at:  
http://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 involving human subjects or core units involved in activities such as 
subject recruitment or testing.

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 plan 
the review.

The letter of intent is to be sent to Dr. Felix F. de la Cruz at the address 
listed under INQUIRIES, below, by June 1, 2000.

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.

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, on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division 
of Extramural Outreach and Information Resources, National Institutes of 
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 
301-435-0714, E-mail: Grantsinfo@nih.gov. 

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
stapled to the bottom of the face page of the application and must display the 
RFA number HD-00-017.  A sample RFA label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this is 
in the pdf format.  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 should be 
sent to:

L. R. Stanford, Ph.D.
Director, 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)

Applications must be received by July 18, 2000.  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 for 
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 Subcommittee at 
its March 2001 meeting, in accordance with the review criteria stated below.  
As part of the initial merit review, all applicants will receive a written 
critique and may undergo a process in which only those applications deemed to 
have the highest scientific merit will be discussed, assigned a priority 
score, and receive a second level review by the National Advisory Child Health 
and Human Development Council.

Review Criteria

All applications responding to this RFA will be evaluated according to the 
review criteria for core units, New Program Development projects, and the 
overall center as outlined in the NICHD P30 Center Core Grant Guidelines 
(http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm. 

SCHEDULE

Letter of Intent Receipt Date:    June 1, 2000
Application Receipt Date:         July 18, 2000
Peer Review Date:                 March 2001
Council Review:                   June 2001
Earliest Anticipated Start Date:  July 1, 2001

AWARD CRITERIA

In addition to the scientific and technical merit of the application, as 
determined by peer review, factors that will be considered in making the 
awards include:

o 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-effectiveness of the core facilities.

o cost of the Center, and

o availability of funds.

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.
Chief, Mental Retardation and Developmental Disabilities Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B-09, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1383
FAX:  (301) 496-3791
E-mail:  fd14a@nih.gov 

Direct inquiries regarding fiscal matters to:

Mr. Douglas Shawver
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A-17, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
E-mail:  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 
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 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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