kristoff@GENBANK.BIO.NET (Dave Kristofferson) (01/25/91)
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.
----------------------------------------------------------------------
NIH GUIDE - Vol. 20, No. 4, January 25, 1991
NOTICES
"OTHER SUPPORT" IN PHS GRANT APPLICATIONS ............(84/110).............. 1
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
"OTHER SUPPORT" IN NIH AND ADAMHA R&D CONTRACT PROPOSALS ..(113/133)........ 1
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
CONFERENCE: FOSTERING SCIENTIFIC INTEGRITY IN BIOMEDICAL RESEARCH ......... 1
National Institutes of Health (136/166)
Index: NATIONAL INSTITUTES OF HEALTH
ANIMAL WELFARE EDUCATION PROGRAM: SURGERY AND POST-SURGICAL CARE .......... 2
National Institutes of Health (169/209)
Index: NATIONAL INSTITUTES OF HEALTH
METHODS OF MOLECULAR MECHANICS AND DYNAMICS OF BIOPOLYMERS WORKSHOP ........ 2
National Center for Research Resources (212/259)
Index: RESEARCH RESOURCES
NOTICES OF AVAILABILITY (RFPs AND RFAs)
EPIDEMIOLOGICAL, CLINICAL, BASIC, AND INTERVENTION STUDIES FOR
IMPROVING ORAL HEALTH IN OLDER AMERICANS AND OTHERS AT HIGH RISK
(NIDR RESEARCH AND ACTION PROGRAM) (RFP) ..................(265/345)........ 3
National Institute of Dental Research
Index: DENTAL RESEARCH
SALMONELLA MUTAGENICITY TESTING (SMALL BUSINESS SET ASIDE) (RFP) ........... 4
National Institute of Environmental Health Sciences (348/391)
Index: ENVIRONMENTAL HEALTH SCIENCES
SALMONELLA MUTAGENICITY TESTING (RFP) .....................(401/444)........ 5
National Institute of Environmental Health Sciences
Index: ENVIRONMENTAL HEALTH SCIENCES
MAINTENANCE AND OPERATION OF A SYNTHETIC CHEMICAL FACILITY (RFP) ........... 5
National Institute of Child Health and Human Development (447/516)
Index: CHILD HEALTH, HUMAN DEVELOPMENT
BASIC AND CLINICAL RESEARCH ON THE URINARY BLADDER AND PELVIC
MUSCULATURE IN INTERSTITIAL CYSTITIS (RFA DK-91-04) .......(519/685)........ 6
National Institute of Diabetes and Digestive and Kidney Diseases (1204/1543)
Index: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
RESEARCH CENTER OF EXCELLENCE IN PEDIATRIC NEPHROLOGY AND UROLOGY
(RFA DK-91-07) .................................(688/835, 1546/2058)........ 8
National Institute of Diabetes and Digestive and Kidney Diseases
Index: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
CHILD HEALTH RESEARCH CENTERS (RFA HD-91-04) ...(838/968, 2061/2802)........10
National Institute of Child Health and Human Development
Index: CHILD HEALTH, HUMAN DEVELOPMENT
SPECIAL CARE UNITS FOR ALZHEIMER'S DISEASE (RFA AG-91-06) ..(971/1076)......12
National Institute on Aging (2805/3495)
Index: AGING
ONGOING PROGRAM ANNOUNCEMENTS
ACADEMIC RESEARCH ENHANCEMENT AWARD (PA-91-22) ..........(1082/1188)........13
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
NOTICES
"OTHER SUPPORT" IN PHS GRANT APPLICATIONS
P.T. 34; K.W. 1014002, 1014006
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
The PHS 398 (Rev. 10/88) and PHS 2590 (Rev. 10/88) grant application forms
include a section on OTHER SUPPORT, where applicants are expected to list all,
including both Federal and non-Federal, active support and pending and planned
requests for support of research and research-related activities by all key
personnel listed for each application. This information is important to PHS
review-award processes to help evaluate the compatibility of application
requests with investigators' capabilities and responsibilities, and eliminate
unwarranted duplication of support for investigators' efforts. Application
instructions emphasize the requirement for complete, accurate, and reliable
information. In signing the face page of the application the principal
investigator/program director and the applicant institution official certify
that the application information is accurate and complete.
Applicants are reminded of the necessity to provide the full and reliable
information requested. As noted in the instructions, "Incomplete, inaccurate,
or ambiguous information about OTHER SUPPORT could lead to delays in review of
the application." Further, applicants should be cognizant that serious
consequences could result if failure to provide complete and accurate
information be construed as an attempt to mislead PHS agency advisory groups
and staff in their review and award responsibilities.
"OTHER SUPPORT" IN NIH AND ADAMHA R&D CONTRACT PROPOSALS
P.T. 34; K.W. 1014002, 1014006
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Documentation required in National Institutes of Health and Alcohol, Drug
Abuse, and Mental Health Administration uniform Request for Proposals include
Standard Form 1411, Contract Pricing Proposal Cover Sheet, which instructs
offerors to identify any contracts or subcontracts they have been awarded "for
the same or similar items" within the past three years. Additionally,
offerors are required to provide a Summary of Related Activities, identifying
all active federal contracts, cooperative agreements, grants, and commercial
agreements, and submitted proposals, including actual and proposed levels of
effort for all key individuals in the proposal to NIH.
As with PHS grant applications, mentioned just above, offerors should be aware
that serious consequences could result if their failure to provide complete
and accurate information be construed as an attempt to mislead agency advisory
groups and staff in their review and award responsibilities.
CONFERENCE: FOSTERING SCIENTIFIC INTEGRITY IN BIOMEDICAL RESEARCH
P.T. 42; K.W. 1014004, 1014006
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.
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 1
DATES: April 25-26, 1991
SITE: The Adams Mark Hotel, St. Louis, MO
PROGRAM AND REGISTRATION INFORMATION: Telephone: (800) 325-9862, interstate
(314) 362-6893, in Missouri
ANIMAL WELFARE EDUCATION PROGRAM: SURGERY AND POST-SURGICAL CARE
P.T. 42; K.W. 0201011, 0785210
National Institutes of Health
The National Institutes of Health, Office for Protection from Research Risks,
is cosponsoring with The Medical University of South Carolina an animal
welfare education program entitled, "Surgery and Post-Surgical Care." The
workshop will be held in Charleston, South Carolina at the Mills House Hotel,
Meeting & Queen Streets, on April 4-5, 1991.
The meeting is open to institutional administrators, Institutional Animal Care
and Use Committee (IACUC) members, laboratory animal veterinarians,
investigators, and other institutional staff who have responsibility for
high-quality management of institutional animal care and use programs. The
meeting will focus on NIH and USDA regulations pertaining to animal use in
biomedical research and instruction. The emphasis of the workshop is surgery,
post-surgical care, anesthesia, and analgesia in experimental animals.
Registration is limited. Hotel reservations should be made by March 1.
For further information, please contact:
Dr. M. Michael Swindle
Department of Comparative Medicine
Medical University of South Carolina
Charleston, SC 29425
Telephone: (803) 792-3625
For additional information regarding future workshops, contact:
Mrs. Roberta Sonneborn
Executive Assistant for Animal Welfare Education
Office for Protection from Research Risks
National Institutes of Health
Building 31, Room 5B59
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-7163
FAX: (301) 402-0527
METHODS OF MOLECULAR MECHANICS AND DYNAMICS OF BIOPOLYMERS WORKSHOP
P.T. 42; K.W. 0780018, 0760060
National Center for Research Resources
The Pittsburgh Supercomputing Center (PSC) is conducting a three-day workshop
on "Methods of Molecular Mechanics and Dynamics of Biopolymers," April 7-10,
1991. This program is funded by a grant from the Biomedical Research
Technology Program, National Center for Research Resources, National
Institutes of Health.
The workshop will familiarize biomedical researchers with computational
methods and provide practice in applying supercomputing resources to problems
of concern in molecular mechanics. Practical experience on a Cray Y-MP/832
will be gained in applications to: (1) the theory and practice of molecular
mechanics and dynamics; (2) the development and refinement of molecular
mechanics force fields; (3) the problem of conformation mapping and analysis
of polypeptide structures, including the refinement of structure from measured
NMR data; and (4) computation of interaction energies and free energies for
protein-drug interactions and conformational thermodynamics. The use of
state-of-the-art macromolecular computational packages will be illustrated.
The workshop leaders are Dr. Charles L. Brooks III of Carnegie Mellon
University and Dr. Kenneth Merz of the Pennsylvania State University.
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 2
Previous programming or supercomputing experience is desirable but not
necessary. A half-day session on April 7, led by PSC staff members, will
focus on the operation of the VAX, VMS, and UNICOS, the Cray version of the
AT&T System V Unix operating system.
Travel, meals, and hotel accommodations for U.S. academic participants are
supported by the grant. Enrollment is limited to 20 participants. The
deadline for submission of applications is February 28, 1991.
For an application or further information, call or write:
Nancy Kiser
PSC Biomedical Coordinator
Pittsburgh Supercomputing Center
4400 Fifth Avenue
Pittsburgh, PA 15213
Telephone: (412) 268-4960
Internet: kiser@psc.edu
Bitnet: kiser@pscwpsca
NOTICES OF AVAILABILITY (RFPs AND RFAs)
EPIDEMIOLOGICAL, CLINICAL, BASIC, AND INTERVENTION STUDIES FOR IMPROVING ORAL
HEALTH IN OLDER AMERICANS AND OTHERS AT HIGH RISK (NIDR RESEARCH AND ACTION
PROGRAM)
BAA/RFP AVAILABLE: NIH-NIDR-1-91-4R
P.T. 34; K.W. 0715148, 0785035, 0785055, 0411005
National Institute of Dental Research
The National Institute of Dental Research (NIDR) is soliciting contract
proposals for research to aid in implementing the NIDR's Research and Action
Program to Improve the Oral Health of Older Americans and Other Adults at
Risk. This is a notice of an anticipated Broad Agency Announcement (BAA), RFP
NO. NIH-NIDR-1-91-4R, to be issued approximately February 12, 1991, with a
closing date for proposals of May 1, 1991.
Offerors are encouraged to submit proposals for epidemiological, clinical,
basic, and intervention studies relevant to reducing tooth mortality in adult
and other groups at higher risk of suffering tooth mortality or related oral
diseases. Supplementary materials on the aims and scope of the NIDR's
Research and Action Program will be provided with the BAA package. Proposals
shall not exceed a period of performance of more than three years. Proposals
based on an initial feasibility phase, and subject to additional review, may
also be submitted.
Proposals are expected to address at least one of the following topics:
1. Identifying individuals at higher risk of tooth mortality, or oral
diseases directly relevant to tooth loss, or developing improved methods for
predicting patterns of tooth mortality.
2. Identifying, developing, or testing methods for preventing tooth mortality
or related diseases in persons or population subgroups at higher risk.
3. Developing and testing materials or procedures that require removal of
less tooth structure.
4. Assessing short- and long-term changes in tooth mortality or oral disease
status resulting from health promotion efforts.
5. Assessing the effectiveness, efficacy, and acceptability (including costs)
of measures relevant to reducing tooth mortality.
6. Investigating the influence of barriers to care or the effects of
utilization of dental services on tooth mortality or related diseases.
7. Evaluating the effects of currently available oral health care methods or
of variations in care upon tooth mortality.
8. Identifying, developing, or testing methods to establish knowledge,
attitudes, or behaviors producing reductions in tooth mortality.
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 3
9. Developing and evaluating methods to minimize tooth mortality or the onset
or progression of related oral diseases in medically compromised patients.
10. Characterizing how local oral factors (e.g., salivary function) influence
tooth mortality or related diseases and associated intervention studies to
reduce these diseases or tooth loss.
The BAA solicitation will contain additional information on each research
topic, along with instructions for proposal preparation and submission,
proposal evaluation criteria, and required forms. Proposals may be reviewed
and acted upon as they are received. However, no proposal will be accepted
after 4:00 p.m., Wednesday, May 1, 1991. Five to eight awards are
anticipated. Selection for award will be based on technical merit, cost
realism of proposed effort, greatest advantage to the Government, and
availability of funds.
BAA/RFP No. NIH-NIDR-1-91-4R will be available approximately February 12,
1991, by written request to:
Ms. Marion L. Blevins
Contract Management Section
National Institute of Dental Research
National Institutes of Health
Westwood Building, Room 521
Bethesda, MD 20892
SALMONELLA MUTAGENICITY TESTING (SMALL BUSINESS SET ASIDE)
RFP AVAILABLE: NIH-ES-91-11
P.T. 34; K.W. 1002028, 0780000
National Institute of Environmental Health Sciences
The National Institute of Environmental Health Sciences (NIEHS), National
Institutes of Health (NIH), is soliciting proposals from offerors having the
capability for salmonella mutagenicity testing. This RFP is set aside for
small businesses. The results obtained from this contract will be used for
setting priorities for long-term animal testing and will provide information
on mechanisms of action for selected chemicals. The contract will be required
to test chemicals and evaluate urine samples for mutagenicity in Salmonella.
Two phases are planned. In Phase I, the contractor shall demonstrate that
ability to perform the protocols required with the various strains in an
efficient, effective, and reproducible manner. This phase will involve twelve
(12) chemical samples and one (1) urine sample and should take about four
months. Phase II will be contingent on successful completion of Phase I. In
Phase II the contractor shall test approximately thirty-eight (38) chemical
samples and two (2) urine samples during the remainder of year 1 and fifty
(50) chemical samples and three (3) urine samples for years 2-5. The
chemicals will be tested under code, in triplicate, using at least five dose
levels. A preliminary toxicity experiment will be run on all chemicals prior
to mutagenicity testing. Urines from approximately three (3) dose levels of
animal treatment shall be tested, using triplicate plates. All work shall be
performed in manner compatible with the NTP Health and Safety Minimum
Requirements for In Vitro Toxicology Contractors. The Government estimates
that 0.3 professional person-years and 1 technical person-year will be
required for each year of this contract. This project will cover a five-year
period. The estimated issuance date of RFP NIH-ES-91-11 is January 31, 1991,
and responses will be due approximately 45 days thereafter. The Institute
expects to make one award from this solicitation.
Requests should reference RFP NIH-ES-91-11 and should be forwarded to:
National Institute of Environmental Health Sciences
Contracts and Procurement Management Branch, OM
ATTN: Jo Ann Lewis
79 T.W. Alexander Drive, 4401 Building
P.O. Box 12874
Research Triangle Park, NC 27709
Telephone: (919) 541-7893
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 4
SALMONELLA MUTAGENICITY TESTING
RFP AVAILABLE: NIH-ES-91-12
P.T. 34; K.W. 1002028, 0780000
National Institute of Environmental Health Sciences
The National Institute of Environmental Health Sciences (NIEHS), National
Institutes of Health (NIH), is soliciting proposals from offerors having the
capability for salmonella mutagenicity testing. The results obtained from
this contract will be used for setting priorities for long-term animal testing
and will provide information on mechanisms of action for selected chemicals.
The contract will be required to test chemicals and evaluate urine samples for
mutagenicity in Salmonella. Two phases are planned. In Phase I, the
contractor shall demonstrate the ability to perform the protocols required
with the various strains in an efficient, effective, and reproducible manner.
This phase will involve twelve (12) chemical samples and one (1) urine sample
and should take about four months. Phase II will be contingent on successful
completion of Phase I. In Phase II the contractor shall test approximately
thirty-eight (38) chemical samples and two (2) urine samples during the
remainder of year 1 and fifty (50) chemical samples and three (3) urine
samples per year for years 2-5. The chemicals will be tested under code, in
triplicate, using at least five dose levels. A preliminary toxicity
experiment will be run on all chemicals prior to mutagenicity testing. Urines
from approximately three (3) dose levels of animal treatment shall be tested
using triplicate plates. All work shall be performed in manner compatible
with the NTP Health and Safety Minimum Requirements for In Vitro Toxicology
Contractors. The Government estimates that 0.3 professional person-years and
1 technical person-year will be required for each year of this contract. This
project will cover a five-year period. The estimated issuance date of RFP
NIH-ES-91-12 is January 31, 1991, and responses will be due approximately 45
days thereafter. The Institute expects to make one award from this
solicitation.
Requests should reference RFP NIH-ES-91-12 and should be forwarded to:
National Institute of Environmental Health Sciences
Contracts and Procurement Management Branch, OM
ATTN: Jo Ann Lewis
79 T.W. Alexander Drive, 4401 Building
P.O. Box 12874
Research Triangle Park, NC 27709
Telephone: (919) 541-7893
MAINTENANCE AND OPERATION OF A SYNTHETIC CHEMICAL FACILITY
RFP AVAILABLE: NICHD-CD-91-3
P.T. 34; K.W. 1003006, 1003012, 0750020, 0760085
National Institute of Child Health and Human Development
The Contraceptive Development Branch of the Center for Population Research,
National Institute of Child Health and Human Development (NICHD), has a
requirement for the maintenance and operation of a synthetic chemical facility
for the synthesis of anti-fertility agents on a laboratory scale (1-5 grams)
as well as on a relatively large scale (1,000 grams). The maximum quantities
of any final product to be prepared by multistep synthesis via batchwise
operations will not normally exceed 1,000 grams.
It is desirable that Offerors should have expertise in the synthesis of
optically active steroids, steroid-protein conjugates as immunogenic agents, a
wide variety of unnatural amino acids including resolution work, asymmetric
synthesis, stereocontrolled approach, and determination of their optical
purity, and other non-steroidal compounds including separation of
stereoisomers and/or resolution work. In addition, the capability to perform
High Performance Liquid Chromatography (HPLC) analysis for the detection and
quantification of circulating drugs in serum, urine, and feces from animals,
and to perform analytical work in order to assess the purity of compounds, is
desirable. Specific assignment of compounds and quantities to be prepared
will be determined by the Project Officer. Major emphasis will be on the
preparation of experimental compounds on a laboratory scale (1-5 grams).
As minimum requirements, organizations must have the following in-house
equipment (or indications of anticipated purchase of same): ultraviolet,
infrared and 13C and 1H nuclear magnetic resonance spectrometers (90-100MHz),
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 5
mass spectrometer, polarimeter, gas chromatography, analytical high
performance liquid chromatography preferably equipped with an integrator, and
preparative high-performance liquid chromatography that can provide gram
quantities of purified compounds. The Government does not intend to furnish
any of the above equipment or facilities. The Contractor's facilities must
meet the requirements in compliance with the Occupational Safety and Health
Administration and the contractor must have a nuclear license. The Contractor
must have in-house capabilities and five full-time supporting technical staff
who will devote 100 percent of their time to the project. No subcontracting
will be permitted. The Government estimates the effort to be approximately
5.25 technical staff years annually.
It is desirable that the Principal Investigator is an established synthetic
organic chemist of drug synthesis with a Ph.D. degree and will devote a
minimum of 25% of her/his time to this project.
All responsible sources may submit a proposal that shall be considered by the
agency. It is anticipated that one cost-reimbursement, incrementally funded
type contract will be awarded as a result of the Request for Proposals (RFP)
for a period of sixty (60) months beginning August 1, 1991. The RFP is a
recompetition of contract N01-HD-6-2928 for the "Maintenance and Operation of
a Synthetic Chemical Facility" being performed by the Southwest Foundation for
Biomedical Research, San Antonio, Texas.
This announcement is not an RFP. RFP-NICHD-CD-91-3 will be issued on or about
January 25, 1991. Proposals will be due approximately 45 days thereafter.
Copies of the RFP may be obtained by sending written requests to Mr. Paul J.
Duska at the address listed below. Please enclose a self-addressed label.
Requests may also be made by FAX telephone (301) 496-0962.
Paul J. Duska, Contracting Officer
Contracts Management Branch, OGC
National Institute of Child Health and Human Development
Executive Plaza North, Room 610
9000 Rockville Pike
Bethesda, MD 20892
BASIC AND CLINICAL RESEARCH ON THE URINARY BLADDER AND PELVIC MUSCULATURE IN
INTERSTITIAL CYSTITIS
RFA AVAILABLE: DK-91-04
P.T. 34; K.W. 0705075, 0765035, 0710030
National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Receipt Date: March 1, 1991
Application Receipt Date: April 22, 1991
This Request for Applications (RFA) emphasizes the continued interest of the
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in
funding research studies in all areas of the investigation of the urinary
bladder and the adjacent structures, including the pelvic musculature. The
special emphasis of these studies should address issues that may have
particular relevance to increasing our basic understanding of the disorder of
interstitial cystitis (IC). Investigators from diverse clinical and basic
science disciplines with a research interest in the pathophysiology of bladder
function and its interrelationship with lower pelvic musculature are
encouraged to submit applications.
INTRODUCTION
IC is a chronic, painful, and variably incapacitating disorder that manifests
a symptom complex consisting of pain in the region of the urinary bladder and
associated pelvic musculature and variable motor and sensory dysfunctions of
the urinary bladder.
In order to assure that patient selection for clinical studies is uniform the
NIDDK has established Diagnostic Criteria for research studies on IC. ALL
CLINICAL GRANT APPLICATIONS MUST STATE THAT THE NIDDK IC DIAGNOSTIC CRITERIA
WILL BE APPLIED TO PATIENTS SELECTED FOR INCLUSION IN THE RESEARCH STUDY.
These criteria have been published in: the JOURNAL OF UROLOGY 142(1):
139,1989 and the AMERICAN JOURNAL OF KIDNEY DISEASES 8(4):353, 1989. They may
also be obtained from the Director of the Urology Program, Division of Kidney,
Urologic and Hematologic Diseases.
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 6
SPECIFIC OBJECTIVES AND SCOPE OF RESEARCH
The specific objectives of this RFA are to encourage investigators, not now
working in the field of bladder physiology and pathophysiology, to enter the
field of IC research. Especially encouraged are investigators with research
expertise in the basic and clinical science areas of immunology, infectious
diseases, endocrinology, cellular and molecular biology, and bladder and
muscular neurophysiology and pharmacology.
Areas that need investigation include, but are not limited to, the following:
o The effect of hormones and/or growth regulatory peptides on the
normal function of the bladder and in interstitial cystitis.
o The role of infectious agents in the pathogenesis of IC.
o Inflammatory mediators, including free radicals, in IC
o Comparisons of cellular calcium transport in the normal bladder and
in interstitial cystitis.
o Comparisons of the neurotransmitter innervation of the normal
bladder and adjacent pelvic musculature with those of IC.
o Immunity and autoimmunity in the pathogenesis of IC.
o Surgical interventions in the treatment of IC.
o Innovative forms of therapy for interstitial cystitis.
o Comparison of the role of the pelvic floor musculature in normal
bladder function and in interstitial cystitis.
o The role of glycosaminoglycans and Tamm-Horsefall protein
(uromodulin) in normal bladder physiology and in IC.
o The urothelium in the normal bladder function and in IC.
o Urine constituents specifically associated with IC.
o Genetic factors associated with interstitial cystitis.
APPLICATION, REVIEW, AND FUNDING PROCEDURES
Response to this RFA is limited to individual research project (R01) grant
applications. Applications must be submitted on the revised (10/88) form
PHS-398. Applications from women and minority investigators are encouraged.
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
The following is a brief statement of the NIH and ADAMHA policy regarding the
inclusion of women and minorities in study populations. Applications that are
responsive to this RFA will, by definition, meet the requirement for inclusion
of women. The inclusion of minorities must be addressed in application
submitted responding to this RFA.
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.
Upon receipt, applications will be initially reviewed by the Division of
Research Grants (DRG) for completeness. Incomplete applications will be
returned to the applicant without further consideration. Evaluation for
responsiveness to the program requirements and criteria stated in the RFA is
an NIDDK program staff function. Applications that are judged non-responsive
will be administratively inactivated. Applications responsive to this RFA
will be reviewed for scientific and technical merit in accordance with the
usual NIH peer review procedures by an NIDDK initial review group specifically
convened for this RFA. Following study section review, the applications will
be given a secondary review by the NIDDK Advisory Council.
Up to $1 million are available in support of this RFA. The specific number of
grants and total amount of funds to be awarded depends on the scientific merit
of each application and the total costs of the applications. Each application
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 7
should include travel funds designated for the Principal Investigator to
attend an annual NIDDK research workshop on interstitial cystitis.
Applications must be received by April 22, 1991.
THE RFA LABEL CONTAINED IN THE APPLICATION KIT MUST BE AFFIXED TO THE BOTTOM
OF THE FACE PAGE OF THE ORIGINAL COPY OF THIS APPLICATION. FAILURE TO USE
THIS LABEL COULD RESULT IN DELAYED PROCESSING OF THE APPLICATION. FOR
PURPOSES OF IDENTIFICATION AND PROCESSING, THE RFA NUMBER, DK-91-04, AND TITLE
SHOULD BE TYPED IN ITEM 2 ON THE FACE PAGE OF THE APPLICATION.
The original and four copies of the application must be sent to:
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD 20892**
Two additional copies of the application must be sent under separate cover to:
Dr. Robert Hammond
Chief, Review Branch
Division of Extramural Activities, NIDDK
National Institutes of Health
Westwood Building, Room 406
Bethesda, MD 20892
Letter of Intent: It is requested that the applicant submit a one-page letter
of intent giving the name of the Principal Investigator, any other
investigators, a descriptive title of the proposed research, and the
institution. The letter is not a requirement for application and should be
received by March 1, 1991.
Letters of intent, inquiries, and requests for the more detailed full RFA
should be sent to:
Director, Urology Program, NIDDK/DKUHD
National Institutes of Health
Federal Building, Room 102
Bethesda, MD 20892
Telephone: (301) 496-8248
FAX: (301) 402-0223
The full RFA is available in the electronic version of the NIH Guide for
Grants and Contracts (E-Guide).
RESEARCH CENTER OF EXCELLENCE IN PEDIATRIC NEPHROLOGY AND UROLOGY
RFA AVAILABLE: DK-91-07
P.T. 04; K.W. 0785095, 0785220, 0770005
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date: April 2, 1991
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
invites applications for a pediatric kidney and urology research center grant
(P50) to be awarded in fiscal year 1991. NIDDK anticipates the award of one
pediatric kidney and urology center grant from this solicitation.
BACKGROUND
Kidney and urologic diseases account for substantial and increasing morbidity
and financial burden in the United States. They threaten the health and
wellbeing of over 13 million Americans and accounted for an estimated cost of
at least $50 billion in 1990. Although considerable progress has been made in
understanding the basic physiology and pathophysiology of the normal renal and
urinary systems, there has been only limited progress in unraveling the
mechanisms of disease processes. Renal failure is more frequent in adults,
but the majority have their onset in childhood. A significant proportion of
disorders that lead to end-stage renal disease (ESRD) or cause severe
metabolic imbalances in children are inherited (or are presumed to be) renal
diseases. To date, investigations have provided only detailed morphologic
descriptions of basement membrane abnormalities in only a few of the inherited
glomerular disorders and have characterized the tubular pathology in the
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 8
various inherited cystic diseases. However, at present, the understanding of
the molecular, cellular, and biochemical basis of these disorders is lacking.
OBJECTIVES AND SCOPE
The emphases of this initiative are threefold: (1) to attract new scientific
expertise into the study of the basic mechanisms of pediatric kidney and
urological diseases; (2) to encourage interdisciplinary research in this area;
and (3) to extend these basic investigations into areas that will provide the
background for future innovative clinical and epidemiologic studies of the
causes, therapy, and prevention of pediatric kidney and urologic diseases and
disorders. In approaching the study of these disease processes, it is
anticipated that extensive collaboration will be required between clinical and
basic scientists such as those in cell biology, molecular biology, immunology,
genetics, epidemiology, biochemistry, physiology, and pathology. Individual
institutions with both basic and clinical research capabilities are eligible
to apply. Interinstitutional collaborative research arrangements are also
permitted and encouraged whenever appropriate.
PEDIATRIC NEPHROLOGY
Representative areas of research appropriate for investigation include: (1)
studies of renal disorders of genetic and congenital origin that may lead to
progressive loss of renal function or cause severe metabolic imbalances in
children; (2) identification and study of genes integral to normal renal and
urinary tract development and to differentiation of renal function, including
studies of cellular derivation of the glomerular components, composition, and
characteristics of the embryonic extracellular matrix and endothelial cells.
PEDIATRIC UROLOGY
Examples of representative areas of research appropriate for investigation
include: (1) the pathophysiology of bladder function and dysfunction in the
pediatric population, (2) the development of diagnostic methodology for the
evaluation of these defects.
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
The following is a brief statement of the NIH and ADAMHA policy regarding the
inclusion of women and minorities in study populations. However, for the
purposes of this RFA, women denotes females of all ages.
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
NIDDK expects to award one pediatric research center grant (P50) in fiscal
year 1991 on a competitive basis. Foreign institutions are not eligible to
apply. The anticipated award is for five years and is contingent upon the
availability of appropriated funds. The total amount of available funds to
support this program is anticipated to be no more than $750,000 per year.
Therefore, no applicant may request more than $750,000 in total costs (both
direct and indirect costs) in the initial budget period. Subsequent budget
periods may include a standard escalation factor.
The complete Request for Applications (RFA) and consultation may be obtained
from:
Dr. Ralph L. Bain
Kidney and Urology Research Centers Program Director
DKUHD/NIDDK
Federal Building, Room 102
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-8218
REVIEW PROCEDURES
Applications for an award of a research center grant will be evaluated in a
national competition by the NIH peer review process. Applications will be
reviewed initially by a special review committee convened by the NIDDK and
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 9
reviewed subsequently by the National Diabetes and Digestive and Kidney
Diseases Advisory Council.
METHOD OF APPLYING
Potential applicants are urged to submit a letter of intent to the Program
Director by February 15, 1991, regarding their application. The letter of
intent is nonbinding and is not a precondition for an award. The letter of
intent should include the name(s) of the Principal Investigator(s), principal
collaborators, a descriptive title of the proposed research center, and the
organization(s) involved. Applications must be submitted using PHS Form 398
(Rev. 10/88). The RFA label contained in the application kit must be affixed
to the bottom of the face page of the original copy of the application.
Failure to use this label could result in delayed processing and review of the
application. On line 2 of the application face page type in the title and
number of this RFA.
Mail the completed application (original and four copies) to:
Application Receipt Office
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD 20892**
The special single receipt date for submissions in response to this
announcement is April 2, 1991, with earliest funding September 30, 1991.
This program is described in the Catalog of Federal Domestic Assistance No.
93.849, Kidney, Urologic, and Hematologic Diseases Research. Awards will be
made under the authority of the Public Health Service Act, Title III,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.
CHILD HEALTH RESEARCH CENTERS
RFA AVAILABLE: HD-91-04
P.T. 04; K.W. 0710030, 0770005, 0775000, 0785170, 0785035
National Institute of Child Health and Human Development
Application Receipt Date: April 9, 1991
The National Institute of Child Health and Human Development (NICHD) invites
Center Core Grant applications for a program of Child Health Research Centers
(CHRC). These Centers are intended to provide resources to speed the transfer
of knowledge gained through studies in basic science to clinical applications
that will benefit the health of children. This is to be accomplished by
increasing the number and effectiveness of pediatric investigators who have a
research grounding in basic science and the number of pediatric services that
can stimulate and facilitate the application of these investigators' skills to
research on pressing pediatric problems.
The information in this Request for Applications (RFA) is not identical to
that in the RFA of January 1990 on this subject (HD-90-03), which is obsolete.
Background
The past few years have seen unprecedented advances in the power and speed of
basic science methods applicable to investigations of inherited and acquired
disease. There is a need for researchers who are skilled with these methods
and are interested in applying them to clinical problems in pediatrics. The
NICHD intends to help meet this need by establishing Centers in which nascent
pediatric investigators can develop the appropriate technological expertise.
Objectives and Scope
Under the aegis of a CHRC grant an institution identifies and develops a
scientific area or theme that is relevant to the pediatric research mission of
the NICHD. It is an opportunity for institutions to build a greater capacity
for developing pediatric investigators. Established investigators whose
research is already funded by NIH or other competitively reviewed grants or
contracts combine to establish in their institution a center of excellence in
the chosen subject area. Individuals with a wide range of scientific
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 10
backgrounds, especially those with basic science orientation, are thus
encouraged to interact with each other and with newly trained pediatricians
just embarking on their research careers. A shared core laboratory that
provides services to complement and extend the capabilities of the established
investigators to facilitate the career development of new investigators may be
a part of the Center. The established investigators make available their
expertise and laboratory facilities that, together with the shared core
laboratory comprise the laboratory resources of the Center to be utilized by
junior investigators for new research projects that will enhance their basic
science knowledge and skills. Support for conducting these projects is
provided by the Center.
The CHRC grant may provide funds for three purposes:
1. Administration of the Center.
2. Improvements in the child health-related research program of an
institution in an area of scientific excellence through the establishment and
maintenance of a shared core laboratory.
3. Support for new projects, conducted by junior investigators, designed to
enhance their research skills and produce preliminary data that could lead to
successful competitive grant applications to the NIH or other agencies.
The novel feature of these grants is the flexibility in the use of the funds
awarded for research support and career development, so that decisions about
which new projects and which junior investigators are to be supported are made
by the grantee institution. Both competing and non-competing continuations of
a CHRC grant are contingent on demonstration of good judgment in these
decisions as indicated by scientific progress, success in the initiation of
new competitively awarded research grants and contracts, and the development
of new pediatric investigators.
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.
Mechanisms of Support
CHRC awards are made to a children's hospital or to a department of pediatrics
of an approved medical school that has as a primary teaching site either a
general acute children's hospital or a children's program that is part of a
larger medical institution. Either one must have the organizational
structure, clinical pediatric specialties and subspecialties, and discrete
clinical and research facilities sufficient to ensure the linkage of basic
research and clinical application that will meet the purposes of the CHRC
program. The Principal Investigator of the grant must be the chairperson of
the department of pediatrics or the chief of the pediatric service.
The mechanism for funding of these Centers is the P30 grant that provides core
support for laboratories and administrative resources applicable to a number
of different research projects. Awards are for five years at a maximum level
of $400,000 (direct plus indirect cost) annually and are renewable for two
years.
Application Procedure
Applications must be submitted on form PHS-398 (rev. 10/88). Detailed
instructions for application are available as additional information.
Additional Information
Potential applicants should request detailed information about CHRC grants
before preparing an application. Information is available from:
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 11
Ephraim Y. Levin, M.D.
Medical Officer
Endocrinology, Nutrition and Growth Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Room 637, Executive Plaza North
Rockville, MD 20852
Telephone: (301) 496-5593
SPECIAL CARE UNITS FOR ALZHEIMER'S DISEASE
RFA AVAILABLE: AG-91-06
P.T. 34; K.W. 0710010, 0715180, 0785035
National Institute on Aging
Letter of Intent Receipt Date: February 20, 1991
Application Receipt Date: April 10, 1991
I. INTRODUCTION
The National Institute on Aging (NIA) invites applications for cooperative
agreements (U01) for social and behavioral research on the impacts of Special
Care Units (SCUs). Special Care Units are defined here as specialized
facilities designed for people with Alzheimer's disease (AD) in long-term care
institutional settings (e.g., nursing homes, board and care, assisted living
environments, adult day care). The impacts of SCUs refer to direct or
indirect outcomes of this form of care on 1) persons with AD and at least one
of the following: 2) family caregivers, 3) health care administrators, 4)
staff, and 5) other (non-demented) persons receiving care in the same
institutional settings. Studies can range from detailed ethnographic analyses
of single institutional settings to highly controlled, randomized trials
testing the efficacy of different components of care. This Request for
Applications (RFA) is coordinated with relevant programs in the Agency for
Health Care Policy and Research, National Center for Nursing Research, and
National Institute of Mental Health.
II. SPECIFIC OBJECTIVES, ELIGIBILITY REQUIREMENTS, AND BUDGETARY
CONSIDERATIONS
The goal of the desired research is to provide systematic data on outcomes of
care in SCUs, and on the factors and processes associated with particular
outcomes. A further objective is to develop measures that can be standardized
across studies and subjected to comparable analyses.
Specific eligibility requirements include:
o Proposed research must be conducted in established SCUs (i.e.,
those that have been in operation for at least six months).
o Investigative teams must have prior experience in conducting health
care research in demented populations.
o Consideration of outcomes in persons with AD and at least one other
participant in care (e.g., family members, health care
administrators, staff, or other non-demented persons receiving
care).
Budgetary considerations:
o This Initiative seeks to fund 4-6 research projects.
o Total costs for each project must not exceed $250,000 in the first
year.
III. MECHANISM OF SUPPORT
Cooperative Agreement: The administrative and funding mechanism to be used to
support these awards will be cooperative agreements between each awardee and
NIA. In a cooperative agreement there is substantial programmatic involvement
of the designated Program Administrator above and beyond the levels
characteristic for traditional program management of grants. The Principal
Investigators and key staff, under the terms of the awards, are required to
meet with the Program Administrator three times in the first year and every
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 12
six months thereafter to standardize key measurements, review progress of
studies, and discuss appropriate analysis techniques.
IV. INCLUSION OF MINORITIES AND WOMEN
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.
V. REVIEW PROCEDURES
Applications will be received by the NIH Division of Research Grants and will
be assigned to the NIA. Responsive applications will be assigned to a special
NIA review group.
VI. METHOD OF APPLYING
A letter of intent, while not required, is requested by February 20, 1991.
The full RFA with additional information about research questions and methods,
eligibility and review criteria, and detailed application procedures, should
be requested from the contact person listed at the end of this announcement.
The deadline for receipt of applications is April 10, 1991.
VII. STAFF CONTACT
A complete copy of the RFA may be obtained from the program coordinator:
Marcia G. Ory, Ph.D.
BSR/NIA/NIH
Building 31, Room 5C35
Bethesda, MD 20892
Telephone: (301) 496-3136
ONGOING PROGRAM ANNOUNCEMENTS
ACADEMIC RESEARCH ENHANCEMENT AWARD
PA: PA-91-22
P.T. 34; K.W. 0710030, 1014006
National Institutes of Health
Application Receipt Date: June 21, 1991
The National Institutes of Health (NIH) is making a special effort to
stimulate research in educational institutions that provide the baccalaureate
training for a significant number of our nation's research scientists but that
historically have not been major recipients of NIH support. Since Fiscal Year
(FY) 1985, Congressional appropriations for the NIH have included funds for
this initiative, which NIH has implemented through the Academic Research
Enhancement Award (AREA) Program.
This award is designed to enhance the research environment of educational
institutions that have not been traditional recipients of NIH research funds.
The AREA funds are intended to support new research projects or expand ongoing
research activities proposed by faculty members of these institutions in areas
related to the health sciences. Because it is anticipated that AREA funds
will be available next year, the NIH is inviting grant applications for the FY
1992 competition for AREA grants.
Eligibility requirements of the AREA Program include the following:
Applicant Institutions
o All domestic institutions offering baccalaureate or advanced
degrees in the sciences related to health are eligible, except
those that have received an NIH Biomedical Research Support Grant
(BRSG) of $20,000 or more per year for four or more years during
the period from FY 1984 through FY 1990.
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 13
o Health professional schools (e.g., schools of medicine, dentistry,
nursing, osteopathy, pharmacy, veterinary medicine, public health,
allied health, and optometry), as well as organizationally discrete
campuses of a university system, are eligible if they meet the
above criterion.
o Multiple applications proposing different research projects may be
submitted by an applicant institution.
Applicant Principal Investigators
o Must not have active research grant support (including an AREA)
from either NIH or the Alcohol, Drug Abuse, and Mental Health
Administration (ADAMHA) at the applicant institution at the time of
award of an AREA grant.
o May not submit a regular NIH or ADAMHA research grant application
for essentially the same project as a pending AREA application.
o Are expected to conduct the majority of their research at their own
institution, although limited access to special facilities or
equipment at another institution is permitted.
o May not be awarded more than one AREA grant at a time nor be
awarded a second AREA grant to continue the research initiated
under the first AREA grant.
Those in doubt about eligibility should consult their institution's Office of
Sponsored Research, or the Director, Special Programs and Initiatives
(Building 31, Room 5B44, NIH, Bethesda, MD 20892, telephone 301-496-1968).
Funding decisions will be based on the proposed research project's scientific
merit and relevance to NIH programs, and the institution's contribution to the
undergraduate preparation of doctoral-level health professionals. Among
projects of essentially equivalent scientific merit and program relevance,
preference will be given to those submitted by institutions that have granted
baccalaureate degrees to 25 or more individuals who, during the period
1980-1990, obtained academic or professional doctoral degrees in the health
related sciences.
AREAs are awarded on a competitive basis. Applicants may request support for
up to a total of $75,000 for direct costs (plus applicable indirect costs) for
a period not to exceed 36 months (maximum request $35,000 in direct costs for
a single year). Although this award is non-renewable, it will enable
qualified individual scientists within the eligible institutions to receive
support for feasibility studies, pilot studies, and other small-scale research
projects preparatory to seeking more substantial funding from other NIH
research grant programs.
Applications for this award will be accepted under the application submission
procedures of the Division of Research Grants (DRG) of NIH. Grant
applications must be prepared and submitted on Form PHS 398 (Rev. 10/88,
Reprinted 9/89). Applicants must obtain the abbreviated format and simplified
instructions from the Office of Grants Inquiries (see address below). These
instructions must be followed in preparing an application. The receipt date
is June 21, 1991.
Those individuals and institutions meeting eligibility requirements and
wishing to receive further information and/or application materials should
write to:
AREA
Office of Grants Inquiries
Division of Research Grants
National Institutes of Health
Westwood Building, Room 449
Bethesda, MD 20892
Telephone: (301) 496-7441
**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
NIH GUIDE - Vol. 20, No. 4, January 25, 1991 - Page 14
------------------------- Full text of RFAs -------------------------
BASIC AND CLINICAL RESEARCH ON THE URINARY BLADDER AND
PELVIC MUSCULATURE IN INTERSTITIAL CYSTITIS
RFA AVAILABLE: DK-91-04
P.T. 34; K.W. 0705075, 0765035, 0710030
National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Date Receipt: March 1, 1991
Application Receipt Date: April 22, 1991
This Request for Applications (RFA) emphasizes the continued
interest of the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK) in funding research studies in
all areas of the investigation of the urinary bladder and
the adjacent structures, including the pelvic musculature.
The special emphasis of these studies should address issues
that may have particular relevance to increasing our basic
understanding of the disorder of interstitial cystitis
(IC). The NIDDK encourages investigators from diverse
clinical and basic science disciplines with a research
interest in the pathophysiology of bladder function and its
interrelationship with lower pelvic musculature to submit
applications for research that investigates such areas as
the etiology, diagnosis, pathophysiology, pathology,
surgical and non-surgical treatment, and prevention of IC.
INTRODUCTION
IC is a chronic, painful, and
variably incapacitating disorder that manifests a symptom
complex consisting of pain in the region of the urinary
bladder and associated pelvic musculature and variable
motor and sensory dysfunctions of the urinary bladder. It
affects a significant percentage of the adult population,
predominatly women. Although the symptom complex was
described nearly a century ago, there had been little
research into this disorder until recently, and the existing
data contain many conflicting and incongruous findings.
The factors that have inhibited advances in the
understanding of this disorder include: the lack of specific
diagnostic criteria, the lack of specific tissue changes at
the histological level, the unpredictable and variable
remission and recrudescence of symptoms, failure of
investigation of associated pelvic musculature, the lack of
a competent animal model for the disorder, and the absence
of a multidisciplinary research approach in the
investigation of the disorder.
In order to assure that patient selection for clinical
studies is uniform the NIDDK has established Diagnostic
Criteria for research studies on IC that must be satisfied
for all patients enrolled in clinical research studies
supported by the NIDDK. ALL CLINICAL GRANT APPLICATIONS
MUST STATE THAT THE NIDDK IC DIAGNOSTIC CRITERIA WILL BE
APPLIED TO PATIENTS SELECTED FOR INCLUSION IN THE RESEARCH
STUDY. These criteria have been published in: the JOURNAL
OF UROLOGY 142(1): 139,1989 and the AMERICAN JOURNAL OF
KIDNEY DISEASES 8(4):353, 1989. They may also be obtained
from the Director of the Urology Program, DKUHD (address below).
BACKGROUND INFORMATION
Interstitial cystitis is defined primarily by two factors:
1) the subjective symptom complex that includes lower
pelvic pain in the region of the urinary bladder, urinary
frequency and urgency; and, 2) characteristic findings seen
on cystoscopic evaluation (glomerulations). Pathological
findings in the bladder with IC are variable and generally
nonspecific. These findings may include
ulcerations, granulation tissue, fibrosis, and mononuclear
and mast cell infiltrates. No microbial infectious agent
has yet been identified with the disorder. There are
numerous therapeutic modalities utilized for symptom
resolution. However, no agent has been shown to either
eradicate the process or to provide long-term, predictable,
symptomatic relief in controlled trials.
SPECIFIC OBJECTIVES AND SCOPE OF RESEARCH
The specific objectives of this RFA are to encourage
investigators, not now working in the field of bladder
physiology and pathophysiology, to enter the field of IC
research and to help focus the work of investigators
already in the field, on topics that will increase the
breadth and depth of knowledge about the etiology,
pathogenesis, prevention, and treatment of bladder disorders,
with special emphasis on the condition called interstitial
cystitis. Especially encouraged are investigators with
research expertise in the basic and clinical science areas
of immunology, infectious diseases, endocrinology, cellular
and molecular biology, and bladder and muscular
neurophysiology and pharmacology.
Areas that need investigation include, but are not limited
to, the following:
o The effect of hormones and/or growth regulatory peptides
on the normal function of the bladder and in interstitial
cystitis.
o The role of infectious agents in the pathogenesis of
interstitial cystitis.
o The role of inflammatory mediators, including free
radicals, in the pathogenesis of interstitial cystitis.
o Histological and pathological findings in bladder tissue
from patients with bladder diseases that may improve the
specificity of particular features for interstitial
cystitis, or may aid in establishing the diagnosis of
interstitial cystitis.
o Comparisons of cellular calcium transport in the normal
bladder and in interstitial cystitis.
o Comparisons of the neurotransmitter innervation of the
normal bladder and adjacent pelvic musculature with those of
interstitial cystitis.
o The role of immunity and autoimmunity in the pathogenesis
of interstitial cystitis.
o Surgical interventions in the treatment of interstitial
cystitis.
o Innovative forms of therapy for interstitial cystitis.
o Basic and clinical studies comparing the role of the
pelvic floor musculature in normal bladder function and in
the dysfunction associated with interstitial cystitis.
o A comparison of the role of glycosaminoglycans and Tamm-
Horsefall protein (uromodulin) in normal bladder physiology
and in interstitial cystitis.
o A comparison of the role of the urothelium in the normal
bladder functional states and in interstitial cystitis.
o Urine constituents specifically associated with
interstitial cystitis.
o Genetic factors associated with interstitial cystitis.
APPLICATION, REVIEW, AND FUNDING PROCEDURES
Response to this RFA is limited to individual research
project (R01) grant applications. Applications must
be submitted on the revised (10/88) form PHS-398,
available in the business or research grants office at most
academic or research institutions, and from the Division of
Research Grants, National Institutes of Health. The purpose
of this solicitation is to encourage applications from
established investigators in related areas of investigation
who are not currently funded by the NIDDK for research in
the area of interstitial cystitis. However, applications
from all investigators will be accepted. Applications from
women and minority investigators are encouraged.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
The following is the NIH and ADAMHA policy regarding the
inclusion of women and minorities in study populations.
Applications that are responsive to this RFA will, by definition,
meet the requirement for inclusion of women. The inclusion of
minorities must be addressed in application submitted responding
to this RFA.
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 including the broadest possible representation of minority
groups. However, NIH recognizes that it may not be feasible or
appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority
populations (i.e., Native Americans (including American Indians
or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics).
The rationale for studies on single minority population groups
should be provided.
For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment
of diseases, disorders or conditions, including but not limited to
clinical trials.
The usual NIH policies concerning research on human subjects also
apply. Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.
However, every effort should be made to include human tissues
from women and racial/ethnic minorities when it is important to
apply the results of the study broadly, and this should be
addressed by applicants.
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of research
involving foreign population groups to the United States'
populations, including minorities.
If the required information is not contained within the
application, the application will be returned.
Peer reviewers will address specifically whether the research
plan in the application conforms to these policies. If the
representation of women or minorities in a study design is
inadequate to answer the scientific question(s) addressed AND the
justification for the selected study population is inadequate, it
will be considered a scientific weakness or deficiency in the
study design and will be reflected in assigning the priority
score to the application.
All applications for clinical research submitted to NIH are
required to address these policies. NIH funding components will
not award grants or cooperative agreements that do not comply
with these policies.
Upon receipt, applications will be initially reviewed by the
Division of Research Grants (DRG) for completeness.
Incomplete applications will be returned to the applicant
without further consideration. Evaluation for
responsiveness to the program requirements and criteria
stated in the RFA is an NIDDK program staff function.
Applications that are judged non-responsive will be
administratively inactivated but may be submitted as
investigator-initiated research grants at the next
receipt date.
Applications responsive to this RFA will be reviewed for
scientific and technical merit in accordance with the usual
NIH peer review procedures by a NIDDK initial review group specifically
convened for this RFA. Following study section review, the
applications will be given a secondary review by the NIDDK
Advisory Council.
Up to $1 million are available in support of this RFA. The
specific number of grants and total amount of funds to be
awarded depends on the scientific merit of each application
and the total costs of the applications. Because a major
intent of this request is to broaden the scope of research
on interstital cystitis and to increase the number of
investigators in the field, applicants should keep this in
mind when constructing their budgets. Each application
should include travel funds designated for the Principal
Investigator to attend an annual NIDDK research workshop on
interstitial cystitis.
Applications must be received by April 22, 1991, to be
considered for review and funding through this RFA.
THE RFA LABEL CONTAINED IN THE APPLICATION KIT MUST BE
AFFIXED TO THE BOTTOM OF THE FACE PAGE OF THE ORIGINAL COPY
OF THIS APPLICATION. FAILURE TO USE THIS LABEL COULD RESULT
IN DELAYED PROCESSING OF THE APPLICATION. FOR PURPOSES OF
IDENTIFICATION AND PROCESSING, THE RFA NUMBER, DK-91-04, AND
TITLE SHOULD BE TYPED IN ITEM 2 ON THE FACE PAGE OF THE
APPLICATION.
The original and four copies of the application must be
sent to:
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD 20892**
Two additional copies of the application must be sent
under separate cover to:
Dr. Robert Hammond
Chief, Review Branch
Division of Extramural Activities, NIDDK
National Institutes of Health
Westwood Building, Room 406
Bethesda, MD 20892
Letter of Intent: It is requested that the prospective
applicant submit a one-page letter of intent that
includes a
descriptive title of the research, the name address and
telephone number of the Principal Investigator, the names of
other key personnel, and identification of any other
participating institutions. Such letters are requested for
the purpose of providing an indication of the number and
scope of applications to be expected and for advising
potential applicants on the suitability of the proposed
project to the intent of the RFA. A letter of intent is not
binding and it will not enter into the review of subsequent
applications. It is not a requirement for application. The
letter of intent should be received by March 1, 1991.
Letters of intent and any inquiries about this RFA must be
sent to:
Director, Urology Program, NIDDK/DKUHD
National Institutes of Health
Federal Building, Room 102
Bethesda, MD 20892
Telephone: (301) 496-8248
FAX: (301) 402-0223
SUMMARY OF APPLICATION, REVIEW AND FUNDING DATES
Letter of Intent Due: March 1, 1991
Receipt date for Application: April 22, 1991
Initial Review: June/July 1991
Advisory Council Review: September 1991
Earliest Date of funding: September 30, 1991
These programs are described in the catalog of Federal
Domestic Assistance No. 93,849-Kidney, Urologic and
Hematologic Diseases Research. Awards will be made
under the authority of the Public Health Service Act, Title
III, Section 301 (Public Law 78-4110, 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.