EXPLORATORY NEONATAL BRAIN DISORDERS RESEARCH GRANTS

NIH GUIDE, Volume 21, Number 39, October 30, 1992



RFA AVAILABLE:  NS-93-001



P.T. 34



Keywords:

  Brain 

  Infants 

  Neurological Disorders 

  Injury 

  Biomedical Research, Multidiscipl 

  Diagnosis, Medical 



National Institute of Neurological Disorders and Stroke



Letter of Intent Receipt Date:  January 15, 1993

Application Receipt Date:  April 8, 1993



THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS

ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION.

POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN

INQUIRIES, BELOW.



PURPOSE



The National Institute of Neurological Disorders and Stroke (NlNDS)

announces an RFA for exploratory grant applications for the

development of research centers on neonatal brain disorders.  The

NlNDS invites initiatives directed towards the planning of new or

expansion of existing resources to explore various approaches to

studying the newborn at risk for brain injury.  These initiatives

should be well-focused and integrate multidisciplinary research

capacities, encouraging combined basic and clinical research, to

advance the understanding of fetal and neonatal neurological

integrity and vulnerability to brain injury and thereby promote more

sensitive diagnoses, effective intervention and prevention of

neonatal brain disorders.



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,

Exploratory Neonatal Brain Disorders Research Grants, is related to

the priority areas of maternal and infant health, chronic disabling

conditions, and clinical preventive services.  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 organizations only.  The

Center Director or Principal Investigator must be active in a

discipline related to the study and (or) treatment of neonatal brain

disorders and must demonstrate the potential for developing and

directing a research program.  Interrelated biomedical research

projects included in the interdisciplinary research centers should be

conducted by scientists who represent a variety of disciplines within

basic, applied, and clinical science and from whose interactions, new

scientific leads may be readily developed and effectively utilized by

others.  The exploratory research center program must be organized

around a central research theme and must encompass plans for and

development of a sufficient number of scientifically meritorious

research activities  to permit an effective collaborative effort

among the participating investigators.



To be eligible for competition under this RFA, applicants must

document the existence of, or potential for ongoing basic applied and

clinical research related to neonatal brain disorders; research

resources in the encompassing fields, e.g., obstetrics, perinatology,

neonatology, neonatal neurology, neurological sciences, and

biostatistics; clinical facilities that receive and track adequate

numbers and types of neonatal and infantile neurological

disabilities; cooperation among investigators within the scientific

disciplines such that scientific leads may be effectively

implemented; and a plan for further development of individual

investigators, fellows, or clinicians in specialized techniques or

procedures relevant to research on neonatal brain disorders.



MECHANISMS OF SUPPORT



This RFA will use the National Institutes of Health (NIH) Exploratory

Grants (P20) mechanism.  Responsibility for the planning, direction,

and execution of the proposed project will be solely that of the

applicant.  However, prospective applicants are encouraged to

communicate with the NINDS program contact named in INQUIRIES, below,

as early as possible in the planning stages for preparing the

exploratory grant applications.  The total project period for

applications submitted in response to the present RFA may not exceed

three years and annual direct costs of $350,000.



This RFA is a one-time solicitation for exploratory center (P30)

grants only.  Future unsolicited competing applications, beyond the

exploratory stage and eligible for center status, are welcome to

compete with all investigator-initiated applications and be reviewed

according to the customary peer review procedures.



FUNDS AVAILABLE



It is expected that up to $1.5 million in total costs will be

available for the first year of support (FY 93) to fund up to three

neonatal brain disorders research center awards as a result of this

announcement.  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 NlNDS, awards

pursuant to this RFA are contingent upon the availability of funds

for this purpose.



RESEARCH OBJECTIVES



Background



Neonatal brain disorders are an important cause of mortality and

morbidity contributing to the development of autism, cerebral palsy,

mental retardation and a myriad of learning and developmental

neurological and cognitive disabilities.  Dramatic improvements in

obstetrical care and treatment of neonatal respiratory disease have

resulted in an increased survival of premature infants with a greater

attention focused on the morbidity and mortality associated with

neurological complications.  Advances in fetal assessment, especially

through the use of real-time ultrasound scanning, has increased our

awareness of the prenatal origin of many of the neurological

abnormalities detected in the newborn.  It is increasingly recognized

that genetic endowment, metabolic disorders, infection, environmental

factors such as drugs, toxins, nutrition, intrauterine growth

retardation (IUGR), and prenatal neurological insults may influence

vulnerability to brain injury, intrapartum events, and postnatal

outcome.  New technologies such as positron emission tomography

(PET), nuclear magnetic resonance spectroscopy (MRS), and near

infrared spectroscopy (NlRS) available to study such disorders, as

well as advances in neonatal brain research, including animal studies

of mechanisms of brain injury and promising new therapies (nerve

growth factors, calcium channel blockers, free radical scavengers)

have provided a rapidly expanding knowledge base.



Research Goals and Scope



It is the intent of this RFA to award exploratory grants to generate

protocol planning, multidisciplinary research capacity, and pilot

data as the basis for future neonatal brain research center

applications.  The long term goal is to develop neonatal brain

research centers capable of generating complex research initiatives,

answering important research questions, and providing, through the

individual components, a comprehensive, integrated, and cohesive

approach to neonatal brain injury.  Areas of high research interest

appropriate to the RFA include, but are not limited to:



o  conditions such as intracranial hemorrhage in low birthweight

infants, neonatal seizures, hypoxic/ischemic encephalopathy in the

pre- and full-term infant, nutrition and intrauterine growth

retardation, and metabolic disorders relevant to brain development

and function.



o  expanding the knowledge base of the etiology and pathogenesis of

neonatal brain disorders, exploring methods to increase the

capability for early and precise diagnosis, and correlating detected

pathology and dysfunction with clinical course.



o  promoting an identification and understanding of the

neurologically normal fetus and the high risk fetus that will allow

for intrauterine and perinatal prevention of brain injury.



o  promoting the development of noninvasive neurodiagnostic

techniques for assessment of neurological injury, such as NlRS and

MRS, to further identify which infants may benefit from treatment

intervention.



o  evaluating and refining current therapies and developing new ones,

accurately assessing mortality and chronic neurologic disability with

the goal of developing strategies for the prevention of the initial

disorder and/or for prevention or amelioration of long-term

disabilities of the nervous system.



o  experimental animal models of brain injury consistent with the

neuropathological correlates in the developing human nervous system,

exploring mechanisms of injury and/or therapeutic interventions.



SPECIAL INSTRUCTIONS



Exploratory Grants (P20)



In developing the scope of a research program that would eventually

qualify for center support, applicants should base their applications

on the goal of creating a clinical research center that would, at the

end of an exploratory grant period, meet the qualifications contained

in the Application Guidelines:  Program Project and Research Center

Grants (revised 06/92).  These guidelines may be obtained from the

program contact named in INQUIRIES, below.  Therefore, the format for

these exploratory grant applications should address at least the

following essential components of the future center:



o  The feasibility of developing a research program centered around a

unifying theme relevant to neonatal brain injury research and

treatment



o  a component devoted to fundamental research of the vulnerability

of developing brain to injury



o  a component devoted to clinical research on neonatal brain injury,

including plans for research that may lead to the development of new

therapeutic interventions, the refinement of existing forms of

therapy or the preclinical testing of these forms of therapy



o  an administrative core devoted to the integration and coordination

of activities within the research center and among the several

research centers selected for funding.



Recognizing that in many cases the emphasis will be on future

research possibilities, applicants should stress the existing and the

potential strengths of the applicant organization for the development

of a clinical research center.  Appropriate areas may include, but

are not limited to:  development of additional research capabilities

for basic, applied, and clinical research; potential arrangements for

improved capabilities for preclinical testing of new or refined

methods of diagnosis and treatment of neonatal brain disorders;

potential arrangements for collaborations that would strengthen

existing research interests; identification of personnel that would

be considered essential for the future center and possibilities for

their successful recruitment; development of plans for acquiring or

providing special research and clinical skills; and possible

collaborations that would ensure the availability of patients for

clinical studies.  This information is best placed under section IV.

C Research Plan in the Application Guidelines: Program Project and

Research Center Grants (revised 06/92).



If proposed programs are expansions or modifications of existing

resources or would draw upon projects currently funded under other

award mechanisms or by other NIH Institutes, a mechanism should be

developed for maintaining such research in a way that preserves its

own identity while complementing the center, allowing for appropriate

direct addition of new resources and avoiding duplication and

overlap.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN

CLINICAL RESEARCH STUDIES



For projects involving clinical research, NIH requires applicants to

give special attention to the inclusion of women and minorities in

study populations.  If women or minorities are not included in the

study populations for clinical studies, a specific justification for

this exclusion must be provided.  Applications without such

documentation will not be accepted for review.



LETTER OF INTENT



Prospective applicants are asked to submit, by January 15, 1993 , a

letter of intent that includes a descriptive title of the proposed

research, the name, address, and telephone number of the Principal

Investigator names and addresses of coinvestigators responsible for

each project within the center, descriptive titles of individual

projects and required components, and identification of collaborating

institutions.



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 is important in planning for the review of

applications.  It allows NlNDS staff to estimate the potential review

workload, select appropriate reviewers, and avoid conflict of

interest in the review.



The letter of intent is to be sent to Dr. Giovanna M. Spinella at the

address listed under INQUIRIES.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS

398 (rev. 9/91) according to instructions contained in the

application kit.  Application kits are available from most

institutional offices of sponsored research and may be obtained from

the Office of Grants Inquiries, Division of Research Grants, National

Institutes of Health, Westwood Building, Room 449, Bethesda, MD

20892, telephone 301-496-7441.  In conjunction with the PHS 398,

applicants must use the application format as described in the NlNDS

pamphlet, Application Guidelines:  Program Project and Research

Center Grants (rev. 06/92), that may be obtained from the contacts

listed under INQUIRIES.



The RFA label available in the PHS 398 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 "Exploratory Neonatal Brain

Disorders Research Grants" and number must be typed in 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:



Chief, Scientific Review Branch

Division of Extramural Activities

National Institute of Neurological Disorders and Stroke

Bethesda, MD  20892

Telephone:  (301) 496-9223

FAX:  (301) 401-0182



Applications must be received by April 08, 1993.  If an application

is received after that date, it will be returned to the applicant.

The Division of Research Grants (DRG) will not accept any application

in response to this announcement 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 and referral by the Division of Research Grants (DRG),

applications will be reviewed by NlNDS staff to determine

programmatic responsiveness to this RFA.  Applications judged

unresponsive will be returned to the applicant.  All applications

that are complete and responsive may be subjected to a triage by an

NlNDS review group to determine relative scientific merit among the

applications.  The NlNDS may administratively withdraw those

applications judged to be noncompetitive for award.  Those

applications judged to be competitive for award will be further

reviewed for scientific and technical merit by a peer review group

convened by the NlNDS.  No site visits will be made.  A second level

of review will be carried out by the National Advisory Neurological

Disorders and Stroke Council.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications.  The quality of the proposed project as determined by

peer review, availability of funds, and program balance among

research areas of the announcement will be used in making funding

decisions.



INQUIRIES



Written and telephone inquiries concerning this RFA are encouraged.

The opportunity to clarify any issues or questions from potential

applicants is welcome.



Direct inquiries regarding programmatic issues, requests for the RFA,

and requests for the NINDS pamphlet to:



Giovanna M. Spinella, M.D.

Developmental Neurology Branch

Division of Developmental, Convulsive, and Neuromuscular Disorders

National Institute of Neurological Disorders and Stroke

Federal Building, Room 820

Bethesda, MD  20892

Telephone:  (301) 496-5821

FAX:  (301) 402-0887



Direct inquiries regarding fiscal matters to:



Gary P. Fleming, J.D.

Grants Management Branch

National Institute of Neurological Disorders and Stroke

Federal Building, Room 1004

Bethesda, MD  20892

Telephone:  (301) 496-9231



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance No. 93.853, Clinical Research Related Neurological

Disorders and No. 93.854, Biological Basis Research in the

Neurosciences.  Awards are made under authorization of the Public

Health Service Act, Title IV, Part A (Public Law 78-410, as amended

by Public Law 99-150,42 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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