Full Text HD-94-014

DEVELOPMENTAL DISABILITIES PREVENTION RESEARCH CENTER

NIH GUIDE, Volume 23, Number 5, February 4, 1994

RFA:  HD-94-014

P.T. 34

Keywords: 
  PHYSIOLOGICAL/DEVELOPMENT PROCESS 
  Disease Prevention+ 
  Mental Retardation 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  March 31, 1994
Application Receipt Date:  May 18, 1994

PURPOSE

The budget appropriation report language for the National Institute
of Child Health and Human Development (NICHD) for fiscal year 1994
indicated that funds were provided to establish "... a Developmental
Disabilities Prevention Research Center within a university
affiliated program (UAP), which shall investigate the critical
problems of prevention and amelioration of mental retardation,
specifically including: a specialized research center engaged in the
multidisciplinary analysis of myelinogenesis as a critical period
that is highly vulnerable to nutritional status during fetal and
postnatal brain development."  In response to this Congressional
mandate, the Mental Retardation and Developmental Disabilities Branch
(MRDD), Center for Research for Mothers and Children (CRMC), NICHD,
invites applications for a specialized research center that will
develop new knowledge concerning diagnosis, prevention, treatment,
and amelioration of mental retardation and developmental
disabilities, with special emphasis on vulnerable periods in fetal
and postnatal brain development.  One specialized center may be
supported in response to this request for applications (RFA).

Specialized Research Centers on mental retardation are awarded funds
for centralized research services and facilities and for the support
of comprehensive research projects on topics deemed to be of high
priority because of their significance to the etiology, diagnosis,
prevention, treatment, or amelioration of mental retardation and
developmental disabilities.  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.  Because of the diversity of causes of
mental retardation, which include genetic, infectious, metabolic,
toxic, nutritional, and other factors, and the interaction of
biological, behavioral, social, and cultural factors which could
affect the severity of its clinical manifestations, research
approaches on the prevention or amelioration of MRDD may require the
collaborative efforts of several scientific disciplines.

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,
Developmental Disabilities Prevention Research Center, is related to
the priority area on chronic disabling conditions.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report:
Stock No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone
202-783-3238).

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,
provided they have an existing University Affiliated Program (UAP).
Public Law 88-164, Title I, Part B authorized construction of
University Affiliated Facilities, "for the purpose of assisting in
the construction of clinical facilities, providing, as nearly as
practicable, a full range of inpatient and outpatient services for
the mentally retarded and facilities which will aid in demonstrating
provision of specialized services for the diagnosis and treatment,
education, training, or care of the mentally retarded or in the
clinical training of physicians and other specialized personnel
needed for research, diagnosis and treatment, education, training, or
care of the mentally retarded..."

Applicants to this RFA may collaborate, through consultation or
contractual arrangements, with foreign investigators.  Applications
from minority individuals and women are encouraged.

MECHANISM OF SUPPORT

This RFA will use the NIH Specialized Center grant mechanism (P50).
The applications should be prepared in a manner consistent with the
information presented in the publication, National Institute of Child
Health and Human Development, Research Center Programs, which is
available from the NICHD office listed below.  Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant.  The total project period for
applications submitted in response to this RFA may not exceed five
years.  The anticipated date of award is September 30, 1994.

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all
investigator-initiated applications and will be reviewed according to
the customary NIH peer review procedures.

FUNDS AVAILABLE

Applications submitted in response to this RFA will compete for
$600,000 in direct costs that will be made available for the first
year of support.  Only one award will be made.

RESEARCH OBJECTIVES

The MRDD Branch supports research that relates to the biological,
behavioral and social processes that contribute to, or influence the
development of, mental retardation and developmental disabilities.
Prevention of MRDD, and amelioration of the clinical manifestations
of those afflicted, constitute areas of special emphasis within the
Branch.  To accomplish its mission, the MRDD Branch provides
financial support for research grants, core facilities in the Mental
Retardation Research Centers, specialized research centers, research
contracts for the development of research resources, and for
dissemination of information to the scientific community and the
public.

This RFA solicits applications that will contribute to a better
understanding of the causes, diagnosis, prevention, treatment and
amelioration of mental retardation and developmental disabilities.
NICHD encourages basic and clinical research, using animal models and
human subjects, addressing genetic, environmental and other factors
that affect brain development.  Research on the effects of
malnutrition (protein, calorie, trace metals, vitamins), on
myelinogenesis is of particular interest.  Research projects on the
effects of various types of intervention strategies, including
nutritional supplementation, on neuropsychological development, are
also encouraged.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders
and conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information should be included in the form PHS 398
in Sections 1-4 of the Research Plan AND summarized in Section 5,
Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 31, 1994, a
letter of intent that includes a descriptive title of the proposed
research, address, and telephone number of the Principal
Investigator, titles of the component subprojects and the principal
investigator, core facilities, when applicable, and the director of
each core, names 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 subsequent applications, the information
that it contains allows Institute staff to estimate the potential
review workload and to avoid possible conflict of interest in the
review.

The letter of intent is to be sent to Dr. Felix F. de la Cruz at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted using PHS 398 (rev. 9/91).
Application kits containing this form and the necessary instructions
are available in most institutional offices of sponsored research and
may be obtained from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, Westwood Building,
Room 449, Bethesda, MD 20892, telephone (301) 435-0714.

The RFA label available in the PHS 398 (rev. 9/91) 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
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E-03
Bethesda, MD  20892

Applications must be received by May 18, 1994.  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, the applications will be reviewed for completeness by
DRG, and responsiveness to the RFA by NICHD staff.  Incomplete
applications will be returned to the applicant without further
consideration.  If the application is not responsive to the RFA,
Institute staff will contact the applicant to determine whether to
return the application to the applicant or submit it for review in
competition with unsolicited applications at the next review cycle.

Applications may be triaged by a peer review group on the basis of
relative competitiveness.  In that case, the NIH will withdraw from
further competition those applications judged to be non-competitive
for an award and notify the applicant Principal Investigator and
institutional official.  Applications judged to be competitive will
undergo further scientific merit review.  Applications that are
complete and responsive will be evaluated for scientific and
technical merit by a review panel convened solely for this purpose by
the Division of Scientific Review, NICHD.  The second level of review
will be provided by the National Advisory Child Health and Human
Development Council.

Review Criteria

Review criteria for RFAs are generally the same as those for
unsolicited research grant applications, and include:

o  scientific, technical, or medical significance of the application;

o  appropriateness and adequacy of the experimental approaches
proposed to carry out the research;

o  coordination, interrelationship, cohesiveness, and synergism among
the individual research projects and core components; relationship of
the program objectives to the common theme; the advantages of
pursuing the proposed research as a P50 rather than through
individual research grants;

o  qualifications and research experience of the Principal
Investigator for the entire program, and the Principal Investigators
for the component projects;

o  participation of a suitable number of responsible, experienced
investigators;

o  the specific scientific objectives of each project that will
benefit from, depend upon, or contribute to collaborative
interactions with the other component projects within the P50 (i.e.,
objectives that can be accomplished with greater effectiveness,
and/or economy of effort, etc.);

o  an appropriate organizational and administrative structure for
effective attainment of program objectives;

o  arrangements for internal quality control of ongoing research, the
allocation of funds, day-to-day management, contractual agreements,
and internal communication and cooperation among program
investigators;

o  availability and quality of resources and research environment;

o  appropriateness of the proposed budget and duration in relation to
the proposed research;

o  when applicable, quality of proposed core facilities;

o  adequacy of plans for the protection of human subjects;

o  adequacy of plans to protect against or minimize adverse effects
on animals; and

o  inclusion of women and minority subjects in research.

AWARD CRITERIA

In addition to the scientific and technical merit of the application,
the following factors will be considered in making an award:

o  relevance to mental retardation;
o  access to unique populations; and
o  institutional commitment and support.

The anticipated date of award is September 30, 1994.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Requests for the NICHD Research Center Programs guidelines and
inquiries regarding programmatic, technical, and scientific issues,
may be directed 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

Inquiries regarding fiscal and administrative matters may be directed
to:

Mr. E. Douglas 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

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 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.

.

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