Subject: NIH GUIDE - V20(25) 06/28/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 28 Jun 91 09:36 EST

Hi Paul:
The NIH Guide has arrived.  It will be forwarded in 6 parts.
Please post this one to the NIH Listserver as:
NIHGUIDE.910628.
                   Thanks, Mary Broaddus
 
NIH GUIDE - Vol. 20, No. 25, June 28, 1991
 
$$INDEX BEGIN **********************************************************
 
                   NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
$$INDEX R1 *************************************************************
 
PERSPECTIVE STUDY OF PERSISTENT OR RECURRENT ARTHROPATHY AND OTHER
POTENTIAL ADVERSE EVENTS FOLLOWING RUBELLA VACCINATION OF ADULT WOMEN
(RFP)
Centers for Disease Control
Index:  CENTERS FOR DISEASE CONTROL
 
$$INDEX R2 *************************************************************
 
PEDIATRIC AND PERINATAL HIV CLINICAL TRIALS CENTERS (Sources Sought)
National Institute of Child Health and Human Development
Index:  CHILD HEALTH, HUMAN DEVELOPMENT
 
$$INDEX R3 09/13/91 ****************************************************
 
EXPANSION OF THE PEDIATRIC AIDS CLINICAL TRIAL UNITS (RFA AI-91-10)
National Institute of Allergy and Infectious Diseases
Index:  ALLERGY, INFECTIOUS DISEASES
 
$$INDEX R4 11/15/91 ****************************************************
 
RESEARCH ON THE PREVENTION OF ALCOHOL-RELATED PROBLEMS AMONG
ETHNIC MINORITIES (RFA AA-91-04)
National Institute on Alcohol Abuse and Alcoholism
Office for Substance Abuse Prevention
Index:  ALCOHOL ABUSE, ALCOHOLISM, SUBSTANCE ABUSE PREVENTION
 
$$INDEX R5 12/16/91 ****************************************************
 
ALCOHOL RESEARCH CENTER GRANTS (RFA AA-91-02)
National Institute on Alcohol Abuse and Alcoholism
Index:  ALCOHOL ABUSE, ALCOHOLISM

                        ONGOING PROGRAM ANNOUNCEMENTS
 
$$INDEX P1 *************************************************************
 
RESEARCH ON MANAGED MENTAL HEALTH CARE (PA-91-71)
National Institute of Mental Health
Index:  MENTAL HEALTH
 
$$INDEX P2 *************************************************************
 
MOVEMENT DISORDERS (PA-91-72)
National Institute of Neurological Disorders and Stroke
Index:  NEUROLOGICAL DISORDERS, STROKE
 
$$INDEX END ************************************************************
 
                   NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
$$R1 BEGIN 200-91-0931(P) **********************************************
 
PERSPECTIVE STUDY OF PERSISTENT OR RECURRENT ARTHROPATHY AND OTHER
POTENTIAL ADVERSE EVENTS FOLLOWING RUBELLA VACCINATION OF ADULT WOMEN
 
RFP AVAILABLE:  200-91-0931(P)
 
P.T. 34, II; K.W. 0715006, 0740075
 
Centers for Disease Control
 
The Centers for Disease Control contemplates award of a 48-month
research contract to study persistent or recurrent arthropathy and other
potential adverse events following rubella vaccination of adult women.
The purpose of the contract is to compare the rate and severity of these
events following rubella vaccination of seronegative and seropositive
adult women to the rate in seropositive adult women not receiving
rubella vaccine.
 
Written requests for copies of the solicitation will be honored if
received within 45 days of the Request for Proposals (RFP) issue date,
which will be on or about June 24, 1991.  The date specified for the
receipt of the offers will be approximately 90 days after the RFP issue
date.  Requests for the RFP must cite RFP No. 200-91-0931(P).  Telephone
requests will not be accepted.  All responsible sources may submit a
proposal that shall be considered by the Agency.
 
Requests for the RFP and questions about this announcement should be
directed to:
 
Mark Federer
Centers for Disease Control
Procurement and Grants Office
Program Acquisitions Branch
255 East Paces Ferry Road, N.E.
Room 314
Atlanta, GA  30305
 
$$R1 END ***************************************************************
 
$$R2 BEGIN NA-01-01*****************************************************
 
PEDIATRIC AND PERINATAL HIV CLINICAL TRIALS CENTERS
 
SOURCES SOUGHT FOR SUBCONTRACTING OPPORTUNITES
 
P.T. 34; K.W. 0715008, 0745027, 0785170, 0755015, 0403020
 
National Institute of Child Health and Human Development
 
Under Contract #NO1-HD-7-2925 with Westat, Inc., the National Institute
of Child Health and Human Development sponsors a network of clinical
centers that participate in clinical trials of therapies to prevent
pediatric HIV infection or treat pediatric HIV disease.  Clinical
centers serve as subcontractors to Westat.  NICHD and Westat intend to
award additional subcontracts to expand patient access to trials.
Preference will be given to clinical centers that can conduct both
perinatal and pediatric protocols, have no other source of NIH funding
for HIV-related clinical trials, and are located in areas where patients
do not have reasonable access to existing clinical trials centers.
Interested parties must submit three copies of a statement of
capabilities, including a description of clinics for HIV-infected women
and children, an estimated number of available patients, a description
of staff qualifications, and a description of HIV-related research
experience, to:
 
Mr. Stephen Durako
Vice President
Westat, Inc.
1650 Research Boulevard
Rockville, MD  20850
 
One additional copy of the response must also be sent to:
 
Dorothy McKelvin
OGC, CMB
National Institute of Child Health and Human Development
9000 Rockville Pike
EPN, Room 515
Rockville, MD  20892
 
The response must be received by 5:00 p.m. on July 15, 1991.
 
$$R2 END ***************************************************************
 
$$R3 BEGIN AI-91-10 FULL-TEXT ******************************************
 
EXPANSION OF THE PEDIATRIC AIDS CLINICAL TRIAL UNITS
 
RFA AVAILABLE:  AI-91-10
 
P.T. 34; K.W. 0715008, 0785170, 0755015
 
National Institute of Allergy and Infectious Diseases
 
Application Receipt Date:  September 13, 1991
 
PURPOSE
 
The purpose of this Request for Applications (RFA) is to provide support
for the expansion of the pediatric AIDS clinical trials program through
the establishment of new pediatric clinical trial units.  Pediatric
components of adult AIDS Clinical Trial Units (ACTUs) that are currently
enrolling patients, subunits of pediatric ACTUs currently enrolling
patients, and new applicants are invited to apply.  Upon funding, each
new unit will be a free-standing pediatric unit; thus, the Principal
Investigator is expected to be a pediatrician.  This RFA specifically
addresses and outlines requirements for ancillary services including
outreach for pediatric and adolescent populations.  While the inclusion
of adolescents is encouraged, the main thrust of the RFA is on infants
and children.  We expect that applications will include obstetricians
and their services as a part of the research team.  Applications
considered responsive to this RFA must demonstrate a capability to
conduct pediatric clinical trials and provide the necessary ancillary
services and outreach for HIV-infected infants, children, adolescents,
and their families.  The RFA focuses on these ancillary services because
of the critical link between provision of such services and the ability
to recruit and maintain pediatric patients in clinical trials.  Because
of the increasing incidence of maternal-fetal transmission, applicants
are required to describe the capability to conduct perinatal
transmission studies or plans to develop such capability.  Need for
increased attention to studies of primary HIV infection, opportunistic
infections, neurologic complications of HIV infection and enrollment of
HIV-infected adolescents into clinical trials must be addressed.  Strong
emphasis will be placed on the enrollment of study participants from
populations currently underrepresented in clinical trials (e.g., infants
and children of minority women and substance abusers and disenfranchised
youth).
 
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,
Expansion of the Pediatric AIDS Clinical Trial Units, is related to the
priority area of HIV infection.  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, D.C. 20402-9325 (telephone 202-783-3238).
 
Clinical Core Funding will provide the resources required to maintain an
infrastructure sufficient to maintain an agreed-upon minimum number of
new patients onto protocols each year.  A portion of the total AIDS
Clinical Trial Group (ACTG) pediatric budget may be set aside and
designated as Incentive Funding.  These funds will be awarded either as
administrative supplements after review by the Treatment Research
Program and Division of Extramural Activities staff or as competing
supplements.  Awards will be made consistent with National Institutes of
Health (NIH) and National Institute of Allergy and Infectious Diseases
(NIAID) policies and will support various activities including, but not
limited to, the following:  (1) augmenting awards to pediatric ACTUs
able to accrue a greater than expected number of patients into
high-priority protocols; (2) availability in mid-period of priority
protocols established by the ACTG and the NIAID that require funding not
included in the Clinical Core Funding budget; and (3) providing limited
support to institutions whose investigators contribute a substantial
amount of uncompensated time and effort to ACTG committees or other
program activities.
 
RESEARCH OBJECTIVES
 
The aim of this initiative is to broaden the cooperative network of
institutions and investigators with the capability to provide an
effective and efficient system to evaluate the safety and efficacy of
therapeutic interventions against HIV infection, AIDS, and its
associated conditions in children and adolescents.  Emphasis will be
placed on the provision of ancillary services, the inclusion of
obstetrical and perinatal research, and the inclusion of women and
minorities.  This goal will be accomplished through the accrual of
pediatric patients into trials, analysis of the results of these trials,
and publication of their findings.  Throughout this process, the
participation of awardee clinical investigators from individual clinical
trial units, with substantive involvement of the NIAID under the
cooperative agreement mechanism, is key in the overall ACTG efforts.
 
MECHANISM OF SUPPORT
 
Awards under this RFA will be made as cooperative agreements.
Assistance provided through the cooperative agreement differs from the
traditional research grant in that the Government component (NIAID)
anticipates substantial programmatic involvement during performance of
the award.  It should be understood, however, that applicants must
define their objectives in accord with individual interests and
approaches to conducting the research.  It is anticipated that
approximately six to ten new pediatric ACTUs will be funded to
supplement the current pediatric clinical trials group.  Ongoing
pediatric subunits or components of adult ACTUs that are successful in
competing for these awards will cease to exist as such.  The approximate
total amount of this RFA will be $7.6 million.  This level of support is
dependent on the receipt of a sufficient number of applications of high
scientific merit and availability of funds.  Awards will be made for a
12-month budget period within a total project period of five years.
Continuation awards for new budget periods within an approved project
period will be made on the basis of satisfactory performance and
availability of funds.  The anticipated award date will be February 14,
1992.  It is anticipated that the NIAID will continue this program after
the initial project period through a competitive renewal of the
cooperative agreements, however, continuation is contingent upon
available funds and NIAID priorities.
 
SPECIAL INSTRUCTIONS FOR THE 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 or adequately
represented in the study population for clinical studies, a specific
justification for this exclusion or inadequate representation must be
provided.  Applications without such documentation will not be accepted
for review.
 
APPLICATION AND REVIEW PROCEDURES
 
The research grant application form PHS 398 (rev. 10/88) must be used
in applying.  Upon receipt, applications will be reviewed by NIH staff
for completeness and responsiveness.  Incomplete applications will be
returned to the applicant without further consideration.  Failure to
address all minimum requirements in the Specific Instructions, Section 2
of the RFA will result in the application being considered
nonresponsive.  If the application is not responsive to the RFA, NIH
staff will return it to the applicant.
 
Those applications that are complete and responsive will be evaluated in
accordance with the criteria stated below for scientific/technical merit
by an appropriate peer review group convened by the NIAID.  Those
applications may be subjected to triage by a Special Review Committee to
determine their scientific merit relative to other applications received
in response to this RFA.  The NIH will administratively withdraw from
competition those applications judged to be noncompetitive and notify
the applicants and institutional business official.  The second level
review will be provided by the National Advisory Allergy and Infectious
Diseases Council.
 
INQUIRIES
 
Copies of the complete RFA describing the research goals and scope, the
cooperative agreement mechanism, the review criteria, and other
application requirements may be obtained from:
 
Tina Johnson, M.A.
National Institute for Allergy and Infectious Diseases
6003 Executive Boulevard, Room 201W
Rockville, MD  20892
Telephone:  (301) 496-8214
 
Written or telephone inquiries of a budgetary nature should be addressed
to:
 
Ms. Jane Unsworth
National Institute of Allergy and Infectious Diseases
Westwood Building, Room 706
Bethesda, MD  20892
Telephone:  (301) 496-7075
 
$$R3 END ***************************************************************
 
$$R4 BEGIN AA-91-04 FULL-TEXT ******************************************
 
RESEARCH ON THE PREVENTION OF ALCOHOL-RELATED PROBLEMS AMONG ETHNIC
MINORITIES
 
RFA AVAILABLE:  AA-91-04
 
P.T. 34, FF; K.W. 0404003, 0745027, 0404000
 
National Institute on Alcohol Abuse and Alcoholism
Office for Substance Abuse Prevention
 
Application Receipt Date:  November 15, 1991
 
PURPOSE
 
The primary purpose of this Request for Applications (RFA) is to
encourage and facilitate alcohol abuse prevention research focused on
Black Americans, Hispanic Americans, American Indians, Alaskan Natives,
and Asian/Pacific Americans.  The research envisioned will develop and
test prevention strategies that are effective for these minority
populations that are at elevated risks for specific types of alcohol
problems and have diverse and distinctive sociocultural characteristics
that must be considered in the development and implementation of
prevention activities.
 
The 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, "Research on the
Prevention of Alcohol-Related Problems among Ethnic Minorities," is
related to the priority area of alcohol and other drugs.  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, D.C. 20402-9325 (telephone
202-783-3238).
 
RESEARCH OBJECTIVES
 
This RFA calls for diverse prevention and pre-intervention studies
directed specifically to ethnic minority populations.  Prevention
research investigates ways of reducing the adverse personal and social
consequences of alcohol abuse guided by the public health model that
views alcohol-related problems as arising through a complex of
individual, interpersonal, and social factors.  The research may focus
on entire communities, specific environments or high-risk groups, or
individual behavior.
 
Studies of the effectiveness of environmental prevention strategies in
minority settings may include national, state, or community-wide
policies designed to control alcohol availability and reduce demand for
such products including; (1) strengthening and/or enforcing alcohol
beverage control laws regulating the hours of operation and the location
and number of outlets for sales of alcoholic beverages; (2) enhancing
enforcement of minimum drinking age laws; (3) implementing server
training programs; and (4) raising taxes on alcoholic beverages.
 
Research strategies oriented to changing individual behavior,
particularly that of youth, adolescents, and pregnant women, include
further scrutiny of those programs that have been successfully tested in
the general community but need adaptation to ethnic minorities and
evaluation of their efficacy.  Also needed is the systematic testing of
prevention programs that appear to have been successfully implemented
within ethnic communities but tested on only a limited scale and/or not
systematically evaluated.
 
Applicants also may propose pre-intervention studies of sociocultural
factors that may contribute to the occurrence or reduction of
alcohol-related problems among ethnic minorities.  Sociocultural factors
related to the use of alcohol in ethnic minority communities of
particular interest include:  socialization processes and the role of
the family; peer group influences on alcohol-related behavior;
acculturation and the change process in response to immigration and
migration; the effects of gender roles on alcohol consumption patterns;
the effects of mass media messages; and the contributions of community
institutions to alcohol use and abuse.
 
METHODOLOGICAL ISSUES
 
Research in the areas discussed above may be cast within any of the
standard research traditions.  If applicants do not have the full range
of methodological and technical skills requisite to the design and
analysis of the proposed research, they are strongly urged to consult
with statisticians or other relevant specialists.  Studies involving
interventions must include comprehensive evaluation components that are
conceptually and procedurally integrated with the overall research
program.  The three areas of evaluation (formative, procedural, and
outcome) provide information relevant to the interpretation of the
research findings.
 
Of central importance in the planning and execution of these studies is
careful attention and sensitivity to the unique aspects of the culture
of the group(s) under study.
 
MECHANISMS OF SUPPORT
 
Applicants may submit research project grants (R01s) requesting up to
four years of support.  Applications in response to this RFA will
compete for $800,000 in new grant money that is expected to be made
available for this purpose in fiscal year 1992.  It is anticipated that
three to five projects will be supported.
 
REVIEW PROCEDURES
 
Applications submitted in response to this RFA will be assigned to an
Initial Review Group (IRG) in accordance with established Public Health
Service Referral Guidelines.  The IRG, consisting primarily of
non-Federal scientific and technical experts, will review applications
for scientific and technical merit.  Applications will receive a second
level review by the National Advisory Council on Alcohol Abuse and
Alcoholism and the Advisory Committee on Substance Abuse Prevention,
where reviews may be based on policy considerations as well as
scientific merit considerations.  Only applications recommended for
approval by these advisory bodies may be considered for funding.
 
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN IN CLINICAL RESEARCH STUDIES
 
For projects involving clinical research, the National Institute on
Alcohol Abuse and Alcoholism (NIAAA) requires applicants to give special
attention to the inclusion of women in study populations.  If women are
not included in the study population for clinical studies, a specific
justification for this exclusion must be provided.  Applications without
such documentation will not be accepted for review.
 
APPLICATION PROCEDURES
 
Applicants must use the grant application form PHS 398 (revised 10/88).
Application kits containing the necessary forms and instructions may be
obtained from business offices or offices of sponsored research at most
universities, colleges, medical schools, and other major research
facilities and from:
 
National Clearinghouse for Alcohol and Drug Information
Post Office Box 2345
Rockville, Maryland 20852
Telephone:  (301) 468-2600
 
INQUIRIES
 
For the complete RFA and pre-application consultation, contact:
 
Elsie Taylor or Susan E. Martin
Prevention Research Branch
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
5600 Fishers Lane, Room 13C-23
Rockville, MD  20857
Telephone:  (301) 443-1677
 
For fiscal and administrative matters, contact:
 
Elsie Fleming
Chief, Management Review and Assistance Section
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Parklawn Building, Room 16-86
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4703
 
$$R4 END ***************************************************************
 
$$R5 BEGIN AA-91-02 FULL-TEXT ******************************************
 
ALCOHOL RESEARCH CENTER GRANTS
 
RFA AVAILABLE:  AA-91-02
 
P.T. 04; K.W. 0404003, 0745020, 0745027, 0755030, 0745070
 
National Institute on Alcohol Abuse and Alcoholism
 
Application Receipt Date:  December 16, 1991
 
PURPOSE AND OBJECTIVES
 
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides
grant support for Alcohol Research Centers to conduct interdisciplinary
research on alcoholism and alcohol abuse.  The Center grants program is
interrelated with and complementary to all other research support
mechanisms and scientific activities that comprise the NIAAA programs of
research on the nature, causes, diagnosis, treatment, control,
prevention, and consequences of alcohol abuse and alcoholism.  The
Alcohol Research Centers Grant program provides long-term (typically,
for five years) support for interdisciplinary research programs with a
distinct focus on a particular theme relating to alcoholism, alcohol
abuse, and other alcohol-related problems.  The program is intended to
encourage outstanding scientists from biomedical, behavioral, social
science, and other relevant disciplines to bring a full range of
expertise, approaches, and advanced technologies to the study of
problems related to alcohol abuse and alcoholism.  Research to improve
knowledge of other drug abuse and mental disorders that co-occur with
alcohol abuse disorders is also encouraged.
 
A Center is expected to be a source of scientific excellence and,
through sustained excellence, to become a significant regional or
national research resource.  In addition, the applicant institution is
expected to afford opportunities for research training to persons from
various disciplines and professions.
 
MECHANISM OF SUPPORT
 
A Specialized Center Grant (P50) is a comprehensive, broad-based
multidisciplinary, multi-investigator, long-term program of combined
research and research support activity planned around a specific major
research objective or research theme.  In addition to providing support
for shared resources, this type of Center supports a full range of
basic, developmental, clinical, and/or applied research components;
allows for growth and development through pilot projects; and is
intended to provide state-of-the-art leadership in the alcohol field.
 
It is estimated that approximately $13-14 million will be available in
FY 1993 to fund approximately eight Centers.
 
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
 
For projects involving clinical research, ADAMHA requires applicants to
give special attention to the inclusion of women and minorities in study
populations.  If women and 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.
 
APPLICATION SUBMISSION
 
Applicants must use the grant application form PHS 398 (rev. 10/88).
The title and number of this Request for Applications, "Alcohol Research
Center Grants, AA-91-02" must be typed in item number 2 on the face page
of the PHS 398 application form.
 
REVIEW PROCEDURES
 
Each Center application will be reviewed by a group of experts to
evaluate the scientific and technical merit of the proposal.
Recommendations from this review will be presented to the National
Advisory Council on Alcohol Abuse and Alcoholism that will make a final
recommendation to the Director, NIAAA.
 
INQUIRIES
 
For a copy of the RFA and preapplication consultation contact:
 
Dr. Ernestine Vanderveen
Associate Director
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
5600 Fishers Lane, Room 16C-06
Rockville, MD  20857
Telephone:  (301) 443-1273
 
For fiscal and administrative matters, contact:
 
Ed Ellis
Grants Management Specialist
Management Review and Assistance Section
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Parklawn Building, Room 16-86
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4703
 
$$R5 END ***************************************************************
 
                        ONGOING PROGRAM ANNOUNCEMENTS
 
$$P1 BEGIN PA-91-71 ****************************************************
 
RESEARCH ON MANAGED MENTAL HEALTH CARE
 
PA:  PA-91-71
 
P.T. 34; K.W. 0715095, 0715129, 0730000, 0755018
 
National Institute of Mental Health
 
The National Institute of Mental Health (NIMH) expects to develop and
expand scientific knowledge on the wide range of managed care programs.
Researchers are encouraged to develop rigorous research designs for
exploring the effect of managed mental health care.  Such designs
include natural experiments or quasi-experimental designs with
comparison groups.  Secondary data analysis of existing data sets may be
adequate for some studies, as may other designs.  Study populations
should include subjects with primary mental disorders and/or those with
co-occurring disorders such as alcohol or drug abuse.
 
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.  The PHS urges
applicants to submit work plans that address specific objectives of
"Healthy People 2000."  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, D.C. 20042-9325 (telephone 202-783-3238).
 
Applications may be submitted by any public or private, nonprofit or
for-profit organization, including units of State or local governments.
Women and minority investigators are encouraged to apply.
 
Research support may be requested through applications for a research
grant (RO1), small grant (R03), and First Independent Research and
Transition (FIRST) award (R29).  Applications must be prepared on the
current version of the form PHS 398 (revised 10/88).  All applications
must clearly indicate the relevance of the proposed work to the stated
purpose of this announcement.
 
Applications for this grant are encouraged to include both women and
minorities in study populations, unless scientific evidence or other
justification for not including them is provided.  Applications should
include in their study design gender and/or minority representation
appropriate to the scientific objectives of the work proposed.  If
representation of women or minorities is not feasible or appropriate,
the reasons must be explained and justified.
 
Applicants should also be aware that the Department of Health and Human
Services has regulations for the protection of human subjects and has
developed additional regulations for the protection of children.  A copy
of these regulations, 45 CFR 46, Protection of Human Subjects, is
available from the Office for Protection from Research Risks, National
Institutes of Health, Building 31, Room 5B39, Bethesda, Maryland 20892.
 
Applications will be reviewed according to the usual PHS receipt and
review schedule.  Applications will be reviewed for scientific merit by
an initial review group (IRG) composed primarily of non-Federal
scientific experts.  Final review is by the appropriate National
Advisory Council.  Only applications recommended for approval by the
Council may be considered for funding.
 
Review criteria include evidence of familiarity with relevant research
literature; adequacy of the theoretical and conceptual framework of the
proposed research and appropriateness of research methods; scientific
quality of the project design and methodology; demonstrated research
capability, experience, and commitment of the proposed research staff;
demonstrated access to research subjects or data bases to conduct the
research; adequacy of facilities, general environment, and core
resources for the development and implementation of the proposed
research; evidence of cooperation and commitment for persons and
organizations whose support is essential for the conduct of the
research; adequacy of the plan to protect research subjects;
appropriateness of the budget requested; generalizability of the
results; and applicability to minority populations and women.
 
Award criteria include IRG and Council recommendations, program needs
and priorities, and availability of funds.
 
For a copy of the full announcement or for further information on
research issues, applicants may contact:
 
Paul Widem, Chief, or Agnes Rupp, Ph.D.
Mental Health Economics Research Program
Services Research Branch
Division of Applied and Services Research
National Institute of Mental Health
Room 18C-14, 5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4233
 
Further information on grants management issues may be obtained from:
 
Stephen J. Hudak
Grants Management Branch
National Institute of Mental Health
Room 7C-26, 5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4456
 
Under authority of Section 301 of the Public Health Service Act as
amended, PL 78-410, 42 U.S.C., 241 and the Catalog of Federal Domestic
Assistance 93.242.
 
$$P1 END ***************************************************************
 
$$P2 BEGIN PA-91-72 ****************************************************
 
MOVEMENT DISORDERS
 
PA:  PA-91-72
 
P.T. 34; K.W. 0715060, 0785035, 0785210, 0710100
 
National Institute of Neurological Disorders and Stroke
 
PURPOSE
 
An existing National Institute of Neurological Disorders and Stroke
(NINDS) Program Announcement, published June 6, 1980, is being reissued
to notify the scientific community of continuing NINDS interest in
movement disorders with particular emphasis on dystonia, tremor,
Parkinson's disease, and other basal ganglia degenerative disorders.
The emphasis on dystonia is in response to the 1991 House and Senate
Appropriations Reports.  The NINDS invites grant applications to support
neurological research leading to a better understanding of the etiology
and pathogenesis of a variety of movement disorders, with the intent of
improving the early diagnosis and the treatment of these nervous system
dysfunctions and ultimately facilitating their prevention.
 
BACKGROUND INFORMATION
 
Neurological disorders of movement include dystonia, Parkinson's and
Huntington's diseases, other basal ganglia degenerations (such as
Progressive Supranuclear Palsy and Striatonigral Degeneration), and
other diseases of varied causation characterized by tics, tremors,
chorea, athetosis, and ballism.  Most of these neurological disorders
are progressive and may be associated with dementia, ataxia, and other
neurological abnormalities, in addition to abnormal motor activity.  In
some cases, the symptoms reflect abnormal function of specific brain
nuclei or classes of neurons; in others the abnormality is unknown.  In
no case is the pathophysiological process adequately understood.
 
Dystonic movements can result from a number of causes.  Typical torsion
spasms are twisting in nature and usually repetitive in occurrence.  The
symptom severity and natural history are variable, making treatment
evaluation measures and prevalence estimates difficult.  Essential
tremor is among the most common of all neurological disorders.  It is
generally benign in course but may, at times, become a significant cause
of disability.
 
The individual cost of medical care in these neurological disorders and
the societal costs from lost or diminished function can be considerable.
 
RESEARCH GOALS AND SCOPE
 
Multidisciplinary and collaborative studies are encouraged.
Experimental studies may focus on anatomical, pathological, biochemical,
physiological, or pharmacological aspects of any of these diseases.
 
There is particular need for work in the following:  (1) more precise
definition of the anatomical and/or physiological lesion; (2)
identification of characteristic abnormalities in non-neural tissues,
such as blood, skin, or muscle, that are more amenable to biopsy or
tissue culture; (3) development of animal models, experimental or
genetic, that mimic significant aspects of a movement disorder; (4)
molecular genetics; and (5) advanced neuroimaging research.
 
Existing therapies for the movement disorders are, in general,
unsatisfactory.  Many drugs currently used are either ineffective over
long periods of time or associated with undesirable side effects.  For
this reason, experimental therapeutic studies on animal models of
movement disorders and studies of appropriate in vivo systems are
encouraged.
 
MECHANISMS OF SUPPORT
 
Applicants may apply for the research project grant (RO1), research
program project (PO1), research center grant (P50), and First
Independent Research Support and Transition Award (R29).  Prospective
applicants are encouraged to communicate with the Institute staff listed
at the end of the announcement regarding the appropriate funding
mechanism.  Both basic science and clinical investigations are
encouraged to address relevant research issues.
 
APPLICATION AND REVIEW PROCEDURES
 
Applications must be prepared on form PHS 398 (revised 10/88) according
to instructions contained in the application kit.  Application kits are
available from most institutional business offices and may be obtained
from the Division of Research Grants at the address given below:
 
Office of Grants Inquiries
National Institutes of Health
Division of Research Grants
Westwood Building, Room 449
5333 Westbard Avenue
Bethesda, MD  20892
 
Check "yes" in item two on the face sheet of the application and type
"Movement Disorders, PA-91-72."
 
Applicants for the P01 or P50 should use the application format as
described in the NINDS pamphlet, "Application Guidelines:  Program
Project and Clinical Research Center Grants" (revised 10/89), that may
be obtained from the contacts listed under INQUIRIES.
 
Applications will be judged on scientific merit and program relevance in
accordance with NIH policy and procedures involving peer review.  An
initial review will be made by an appropriate study section of the
Division of Research Grants for research grants and FIRST awards, and by
an appropriate institute committee for program projects and centers.  A
second level of review will be made by an appropriate national advisory
council.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 Section 2,
A-D of the research plan and summarized in Section 2, E, Human Subjects.
Applicants/offerors are urged to assess carefully the feasibility of
incuding 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.
 
Deadlines for the receipt of applications are February 1, June 1, and
October 1.
 
The original and six copies of the application must be sent directly to:
 
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
INQUIRIES
 
For further information regarding this announcement, potential
applicants should write or call:
 
Philip H. Sheridan, M.D., Chief
Developmental Neurology Branch
Division of Developmental, Convulsive, and Neuromuscular Disorders
NINDS
Federal Building, Room 8C10
Bethesda, MD  20892
Telephone:  (301) 496-6701
 
or
 
Eugene J. Oliver, Ph.D.
Division of Demyelinating, Atrophic, and Dementing Disorders
NINDS
Federal Building, Room 806
Bethesda, MD  20892
Telephone:  (301) 496-1431
 
The program to which the intended grants relate is described in the
Catalog of Federal Domestic Assistance, entry number 93.853 - Clinical
Research Related Neurological Disorders, and 93.854 - Biological Basis
Research in the Neurosciences.  Grants will be awarded under the
authority of the Public Health Service Act, Title IV, Section 301
(Public Law 78-410, as amended; 42 USC 241) and administered under PHS
grant policies and Federal Regulations 42 CFR Part 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.
 
$$P2 END ***************************************************************
 
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS
THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH.
APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO
FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS.  THE
ADDRESS FOR THE WESTWOOD BUILDING IS:
 
5333 Westbard Avenue
Bethesda, Maryland 20816

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