kristoff@GENBANK.BIO.NET (Dave Kristofferson) (03/08/91)
NOTE: The NIH Guide may be split into more than one mail message to
avoid truncation during e-mail distribution. The first message always
begins with the RFP/RFA summary sections followed by the appended
texts of the full RFP/RFAs.
This particular issue has a large number of RFP/As which will be
posted in stages over the next few days to avoid network congestion.
----------------------------------------------------------------------
$$XID NIHGUIDE 19910308 V20N10 P1O2 ************************************
X-comment: RFAS described: HD-91-02, MH-91-04, MH-91-05, AG-91-10, MH-91-06,
DK-91-08, HD-91-06, HD-91-07, HD-91-10, CA-91-11,
CA-91-12, CA-91-13, AI-91-08
$$INDEX BEGIN **********************************************************
NIH GUIDE - Vol. 20, No. 10, March 8, 1991
NOTICES
$$INDEX N1 *************************************************************
CONFERENCE: FOSTERING SCIENTIFIC INTEGRITY IN BIOMEDICAL RESEARCH
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
NOTICES OF AVAILABILITY (RFPs AND RFAs)
$$INDEX R1 *************************************************************
NATIONAL EPIDERMOLYSIS BULLOSA REGISTRY - CLINICAL COORDINATING CENTER
(RFP)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Index: ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES
$$INDEX R2 *************************************************************
NATIONAL EPIDERMOLYSIS BULLOSA REGISTRY - CLINICAL SITES (RFP)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Index: ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES
$$INDEX R3 06/10/91 ****************************************************
EVENT RECORDINGS OF HIGH RISK INFANTS ON APNEA MONITORS (RFA HD-91-02)
National Institute of Child Health and Human Development
Index: CHILD HEALTH, HUMAN DEVELOPMENT
$$INDEX R4 05/22/91 ****************************************************
SHORT-TERM CLINICAL TRAINING GRANTS IN DIAGNOSIS AND TREATMENT OF
DEPRESSIVE DISORDERS (RFA MH-91-04)
National Institute of Mental Health
Index: MENTAL HEALTH
$$INDEX R5 05/22/91 ****************************************************
SHORT-TERM GRANTS FOR TRAINING MEDICAL STUDENTS IN THE DIAGNOSIS AND
TREATMENT OF DEPRESSIVE DISORDERS (RFA MH-91-05)
National Institute of Mental Health
Index: MENTAL HEALTH
$$INDEX R6 05/21/91 ****************************************************
COOPERATIVE CLINICAL STUDIES FOR THE TREATMENT OF COGNITIVE IMPAIRMENT
AND BEHAVIORAL DISORDERS ASSOCIATED WITH ALZHEIMER'S DISEASE (RFA
AG-91-10)
National Institute on Aging
Index: AGING
$$INDEX R7 05/22/91 ****************************************************
COOPERATIVE AGREEMENT FOR MULTI-SITE TRIALS OF BEHAVIORAL STRATEGIES TO
PREVENT THE FURTHER SPREAD OF HIV INFECTION (MH-91-06)
National Institute of Mental Health
National Institute on Drug Abuse
National Institute on Alcohol Abuse and Alcoholism
National Institute of Child Health and Human Development
Centers for Disease Control
Health Resources and Services Administration
Index: MENTAL HEALTH, DRUG ABUSE, ALCOHOL ABUSE, ALCOHOLISM, CHILD
HEALTH, HUMAN DEVELOPMENT, CENTERS FOR DISEASE CONTROL,
HEALTH RESOURCES AND SERVICES
$$INDEX R8 05/15/91 ****************************************************
STUDIES ON THE ETIOLOGY AND PATHOGENESIS OF POLYCYSTIC KIDNEY
DISEASE (RFA DK-91-08)
National Institute of Diabetes and Digestive and Kidney Diseases
Index: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
$$INDEX R9 06/17/91 ****************************************************
COOPERATIVE SPECIALIZED INFERTILITY RESEARCH CENTER PROGRAM (HD-91-06)
National Institute of Child Health and Human Development
Index: CHILD HEALTH, HUMAN DEVELOPMENT
$$INDEX R10 06/17/91 ***************************************************
COOPERATIVE CONTRACEPTIVE DEVELOPMENT RESEARCH CENTERS PROGRAM
(HD-91-07)
National Institute of Child Health and Human Development
Index: CHILD HEALTH, HUMAN DEVELOPMENT
$$INDEX R11 07/24/91 ***************************************************
EFFECT OF SPECIFIC COMPONENTS OF HUMAN MILK ON THE NURSLING (RFA
HD-91-10)
National Institute of Child Health and Human Development
Index: CHILD HEALTH, HUMAN DEVELOPMENT
$$INDEX R12 05/17/91 ***************************************************
MINORITY ONCOLOGY LEADERSHIP ACADEMIC AWARD (RFA CA-91-11)
National Cancer Institute
Index: CANCER
$$INDEX R13 05/17/91 ***************************************************
CLINICAL INVESTIGATOR AWARD FOR RESEARCH ON SPECIAL POPULATIONS (RFA
CA-91-12)
National Cancer Institute
Index: CANCER
$$INDEX R14 05/17/91 ***************************************************
MINORITY SCHOOL FACULTY DEVELOPMENT AWARD (RFA CA-91-13)
National Cancer Institute
Index: CANCER
$$INDEX R15 10/21/91 ***************************************************
RESEARCH UNITS ON PELVIC INFLAMMATORY DISEASE AND ITS SEQUELAE (RFA
AI-91-08)
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
$$INDEX END ************************************************************
NOTICES
$$N1 BEGIN *************************************************************
CONFERENCE: FOSTERING SCIENTIFIC INTEGRITY IN BIOMEDICAL RESEARCH
P.T.
National Institutes of Health
The National Institutes of Health (NIH), the Association of American
Medical Colleges, and Washington University School of Medicine are
co-sponsoring an interactive conference for biomedical investigators,
research administrators, and university attorneys with an interest in
fostering the integrity of scientists. The goals of the workshop are to
discuss the scope of the problem of scientific misconduct; to identify
perceived or real factors contributing to misconduct; to discuss the
roles of Congress, NIH, and institutions in managing allegations of
scientific misconduct; to examine how well specific institutions have
dealt with allegations of fraud, plagiarism or other unacceptable
scientific practices; to discuss any special ethical considerations
associated with Industry/University ties; and to discuss the
responsibilities of authors and collaborators in maintaining scientific
integrity in research. Several break-out sessions will address focussed
topics of particular concern.
This conference is approved for credit in AMA Category 1.
DATES: April 25-26, 1990
SITE: The Adams Mark Hotel, St. Louis, MO
PROGRAM AND REGISTRATION INFORMATION: Telephone: (800) 325-9862,
interstate
(314) 362-6893, in
Missouri
$$N1 END ***************************************************************
NOTICES OF AVAILABILITY (RFPs AND RFAs)
$$R1 BEGIN NIH-NIAMS-91-1 **********************************************
NATIONAL EPIDERMOLYSIS BULLOSA REGISTRY - CLINICAL
COORDINATING CENTER
RFP AVAILABLE: RFP-NIH-NIAMS-91-1
P.T. 04; K.W. 0780030, 0785045, 0755018
National Institute of Arthritis and Musculoskeletal and Skin Diseases
The National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS) has a requirement for the
continuation of a Clinical Coordinating Center for the
National Epidermolysis Bullosa Registry. The National
Epidermolysis Bullosa Registry (NEBR) that will consist
of one (1) Clinical Coordinating Center and four (4)
Clinical Sites, is aimed at searching for the basic defect,
improving methods of diagnosis, and developing effective
methods in treatment and prevention. The NEBR will
continue to: (1) develop a roster of well-characterized
patients with the different forms of Epidermolysis Bullosa
(EB). Selected patients will be requested to contribute
specimens and to be followed as part of diagnostic, research,
and in some cases therapeutic, protocols; (2) determine with
accuracy and precision the incidence and prevalence of disease
by clinical genetic type in a sufficiently broad geographic
region to permit extrapolation of data to the United States
as a whole; (3) increase information on genetics, particularly
family patterns or sporadic occurrence of disease, including
penetrance and severity; (4) assess disease distribution
geographically, to search for clusters and patterns and
assess the societal and economic impact of the disease;
(5) develop a pool of patients of the same genetic type from
a wide variety of studies on pathogenesis and genetics of EB,
including support for the banking of appropriate tissue
specimens; and (6) foster and support well designed and well
executed clinical trials of new therapeutic interventions in
carefully selected groups of patients with one or another
form of EB.
The responsibilities of the Clinical Coordinating
Center are primarily the coordination of the clinical and
basic science aspects of the NEBR and, to a lesser degree,
the handling of the raw data. Performance of the primary functions
of the Clinical Coordinating Center,
both at the time of the award and during the contract
period, will require extensive and continuing hands-on
involvement in the clinical laboratory and basic science
aspects of EB. It is necessary that the Clinical Coordinating
Center be located at one of the Clinical Sites. (Offerors
to this solicitation must also submit proposals in response
to RFP No. NIH-NIAMS-91-4, "National Epidermolysis Bullosa
Registry - Clinical Sites", published in this issue of the NIH Guide for
Grants and Contracts.)
This Request for Proposals, RFP No. NIH-NIAMS-91-1, will be
available on or about March 22, 1991, with a closing date set
for May 6, 1991. To receive a copy of the RFP, please supply
this office with two (2) self-addressed mailing labels.
Requests for the RFP should be sent to the
following address:
Patrick M. Sullivan, Acting Chief
Contracts Management Branch
National Institute of Arthritis and
Musculoskeletal and Skin Diseases
National Institutes of Health
Westwood Building, Room 602
5333 Westbard Avenue
Bethesda, MD 20892
This advertisement does not commit the Government to award a
contract.
$$R1 END ***************************************************************
$$R2 BEGIN NIH-NIAMS-91-4 **********************************************
NATIONAL EPIDERMOLYSIS BULLOSA REGISTRY - CLINICAL SITES
RFP AVAILABLE: RFP-NIH-NIAMS-91-4
P.T. 04; K.W. 0780030, 0785045, 0755018
National Institute of Arthritis and Musculoskeletal and Skin Diseases
The National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS) has a requirement for the
continuation of Clinical Sites for the National
Epidermolysis Bullosa Registry. The National
Epidermolysis Bullosa Registry (NEBR), which will
consist of one (1) Clinical Coordinating Center and four
(4) Clinical Sites, is aimed at searching for the basic
defect, improving methods of diagnosis, and developing
effective methods in treatment and prevention. The NEBR
will be continued to: (1) develop a roster of well
characterized patients with the different forms of
Epidermolysis Bullosa (EB). Selected patients will be
requested to contribute specimens and to be followed as
part of diagnostic, research, and in some cases
therapeutic, protocols; (2) determine with accuracy and
precision the incidence and prevalence of disease by
clinical genetic type in a sufficiently broad geographic
region to permit extrapolation of data to the United States
as a whole; (3) increase information on genetics,
particularly family patterns or sporadic occurrence of
disease, including penetrance and severity; (4) assess
disease distribution geographically, to search for
clusters and patterns and assess the societal and economic
impact of the disease; (5) develop a pool of patients of
the same genetic type for a wide variety of studies on
pathogenesis and genetics of EB, including support for the
banking of appropriate tissue specimens; and (6) foster and
support well-designed and well-executed clinical trials of
new therapeutic interventions in carefully selected groups
of patients with one or another form of EB. The Clinical
Sites will be responsible for direct contact with EB
patients and for their enrollment in the registry. This
will include standardized history, physical examination,
general laboratory examination, and those specialized
studies required for EB diagnosis.
Determination of the
studies required for the diagnosis of EB and its subgroups
will be the responsibility of the offerors. Clinical sites will be
responsible for the conduct of clinical trials and
for the submission of tissue specimens from appropriate
patients for tissue banking. (The Clinical Coordinating
Center must be located at a Clinical Site. Please refer
to RFP No. NIH-NIAMS-91-1, published in this issue of the NIH Guide
for Grants and Contracts.)
The institute plans to make four awards from this solicitation.
This Request for Proposals, RFP No. NIH-NIAMS-91-4, will be
available on or about March 22, 1991, with a closing date
set for May 6, 1991. To receive a copy of the RFP, please
supply this office with two (2) self-addressed mailing labels.
Since a limited number of copies will be printed, requests
shall be filled on a first-come-first-served basis until the
supply is exhausted. Requests for the RFP should be sent to
the following address:
Patrick M. Sullivan, Acting Chief
Contracts Management Branch
National Institute of Arthritis and
Musculoskeletal and Skin Diseases
National Institutes of Health
Westwood Building, Room 602
5333 Westbard Avenue
Bethesda, MD 20892
This advertisement does not commit the Government to award a
contract.
$$R2 END ***************************************************************
$$R3 BEGIN HD-91-02 FULL-TEXT ******************************************
EVENT RECORDINGS OF HIGH RISK INFANTS ON APNEA MONITORS
RFA AVAILABLE: HD-91-02
P.T. 34; K.W. 0765035, 0706020, 0403020, 1004008
National Institute of Child Health and Human Development
Application Receipt Date: June 10, 1991
The Pregnancy and Perinatology Branch (PPB) of the Center
for Research for Mothers and Children (CRMC) of the
National Institute of Child Health and Human Development
(NICHD) invites applications from clinical investigators and
statisticians willing to participate with NICHD under a
cooperative agreement in a multi-center collaborative study
regarding the usefulness of home monitors in the management
of infantile apnea. Applications are sought from clinical
centers intending to participate as clinical units in the
study and from institutions intending to serve as a Data
Coordinating and Analysis Center. An institution may apply
for either function or both.
The Public Health Service is committed to achieving the
health promotion and disease prevention objectives of
Healthy People 2000, a PHS-led national activity. This
Request for Applications (RFA), "Event Recordings of High
Risk Infants on Apnea Monitors," is related to the priority
area of "Maternal and Infant Health."
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).
BACKGROUND
Each year between 6,000 and 7,000 infants in the United
States die with a diagnosis of Sudden Infant Death Syndrome
(SIDS). SIDS is defined as the "sudden death of an infant
or young child, which is unexpected by history, and in which
a thorough postmortem examination fails to demonstrate an
adequate cause of death."
In order
to conduct an investigation of whether infantile apnea
monitors are obtaining appropriate data to identify and
describe life-threatening events, we must study a
subpopulation of infants who have been diagnosed as "at
risk" for sudden death. These infants, for whom home
monitoring of respiration and heart rate is medically
indicated, include: premature infants who have apnea at time
of discharge from the hospital, infants who have experienced a
severe apparent life-threatening event (ALTE), and
subsequent siblings of SIDS victims.
The NICHD intends to establish a network of clinical trial
sites, with central data management and data analysis,
that will evaluate home apnea monitoring in high-risk
infants. The specific aims of the study conducted in
response to this solicitation are to obtain physiologic
parameters of cardiorespiratory episodes in infants at risk
for life-threatening events, improve the quality of home
monitoring, and determine compliance in monitor use.
STUDY ORGANIZATION AND SCOPE
The NICHD will establish a network of approximately five
clinical units and a Data Coordinating and Analysis Center
that will develop and conduct a standard, common protocol,
under a cooperative agreement with NICHD. The clinical
units will have primary responsibility for enrollment and
evaluation of study participants. One of the units will
serve as a Clinical Trial Operations Center for primary
central data collection and to support the sites
regarding protocol implementation. The Data
Coordinating and Analysis Center will have responsibility
for data collection and management.
The work accomplished under the cooperative agreement is
expected to follow this general outline (duration of phases
are estimates only):
Phase 1 (12 months): The Steering Committee, composed of
Principal Investigators and NICHD staff, will:
o identify study objectives, considering the relevant
research questions, and available resources.
o develop the standard protocol and data forms.
o develop a standard system for analysis of event
recordings and polysomnograms.
o develop a database management system, with primary input
from the Data Coordinating and Analysis Center and
consultant NICHD statisticians.
o adopt/develop standard manuals and training programs for
physicians and parents to support the appropriate use of
the monitors and to optimize compliance.
o adopt/develop standard autopsy, pathology, and death
scene investigation protocols for all infant deaths
within the first year of life.
The Clinical Units and Data Coordinating and Analysis Center
will enroll a limited number of infants in a pilot test of
the protocol and data management system.
The awardees will hire and train staff in preparation for
protocol implementation and data management.
The Data Coordinating and Analysis Center will develop a
quality assurance system.
Note: Phases 2 and 3 will run concurrently.
Phase 2 (44 months): The Clinical Units will evaluate and
enroll patients into the protocol. Every effort will be
made to enroll minority populations. The units will collect
data with adequate attention to the fidelity of records and
will provide information in uniform data format for
analysis. The Data Coordinating and Analysis Center will
implement the data coordination and quality assurance
systems and provide data summaries to the Steering
Committee as determined by the protocol.
Phase 3 (30 months): Based on reports of the aggregated
data, and recommendations of the Data Safety and Monitoring
Board (DSMB), the Steering Committee will decide to modify
the protocol or determine the need to terminate the study
because the data is sufficient to meet the objectives of the
protocol. (The DSMB will be empowered to oversee the safety
of the study.)
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES
IN CLINICAL RESEARCH STUDY POPULATIONS
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 adequately represented in the study
populations 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.
MECHANISM OF SUPPORT - Terms of the Agreement
The funding mechanism to be used to assist the scientific
community in undertaking this system of clinical
investigation will be a cooperative agreement between the
participating units and NICHD. The major difference between
a cooperative agreement and a research grant is that there
will be substantial programmatic involvement of NICHD staff
above and beyond the levels required for traditional program
management of grants. All parties will agree to accept the
coordinating role of the group and the participatory and
cooperative nature of the group process.
Up to
$ 1,500,000 in direct costs has been set aside for the first
year of these Cooperative Agreements, and it is anticipated
that five meritorious applications, including the Data
Coordinating and Analysis Center, will be funded.
The special terms of Award of Cooperative Agreement are in
addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, DHHS grant administration
regulations at 45 CFR Part 74, and other DHHS, PHS, and NIH
grant administration policies. The NICHD review procedure
in no way affects the right of a recipient of a cooperative
agreement to appeal an adverse determination under the terms
of PHS regulations at 42 CFR Part 50, Subpart D, and DHHS
regulations at 45 CFR Part 16. Business management aspects
of these awards will be administered by the NICHD Grants
Management Branch in accordance with DHHS, PHS, and NIH
grant administration requirements.
ADDITIONAL INFORMATION
Potential applicants should obtain a detailed RFA
from:
Marian Willinger, Ph.D.
Health Scientist Administrator
Pregnancy and Perinatology Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Executive Plaza North, Room 643
Bethesda, MD 20892
Telephone: (301) 496-5575
Inquiries regarding grants management and administrative
policy may directed to:
Douglas Shawver
Supervisory Grants Management Specialist
Grants Management Branch
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 505
Bethesda, MD 20892
Telephone: (301) 496-1303
This program is described in the Catalog of Federal Domestic
Assistance No. 93.865, Research for Mothers and Children.
Awards will be made under the authority of the Public Health
Service Act, Section 301 (42 USC241), and administered under
PHS grant policies and Federal Regulations 42 CFR Part 52
and 45 CFR Part 74. This program is not subject to review
under the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.
$$R3 END ***************************************************************
$$R4 BEGIN MH-91-04 FULL-TEXT ******************************************
SHORT-TERM CLINICAL TRAINING GRANTS IN DIAGNOSIS AND
TREATMENT OF DEPRESSIVE DISORDERS
RFA AVAILABLE: MH-91-04
P.T. 34; K.W. 0720005, 0715072, 0745020, 0745060, 0745070
National Institute of Mental Health
Application Receipt Date: May 22, 1991
The National Institute of Mental Health seeks
applications for programs of short-term (not to exceed
5 days' duration) continuing education. Each program
will be carried out at multiple locations and will
provide continuing education for primary care providers
and mental health professionals. This initiative is
intended to provide for the development of effective
training that will give primary care providers and mental
health professionals a didactic and experiential program
to increase their capacity to recognize, diagnose, and
treat clinical depression effectively, in a manner
appropriate to their discipline.
Applications may be submitted by a department of
psychiatry in or associated with a school of medicine or
a free-standing mental health institution with an
approved psychiatry residency program, a university-
based department of psychology or a school of
professional psychology, a college or university school
of nursing which offers a graduate program in psychiatric
nursing, or a school of social work with a graduate
program.
The mechanism of support for these awards will be the
Continuing Education Grants (T15).
The period of support is up to 3 years, although no firm
commitment can be made beyond the first year. Therefore,
activities in the first year must be significant with a
minimum of six programs provided at six different sites
in each grant year. It is expected that up to four
awards may be made in fiscal year 1991, each award not
to exceed $125,000 total costs per award in fiscal year
1991.
The receipt date for applications is May 22, 1991. It
is suggested that potential applicants send a brief
letter of their intention to Harold Goldstein (see
below). Dr. Goldstein is also available for consultations
on program development, eligibility, and fiscal and administrative
matters, contact:
Harold Goldstein, Ph.D.
Director of Training, D/ART Program
Prevention Research Branch
Division of Clinical Research
National Institute of Mental Health
Parklawn Building, Room 14C-02
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-4140
$$R4 END ***************************************************************
$$R5 BEGIN MH-91-05 FULL-TEXT ******************************************
SHORT-TERM GRANTS FOR TRAINING MEDICAL STUDENTS IN THE
DIAGNOSIS AND TREATMENT OF DEPRESSIVE DISORDERS
RFA AVAILABLE: MH-91-05
P.T. 34; K.W. 0720005, 0715072, 0745020, 0745060, 0745070
National Institute of Mental Health
Letter of Intent Receipt Date: May 1, 1991
Application Receipt Date: May 22, 1991
The National Institute of Mental Health requests
applications from medical schools to develop and
implement training of predoctoral medical students in the
diagnosis and treatment of clinical depression according
to a basic curriculum presented in this request for
applications. Support is available for the detailed
development of this curriculum, its implementation, and
evaluation of its educational effectiveness. The goal
of the training is to prepare medical students to deal
with depressive disorders as these disorders appear in
medical settings.
Applications may be submitted by accredited schools of
medicine and osteopathy, with a special interest in
applications from departments of family medicine,
internal medicine, obstetrics and gynecology, and other
nonpsychiatric specialties.
The mechanism of support for these awards will be the
Continuing Education Grants (T15).
The period of support is 1 year. It is expected that up
to 10 awards will be made, each award not to exceed
$15,000 total costs per award. To qualify for fiscal
year 1991 funding, applications must be submitted for the
receipt date of May 22, 1991.
It is suggested that a letter of intention be sent to
Harold Goldstein, Ph.D., Director for Training, D/ART,
to be received by May 1, 1991, at the address below. For
questions of eligibility, fiscal and administrative matters
and for assistance in developing
applications, prospective applicants should consult Dr.
Goldstein. His mailing address is:
Prevention Research Branch
Division of Clinical Research
National Institute of Mental Health
Parklawn Building, Room 14C-02
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-4140
$$R5 END ***************************************************************
$$R6 BEGIN AG-91-10 FULL-TEXT ******************************************
COOPERATIVE CLINICAL STUDIES FOR THE TREATMENT OF COGNITIVE
IMPAIRMENT AND BEHAVIORAL DISORDERS ASSOCIATED WITH
ALZHEIMER'S DISEASE
RFA AVAILABLE: AG-91-10
P.T. 34; K.W. 0715180, 0414005, 0715020, 0795005, 0740020
National Institute on Aging
Letter of Intent Receipt Date: April 1, 1991
Application Receipt Date: May 21, 1991
BACKGROUND
The National Institute on Aging (NIA) is inviting cooperative
agreement (U01) applications from established clinical
investigators to organize and conduct multi-site clinical
studies on the efficacy of a number of compounds in
ameliorating cognitive impairment and non-cognitive
behavioral disorders of Alzheimer's disease. Each applicant
should organize a group of investigators and institutions
that is capable of screening and clinically evaluating
compounds to determine those that should be studied in more
formal and extensive double-blind clinical trials. The U.S.
Congress, as part of the Fiscal Year 1991 appropriation for
NIA, mandated that NIA "explore new treatment and management
methods, including testing promising drugs such as nerve
growth factor and acetylcarnitine, that could safely and
effectively slow or reverse the symptoms of Alzheimer's
disease."
RESEARCH OBJECTIVES AND SCOPE
The objective of this Request for Applications (RFA) is to support
cooperative clinical studies to evaluate a number of compounds for
efficacy in treating the symptoms of Alzheimer's disease and select the
compounds that should go on to full-scale clinical trials. Because of
the need for a large and diverse base for patient recruitment and study,
it is expected that there will be one applicant site with a number of
cooperating sites to be supported by subcontract or consortium
agreements. Applications must contain a Clinical Data Coordinating
Center to provide data management, reporting services, data analysis,
and overall study coordination and management.
MECHANISM OF SUPPORT
The award will be made as a COOPERATIVE AGREEMENT (U01).
NIA, in awarding the Cooperative Agreement, anticipates
substantial involvement of a designated Program Administrator
during performance of the award. It is anticipated that one
award will be made for up to $3,250,000 total cost per year
for up to 5 years. The start date will be on or before
September 30, 1991.
APPLICATION AND REVIEW PROCEDURES
In preparing applications, instructions for form PHS 398
(10/88 revision, reprinted 9/89), supplemental information
available from NIA program staff, and additional instructions
included in the full RFA must be used. Applications judged by
staff to be nonresponsive to the RFA will be returned to the
applicant without review. Responsive applications may then
receive a preliminary review by a subcommittee of the review
panel to establish those applications deemed to be
competitive. Those judged noncompetitive for award will be
withdrawn from further competition. Applications judged to be
competitive will be given full review by a special review
group convened by NIA. Following review by the initial
review group, the applications will be considered by the
National Advisory Council on Aging.
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 or adequately represented in the
study populations 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.
Applicants should obtain the full RFA and supplemental
information and discuss their plans with and direct any other
inquiries to:
Neil Buckholtz, Ph.D.
NNA, NIA, NIH
Building 31, Room 5C35
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-9350
FAX: (301) 496-1494
Inquiries regarding fiscal matters may be addressed to:
Mr. Joseph Ellis
Grants Management Officer
National Institute on Aging
Building 31, Room 5C07
Bethesda, MD 20892
Telephone: (301) 496-1472
Although not a prerequisite for applying, potential
applicants are encouraged to submit a non-binding letter of
intent by April 1, 1991 to Dr. Buckholtz at the address
indicated above. Applications must be complete and received
by May 21, 1991.
$$R6 END ***************************************************************
$$R7 BEGIN MH-91-06 FULL-TEXT ******************************************
COOPERATIVE AGREEMENT FOR MULTI-SITE TRIALS OF
BEHAVIORAL STRATEGIES TO PREVENT THE FURTHER SPREAD OF
HIV INFECTION
RFA AVAILABLE: MH-91-06
P.T. 34; K.W. 0715008, 0755015, 0404000, 0745027
National Institute of Mental Health
National Institute on Drug Abuse
National Institute on Alcohol Abuse and Alcoholism
National Institute of Child Health and Human Development
Centers for Disease Control
Health Resources and Services Administration
Application Receipt Date: May 22, 1991
The National Institute of Mental Health is requesting
applications for additional Extramural Research Groups
(ERGs) to enter into an existing multi-site, multi-
population collaborative study to test behavioral
interventions to prevent the further spread of HIV
infection. The purpose is to support a coordinated
prevention trial to develop effective HIV-prevention
strategies. The goals are to develop behavioral
intervention strategies for groups that have not been
reached effectively by existing prevention efforts, to
assess existing interventions and improve the existing
strategies that have shown some effectiveness, to
develop an overall effective intervention program to
promote behavioral change that will prevent the further
spread of the HIV epidemic, and to establish causal
links between behavioral interventions and behavioral
change across populations.
Applications may be submitted by any public or private nonprofit or
for-profit organizations such as universities, colleges, hospitals,
laboratories, units of State or local governments, and eligible agencies
of the Federal Government. Applications from foreign institutions are
accepted only if the data or other unique opportunities are not
available in the United States. Women and minority investigators are
encouraged to apply. For projects involving clinical research,
NIH/ADAMHA 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.
In fiscal year 1991, a minimum of $1.5 million will be
available for this entire Cooperative Agreement. It is
expected that a minimum of three to five awards will be
made to new ERGs in fiscal year 1991.
Applications must be received by May 22, 1991. The
earliest possible start date will be September 1991.
Potential applicants should contact Dr. Isa Fernandez
for consultation concerning submission of proposed
projects in response to this request, at the address
listed below:
Isa Fernandez, Ph.D.
Staff Collaborator, Office of AIDS Programs
National Institute of Mental Health
5600 Fishers Lane
Room 11C-18, Parklawn Building
Rockville, MD 20857
Telephone: (301) 443-7281
For fiscal and administrative matters, contact;
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane
Parklawn Building, Room 7C-15
Rockville, MD 20857
Telephone: (301) 443-4414
$$R7 END ***************************************************************
$$R8 BEGIN DK-91-08 FULL-TEXT ******************************************
STUDIES ON THE ETIOLOGY AND PATHOGENESIS
OF POLYCYSTIC KIDNEY DISEASE
RFA AVAILABLE: DK-91-08
P.T. 34; K.W. 0785095, 0755030, 0765033
National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Receipt Date: April 17, 1991
Application Receipt Date: May 15, 1991
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) through the Division of Kidney, Urologic
and Hematologic Diseases (DKUHD), invites research grant
applications directed at defining and further characterizing
the etiology and pathogenesis of Polycystic Kidney Disease
(PKD).
BACKGROUND
Polycystic Kidney Disease is the most common genetic
disease, affecting 500,000 Americans, and 7,000 new patients
are recognized each year. Since 1982, the number of newly
diagnosed patients has risen steadily, with a compound
annual rate of 5.7 percent. Each child of an affected
parent has a fifty percent chance of inheriting the gene.
Two major types of PKD are recognized, autosomal dominant
PKD and autosomal recessive PKD.
Polycystic Kidney Disease ranks first among the inherited
and congenital conditions leading to end-stage renal disease
(ESRD); it ranks fourth as a primary cause of ESRD and as a
basic diagnosis among newly identified ESRD patients. Males
and females are affected equally, and its worldwide
distribution appears to demonstrate that it affects all
races.
OBJECTIVES AND SCOPE
The purpose of this Request for Applications (RFA) is to stimulate
high quality research studies to further the understanding
of the etiology and pathogenesis of PKD. Applications
proposing clinical trials are not requested at this time.
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.
MECHANISM OF SUPPORT
The support mechanism for this program will be the
traditional, individual, investigator-initiated Research
Grant (RO1) Application.
Approximately $1.2 million in total direct and indirect
costs are anticipated to be available to fund applications
submitted in response to this RFA. However, the funding of
such applications is contingent on the actual availability
of funds, and the receipt of applications of sufficient
scientific merit. It is anticipated that five to seven
awards will be made, for up to an average of 4 years per
award. Support for successful applications will begin on
September 30, 1991. The current policies and requirements
that govern the review, funding, and performance of research
grant programs of the NIH will prevail.
APPLICATIONS AND REVIEW PROCEDURES
Applications will be reviewed initially by the Division of
Research Grants (DRG) for completeness and will be assigned
to a special NIDDK review group. Evaluation for
responsiveness to the RFA is an NIDDK program staff
responsibility. Applications that are judged non-responsive
will be returned to the applicant but may be resubmitted as
investigator-initiated applications at the next receipt
date. Those applications judged to be both responsive and
competitive will be evaluated for scientific/technical merit
by an appropriate initial review group convened by the NIDDK
Review Branch. The second level of review by the National
Diabetes, Digestive and Kidney Advisory Council will make
recommendations regarding funding.
METHOD OF APPLYING
Applications should be submitted on Form PHS 398 (revised
10/88) available in the Business or Research Grants Offices
of most academic or research institutions, and from the
Office of Grants Inquiries, Division of Research Grants,
Room 449, Westwood Building, 5333 Westbard Avenue, National
Institutes of Health, Bethesda, Maryland, 20892.
Applications will be accepted until close of business on May
15, 1991. No extensions will be granted on the application
deadline.
INQUIRIES
Copies of the full RFA may be obtained from:
Gladys H. Hirschman, M.D.
Director, Chronic Renal Diseases Program
National Institute of Diabetes and Digestive and Kidney Diseases
Federal Building, Room 102
Bethesda, MD 20892
Telephone: (301) 496-8218
For fiscal and administrative matters, contact:
Ms. Donna Huggins
Grants Management Specialist
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 653
Bethesda, MD 20892
Telephone: (301) 496-7467
of Research Grants is June 17, 1991. Late applications will
not be accepted.
Budget:
The format/form/instructions for budget estimates provided
with research grant application kit (PHS 398) should be
followed. Indirect costs will be awarded in the same manner
as for research grants. Budgets will be reviewed on the
basis of appropriateness for the work proposed. Allowable
costs in the requested budget categories for individual
research projects should not be in excess of the amounts
generally requested for a regular research grant. Cost will
be a factor in the selection for funding. Include best
estimates for staffing needs, even though it is expected
that some budget modifications will be needed once the final
research project protocol(s) have been developed.
Since the final protocol(s) for this study will not be
exactly known at the time of submission of the application,
the budget request should be based on the plan proposed by
the applicant and should reflect the scope of the Center
project as submitted. The first year budgets requested for
each Center may not exceed $750,000 in total (direct and
indirect) costs for the first (01) year. It should be kept
in mind that the first year budgets recommended by the
review group for the two Centers may exceed the funding
available and necessitate adjustments by negotiations
between NICHD and each Center.
The second (02) year should be structured to accommodate an
anticipated doubling in funding for these Centers as
discussed on page 5. Budgets from the third (03) year
onward may not exceed 120 percent of the previous year's
budget. The budget projection should also include estimates
of travel expenses for the Principal and Project
Investigators attending two meetings of two days each of the
Steering Committee per year. The first meeting will be a
Phase I meeting held in Bethesda, Maryland, in October 1991.
A detailed summary of all sources of actual and pending
support for each key investigator participating in the study
with grant or other award number identification and percent
effort committed should be included in the application.
Additional Information:
Timetable
Application Receipt Date: June 17, 1991
Initial Review Date: June/July 1991
Review by NACHHD Council: September 1991
Earliest Award Date: September 1991
For further information, please contact:
Program/Scientific Matters: Administrative Policy:
Michael E. McClure, Ph.D. Ms. Melinda Nelson
Chief Office of Grants & Contracts
Reproductive Sciences Branch National Institute of Child
Center for Population Research Health and Human
National Institute of Child Development
Health and Human National Institutes of Health
Development Executive Plaza North,
National Institutes of Health Room 505
Executive Plaza North, Bethesda, Maryland 20892
Room 603 Telephone: (301) 496-5481
Bethesda, Maryland 20892
Telephone: (301) 496-6515
This program is described in the Catalog of Federal Domestic
Assistance No. 93.864, Population Research. Awards will be
made under the authority of the Public Health Service Act
301 (42 USC 241) and 441 (USC 289d) 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.
$$R8 END ***************************************************************
$$R9 BEGIN HD-91-06 FULL-TEXT ******************************************
COOPERATIVE SPECIALIZED INFERTILITY RESEARCH CENTER PROGRAM
RFA AVAILABLE: HD-91-06
P.T. 34; K.W. 0413002, 0745020, 0745070
National Institute of Child Health and Human Development
Letter of Intent Receipt Date: March 29, 1991
Application Receipt Date: June 17, 1991
OVERVIEW
The National Institute of Child Health and Human Development
(NICHD) invites applications from investigators willing to
participate with the NICHD under a cooperative agreement in
a multicenter cooperative research program aimed at
developing new approaches for the diagnosis and/or treatment
of infertility. Recognizing that the complexity of
infertility research severely limits the progress that can
be achieved by individual investigators working alone, the
NICHD will establish at least two (2) Specialized
Infertility Research Centers to conduct accelerated
preclinical and clinical research and development studies on
promising new leads in infertility research. The
cooperating Specialized Infertility Research Centers will
also serve as national resources for the career development
of young scientists electing to pursue research in
high priority areas of infertility research. Grantee
institutions in the continental United States that meet the
requirements stated are eligible to participate.
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 for a Cooperative
Specialized Infertility Research Centers Program is related
to the priority area of Family Planning.
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 GOALS AND CENTER REQUIREMENTS
The research goals pursued by these Centers will focus on
the early diagnosis and/or therapy of infertility. The
scope of this RFA includes those female factors most often
contributing to infertility or undesired surgical sterility
(endometriosis, chronic ovulatory dysfunction, or uterine
myomata-related dysfunctional bleeding) or those male
factors associated with ineffective sperm production
(quality or quantity).
Center requirements include an experienced Principal
Investigator of recognized ability who is committed to and
involved in human infertility research, the local or
consortium availability of competent and experienced
scientific experts to direct the Center's individual
research projects or cores, access to the technical
resources and facilities necessary for the conduct of the
proposed experimental protocols, a research environment
conducive to the training of young investigators in
infertility research, a willingness of the investigators to
participate in a coordinated, cooperative
research program involving two or more Centers with multiple
interactive research projects and substantive evidence of
departmental and institutional support and commitment to the
proposed Center.
MECHANISM OF SUPPORT
The funding mechanism to be used to assist the scientific
community in undertaking this Program of basic and applied
research will be the U54 cooperative agreement mechanism
between participating Centers and the NICHD. It is expected
that up to two (2) applications will be funded for a five
(5)-year period, contingent upon the receipt of a sufficient
number of meritorious proposals, within the total cost limit
of $1,000,000 available for the first year of this Program.
The major difference between a cooperative agreement and a
research grant is that there will be substantial
programmatic involvement of an NICHD staff Research
Coordinator above and beyond the levels required for
traditional Program management of grants.
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 or inadequately represented in the
study populations 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.
REVIEW PROCEDURES
An administrative review of the content of applications
meeting the above NIH guideline will also be done by NICHD
staff upon receipt of the application. Any application that
does not meet the minimal requirements for a center project
as specified in this RFA will be judged to be unresponsive
to this RFA and will be returned to the applicant without
technical review.
Applications that are complete and responsive may be
subjected to a triage procedure by peer review to determine
their general competitiveness. In accord with NIH policy,
brief summary statements will be provided to the Principal
Investigator of applications judged to be noncompetitive for
award. Applications judged to be competitive for awards
will be reviewed in detail in accordance with established
NIH peer review procedures for research grants. Project
site visits are neither planned nor a prerequisite of the
scientific merit review procedure. Peer review will be
conducted first for scientific and technical merit by a
special review committee convened specifically for this
purpose by the Division of Scientific Review, NICHD. This
will be followed by a second-level review by the National
Advisory Child Health and Human Development (NACHHD) Council
in September 1991.
APPLICATION PROCEDURES
Interested applicants should contact the Chief, Reproductive
Sciences Branch (RSB) for an advisory consultation regarding
Cooperative Specialized Infertility Research Center (U54)
grants. If an applicant intends to apply, it is strongly
recommended, but not mandatory, that applicants send a
letter of intent by March 29, 1991 to the Chief, RSB at the
address listed below. This letter should indicate the title
of the proposed center and the names of the key
investigators for the proposed subprojects. Applicants are
encouraged to send it as soon as they decide to apply for
the grant so that the RSB staff can be of maximum assistance
in the application process.
Applications must be submitted on form PHS 398 (revised
10/88, reprinted 9/89), which is available in most
institutional business offices or from the Division of
Research Grants, Office of Grant Inquiries, NIH, Westwood
Building, Room 449, Bethesda, Maryland 20892 or calling NIH
(301/496-7441).
ADDITIONAL INFORMATION
Potential applicants are encouraged to request a detailed
Request for Applications by contacting:
Michael E. McClure, Ph.D.
Chief, Reproductive Sciences Branch
Center for Population Research
National Institute of Child Health and Human Development
National Institutes of Health
Executive Plaza North, Room 603
Bethesda, MD 20892
Telephone: (301) 496-6515
For further information concerning administrative policy, contact:
Ms. Melinda Nelson
Office of Grants & Contracts
National Institute of Child Health and Human Development
National Institutes of Health
Executive Plaza North, Room 505
Bethesda, MD 20892
Telephone: (301) 496-5481
This program is described in the Catalog of Federal Domestic
Assistance No. 93.864, Population Research. Awards will be
made under the authority of the Public Health Service Act
301 (42 USC 241) and 441 (USC 289d) 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.
$$R9 END ***************************************************************