kristoff@GENBANK.BIO.NET (Dave Kristofferson) (02/16/91)
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. 7, February 15, 1991
NOTICES
INCREASED STIPENDS FOR JUNIOR AND SENIOR APPOINTEES TO MINORITY ACCESS
TO RESEARCH CAREERS HONORS UNDERGRADUATE RESEARCH TRAINING GRANTS .......... 1
National Institutes of Health (164/187)
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
WORLD AIDS FOUNDATION ................................(190/246)............. 1
Fogarty International Center
Index: FOGARTY INTERNATIONAL CENTER
NOTICES OF AVAILABILITY (RFPs AND RFAs)
MUCOSAL IMMUNIZATION RESEARCH GROUP (RFP) ............(252/286)............. 2
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
ROLE OF ENHANCED CELL PROLIFERATION IN CHEMICAL CARCINOGENESIS (RFP) ....... 2
National Institute of Environmental Health Sciences (289/329)
Index: ENVIRONMENTAL HEALTH SCIENCES
NON-HUMAN PRIMATE MODEL TO STUDY THE EFFECTS OF VACCINES IN PREGNANT
FEMALES AND THEIR OFFSPRING (RFP) ....................(332/384)............. 3
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
COLLECTION AND TAXONOMY OF SHALLOW WATER MARINE ORGANISMS (RFP) (387/447)... 3
National Cancer Institute
Index: CANCER
MOLECULAR ANALYSES OF RADIATION-INDUCED GENETIC DAMAGE (RFA CA-91-07) ...... 4
National Cancer Institute (450/521, 1844/2127)
Index: CANCER
PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS (RFA GM-91-01) ......... 5
National Institute of General Medical Sciences (524/740)
Index: GENERAL MEDICAL SCIENCES
BASIC RESEARCH ON OSTEOPOROSIS (RFA AR-91-02) ..(743/872, 2130/2416)........ 8
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Index: ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES, DIABETES,
DIGESTIVE DISEASES, KIDNEY DISEASES
CLINICAL AND EPIDEMIOLOGY RESEARCH ON OSTEOPOROSIS (RFA AR-91-03) ..........10
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Index: ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES, DIABETES,
DIGESTIVE DISEASES, KIDNEY DISEASES (881/1016, 2419/2786)
EFFECTIVE DISSEMINATION OF HEALTH SERVICES RESEARCH FINDINGS AND
MEDICAL PRACTICE GUIDELINES (RFA AHCPR-91-01) ..(1019/1178, 2789/3253)......11
Agency for Health Care Policy and Research
Index: HEALTH CARE POLICY, HEALTH CARE RESEARCH
MINORITY DISSERTATION RESEARCH GRANTS IN AGING, 1991 (RFA AG-91-07) ........13
National Institute on Aging (1181/1314, 3256/3636)
Index: AGING
COOPERATIVE AGREEMENTS FOR PREVENTION CLINICAL TRIALS UTILIZING
INTERMEDIATE ENDPOINTS AND THEIR MODULATION BY CHEMOPREVENTIVE AGENTS
(RFA CA-91-08) ...................................(1317/1409, 3639/4503)....15
National Cancer Institute
Index: CANCER
CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS (RFA AG-91-05) .......16
National Institute on Aging (1412/1550, 4506/5234)
Index: AGING
ONGOING PROGRAM ANNOUNCEMENTS
MECHANISMS OF HIV PATHOGENESIS IN PEDIATRIC POPULATIONS (PA-91-25) .........18
National Institute of Allergy and Infectious Diseases (1556/1809)
Index: ALLERGY, INFECTIOUS DISEASES
ERRATUM
MULTICENTER COOPERATIVE AGREEMENT FOR STUDYING NEURAL TUBE DEFECTS
IN MUTANT MICE (RFA HD-91-09) .........................(1815/1826)..........21
National Institute of Child Health and Human Development
Index: CHILD HEALTH, HUMAN DEVELOPMENT
NOTICES
INCREASED STIPENDS FOR JUNIOR AND SENIOR APPOINTEES TO MINORITY ACCESS
TO RESEARCH CAREERS HONORS UNDERGRADUATE RESEARCH TRAINING GRANTS
P.T. 44; K.W. 0720005, 1014006
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Effective October 1, 1990, the annual stipend level for all juniors and
seniors receiving support through the Minority Access to Research Careers
(MARC) Honors Undergraduate Research Training Grants made under Section 487 of
the Public Health Service Act will increase 3.5 percent to $6,732 per year.
Stipend level adjustments can be made only on the appointment date of the
trainee. These stipend levels are effective only for awards made beginning
with FY 1991 funds; no retroactive adjustments or supplementation of stipends
may be made with MARC funds for awards made prior to October 1, 1990, or for
any appointment made to a grant made with FY 1990 funds. These stipends apply
only to juniors and seniors on awards made under the MARC Honors Undergraduate
Program.
The new stipend levels are to be used in the preparation of future MARC
institutional training applications. They will be administratively applied to
all applications now in the review process.
WORLD AIDS FOUNDATION
P.T. 44; K.W. 0715008, 0502000
Fogarty International Center
The World AIDS Foundation (WAF), jointly sponsored by the U.S. Department of
Health and Human Services and the Institut Pasteur of Paris, France, announces
its intent to support research and education relating to AIDS in the
developing world. The goal of the WAF is to facilitate information exchange
and to assist developing countries to respond to the AIDS pandemic.
The WAF is particularly interested in projects that are catalytic, and, once
in place, could have a multiplicative effect. The WAF is specifically
interested in supporting:
A) short-term, in-country training for clinicians, allied health
professionals, and technicians;
B) fellowships to support training for national experts;
C) development and testing of new concepts and demonstrations for
preventing the spread of HIV; and
D) highly focused workshops that enhance the scientific process and
transfer knowledge needed in the effort against HIV infections and
AIDS.
The limit of any single funding request to the WAF is
$200,000.
Application Procedures:
Concept letters and applications may be prepared in either English or French.
Applicants should submit concept letters for initial consideration. Following
review of concept letters, applicants may be invited to submit complete
proposals. The annual deadline for receipt of concept letters is April 1.
Concept letters, full applications, and inquiries concerning the programs of
the WAF should be directed to either:
World AIDS Foundation
Assistant Secretary for Health
c/o Director, Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
Bethesda, MD 20892
U.S.A.
or
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 1
World AIDS Foundation
c/o Director
Institut Pasteur
28 rue du Docteur Roux
75724 Paris, Cedex 15
FRANCE
NOTICES OF AVAILABILITY (RFPs AND RFAs)
MUCOSAL IMMUNIZATION RESEARCH GROUP
RFP AVAILABLE: NIH-NIAID-DMID-91-31
P.T. 34; K.W. 0710070, 0740023
National Institute of Allergy and Infectious Diseases
The Enteric Diseases Branch, Division of Microbiology and Infectious Diseases,
National Institute of Allergy and Infectious Diseases, requires one Mucosal
Immunization Research Group (MIRG). The MIRG conducts preclinical research in
animals to test and develop novel strategies for mucosal immunization against
a variety of infectious agents. This work includes basic mucosal immunology
as well as applied research on antigen delivery and immune enhancement.
RFP-NIH-NIAID-DMID-91-31 will be available on or about February 19, 1991.
Responses are due April 19, 1991.
It is estimated that a level-of-effort contract will be awarded with
incremental funding over a period of five (5) years. Any responsible offeror
may submit a proposal that will be considered by the Government.
To receive a copy of this RFP, please supply this office with two
self-addressed mailing labels. All inquiries must be in writing and addressed
to the office below:
Mr. Carl Henn
Contract Management Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Control Data Building, Room 326P
6003 Executive Boulevard
Bethesda, MD 20892
This advertisement does not commit the Government to make an award.
ROLE OF ENHANCED CELL PROLIFERATION IN CHEMICAL CARCINOGENESIS
RFP AVAILABLE: NIH-ES-91-14
P.T. 34; K.W. 0715035, 0710040, 0755010, 0755020
National Institute of Environmental Health Sciences
The purpose of this contract is to provide the Government with the skills,
experience, and facilities to perform experiments addressing the role of
enhanced cell proliferation in chemical carcinogenesis. Studies designed to
assess the extent of cell proliferation and cell death in rats and mice will
be performed under similar conditions as the carcinogenicity studies of each
chemical being evaluated (e.g., animal species and strain, route of exposure,
dose, diet, environmental conditions). Standardized procedures will be
utilized for necropsy and histology, clinical chemistry, immunohistochemistry,
histopathological evaluations of stained tissue sections, stereological
analyses of altered hepatic foci, and cell proliferation analyses using
osmotic minipumps to deliver the DNA precursor label. It is expected that the
results of these studies will provide greater insight on the role of
chemically enhanced cell proliferation in chemical carcinogenesis and will
provide guidance for risk assessment processes in determining how
carcinogenicity data obtained in animal models should be extrapolated to
assess the risk of human cancer due to exposure to nongenotoxic chemicals.
The RFP for this 5-year competitive procurement will be released on or about
February 25, 1991, and responses will be due by April 11, 1991. All
responsible sources may submit a proposal that shall be considered. The
Institute plans to make one award from this solicitation.
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 2
Requests must reference RFP NIH-ES-91-14 and must be forwarded to:
National Institute of Environmental Health Sciences
Contracts and Procurement Management Branch
ATTN: Thomas M. Hardee, Contracting Officer
79 T.W. Alexander Drive, 4401 Building
P.O. Box 12874
Research Triangle Park, NC 27709
Telephone: (919) 541-7893
NON-HUMAN PRIMATE MODEL TO STUDY THE EFFECTS OF VACCINES IN PREGNANT FEMALES
AND THEIR OFFSPRING
RFP AVAILABLE: NIH-NIAID-DMID-91-34
P.T. 34; K.W. 0755020, 0740075, 0775020, 0715125
National Institute of Allergy and Infectious Diseases
The Respiratory Diseases Branch, Division of Microbiology and Infectious
Diseases, National Institute of Allergy and Infectious Diseases (NIAID), has a
requirement to develop and characterize a non-human primate animal model
system to study the effects of vaccination of pregnant females on their
offspring. The long-term goal of the research is to gather evidence for the
safety and efficacy of maternal immunization during pregnancy for the
protection of the newborn by placentally transferred antibody against frequent
infant pathogens. The purpose of this research effort would be to provide
baseline information, using a primate model, on several candidate vaccines for
the maternal immunization approach. The theory is that bacterial, or viral
antigens (e.g., type-specific capsular polysaccharides of GBS and Hib or
purified surface proteins of RSV) can protect against systemic infection, and
that antibody elicited by vaccination of women could confer protection to
their infants through placental transfer. Maternal immunization could
therefore be viewed as an approach that might provide short-term passive
immunity, obviating the need for neonatal immunization when it is less likely
to be effective. Indeed, there is circumstantial evidence that placentally
transferred natural maternal antibody can afford protection to the offspring
against infection with Group B Streptococcus types III, Ib, and Ia Hib, E.
coli K1, N. meningitidis groups A and C, and RSV. Passive protection of
newborns for the first few months of life would bring them into age range
where subsequent vaccination could stimulate effective immunity.
This NIAID-sponsored project will take approximately five (5) years to
complete. One cost-reimbursement level of effort contract is anticipated and
that one award will be made. This is an announcement for an anticipated
Request for Proposals (RFP). RFP-NIH-NIAID-DMID-91-34 shall be issued on or
about February 15, 1991, with a closing date tentatively set for April 9,
1991.
Request for the RFP shall be directed in writing to:
Phillip Hastings
Contract Management Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Control Data Building, Room 326P
6003 Executive Blvd.
Bethesda, MD 20892
To receive a copy of the RFP, please supply this office with two-self
addressed mailing labels. All responsible sources may submit a proposal that
will be considered. All requests must be in writing. This advertisement does
not commit the Government to award a contract.
COLLECTION AND TAXONOMY OF SHALLOW WATER MARINE ORGANISMS
RFP AVAILABLE: NCI-CM-27704-30
P.T. 34; K.W. 0780005, 0740012, 0740020
National Cancer Institute
The National Cancer Institute (NCI), Division of Cancer Treatment (DCT),
Developmental Therapeutics Program (DCT), wishes to establish a contract for
the collection and identification of marine organism samples from the
Indo-Pacific region, for evaluation as sources of potential antineoplastic and
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 3
anti-AIDS agents, with the ultimate goal being the discovery of novel
structural types that can be developed for the selective treatment of cancer
and AIDS in humans. The successful offerors will be expected to provide
qualified personnel, materials, and equipment for the collection,
identification, storage, and shipping of 1000 marine samples per year to an
NCI designated extraction facility. Collections will comprise approximately
0.3-1.5 kg (wet weight) of each sample, collected from depths safely accessed
by SCUBA techniques, and each sample will be identified as far as possible at
the time of delivery. Properly prepared voucher specimens of each organism
will be collected for the purposes of unambiguous identification and for
permanent deposition at a minimum of two (2) repositories designated by the
NCI. The contractor will be expected to provide detailed documentation,
including complete identification of each sample collected.
The collection team should include qualified taxonomists, personnel
experienced in SCUBA techniques and marine organism collection. The Principal
Investigator should be trained in marine biology, or a related field, and have
at least five (5) years of experience in marine organism collection and
identification. It is anticipated that recollections of up to 50 marine
samples per year, in quantities of 10-50 kg, will be required. The number of
initial small-scale collections will be reduced in proportion to the number
and size of the large-scale recollections undertaken. Collections will
include species from as wide a variety of families and phyla as possible. The
collection will be heavily weighted for invertebrates with allowance for up to
approximately 20 percent marine plants and with the specific exclusion of
vertebrates. A list of species and genera extensively screened by NCI will be
provided in order to aid in the determination of priorities in the collection
program to the successful contractor. The contractor will be responsible for
obtaining all necessary permits including visas, collecting, shipping and
export permits from foreign governments and agencies, for delivery of samples
and voucher specimens to facilities in the United States. Where necessary,
the Government will provide letters of support. This is a recompetition of a
contract with the Australian Institute of Marine Science. The Institute plans
to make one award from this solicitation.
RFP No. NCI-CM-27704-30 will be issued on or about February 25, 1991, and
proposals will be due approximately April 12, 1991.
Copies of the RFP may be obtained by sending a written request to:
Ms. Elsa B. Carlton, Contract Specialist
National Institutes of Health
National Cancer Institute
Research Contracts Branch, TCS
Executive Plaza South, Room 603
9000 Rockville Pike
Bethesda, MD 20892
MOLECULAR ANALYSES OF RADIATION-INDUCED GENETIC DAMAGE
RFA AVAILABLE: CA-91-07
P.T. 34; K.W. 1002028, 0725015, 1002019, 1002004
National Cancer Institute
Application Receipt Date: May 24, 1991
INTRODUCTION
The Division of Cancer Etiology of the National Cancer Institute invites
applications from interested investigators for molecular studies on the
mutagenic effects of ionizing radiation on mammalian DNA, in vitro and in
vivo.
RESEARCH GOALS AND SCOPE
The purpose of this Request for Applications (RFA) is to encourage research to
characterize the distributions of mutations induced in the DNA of mammalian
cells exposed to ionizing radiations. The objective will be the quantitative
analyses of mutations by their location and frequency of occurrence in defined
DNA-targets (or chromosomal locations for large-scale genetic events) with
sufficient sensitivity to be applied directly to small populations of somatic
cells. Primary emphasis should be placed on basic studies with cultured
mammalian cells, including human cells. Such research could involve a variety
of genetic endpoints and techniques including the use of specific gene
targets, repetitive DNA sequences, and chromosome-specific DNA probes.
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 4
This RFA will permit a wide range of research activities, including, but not
limited to, the following studies:
o To determine if mutation spectra based on point mutations,
deletions, and/or other mutational endpoints may be uniquely
characteristic of exposure to radiation and can be used to
discriminate between cellular exposures to the different forms of
ionizing radiation, between exposures to ionizing radiations versus
exposure to other types of mutagens, or between mutations induced
by exposure to ionizing radiation and those of spontaneous origin.
o To determine the feasibility and merit of amplifying mutations
directly from somatic cells without using genetic selection and
subculturing to amplify mutated DNA for molecular analyses. In
vivo studies should consider the possible complications that may
result from clonal expansion of mutations in progenitor cells into
populations of somatic cells.
o To investigate mutational responses in radiation-exposed somatic
cells as functions of varying doses and dose rates.
o To compare and validate radiation-induced mutation spectra obtained
with cultured cells exposed in vitro with mutation spectra obtained
from somatic cells exposed in vivo.
IV. MECHANISM OF SUPPORT
This program will be supported through the National Institutes of Health (NIH)
traditional research project grant (R01). The intent of this research
initiative is to fund approximately 6 individual research grants, with total
program costs not to exceed $950,000 for the first year.
Copies of the RFA may be obtained from:
Dr. R.A. Pelroy, Ph.D.
Radiation Effects Branch
National Cancer Institute
Executive Plaza North, Suite 530
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-9326
PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS
RFA: GM-91-01
P.T. 22, FF; K.W. 0720005, 1014002
National Institute of General Medical Sciences
Application Receipt Date: May 10, 1991
PURPOSE AND BACKGROUND INFORMATION
The National Institute of General Medical Sciences (NIGMS) is accepting
applications for individual National Research Service Award (NRSA) Predoctoral
Fellowships for Minority Students. This program will provide fellowships for
up to 5 years of support for research training leading to either the Ph.D.
degree or the combined M.D./Ph.D. degrees in the biomedical sciences for
highly qualified students from underrepresented minority groups. Support is
not available for individuals enrolled in medical or other professional
schools, unless they are enrolled in a combined M.D./Ph.D. degree program in
biomedical research.
Since 1981, the Minority Access to Research Careers (MARC) Program of NIGMS
has had a Predoctoral Fellowship Program that provides support for graduates
of its various MARC Honors Undergraduate Research Training programs to attend
graduate school in the biomedical sciences. The intent of the new NIGMS
Minority Predoctoral Fellowship Program is to make graduate fellowships
available to underrepresented minority graduates from all institutions,
including the many minority undergraduate students who have participated in
other NIH-sponsored programs preparing them for research careers. It is
anticipated that, in this way, the number of applicants will be greatly
increased, thus fulfilling the goal of increasing the number of minority
students trained to pursue careers in biomedical research.
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 5
ELIGIBILITY REQUIREMENTS
Eligibility for these awards is limited to students who are U.S. citizens,
non-citizen nationals, and permanent residents from ethnic/racial groups that
are underrepresented in research in the biomedical sciences. An applicant
must currently be enrolled in a Ph.D. or M.D./Ph.D. graduate program in the
biomedical sciences or have been accepted by and agreed to enroll in such a
graduate program the following academic year. For the purpose of this
announcement, underrepresented minority students are defined as individuals
belonging to a particular ethnic or racial group that has been determined by
the applicant's graduate institution to be underrepresented in biomedical or
behavioral research at that institution. In making these awards, the NIH will
give priority consideration to applications from Black, Hispanic, Native
American, and Pacific Islander and other ethnic or racial group members who
have been found to be underrepresented in biomedical or behavioral research
nationally.
MECHANISM OF SUPPORT
This Request for Applications (RFA) solicits applications for National
Institutes of Health (NIH) individual fellowships under the auspices of the
National Research Service Award Act. Prospective student applicants are
strongly advised to seek the assistance of their research advisor or graduate
program director in preparing the application. Except as otherwise stated in
this RFA, awards will be administered under the PHS Grants Policy Statement
and the Guidelines for National Research Service Awards.
For FY 1991, approximately $1.5 million is available for this RFA. 50 to 75
fellowship awards are anticipated, if sufficient numbers of high quality
applications are received. The total period of fellowship support requested
in response to this RFA may not exceed 5 years. Continuation of the award
beyond the first year is based on evidence of satisfactory progress in a
graduate program by the applicant.
The receipt date for applications is May 10, 1991. The NIGMS will announce
subsequent receipt dates at a later time.
STIPENDS AND OTHER EXPENSES
The annual stipend for this Minority Predoctoral Fellowship is $8,800. This
stipend is provided to help meet the fellow's living expenses. A tuition and
fee allowance is paid in accordance with NIH policy. Also provided annually
is a $2,000 institutional allowance that may be used for travel to scientific
meetings as well as for laboratory and other expenses.
PAYBACK REQUIREMENTS
Before individuals can receive an NRSA fellowship, they must sign an agreement
that they will fulfill the payback requirements legislatively mandated under
the NRSA. Recipients must agree to engage in health-related biomedical or
health-related behavioral research and/or teaching for a period equal to the
period of NRSA support in excess of 12 months. Details are found in Part V of
the application instructions (PHS 416-1).
REVIEW PROCEDURE
Upon receipt, applications will be reviewed by NIH staff for completeness and
responsiveness to this announcement. Incomplete or non-responsive
applications will be returned to the applicant without further consideration.
Applications that are complete and responsive will be evaluated for scientific
merit and training potential in accordance with the criteria stated below by
an appropriate peer review group convened by the NIGMS. Applications may be
subjected to preliminary review to determine their merit relative to other
applications received in response to this RFA. The NIH will administratively
withdraw from competition those applications judged to be noncompetitive and
notify the applicant of such withdrawal. Those applications judged to be
competitive will undergo further scientific merit review. The second level of
review will be provided by the NIGMS Fellowship Overview Group.
REVIEW CRITERIA
The review criteria include:
o academic record and research experience of the applicant;
o quality of the graduate program in which the applicant is already
enrolled or plans to enroll;
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 6
o qualifications and research/research training experience of the
mentor (for advanced graduate students); and
o scientific significance and originality of proposed research (for
advanced graduate students).
METHOD OF APPLYING
The fellowship application form PHS 416-1 (revised 4/89) must be used in
applying for these grants. These forms are available at most university
business offices; from the Office of Grants Inquiries, Division of Research
Grants, National Institutes of Health, 5333 Westbard Avenue, Westwood
Building, Room 449, Bethesda, Maryland 20892; and from the NIH program
administrators named below.
The applicant MUST follow all instructions in the application. In addition,
the application MUST include each of the following:
o an official copy of the results of either the Graduate Record Examination or
the Medical College Admission Test (for M.D./Ph.D. applicants).
o an official copy of the applicant's undergraduate transcript and, if
applicable, an official copy of the applicant's graduate transcript.
o a description of the graduate or combined degree program in which the
applicant either is enrolled or has been admitted (Item 29a).
The Research Proposal, Item 29b, should be completed only by students who have
developed thesis research plans.
A statement supporting this application prepared by the applicant's research
advisor (if selected) or the graduate training program director must be
included in Items 33-37. In addition, Item 35 must include (1) certification
that the applicant has been accepted into the graduate training program and
(2) a statement establishing the eligibility of the underrepresented minority
individual for support under this program, including information on
citizenship/residency status. Include in Item 33 the applicable tuition.
In Item 1 of the face page ("TITLE OF RESEARCH TRAINING PROPOSAL"), type
MINORITY PREDOCTORAL FELLOWSHIP PROGRAM - NIGMS. In Item 3 of the face page
("PROGRAM ANNOUNCEMENT AREA"), type RFA GM-91-01. Failure to carry out these
instructions could result in delayed processing of the application that would
preclude the possibility of receiving a grant award.
Submit a signed, typewritten original of the application (including the
Checklist, Personal Data form, at least three sealed reference letters, and
all other required materials) and two (2) signed, exact, clear, single-sided
photocopies of the application, in one package to:
DIVISION OF RESEARCH GRANTS
National Institute of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Applications must be received by May 10, 1991. If an application is received
after that date, it will be returned to the applicant.
If the application submitted in response to this RFA is substantially similar
to a research grant application already submitted to the NIH for review, but
has not yet been reviewed, the applicant will be asked to withdraw either the
pending application or the new one. Simultaneous submission of identical
applications will not be allowed, nor will essentially identical applications
be reviewed by different review committees. Therefore, an application cannot
be submitted in response to this RFA that is essentially identical to one that
has already been reviewed. This does not preclude the submission of
substantial revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.
APPLICATIONS SUBMITTED WITHOUT THE REFERENCE LETTERS WILL BE RETURNED WITHOUT
REVIEW.
INQUIRIES
Written or telephone inquiries concerning this RFA are encouraged and should
be directed to:
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 7
Dr. John C. Norvell or Dr. Classie Hoyle
Westwood Building Westwood Building
Room 907 Room 950
National Institute of National Institute of
General Medical Sciences General Medical Sciences
Bethesda, MD 20892 Bethesda, MD 20892
Telephone: (301) 496-7260 Telephone: (301) 496-7941
SCHEDULE
Application Receipt Date: May 10, 1991
Initial Review: June/July 1991
Secondary Review: August 1991
Anticipated Award Date: September 1991
Awards are made under authorization of the Public Health Service Act, Title
IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 288 and
285) and administered under PHS grant policies and Federal Regulations 42 CFR
Part 66. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
BASIC RESEARCH ON OSTEOPOROSIS
RFA AVAILABLE: AR-91-02
P.T. 34; K.W. 0705050, 0785050, 0760020, 0765030, 0760025, 0760075
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date: May 15, 1991
BACKGROUND
Osteoporosis, a condition in which bone mass is low, represents a major public
health problem in the United States, exacting an enormous societal toll
annually in morbidity and mortality. It affects more than 24 million
Americans and is responsible for at least 1.3 million fractures each year.
Moreover, the frequency of osteoporosis and osteoporosis-related fractures is
expected to increase with the expansion of the elderly population in the
upcoming decades.
Bone remodeling is regulated by a complex interplay of bone cells and factors
that modulate the growth and functional activity of the cells. Although there
has been an explosion of information on the nature of the bone forming and
bone resorbing cells and numerous bone-active factors have been identified,
the regulation of bone remodeling by mechanical, endocrine, and local factors,
especially as they relate to osteoporosis, remains poorly understood.
Following a national scientific conference on RESEARCH ADVANCES IN
OSTEOPOROSIS in February 1990, a meeting of leaders in basic and clinical
osteoporosis research met to develop future research directions and
opportunities. These research directions became part of a report that was
requested last year by the Senate Appropriations Committee. The Report on
HHS-wide Research, Education, and Health Promotion Activities in Osteoporosis
also contained information on the status of current research in osteoporosis
throughout the Department of Health and Human Services. A copy of this report
may be requested by contacting Dr. Joan McGowan at the address listed below.
As follow-up to the report to the Senate Appropriations Committee and to be
responsive to current congressional interest and support for osteoporosis
research, a Request for Applications (RFA) has been issued to solicit
applications in the particular areas of basic research in bone biology that
are specifically and directly applicable to osteoporosis.
RESEARCH GOALS AND SCOPE
Some of the basic research areas that were identified as highly promising
research opportunities are: (1) the effect of local and systemic growth
regulators and osteoinductive factors on bone metabolism relevant to
osteoporosis; (2) the development of animal and cell culture models for
osteoporosis; (3) the role of mechanical/gravitational stress in maintaining
bone mass and preventing bone loss; (4) studies of the mechanism of action on
bone of factors with therapeutic potential, such as fluoride, estrogen, and
other hormones, bisphosphonates; (5) the roles of bone architecture and
strength in osteoporotic fractures; and (6) identification, characterization,
and molecular mechanisms of action of receptors for hormones, growth factors,
and cytokines active in bone cells and relevant to the etiology of
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 8
osteoporosis. Applications addressing other topics directly and specifically
pertinent to osteoporosis and osteoporosis-induced fractures are encouraged.
MECHANISM OF SUPPORT
The support mechanism for this RFA will be the the traditional,
investigator-initiated research grant (R01). Approximately $2,000,000 in
total costs per year for three to five years will be committed by the National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),
specifically to fund applications that are submitted in response to this RFA.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
will provide additional funds to support approximately two projects. The
National Institute on Aging may receive secondary assignment on appropriate
applications.
REVIEW PROCEDURES AND CRITERIA
Applications will be reviewed initially by the Division of Research Grants for
completeness and will be assigned to a special NIAMS review group. Evaluation
for responsiveness to the RFA is an NIAMS and NIDDK program staff function.
Applications that are judged non-responsive will be returned to the applicant
but may be submitted 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 NIAMS Review Branch. The second level of review
by the National Advisory Councils of NIAMS, NIDDK and, in some cases, NIA will
make recommendations regarding funding.
METHOD OF APPLYING
The research grant application form PHS 398 (revised 10/88) must be used in
applying for these grants. These forms are available at most institutional
business offices; from the Office of Grants Inquiries, Division of Research
Grants, National Institutes of Health, Room 449, Westwood Building, 5333
Westbard Avenue, Bethesda, Maryland 20892.
Applications must be received by May 15, 1991. If an application is received
after that date, it will be returned to the applicant.
If the application submitted in response to this RFA is substantially similar
to a research grant application already submitted to the NIH for review, but
has not yet been reviewed, the applicant will be asked to withdraw either the
pending application or the new one. Simultaneous submission of identical
applications will not be allowed, nor will essentially identical applications
be reviewed by different review committees. Therefore, an application cannot
be submitted in response to this RFA that is essentially identical to one that
has already been reviewed. This does not preclude the submission of
substantial revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.
INQUIRIES
Requests for copies of the full RFA may be obtained from:
Dr. Joan A. McGowan
Bone Biology and Bone Diseases Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
5333 Westbard Avenue
Westwood Building, Room 403
Bethesda, MD 20892
Telephone: (301) 496-7495
or
Dr. Ronald Margolis
Director, Endocrinology Research Program
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK/NIH
5333 Westbard Avenue
Westwood Building, Room 604
Bethesda, MD 20892
Telephone: (301) 496-7504
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 9
CLINICAL AND EPIDEMIOLOGY RESEARCH ON OSTEOPOROSIS
RFA AVAILABLE: AR-91-03
P.T. 34; K.W. 0705050, 0785055, 0760020, 0760025, 0755030, 0745027
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date: May 15, 1991
BACKGROUND
Osteoporosis is a disease characterized by low bone mass, microarchitectural
deterioration of bone tissue, and a consequent increase in fracture risk.
Osteoporosis represents a major public health problem in the United States,
exacting an enormous societal toll annually in morbidity and mortality. It
affects more than 24 million Americans and is responsible for at least 1.3
million fractures each year. Moreover the frequency of osteoporosis and
osteoporosis-related fractures is expected to increase with the expansion of
the elderly population in the upcoming decades.
Following a national scientific conference on RESEARCH ADVANCES IN
OSTEOPOROSIS in February 1990, a meeting of leaders in basic and clinical
osteoporosis research met to develop future research directions and
opportunities. These research directions became part of a report that was
requested last year by the Senate Appropriations Committee. The Report on
HHS-wide Research, Education, and Health Promotion Activities in Osteoporosis
also contained information on the status of current research in osteoporosis
throughout the Department of Health and Human Services. A copy of this report
may be requested by contacting Dr. Joan McGowan at the address listed below.
As follow-up to the report to the Senate Appropriations Committee and to be
responsive to current congressional interest and support for osteoporosis
research, a Request for Applications (RFA) has been issued to solicit
applications in the particular areas of clinical and epidemiologic research
that are specifically and directly applicable to osteoporosis.
RESEARCH GOALS AND SCOPE
This RFA is intended to foster and enhance research specifically directed to
prevention and treatment strategies, as well as epidemiologic studies of
osteoporosis. These areas include: 1) studies on maximizing bone mass in
early life; 2) biochemical markers of bone remodeling; 3) non-invasive
measurement of bone density/mass and structure; 4) further studies of sex
hormone use in osteoporosis; 5) the role of exercise in prevention and
treatment of osteoporosis; 6) development of hormone analogs with specific
therapeutic application in osteoporosis; 7) therapeutic potential for growth
factors; 8) incidence and etiology of osteoporosis in men and blacks; 9)
etiology of juvenile and adult idiopathic osteoporosis; 10) additional
research on risk factors; and 11) research on prevention strategies.
Other clinical and epidemiologic research applications in the field of
osteoporosis are encouraged. In order to be considered responsive to this
RFA, applications must be specifically directed to osteoporosis.
MECHANISM OF SUPPORT
The support mechanism for this RFA will be the the traditional,
investigator-initiated research grant (R01). Approximately $2,000,000 in
total costs per year for three to five years will be committed by the National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),
specifically to fund applications that are submitted in response to this RFA.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
will provide additional funds to support approximately two projects. The
National Institute on Aging may receive secondary assignment on appropriate
applications.
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.
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 10
REVIEW PROCEDURES AND CRITERIA
Applications will be reviewed initially by the Division of Research Grants for
completeness and will be assigned to a special NIAMS review group. Evaluation
for responsiveness to the RFA is an NIAMS and NIDDK program staff function.
Applications that are judged non-responsive will be returned to the applicant
but may be submitted 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 NIAMS Review Branch. The second level of review
by the National Advisory Councils of NIAMS, NIDDK and, in some cases, NIA will
make recommendations regarding funding.
METHOD OF APPLYING
The research grant application form PHS-398 (revised 10/88) must be used in
applying for these grants. These forms are available at most institutional
business offices and from the Office of Grants Inquiries, Division of Research
Grants, National Institutes of Health, Room 449, Westwood Building, 5333
Westbard Avenue, Bethesda, Maryland 20892.
Applications must be received by May 15, 1991. If an application is received
after that date, it will be returned to the applicant. If the application
submitted in response to this RFA is substantially similar to a research grant
application already submitted to the NIH for review, but has not yet been
reviewed, the applicant will be asked to withdraw either the pending
application or the new one. Simultaneous submission of identical applications
will not be allowed, nor will essentially identical applications be reviewed
by different review committees. Therefore, an application cannot be submitted
in response to this RFA that is essentially identical to one that has already
been reviewed. This does not preclude the submission of substantial revisions
of applications already reviewed, but such applications must include an
introduction addressing the previous critique.
INQUIRIES
Copies of the full RFA may be obtained from:
Dr. Joan A. McGowan
Bone Biology and Bone Diseases Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
5333 Westbard Avenue
Westwood Building, Room 403
Bethesda, MD 20892
Telephone: (301) 496-7495
or
Dr. Ronald Margolis
Director, Endocrinology Research Program
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK/NIH
5333 Westbard Avenue
Westwood Building, Room 605
Bethesda, MD 20892
Telephone: (301) 496-7504
EFFECTIVE DISSEMINATION OF HEALTH SERVICES RESEARCH FINDINGS AND MEDICAL
PRACTICE GUIDELINES
RFA AVAILABLE: AHCPR-91-01
P.T. 16; K.W. 0730050, 0730000, 0403004
Agency for Health Care Policy and Research
Application Receipt Dates: April 26, June 1, October 1, 1991, and February 1,
1992
BACKGROUND: The Agency for Health Care Policy and Research (AHCPR) invites
applications to conduct applied research on effective dissemination of
clinical knowledge and medical practice guidelines to affect changes in
practitioner and consumer behavior, improve patient outcomes and, thereby,
improve the effectiveness, quality, and appropriateness of health care.
"Effective dissemination" encompasses the broader concept of diffusion as well
as the actual distribution of knowledge and new information. Additionally,
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 11
the process through which target groups become aware of, receive, accept, and
utilize disseminated information and knowledge is reflected in this term.
PURPOSE AND OBJECTIVES: This Request for Applications (RFA) solicits new
grant applications on issues dealing with the ways in which scientific
information can be presented and disseminated to foster its assimilation and
use by health care providers and patients and, ultimately, to improve the
effectiveness, quality, and appropriateness of medical care. The process and
structural factors influencing dissemination and assimilation need to be
examined. Studies are encouraged that evaluate the dissemination of, and
outcomes associated with, clinical practice guidelines or parameters assisted
by AHCPR and other public and private entities. It also encourages the
assessment and use of models and techniques that effectively disseminate
clinical information and practice guidelines.
ELIGIBILITY: Applicants must be public entities or nonprofit organizations
and institutions. Proposed Principal Investigators must have demonstrated
expertise in dissemination of health services research findings, clinical
research findings, or medical practice guidelines. Applicants must also have
demonstrated (1) capability to conduct and manage applied research or
demonstration and evaluation projects in the area(s) that will be the subject
of the dissemination project; and (2) expertise in communications.
LENGTH OF SUPPORT: Projects will vary from one to three years in length.
Project lengths could be up to five years in rare cases.
MECHANISM OF SUPPORT: All projects will be funded as research grants (RO1).
The earliest start date for funded projects with under $250,000 total direct
costs will be September 30, 1991. The earliest start date for funded projects
with total direct costs greater than $250,000 will be December 1, 1991.
Approximately four to ten grant awards will be issued during FY 1991 and FY
1992 depending upon the number and cost of approved applications. It is
expected that up to $4 million will be spent. Applications for dissemination
research grants in subsequent years will compete equally for funding with
other applications to AHCPR.
PREPARATION OF APPLICATIONS: Each application must be submitted in accordance
with the instructions of form PHS 398 (rev. 10/88). State and local
governments using form DHHS 5161 must submit an original and two copies of the
application. The following requirements must be discussed in the Project
narrative in addition to the requirements specified in the application kit:
Specific Aims
o Where appropriate, the long-term objectives of the project must
specify the product(s) to be disseminated and the audiences to be
targeted.
o The dissemination methods and questions to be addressed should be
discussed in terms of ascertaining the effects of dissemination on
behavior change, characteristics or effectiveness of dissemination
techniques, or the development of an innovative dissemination
model.
Progress Report/Preliminary Studies
o Prior studies conducted by the Principal Investigator pertaining to
dissemination, health services research (especially in the areas
which AHCPR has ongoing work), or communications research that will
contribute to the proposed project should be described.
Experimental Design and Methods
o The specific dissemination model that will be used or developed in
the project should be explicitly addressed in terms of: audiences;
type of product or the knowledge to be disseminated; technique of
dissemination; characteristics or variables of dissemination to be
used and/or examined; and the relationship of the project to the
structure of the health care system, clinical management, health
care outcomes, and health status.
REVIEW PROCEDURES AND CRITERIA: Applications must be submitted to:
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 12
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Applications will be referred to an AHCPR study section for initial review.
Applications requesting total direct costs in excess of $250,000 will also be
reviewed by the National Advisory Council for Health Care Policy, Research,
and Evaluation.
Applications will be reviewed in accordance with the standard AHCPR peer
review procedures. In addition, the following criteria will be considered:
ability of the project's results to be applied to the dissemination of AHCPR
products now and in the future; adherence of the project approach to accepted
principles of communications and dissemination; and ability to analyze the
effects of dissemination on behavior change among practitioners and consumers.
APPLICATION PROCEDURES: Those considering an application to this RFA are
strongly encouraged to discuss their project with AHCPR program administrators
in advance of formal submission.
Use application form PHS 398 (rev. 10/88) (State and local governments may
use form DHHS 5161). These forms may be secured from the Office of Scientific
Review, Agency for Health Care Policy and Research, Room 18A-20, Parklawn
Building, 5600 Fishers Lane, Rockville, Maryland 20857 (telephone
301-443-3091) and from most institutional business offices.
Type in line 2 of the face page of the application the words "RFA AHCPR-91-01:
AHCPR Dissemination Effectiveness" and use the RFA label in the application
package.
The original and 6 copies of the application must be submitted to the Division
of Research Grants as directed in the application instructions. State and
local governments using form DHHS 5161 must submit an original and two copies
of the application.
INQUIRIES: For assistance, consultation on program requirements, and for the
full RFA contact:
Margaret VanAmringe
Director, Center for Research Dissemination and Liaison
5600 Fishers Lane, Room 18A-10
Rockville, MD 20857
Telephone: (301) 443-2904
For budgetary/administrative information, contact:
Ralph Sloat
Grants Management Officer
Agency for Health Care Policy and Research
5600 Fishers Lane, Room 18A-27
Rockville, MD 20857
Telephone: (301) 443-4033
This program is described in the Catalog of Federal Domestic Assistance No.
93.180 and 93.226. Executive Order 12372 does not apply to AHCPR grant
programs.
MINORITY DISSERTATION RESEARCH GRANTS IN AGING, 1991
RFA AVAILABLE: AG-91-07
P.T. 34, FF; K.W. 0710010, 0720005
National Institute on Aging
Application Receipt Date: April 29, 1991
Small grants (R03) to support doctoral dissertation research will be available
in 1991 for underrepresented minorities.(1) Grant support is designed to aid
the research of new minority investigators and to encourage individuals from a
variety of academic disciplines and programs to study problems in aging.
Specific research topics should be discussed with the National Institute on
Aging (NIA). The interests of the programs are given in the full Request for
Applications (RFA). Dissertation research grants will be administered in
accordance with the U.S. Code Annotated, Title 42, Part B, Section 284.
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 13
Awards will depend on the availability of funds. NIA expects to fund up to 20
dissertation research projects in 1991.
(1) Underrepresented minority investigators are defined as individuals
belonging to a particular ethnic or racial group that has been determined by
the grantee institution to be underrepresented in biomedical or behavioral
research at that institution. NIA will give priority to projects from
African-Americans, Native Americans, Hispanics, Pacific Islanders, or other
ethnic or racial group members who have been found to be underrepresented in
geriatric and gerontology research nationally.
ELIGIBILITY
The applicant investigator applying for a dissertation research grant must be
an individual from an underrepresented minority group enrolled in an
accredited doctoral degree program in the biomedical, social, or behavioral
sciences and must have approval of the dissertation proposal by a named
committee. The student must also be conducting or intending to conduct
dissertation research on issues related to aging. Research topics should fit
within one or more of the areas described below for each individual program
(see National Institute on Aging Contacts below).
The applicant must be a registered doctoral candidate in resident or
nonresident status. All requirements for the doctoral degree other than the
dissertation must be completed by the time of the award. This information
must be verified in a letter of certification from the thesis chairperson and
submitted with the grant application (see Application Procedures).
The applicant institution must be domestic and will administer the grant on
behalf of the proposed investigator. The applicant investigator for
dissertation research grant support must be a citizen of the United States or
hold a permanent resident visa. The performance site may be domestic or
foreign.
SCOPE OF AWARDS
Applicant investigators should request support for the amount of time
necessary to complete the dissertation. However, a dissertation research
grant usually is awarded for a period of 12 months or less but may be awarded
for up to 24 months. The total direct costs of the entire project may not
exceed $25,000. A proposal that exceeds this amount will be returned.
Allowable costs include the investigator's salary (not to exceed $10,000);
direct research project expenses such as travel, data processing, and
supplies; and dissertation costs. No tuition nor permanent equipment is
allowed.
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.
HOW TO APPLY
The full RFA and special guidelines for dissertation grant applications should
be requested from the Office of Extramural Affairs (see address below). The
application must be submitted on form PHS 398 (revised 10/88, reprinted 9/89)
available from the university research office and the Division of Research
Grants, 5333 Westbard Avenue, Westwood Building, Room 240, Bethesda, Maryland
20892, telephone (301) 496-7441. The special instructions described here and
in the application kit must be followed. Applications will be assigned to the
NIA for review and possible funding.
Applications must be received by April 29, 1991, and must be sent directly to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
The applicant must submit the original and four copies of the completed
application, which includes a detailed narrative project description (not to
exceed 10 pages) and letters. An additional two copies must be sent to:
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 14
Grants and Contracts Management Office
National Institute on Aging
Building 31, Room 5C07
Bethesda, MD 20892
Att: Minority Dissertation
A letter from the faculty committee or university official directly
responsible for supervising the development and progress of the dissertation
research must be submitted with the application. Details of the letter are
given in the full RFA.
REVIEW PROCESS
Dissertation research grants are competitive. A mail review will be
conducted. Review results and funding decisions will be announced within 5
months after the submission date. Final funding decisions are based on the
recommendations of the reviewers, the relevance of the project to NIA
priorities, and the availability of funds.
NATIONAL INSTITUTE ON AGING CONTACTS
Interested applicants should request the full RFA, additional guidelines for
preparing the application, and discuss the suitability of the mechanism by
letter or by telephone with the person named below. The applicant also will
be referred to the relevant NIA program director to discuss the suitability of
the research topic.
Phyllis B. Eveleth, Ph.D.
Deputy Associate Director and Training Officer
Office of Extramural Affairs
National Institute on Aging
Building 31, Room 5C02
Bethesda, MD 20892
Telephone: (301) 496-9322
COOPERATIVE AGREEMENTS FOR PREVENTION CLINICAL TRIALS UTILIZING INTERMEDIATE
ENDPOINTS AND THEIR MODULATION BY CHEMOPREVENTIVE AGENTS
RFA AVAILABLE: CA-91-08
P.T. 34; K.W. 0755015, 0740018, 0715035, 0710095
National Cancer Institute
Letter of Intent Receipt Date: April 1, 1991
Application Receipt Date: May 24, 1991
PURPOSE
The Division of Cancer Prevention and Control (DCPC), National Cancer
Institute (NCI), invites applications for cooperative agreements to support
clinical trials directed toward examining the role of various chemopreventive
agents and/or diet in the prevention of cancer. This is a follow-up to
earlier Requests for Applications (RFAs) that requested grant applications,
and then later, cooperative agreement applications in this area.
RESEARCH OBJECTIVES
The major objective of this solicitation is to encourage cancer
chemoprevention clinical trials that utilize biochemical and/or biological
markers to identify populations at risk and/or to provide intermediate
endpoints that may predict later reduction in cancer incidence rates.
These studies may be developed in phases, including a pilot phase, that could
later proceed to a full-scale intervention. The main emphasis should be on
small, efficient studies aimed at improving future research designs of
chemoprevention trials, providing biologic understanding of what is happening
in the trials, or providing better, more quantitative and more efficient
endpoints for these trials. After successful completion of the pilot phase
(i.e., demonstrated modulation of marker endpoints by the intervention),
subsequent studies can include Phase III clinical trials involving the
designated agent, the utilization of the monitoring test system, and a cancer
incidence or mortality endpoint.
Investigators may apply at this time for the pilot phase or submit an
application for both phases. However, if the application is for the pilot
phase only, the proposed study must describe its relevance to a clinical
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 15
application and utilize a chemopreventive agent, marker test system, and study
population that could later be the subject of a full-scale, double-blind,
randomized, risk-reduction clinical trial.
MECHANISM OF SUPPORT
Applicants funded under this RFA will be supported through the cooperative
agreement mechanism. An assistance relationship will exist between NCI and
the awardees to accomplish the purpose of the activity. The recipients will
have primary responsibility for the development and performance of the
activity. However, there will be government involvement with regard to: (1)
assistance securing an Investigational New Drug (IND) approval from the Food
and Drug Administration (FDA), (2) monitoring of safety and toxicity, (3)
coordination and assistance in obtaining the chemopreventive agent, and (4)
quality assurance with regard to the clinical chemistry aspects of the study.
Awards will not be made until all arrangements for obtaining the IND, agent,
and its delivery are completed. Final awards will also consider not only the
cost of the clinical trial but also the cost of the agent and its formulation
if necessary.
This RFA solicitation represents a single competition with a specified
deadline of May 24, 1991, for receipt of applications. All applications
received in response to the RFA will be reviewed by the same NCI Initial
Review Group.
To ensure their review, applications must be received by May 24, 1991.
Applications received after that date will not be considered under this RFA.
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.
INQUIRIES
Inquiries and requests for the full RFA may be directed to:
Marjorie Perloff, M.D.
Chemoprevention Branch
Executive Plaza North, Suite 201
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892-4200
Telephone: (301) 496-8563
CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS
RFA AVAILABLE: AG-91-05
P.T. 04; K.W. 0710010, 0745027, 0414005
National Institute on Aging
Letter of Intent Due: April 15, 1991
Application Receipt Date: May 17, 1991
BACKGROUND, GOALS, AND SCOPE: Millions of older Americans suffer from loss of
abilities needed to live a fully independent life. Loss of independence
imposes enormous personal and financial burdens on older persons and their
families. Dependence is not inevitable in old age. It results from disabling
conditions that are potentially, if not currently, preventible or reversible.
The development and testing of interventions to reduce disability and increase
independence thus offers immense benefits and potential savings in health care
costs. In response to this need, Congress amended the Public Health Service
Act in 1990 to authorize the establishment of Claude D. Pepper Older Americans
Independence Centers (OAICs). The overall goals of the OAIC program are: to
develop and test interventions to increase or maintain abilities needed for
independence of older persons and to train researchers capable of leading and
conducting research programs in the above activities. OAICs will support:
INTERVENTION STUDIES: These studies are the major research components of
OAICs. At least one approved intervention research project is required for
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 16
approval of an OAIC. Proposed intervention studies must test efficacy of
interventions to prevent or ameliorate functional impairments contributing to
loss of independence. Each proposed intervention study should also include
planned investigations of mechanisms underlying the intervention's effects (or
lack of effects) on functional status, factors affecting recruitment into the
study, participants' compliance once enrolled, cost-effectiveness, and effects
on health care utilization of the intervention(s) tested.
Examples of study topics include:
o interventions to prevent or reduce frailty and physical performance
disabilities, cognitive disability, affective disorders, sensory
disabilities, and/or co-morbidity associated with these conditions;
o interventions to reduce risk of disabling events such as hip
fractures and strokes, and impairments following these events;
o interventions to prevent or reduce disabilities in complex
functions involving combined motor, sensory, and cognitive
performance;
o interventions to prevent or reduce disabling side effects from
medication use;
o interventions to prevent, lessen, or shorten temporary disability
from exacerbation or complications of chronic diseases of older
persons;
o interventions to prevent or rduce disabling sequelae of menopause
and associated estrogen deficiency;
o combined intervention strategies to prevent or ameliorate
disabilities in older persons with multiple impairments.
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.
INTERVENTION DEVELOPMENT STUDIES: OAICs will also support intervention
development studies to identify, develop, or refine potential interventions to
preserve or increase independence. Types of such studies include preliminary
tests of therapies to test their effects on physiologic and/or behavioral
factors known to affect functional status, and studies to identify or confirm
reversible or preventible risk factors for disability and/or disabling events.
Large-scale epidemiologic studies are outside the scope of this RFA.
RESEARCH RESOURCES CORES: Applicants may request core resource support to
enhance the quality of OAIC research projects, i.e., Intervention Studies,
Intervention Development Studies, and Pilot Research Projects.
RESEARCH DEVELOPMENT CORE: This core will provide salary and other support
for junior faculty and research associates to acquire abilities in all phases
of research to develop interventions that enhance independence, including
clinical trials, studies of mechanisms underlying treatment response, and
cost-effectiveness/health care utilization studies. The Research Development
Core will also support pilot research projects on topics related to the
activities of the OAIC.
DEMONSTRATION AND INFORMATION DISSEMINATION PROJECTS: OAICs must include
activities to translate findings from their research into health care
practice.
LEADERSHIP/ADMINISTRATIVE CORE: Applicants may request funds for the OAIC
Director, OAIC Administrator, and support staff. The OAIC Director should be
a scientist who can provide effective administrative and scientific leadership
and coordination with OAIC intervention studies. An OAIC Administrator who
will assist the Director in managing the Center, addressing issues of fiscal
management and compliance with institutional, PHS, NIH, and NIA policies, must
be identified.
MECHANISM AND SCALE OF SUPPORT: Older Americans Independence Centers will be
supported through comprehensive center grants (P60). The total costs (direct
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 17
plus indirect) requested per application for the first year may not exceed
$1,500,000. Plans are to make up to 3-4 awards depending upon availability of
funds. Up to $3.9 million (total cost) for first-year expenses, and
additional approved expenses for up to five years, will be committed in Fiscal
Year 1991 to fund applications submitted in response to this RFA, subject to
receipt of high-quality applications and availability of funds.
REVIEW PROCEDURES AND CRITERIA, AND METHOD OF APPLYING: Applications will be
received by the NIH Division of Research Grants and assigned to NIA.
Responsive applications will be assigned to a special institute review group
for review. Customary scientific review criteria will be applied, including
significance of the research project to the goals of the RFA. A complete copy
of the RFA and program guidelines may be obtained from the NIA contact listed
below. Applications must be submitted on the standard PHS 398 (rev. 10/88,
reprinted 10/89) application form. The deadline for receipt of applications
is May 17, 1991. On item 2 of the face page of the application, applicants
should enter: NIA RFA--Claude Pepper Older Americans Independence Center,
AG-91-05. The RFA label available in the application form PHS 398 must be
affixed to the bottom of the face page and placed on top of the entire
package. Failure to use this label could result in delayed processing of the
application and prevent it from reaching the review committee in time for
review.
A complete copy of the RFA and program guidelines may be obtained from:
Stanley L. Slater, M.D.
Geriatrics Program, NIA
Building 31, Room 5C27
Bethesda, MD 20892
Telephone: (301) 496-6761
ONGOING PROGRAM ANNOUNCEMENTS
MECHANISMS OF HIV PATHOGENESIS IN PEDIATRIC POPULATIONS
PA: PA-91-25
P.T. 34; K.W. 0715008, 0765033, 0745027, 0770005, 0715125, 0710070
National Institute of Allergy and Infectious Diseases
Application Receipt Dates: May 1, September 1, January 2
PURPOSE
The National Institute of Allergy and Infectious Diseases (NIAID) is
designated as the lead institute for the investigation of the pathogenesis,
prevention, and treatment of the human immunodeficiency virus (HIV)
responsible for the acquired immunodeficiency syndrome (AIDS). HIV-infected
women as well as children born to HIV-infected women are the fastest growing
populations of AIDS patients. The clinical manifestations of pediatric AIDS
differ from those seen in adults. Recurrent bacterial infections, lymphocytic
interstitial pneumonitis and encephalopathy, as well as neurological and
physical growth deficits, are commonly observed in children with HIV
infection. Immune dysfunction is found in children with greater than 1500 CD4
T cells/mm3. Compared to adults, opportunistic infections and AIDS symptoms
appear much earlier after infection in most children, with 50 percent
diagnosed before one year of age and 82 percent within the first three years.
Little is known concerning the mechanisms of pathogenesis of HIV infection in
the immature host, and this lack of knowledge makes it difficult to define
effective treatment strategies.
RESEARCH OBJECTIVE
The objective of this program announcement is to stimulate research on the
mechanisms of HIV pathogenesis in hosts with developing immune and
neurological systems.
Applications that focus on specific strategies to determine the mechanisms of
HIV pathogenesis in pediatric populations are encouraged. These strategies
may include, but are not limited to, the following areas:
1. Determine the cells/organs harboring HIV, the time and mode of infection
(in utero, perinatal, breast milk), the route and mechanisms of viral spread,
cell tropism, and genetic variation in pediatric HIV infection.
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 18
2. Determine if there is transfer of maternal immunity to the fetus, and if
so, define the parameters (e.g., viral load, time, mechanism). Identify
strategies to induce or amplify protective immune response(s) in
immunosuppressed individuals.
3. Define the mechanisms for the immunologic abnormalities in pediatric
populations.
A. Abnormalities in humoral immunity: Which regulatory mechanism(s)
are impaired? Which regulatory mechanisms determine whether
immunoglobulin levels are elevated or deficient?
B. Abnormalities in cellular immunity.
C. Abnormalities in antigen presenting cells.
D. Abnormalities in regulation, production, and/or expression of
cytokines and/or lymphokines.
4. Define the cellular factors in the immature host that interact with viral
regulatory elements.
5. Define the mechanisms for neurologic abnormalities and neuropathology in
pediatric populations.
6. Define the factors and co-factors influencing/causing lymphocytic
interstitial pneumonitis and the mechanisms of pathogenesis.
7. Define the pathogenic mechanisms that allow recurrent bacterial
infections, viral infections (e.g., EBV, CMV, JC), fungal, and other
opportunistic infections in children with HIV infection.
8. Define the host and viral factors that determine the accelerated course of
HIV disease progression in some infants and children and that allow latency in
other children for many years.
9. Define appropriate animal models for the study of pediatric AIDS.
The approaches outlined above are not intended to be comprehensive nor are
they required. All research strategies that will lead to insights into the
mechanism of pathogenesis in pediatric HIV infection are encouraged under this
program announcement.
MECHANISM OF SUPPORT
The NIAID encourages investigator-initiated research on topics relevant to
pediatric AIDS. This program announcement invites R01 applications from
investigators who wish to play an active role in defining the direction of
such research. Although no funds are specifically set aside for funding
grants submitted in response to this program announcement, the NIH regards
high quality research in pediatric AIDS as an area of high priority. The
total project period for applications submitted in response to this program
announcement should not exceed five years for domestic institutions and three
years for foreign institutions.
ELIGIBILITY
Applications may be submitted by nonprofit or for-profit organizations and by
public or private entities such as universities, colleges, hospitals,
laboratories, units of State or local governments, and eligible agencies of
the Federal Government. Minority individuals and women are encouraged to
apply. Both foreign and domestic institutions are eligible to apply.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES
CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY
POPULATIONS
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research
grants and cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study; special
emphasis should be placed on the need for inclusion of minorities and women in
studies of diseases, disorders and conditions which disproportionately affect
them. This policy is intended to apply to males and females of all ages. If
women or minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 19
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.
REVIEW PROCEDURES
Although most applications in response to this announcement are expected to be
assigned to the NIAID, whenever there is inter-institute programmatic overlap
in the proposed research, the PHS Referral Guidelines will prevail in
assignment of applications to the institutes. Applications will be reviewed
for scientific and technical merit in accordance with the usual NIH peer
review procedures by the Division of Research Grants (DRG) study sections
specially constituted to review AIDS grant applications. Following study
section review, the applications will receive a second-level review by an
appropriate national advisory council. The earliest award date for successful
applications will be no more than six months from the receipt date.
AWARD CRITERIA
Applications will compete for available funds with all other approved
applications. The following will be considered in making funding decisions:
o Quality of the proposed project as determined by peer review
o Availability of funds
o Balance among research areas
Applications from institutions that have a General Clinical Research Center
(GCRC) funded by the NIH National Center for Research Resources may identify
the GCRC as a resource for conducting the proposed research by including a
letter of agreement from either the GCRC program director or Principal
Investigator.
NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 20
METHOD OF APPLYING
Applications must be submitted on the grant application form PHS 398 (rev.
10/88) and will be accepted at the regular application deadlines as indicated
below. The relevant dates for applications for AIDS-related research are:
Receipt Date Initial Review Council Review - Earliest Award
May 1 June/July September/October - Nov. 1
September 1 October/November January/February - March 1
January 2 February/March May/June - July 1
Application kits are available at most institutional business and
grant/contract offices and may be obtained from the Office of Grants
Inquiries, Division of Research Grants, Westwood Building, Room 449, National
Institutes of Health, Bethesda, Maryland 20892. The title and number of this
announcement, MECHANISMS OF HIV PATHOGENESIS IN PEDIATRIC POPULATIONS,
PA-91-25, must be typed in item 2 on the face page of the application.
The completed original application and twenty-three copies must be sent or
delivered to:
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
5333 Westbard Avenue
Bethesda, MD 20892**
INQUIRIES
Requests for further information may be directed to:
Gregory Milman, Ph.D., Chief
Pathogenesis Branch/DAIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Blvd., Room 242P
Bethesda, MD 20892
Telephone: (301) 496-8378
FAX: (301) 480-5703
This program is described in the Catalog of Federal Domestic Assistance No.
93.856 - Microbiology and Infectious Disease Research and 93.855 - Allergy,
Immunology and Transplantation Research. Grants are awarded under the
authority of the Public Health Service Act, Title IV, Section 301 as amended,
Public Law 78-410, Public Law 97-219; Public Law 99-158; Public Law 99-500;
and Report 99-711 to accompany HR 5233 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.
ERRATUM
MULTICENTER COOPERATIVE AGREEMENT FOR STUDYING NEURAL TUBE DEFECTS IN MUTANT
MICE
RFA: HD-91-09
P.T. 34; K.W. 0710030, 1002004, 1002019, 1002059, 0755030
National Institute of Child Health and Human Development
The number assigned to the above RFA (RFA HD-91-01), which appeared in the
February 1 issue of the NIH Guide for Grants and Contracts (Vol. 20, No. 5),
is in error. It should be changed to 'RFA 91-HD-09'.
**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. 7, February 15, 1991 - Page 21