kristoff@GENBANK.BIO.NET (Dave Kristofferson) (10/18/90)
NIH GUIDE - Vol. 19, No. 38, October 19, 1990
NOTICES
THE NATIONAL CELL CULTURE CENTER .....................(84/117)............... 1
National Center for Research Resources
Index: RESERCH RESOURCES
HEALTH AND SAFETY GUIDELINES FOR GRANTEES AND CONTRACTORS ..(120/223)........ 1
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
NOTICES OF AVAILABILITY (RFPs AND RFAs)
DETAILED DRUG EVALUATION OF ANTI-AIDS AGENTS (RFP) .........(229/291)........ 2
National Cancer Institute
Index: CANCER
REFERENCE LABORATORY FOR NONTUBERCULOUS MYCOBACTERIA ISOLATED
FROM AIDS PATIENTS (RFP) ...................................(294/335)........ 3
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
EVALUATION OF AIDS THERAPIES IN ANIMAL RETROVIRAL MODELS SIV (RFP) .......... 4
National Institute of Allergy and Infectious Diseases (338/381)
Index: ALLERGY, INFECTIOUS DISEASES
TECHNICAL SUPPORT SERVICES FOR THE NIDDK EPIDEMIOLOGY COMMITTEE (RFP) ....... 4
National Institute of Diabetes and Digestive and Kidney Diseases (384/420)
Index: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
EVALUATION OF PHARMACOKINETICS OF AIDS THERAPIES IN NON-HUMAN
PRIMATES (RFP) ..............................................(423/466)....... 5
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
MECHANISMS OF TOXICITY OF THERAPEUTIC AGENTS USED FOR HIV AND
AIDS-RELATED DISEASES (RFA ES-91-01) .............(481/618, 884/1099)........ 6
National Institute of Environmental Health Sciences
Index: ENVIRONMENTAL HEALTH SCIENCES
ONGOING PROGRAM ANNOUNCEMENTS
FOGARTY SENIOR INTERNATIONAL FELLOWSHIPS FOR U.S. SCIENTISTS (PA-91-02) ..... 7
Fogarty International Center (624/793)
Index: FOGARTY INTERNATIONAL CENTER
COGNITION AND MENTAL HEALTH: BEHAVIORAL AND NEURAL APPROACHES (PA-91-03) ...10
National Institute of Mental Health (801/870)
Index: MENTAL HEALTH
NOTE: The NIH Guide for Grants and Contracts will not be published
on October 26, 1990. The next issue will be November 2, 1990.
NOTICES
THE NATIONAL CELL CULTURE CENTER
P.T. 34; K.W. 0780005, 0780015
National Center for Research Resources
The National Cell Culture Center is a resource available to researchers
throughout the country. The Center will provide biomedical investigators with
customized services for large quantity production of animal cells and secreted
proteins. The goal is to facilitate basic research and ease the burden placed
on scientists by large-scale cell production. The Center, directed by Dr.
Mark Hirschel, provides cells in suspension and monolayer cultures in
quantities ranging from 25 to 150 liters.
In addition, cell-secreted products such as monoclonal antibodies, are
available in quantities of 1 to 100 grams.
An application form, obtained from the Cell Culture Center, must contain a
description of the relevant research project. Following approval of the
application by the Cell Culture Center's Scientific Advisory Board, the cell
line is sent to the Center, and grown to the requested amount. Researchers
are charged only for the consumable materials and a portion of the labor costs
required for each project. Application forms and inquiries should be directed
to:
Mark Hirschel, Ph.D.
Director
National Cell Culture Center
Endotronics, Inc.
Minneapolis, MN 55433
Telephone: 1-800-325-1112
The Cell Culture Center is supported by a cooperative agreement award from the
National Center for Research Resources, NIH.
HEALTH AND SAFETY GUIDELINES FOR GRANTEES AND CONTRACTORS
P.T. 34; K.W. 1014002, 0725010, 0725020
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
This notice is a republication, with minor modifications, of an April 1989
issuance on this subject. It is being reissued to emphasize its continuing
importance.
Organizations receiving grant or contract awards are responsible for
protecting their personnel from hazardous conditions. The Government is not
legally liable for accidents, illnesses, or claims arising out of research
performed under its awards, but the National Institutes of Health (NIH) and
the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) are
nonetheless aware that a variety of hazards threaten the safety and health of
both laboratory and clinical research personnel. Accordingly, the guidelines
that follow are designed to (1) identify potential hazards, (2) advise awardee
organizations and investigators of certain standards that should be considered
in order to address particular health and/or safety concerns, and (3)
emphasize that concerns about potentially hazardous conditions could result in
grant or contract funding delays until those concerns have been resolved to
the satisfaction of the awarding component.
1. Sources of potential danger to research personnel include the following
classes of hazard:
a. Biohazards (e.g., Human Immunodeficiency Virus, HIV; other
infectious agents; oncogenic viruses).
b. Chemical hazards (e.g., carcinogens; chemotherapeutic agents; other
toxic chemicals; flammable or explosive materials).
c. Radioactive materials.
2. The following guidelines and standards contain information designed to
assist grantees and contractors in providing a safe work environment for
research personnel. Therefore, depending upon the particular safety hazard at
NIH GUIDE - Vol. 19, No. 38, October 19, 1990 - Page 1
issue, grantees and contractors are expected to consult these guidelines.
Single copies may be obtained from:
Division of Safety
Office of Research Services
National Institutes of Health
Building, 31, Room 1C02
Bethesda, MD 20892
a. Biosafety in Microbiological and Biomedical Laboratories, U.S.
Department of Health and Human Services, Centers for Disease
Control and the National Institutes of Health. HHS Publication No.
(CDC) 88-8395. Additional copies may be purchased from U.S. GPO,
Washington, D.C. 20402 at a cost of $3.75 per copy. The stock # is
17-40-508-3.
b. Recommendations for Prevention of HIV Transmission in Health-Care
Settings. Morbidity and Mortality Report, August 21, 1987, Vol.
35, No. 2S.
c. Update: Universal Precautions for Prevention of Transmission of
Human Immunodeficiency Virus, Hepatitis B Virus, and Other
Bloodborne Pathogens in Health-Care Settings. Morbidity and
Mortality Weekly Report, June 24, 1988, Vol. 37, No. 24.
d. NIH Guidelines for the Laboratory Use of Chemical Carcinogens, NIH
Publication No. 81-2385.
The following materials are also recommended and may be purchased
from:
National Academy Press
2102 Constitution Avenue, N.W.
Washington, D.C. 20418
A. Prudent Practices for Handling Hazardous Chemicals in the
Laboratory. Price $19.95
B. Prudent Practices for the Disposal of Chemicals from the
Laboratory. Price $19.95
C. Biosafety in the Laboratory: Prudent Practices for Handling and
Disposal of Infectious Materials. Price $29.95
3. Grant applications and contract proposals posing special hazards typically
are identified during the initial review process, but such concerns can
formally be expressed by agency staff or consultants at any time prior to
award. Regardless of the timing of the described concern, grant or contract
funding could be delayed until the matter has been resolved to the
satisfaction of the awarding component.
Special hazards that are identified after an award is made may lead to
suspension of work under the grant or contract pending corrective action by
the awardee. (See 45 CFR 74, Subpart M, concerning grant suspension and 48
CFR 12.5 concerning contract "stop work" orders.)
Grantee and contractor organizations are not required to submit documented
assurance of their specific attention to the guidelines and standards
identified in section 2 of this notice. However, where dictated by the
circumstances, grantees and contractors should be able to provide evidence
that pertinent health and safety standards have been considered and, where
necessary, have been put in practice. Such evidence may be requested by
appropriate NIH and ADAMHA staff; for example, during a site visit.
NOTICES OF AVAILABILITY (RFPs AND RFAs)
DETAILED DRUG EVALUATION OF ANTI-AIDS AGENTS
RFP AVAILABLE: NCI-CM-17525-27
P.T. 34; K.W. 0715008, 0740012, 0760035, 0710100
National Cancer Institute
The Developmental Therapeutics Program (DTP), Division of Cancer Treatment
(DCT), National Cancer Institute (NCI), is seeking contractors to conduct a
NIH GUIDE - Vol. 19, No. 38, October 19, 1990 - Page 2
number of specialized in vitro and in vivo studies on compounds that are known
to inhibit the growth and/or cytopathic effects of human immunodeficiency
virus (HIV) and other similar retroviruses. Studies will be conducted to
assess the antiviral efficacy of potential anti-HIV agents newly identified by
the DTP anti-HIV in vitro screen. Emphasis will be placed on experiments to
determine the influence of dose, exposure time, and route of administration on
the antiviral activity of new agents in small animal retroviral model(s), and
to compare the in vivo effects with the in vitro effects obtained with the
same virus. Additional studies may include those to evaluate compound
tolerance in small animals, compare efficacies of related compounds and
determine the synergistic potential of compounds in combination. Information
gathered by the contract will be used to help in the determination of the most
appropriate candidate compound(s) for development and to devise and recommend
treatment strategies for clinical trial. In order to protect the laboratory
environment and safety of personnel, any offeror proposing to conduct studies
using HIV (or other retroviruses with similar pathogenic potential in man)
must utilize facilities meeting Biosafety Level 3 criteria. Compounds to be
studied will be selected and assigned by the Government. As compounds of a
commercially confidential nature (discreet) may be evaluated, pharmaceutical
and chemical firms will be excluded from the competition. Also, since
structural formulae of discreet materials may be provided by the Government on
occasion, the organization must be willing to sign a confidentiality of
information statement.
The Principal Investigator (PI) should have a M.D., D.V.M., or Ph.D. in one of
the relevant biological sciences (or equivalent experience), should have
managerial experience, and experience either in managing an in vivo screening
program utilizing small animals or in evaluating the efficacy, toxicity, or
mechanism of antiviral agents. The PI should devote approximately 25 percent
of his/her time to the project. It is anticipated that one incrementally
funded contract will be awarded for a period of three (3) years. Each
increment will be for a period of one year. The contract will be written on a
"level of effort" basis specifying that the contractor is to furnish
approximately 31,500 direct labor hours over three years (10,500 labor hours
per year).
RFP No. NCI-CM-17525-27 will be available on or about October 31, 1990.
Responses will be due December 17, 1990. Copies of the RFP may be obtained by
sending a written request to:
Mr. Johnny Jordan
Contract Specialist
Treatment Contracts Section
Research Contracts Branch
National Cancer Institute
Executive Plaza South, Room 603
Bethesda, MD 20892
This project is a recompetition of the work being done under contract number
N01-CM-87274 Southern Research Institute, Alabama. No collect calls will be
accepted.
REFERENCE LABORATORY FOR NONTUBERCULOUS MYCOBACTERIA ISOLATED FROM AIDS
PATIENTS
RFP AVAILABLE: RFP-NIH-NIAID-DAIDS-91-12
P.T. 34; K.W. 0715008, 0755018, 0755010
National Institute of Allergy and Infectious Diseases
The Treatment Research Program, Division of AIDS (DAIDS), National Institute
of Allergy and Infectious Diseases, has a need for organizations having the
capability and facilities to assemble and maintain a scientific database on
the results of the testing of nontuberculous mycobacteria originating from
patient materials that are infected with HIV; perform quantitative cultures
and standardized in vitro antibiotic susceptibility testing; and, perform
classification of isolates for serotyping, prepare necessary reagents, and
maintain collections of verified serotypes.
This is an announcement of an anticipated Request for Proposal (RFP).
RFP-NIH-NIAID-DAIDS-91-12 was issued on October 4, 1990. Closing date for
receipt of proposals is tentatively set for November 19, 1990.
The announcement of availability of this RFP appeared in the
Commerce Business Daily on September 17, 1990. The NIH regrets
NIH GUIDE - Vol. 19, No. 38, October 19, 1990 - Page 3
the delay in the publication of this announcement in the NIH
Guide for Grants and Contracts.
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.
Request for the RFP shall be directed in writing to:
Mr. Phillip Hastings Contract Management Branch Control Data Corp. Bldg., Rm.
222P 6003 Executive Boulevard National Institute of Allergy and Infectious
Diseases National Institutes of Health Bethesda, MD 20892 Telephone: (301)
496-0194
This advertisement does not commit the Government to make awards.
EVALUATION OF AIDS THERAPIES IN ANIMAL RETROVIRAL MODELS SIV
RFP AVAILABLE: RFP-NIH-NIAID-DAIDS-91-09
P.T. 34; K.W. 0715008, 0740012, 0710100
National Institute of Allergy and Infectious Diseases
The Basic Research and Development Program of the Division of AIDS, National
Institute of Allergy and Infectious Diseases (NIAID), NIH has a requirement
for evaluations of anti-retroviral therapies against SIV using both in vitro
and in vivo non-human Primate Animal Model Test Systems. A companion RFP
(RFP-NIH-NIAID-DAIDS-91-10) is available to provide pharmacokinetics studies
to support and complement the current initiative. These model systems will be
used by the Division of AIDS of the NIAID in its efforts to develop
anti-retroviral drugs and therapies, and to better understand how therapies
may be used to treat or prevent HIV infection and associated disease in
humans. Because of the similarities between SIV and HIV, and the
physiological closeness of non-human primates to humans, these models are
important in helping determine priorities for therapies to enter clinical
trials. The model systems to be investigated should reflect the clinical,
immunological, and virological aspects of HIV infections in humans. It is
anticipated that this information will permit the improved understanding of
treatment of HIV infections in humans. This announcement is a recompetition
and expansion of a previous program; multiple awards are anticipated. The
issuance of the RFP will be on or about October 11, 1990, and proposals will
be due by COB on or about January 8, 1991.
Request for the RFP shall be directed in writing to:
Ms. Mary Anne Glitz
Contract Management Branch
Control Data Corp. Bldg., Rm. 222P
6003 Executive Boulevard
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-1642
To receive a copy of the RFP, please supply this office with two
self-addressed mailing labels. All responsible sources may submit a proposal
which will be considered.
This advertisement does not commit the Government to make awards.
TECHNICAL SUPPORT SERVICES FOR THE NIDDK EPIDEMIOLOGY COMMITTEE
RFP AVAILABLE: RFP-NIH-NIDDK-91-1
P.T. 34; K.W. 0785055, 0755018, 1010013
National Institute of Diabetes and Digestive and Kidney Diseases
THIS ACQUISITION IS 100 PERCENT SMALL BUSINESS SET-ASIDE
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
is seeking an organization to provide technical support services for the NIDDK
Epidemiology Committee. These services shall include the performance of tasks
that involve the following: data management and data processing support in
analysis of complex biomedical data files; epidemiologic and biostatistical
NIH GUIDE - Vol. 19, No. 38, October 19, 1990 - Page 4
consultation in assessment and analysis of data relating to the various
diseases under the purview of the NIDDK; and preparation of technical reports
on these analyses.
This acquisition is under a 100 percent Small Business Set-Aside.
This Request for Proposals, RFP No. NIH-NIDDK-91-1, will be issued on or about
October 22, 1990, with a closing date December 7, 1990. To receive a copy of
this RFP, please supply this office with two self-addressed mailing labels and
cite the RFP number referenced above. Requests must be in writing and
addressed to:
Shirley A. Shores
Contracts Management Branch
National Institute of Diabetes and Digestive and
Kidney Diseases
Westwood Building, Room 602
Bethesda, MD 20892
This advertisement does not commit the Government to make an award.
EVALUATION OF PHARMACOKINETICS OF AIDS THERAPIES IN NON-HUMAN PRIMATES
RFP AVAILABLE: RFP-NIH-NIAIDS-DAIDS-91-10
P.T. 34; K.W. 0715008, 0710100
National Institute of Allergy and Infectious Diseases
The Basic Research and Development Program of the Division of AIDS, National
Institute of Allergy and Infectious Diseases (NIAID), NIH, has a requirement
for the evaluation of pharmacokinetics of AIDS therapies in non-human
primates. In addition, this initiative is intended to provide
pharmacokinetics support to other contracts using non-human primates to test
efficacy of anti-retroviral therapies. Many of the drugs to be evaluated are
provided from outside sources; thus, the contractor must be bound by the same
terms of confidentiality as the Division of AIDS of the NIAID in its efforts
to develop antiretroviral drugs and therapies; specifically, information will
be used in the design of trials in animal models and, where appropriate, in
the design of clinical trials. Because of the similarities between the
physiology of non-human primates to humans, these models are important in
helping determine priorities for therapies to enter clinical trials. It is
anticipated that this information will permit the improved understanding of
treatment of HIV infections in humans. This announcement is a new
solicitation; a single award is ancticipated. The issuance of the RFP will be
on or about October 11, 1990, and proposals will be due by COB on or about
January 8, 1991. This NIAID-sponsored project will take approximately 5 years
to complete. A cost-reimbursement contract is anticipated.
Request for the RFP shall be directed in writing to:
Ms. Mary Anne Glitz
Contract Management Branch
Control Data Corp. Bldg., Rm. 222P
6003 Executive Boulevard
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-1642
To receive a copy of the RFP, please supply this office with two
self-addressed mailing labels. All responsible sources may submit a proposal
which will be considered.
This advertisement does not commit the Goverment to make awards.
NIH GUIDE - Vol. 19, No. 38, October 19, 1990 - Page 5
MECHANISMS OF TOXICITY OF THERAPEUTIC AGENTS USED FOR HIV AND AIDS-RELATED
DISEASES
RFA AVAILABLE: ES-91-01
P.T. 34; K.W. 0715008, 0740012, 1007009
National Institute of Environmental Health Sciences
Letter of Intent Receipt Date: December 15, 1990
Application Receipt Date: January 15, 1991
PURPOSE
The National Institute of Environmental Health Sciences (NIEHS) announces the
availability of new funds to support research efforts aimed at understanding
the mechanisms responsible for the toxicologic side effects of therapeutic
agents utilized in the treatment of HIV and HIV-related infections.
RESEARCH GOALS AND SCOPE
This Request for Applications (RFA) is issued to foster research toward
understanding the toxicological effects, as related to their mechanisms of
action, of those agents showing promise for the treatment of the AIDS virus
and AIDS-related infections. The limited number of effective therapies for
HIV available requires that drugs with known side effects continue to be used
in humans. Hence, because of their toxicity, the use of these drugs in humans
is often limited. Therefore, the major research emphasis is directed toward
understanding the toxicological mechanisms of action for these drugs. It is
hoped that by understanding the mechanisms of action, alternative therapies
may be developed.
Drugs of interest include, but are not limited to, the nucleoside analogs.
Mechanistic studies on the toxicity resulting from combining therapeutic
compounds as well as studies on therapeutic agents for opportunistic
infections and other AIDS-related diseases are also encouraged. The
mechanisms of toxicity of the following examples are of particular interest:
o AZT-induced anemia, granulocytopenia, and/or myopathy.
o ddI-induced pancreatitis and peripheral neuropathy.
o ddC-induced peripheral neuropathy.
o ddA-induced immune and renal dysfunction. (Although this compound
is no longer in use, important new information regarding its
mechanism of toxicity could be useful in understanding the
toxicological effects of other prospective agents.)
o Certain cytokines and other biologic agents, given in conjunction
with the nucleoside analogs, appear to have potential in
ameliorating the toxicological effects of the analogs.
Unfortunately, little is known about the mechanism of
cytokine-induced toxicity. These compounds can be especially toxic
to the liver. One particular combination therapy,
AZT/alpha-interferon, can result in a myelotoxic condition. The
mechanism of action in which this toxic condition is caused by this
combination therapy remains to be established.
o Therapeutic agents for treating opportunistic infections in AIDS
patients also have known toxicological effects, e.g. pentamidine.
It is realized that promising new therapeutic agents may become available
between the time of issuance of this announcement and the deadline for receipt
of applications. Consideration may be given to applications looking at the
mechanisms of toxicity of such relatively new but very promising compounds.
ELIGIBILITY CRITERIA
It is important to emphasize that this research initiative is targeted for
those basic research scientists and research clinicians who are specifically
interested in the mechanisms of action of known toxicities. RESEARCH DIRECTED
TOWARD THE SCREENING OF NEW COMPOUNDS FOR TOXIC EFFECTS WILL BE CONSIDERED AS
NON-RESPONSIVE IN TERMS OF THIS ANNOUNCEMENT AND WILL NOT BE REVIEWED FOR
SCIENTIFIC MERIT!
NIH GUIDE - Vol. 19, No. 38, October 19, 1990 - Page 6
INCLUSION OF MINORITIES AND WOMEN IN STUDY POPULATIONS
It is NIH policy that clinical research findings should be of benefit to all
persons at risk of a disease regardless of race or gender. Thus, if patients
are involved in any of the studies, the inclusion of women and minorities as
members of study populations is required. If they are excluded, reasons for
this exclusion must be specified in the application.
MECHANISM OF SUPPORT
The mechanism of support for this activity will be the individual research
grant (R01). Support for grants is contingent upon receipt of appropriated
funds. It is anticipated that four to six meritorious applications will be
funded.
APPLICATION AND REVIEW PROCEDURES
Potential applicants are urged to submit a letter of intent by December 15,
1990. The letter of intent is nonbinding and is not a precondition for an
award. The letter should include the name(s) of the principal investigator
and principal collaborators along with information regarding which therapeutic
agents are to be studied in addition to a brief description of the mechanisms
of toxicity to be explored. This should not exceed two pages.
This RFA is a one-time solicitation with a specified deadline of January 15,
1991, for receipt of applications. Applications are to be submitted on form
PHS 398 (revised 10/88) which is available in the business or grants and
contracts offices at most academic and research institutions.
For the expedited review process, the original and 22 copies are to be sent to
the Division of Research Grants, Grant Application Receipt Office, Westwood
Building, Room 240, National Institutes of Health, Bethesda, Maryland
20892-4500.
Two additional copies should be forwarded to the program official at NIEHS
listed below. The applications will be evaluated for scientific merit by a
special review panel assembled by the Review Branch of NIEHS. Review criteria
include the significance and originality of the research goals and approaches;
feasibility of the research and adequacy of the experimental design; training,
experience, research competence, and dedication of the investigator(s);
adequacy of available facilities; provision for the humane care of animals;
and appropriateness of the requested budget relative to the work proposed.
Recommendations of the review panel will be considered by the National
Advisory Environmental Health Sciences Council at their June meeting. The
earliest award date for successful applications will be July 1, 1991.
INQUIRIES
For a copy of the complete RFA and preapplication consultation, contact:
Dr. Jerry A. Robinson
Program Administrator
Scientific Programs Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 541-7724
ONGOING PROGRAM ANNOUNCEMENTS
FOGARTY SENIOR INTERNATIONAL FELLOWSHIPS FOR U.S. SCIENTISTS
PA: PA-91-02
P.T. 22, 48; K.W. 0720005, 0710030
Fogarty International Center
Application Receipt Dates: January 10, May 10, September 10
PURPOSE
The Senior International Fellowship Program (SIF) was developed to enable U.S.
scientists with more than five years postdoctoral experience to carry out
research at foreign institutions for periods of three to twelve months. The
NIH GUIDE - Vol. 19, No. 38, October 19, 1990 - Page 7
intent is to enhance the exchange of ideas and information in all fields of
biomedical research between U.S. and foreign scientists.
Beginning with the January 10 receipt date, the SIF program has been modified
to provide: up to three separate visits (minimum three months) to the foreign
laboratory within a three-year period after activation, for a maximum of
twelve months; an increase in the foreign living allowance to $24,000 per
year; and an increase in the institutional allowance to $500 per month. The
stipend remains at $15,000 for the year.
BACKGROUND AND OBJECTIVES
The SIF provides opportunities to biomedical, behavioral, or health scientists
for study or research at a foreign institution. Prospective applicants must
have a clear understanding with the foreign host institution about the goals
of the fellowship and the work to be pursued.
The Fogarty International Center (FIC) will not accept any proposal that has
as its major feature brief observational visits; attendance at formal training
courses; or full-time clinical, technical, or teaching services. Successful
applicants, beginning with the January 10, 1991 receipt deadline, are afforded
the opportunity to divide their fellowship into as many as three separate
terms within a three-year period.
ELIGIBILITY
To be eligible for an SIF, an applicant must:
o Hold a doctoral degree in one of the biomedical, behavioral, or
health sciences;
o have 5 years or more postdoctoral experience;
o have had professional experience in one of the biomedical,
behavioral, or health sciences for at least 2 of the last 4 years;
o hold a full-time appointment on the staff of an institution, which
must be a non-Federal public or private not-for-profit research,
clinical, or educational institution;
o be invited by a nonprofit foreign institution;
o be a U.S. citizen or permanent U.S. resident;
o not have received more than one SIF previously; and
o not be employed by the Federal Government.
ELIGIBLE COSTS
SIFs are awarded for a total of 3 to 12 months. The award may be divided into
as many as three terms, utilized over a three-year period, with a minimum time
of three months for any term. Awardees may receive a maximum stipend of
$15,000 per year or $1,250 per month. The level of the stipend depends on the
amount of salary provided by the U.S. employer during the tenure of the
fellowship. The stipend plus the home institution support cannot exceed the
awardee's regular annual salary. No stipend will be provided if the awardee
receives salary support from other Federal sources. Awardees also receive a
foreign living allowance of $24,000 per year or $2,000 per month. This
allowance is not reduced by other support including federal funding. The
institution may advance the fellow up to $6,000 of the recommended allowance
during the first month the fellowship is activated to assist with relocation
expenses. The fellow's round-trip fare, economy class on a U.S. air carrier
between the U.S. city and host city abroad, will be provided for each of the
approved trips (maximum of 3). No travel allowance is provided for family
members. The award will include an institutional allowance of up to $6,000
per year, prorated at $500 per month for each visiting period. The fellow is
expected to use these funds to defray costs of research supplies and equipment
that are required at the foreign host institution.
REVIEW PROCEDURES AND CRITERIA
The initial review process will be conducted by the Division of Research
Grants and the following criteria will enter into the decision to recommend
approval or disapproval and will influence the priority score assigned to
approved applications:
NIH GUIDE - Vol. 19, No. 38, October 19, 1990 - Page 8
o The merit of the applicant's plans for the time spent at the
foreign host institution. The proposal should be relevant to the
biomedical research mission of the NIH and the FIC, related to the
applicant's ongoing work, and a bridge to its continuation after
the fellow returns to his or her home institution. The applicant
should plan to take advantage of special features of the foreign
host environment that are either unavailable or not readily
available in the United States. If more than one visit is planned,
each separate visit must be clearly justified.
o qualifications and background of the applicant to undertake the
proposed project and the ability to complete it within the time(s)
planned at the foreign host institution;
o evidence that the proposed arrangements will provide exchanges on
technical or scientific matters that will benefit the fellow and
the foreign host; and
o evidence that the proposed fellowship will enhance the applicant's
future research career.
Prior to funding, the Fogarty International Center's Advisory Board reviews
all applications for programmatic considerations.
AWARD ACTION
The FIC notifies applicants of their status approximately 6 months after
receipt of their applications. SIFs may be activated any time within 1 year
of the issue date on the official award notice.
Applications not funded at the end of the first complete review cycle will be
carried forward for two additional review cycles for funding consideration
before being automatically withdrawn.
METHOD OF APPLYING
Special application kits can be requested directly from the Fogarty
International Center only. A prospective applicant must:
o Complete the application forms;
o describe the benefits of the fellowship to both the fellow and the
foreign host and to both the applicant's and the host's
institution;
o carefully justify the benefits of each visit proposed for this
fellowship; and
o obtain a letter of invitation and curriculum vitae from the foreign
host. The letter should indicate that an understanding has been
reached with regard to the plan proposed by the applicant.
Receipt dates for completed applications are January 10, May 10, and September
10. Applications received too late for one review will be considered at the
next review cycle.
Note: The Fogarty International Center funds and administers a number of
fellowship programs. Some individuals who are eligible for a Senior
International Fellowship may also be eligible for one or more of these
fellowships; however, candidates can apply for only one fellowship during a
single review cycle.
For further information and the required application kit, please contact:
David A. Wolff, Ph.D.
Chief, International Research and Awards Branch
Fogarty International Center
Building 31, Room B2C21
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-1653
Facsimile: (301) 402-0779
NIH GUIDE - Vol. 19, No. 38, October 19, 1990 - Page 9
COGNITION AND MENTAL HEALTH: BEHAVIORAL AND NEURAL APPROACHES
PA: PA-91-03
P.T. 34; K.W. 0715095, 0404000, 1002030, 0414005
National Institute of Mental Health
The National Institute of Mental Health (NIMH) invites applications, using any
of the available research grant mechanisms, from investigators who seek to
determine the behavioral principles and brain mechanisms of cognition. These
mechanisms will reveal the fundamental behavioral principles and biological
mechanisms of cognition, broadly interpreted, including their development,
maintenance, and pathology over the lifespan of the organism.
Applications may be submitted by public or private nonprofit or for-profit
organizations such as universities, colleges, hospitals, laboratories,
research institutions, units of State or local governments, and eligible
agencies of the Federal Government. Women and minority investigators are
encouraged to apply.
INCLUSION OF MINORITIES IN STUDY POPULATIONS
Applicants are encouraged to give added attention (where feasible and
appropriate) to the inclusion of minorities in study populations for research
into the etiology of diseases, research in behavioral and social sciences,
clinical studies of treatment and treatment outcomes, research on the dynamics
of health care and its impact on disease, and appropriate interventions for
disease prevention and health promotion. If minorities are not included in a
given study, a clear rationale for their exclusion should be provided.
INCLUSION OF WOMEN IN STUDY POPULATIONS
Applicants are encouraged to consider the inclusion of women in the study
populations for all clinical research efforts. Exceptions would be studies of
diseases that exclusively affect males or where involvement of pregnant women
may expose the fetus to undue risks. Gender differences should be noted and
evaluated. If women are not to be included, a clear rationale should be
provided for their exclusion. In order to provide more precise information to
the treatment community, it is recommended that publications resulting from
research in which the study population was limited to one sex for any reason
other than the disease or condition studied exclusively affects that sex,
should state, in the abstract summary, the gender of the population studied,
e.g., "male patients," "male volunteers," "female patients," or "female
volunteers."
Applicants may request support for up to 5 years (renewable for subsequent
periods). Annual awards will be made, subject to continued availability of
funds and progress achieved. Applications will be accepted and reviewed
according to the regular NIMH review schedule.
Additional information concerning this announcement may be obtained from:
Richard Nakamura, Ph.D.
Room 11-105
Telephone: (301) 443-3948
or
Rodney Cocking, Ph.D.
Room 11C-10
Telephone: (301) 443-3942
The address for both of the above is:
Basic Behavioral and Cognitive Science Research Branch
Division of Basic Brain and Behavioral Sciences
National Institute of Mental Health
5600 Fishers Lane
Rockville, MD 20857
NIH GUIDE - Vol. 19, No. 38, October 19, 1990 - Page 10
------------------------- Full text of RFAs -------------------------
MECHANISMS OF TOXICITY OF THERAPEUTIC AGENTS USED FOR HIV AND AIDS-RELATED
DISEASES
RFA Available: ES-91-01
P.T. 34; K.W. 0715008, 0740012, 1007009
NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Letter of Intent Receipt Date: December 15, 1990
Application Receipt Date: January 15, 1991
BACKGROUND
The National Institute of Environmental Health Sciences (NIEHS) announces the
availability of new funds to support research efforts aimed at understanding
the mechanisms responsible for the toxicologic side effects of therapeutic
agents utilized in the treatment of HIV and HIV-related infections. The
NIEHS is the principal Federal Agency with responsibility for conducting and
supporting research concerned with the toxicological effects of chemical,
physical, and biological agents on human health. Since the NIEHS has the
major responsibility for studies on xenobiotic toxicity, it has been given the
task of addressing those issues related to the toxicity of AIDS therapeutic
agents, especially from the standpoint of understanding the mechanisms of
action for their toxicological effects. The NIEHS AIDS Program has been
developing information on target organ toxicity including toxicity to the
immune system, hematologic system, reproductive system, and nervous system and
is working as a part of the combined effort of all the NIH Institutes to
attack the AIDS problem. The information from the NIEHS AIDS Program will be
used to provide comparative toxicity information and to help predict toxicity
for a wide variety of drugs with potential therapeutic value.
With the continuing search for effective drugs to treat those individuals
who have become infected with HIV as well as other AIDS-related infections,
comes a real need to understand the potential side effects and overt toxicity
that arise from chronic drug therapy. Before prospective drugs for HIV
treatment can be utilized in clinical trials, it is important that these
agents be evaluated for toxicity in animals and/or other model systems for
toxicological testing. However, because of the haste to find appropriate
treatment strategies for this terrible disease, many promising therapeutic
agents have been cleared for expanded access to AIDS patients before extensive
information has become available regarding the potential toxicological effects
following chronic exposure. At present, even the most effective drugs, which
do not cure but slow the progress of the disease, are not without untoward
side effects.
For example, several patients treated with dideoxyinosine (ddI), a
nucleoside analog approved for clinical and expanded access trials, have
died of pancreatitis due to toxicological effects of the medication. These
deaths occurred in individuals not being monitored and were most prevalent in
individuals having had a prior history of pancreatic problems which further
illustrates the need to understand the target site and mechanism of toxicity
for these drugs under a variety of conditions. Even zidovudine (AZT), the
most widely used substance at present to combat the AIDS progression, has
unresolved questions regarding its toxicological effects on bone marrow cells
and the mechanism(s) by which that toxicity is caused. Although acute studies
suggest that the anemia is transitory, the hazards associated with long-term
exposure to AZT remain to be elucidated. Some patients, in fact, are
intolerant of this drug therapy. Dideoxyadenosine (ddA) and dideoxycytidine
(ddC) are two other nucleoside analogs that have shown promise for treating
HIV infection. But toxicological side effects, at least for ddC, have been
observed. Understanding the mechanisms of toxicity of these compounds may
provide insight for the development of new therapies to combat the disease and
contribute to our understanding of why some individuals are non-responsive to
the therapies.
Combination treatments using cytokines or other biologic agents with the
nucleoside analogs or an alternating treatment schedule of nucleoside analogs
may prove to be more effective and less toxic. Erythropoietin in conjunction
with AZT treatment has shown promise in reducing the anemia produced by AZT.
Significantly less bone marrow toxicity has been observed in patients given
alternating treatments of AZT and ddC. Other potentially effective drugs
are also being developed on a regular basis. Nonetheless, it is imperative
that toxicological determinations be researched at the very early stages of
therapeutic development. Thus, it is the intent of this program initiative to
focus on those toxicological problems associated with the various therapies
utilized in fighting HIV infection.
RESEARCH GOALS AND SCOPE
This Request for Applications (RFA) is issued to foster
research toward understanding the toxicological
effects, as related to their mechanisms of action, of those agents showing
promise for the treatment of the AIDS virus and AIDS-related infections. The
limited number of effective therapies for HIV available requires that drugs
with known side effects continue to be used in humans. Hence, because of
their toxicity, the use of these drugs in humans is often limited. Therefore,
the major research emphasis is directed toward understanding the toxicological
mechanisms of action for these drugs. It is hoped that by understanding the
mechanisms of action, alternative therapies may be developed.
Drugs of interest include, but are not limited to, the nucleoside analogs.
Mechanistic studies on the toxicity resulting from combining therapeutic
compounds, as well as studies on therapeutic agents for opportunistic
infections and other AIDS-related diseases, are also encouraged. The
mechanisms of toxicity of the following examples are of particular interest:
o AZT-induced anemia, granulocytopenia, and/or myopathy.
o ddI-induced pancreatitis and peripheral neuropathy.
o ddC-induced peripheral neuropathy.
o ddA-induced immune and renal dysfunction.
(Although this compound is no longer in use, important new
information regarding its mechanism of toxicity could be
useful in understanding the toxicological effects of other
prospective agents.)
o Certain cytokines and other biologic agents, given in
conjunction with the nucleoside analogs, appear to have
potential in ameliorating the toxicological effects of the
analogs. Unfortunately, little is known about the mechanism of
cytokine-induced toxicity. These compounds can be especially
toxic to the liver. One particular combination therapy,
AZT/alpha-interferon, can result in a myelotoxic condition.
The mechanism of action in which this toxic condition is caused
by this combination therapy remains to be established.
o Therapeutic agents for treating opportunistic infections in AIDS
patients also have known toxicological effects, e.g. pentamidine.
It is realized that promising new therapeutic agents may become available
between the time of issuance of this announcement and the deadline for receipt
of application. Consideration may be given to applications looking at the
mechanisms of toxicity of such relatively new but very promising compounds.
ELIGIBILITY CRITERIA
It is important to emphasize that this research initiative is targeted for
those basic research scientists and research clinicians who are specifically
interested in the mechanisms of action of known toxicities. RESEARCH DIRECTED
TOWARD THE SCREENING OF NEW COMPOUNDS FOR TOXIC EFFECTS WILL BE CONSIDERED
AS NON-RESPONSIVE IN TERMS OF THIS ANNOUNCEMENT AND WILL NOT BE REVIEWED FOR
SCIENTIFIC MERIT!
INCLUSION OF MINORITIES AND WOMEN IN STUDY POPULATIONS
It is NIH policy that clinical research findings should be of benefit to all
persons at risk of a disease regardless of race or gender. Thus, if patients
are involved in any of the studies, the inclusion of women and minorities as
members of study populations is required. If they are excluded, reasons for
this exclusion must be specified in the application.
MECHANISM OF SUPPORT
The mechanism of support for this activity will be the individual
research grant (R01). Support for grants is contingent upon receipt
of appropriated funds. It is anticipated that four to six meritorious
applications will be funded.
APPLICATION AND REVIEW PROCEDURES
Potential applicants are urged to submit a letter of intent by December 15,
1990. The letter of intent is nonbinding and is not a precondition for an
award. The letter should include the name(s) of the principal investigator
and principal collaborators along with information regarding which therapeutic
agents are to be studied in addition to a brief description of the mechanisms
of toxicity to be explored. This should not exceed two pages.
This RFA is a one-time solicitation with a specified deadline of January 15,
1991, for receipt of applications. Applications are to be submitted on form
PHS 398 (revised 10/88) which is available in the business or grants and
contracts offices at most academic and research institutions. The RFA label
available in the 10/88 revision of Application Form PHS 398 must be affixed to
the bottom of the face page. Failure to use this label could result in
delayed processing of your application such that it may not reach the review
committee in time for review. In addition, the RFA number and title should be
typed on line two of the face page of the application form.
For the expedited review process, the original and 22 copies are to be sent
to the:
Division of Research Grants, NIH
Grant Application Receipt Office
Westwood Building, Room 240
National Institutes of Health
Bethesda, Maryland 20892-4500**
Two additional copies should be forwarded to the program official at NIEHS
listed below. The applications will be evaluated for scientific merit by a
special review panel assembled by the Review Branch of NIEHS. The review will
be conducted in accordance with the usual Public Health Service peer review
procedures for research grants (Study Section). Review criteria include the
significance and originality of the research goals and approaches; feasibility
of the research and adequacy of the experimental design; training, experience,
research competence, and dedication of the investigator(s); adequacy of
available facilities; provision for the humane care of animals; and
appropriateness of the requested budget relative to the work proposed.
Recommendations of the review panel will be considered by the National
Advisory Environmental Health Sciences Council at their June meeting. The
earliest award date for successful applications will be July 1, 1991.
ADDITIONAL INFORMATION
Inquiries related to this Announcement and Letters of Intent should be
directed to:
Dr. Jerry A. Robinson
Program Administrator
Scientific Programs Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, North Carolina 27709
Telephone: (919) 541-7724
This program is described in the Catalog of Federal Domestic Assistance,
No. 93.112, Characterization of Environmental Health Hazards; 93.113,
Biological Response to Environmental Health Hazards; 93.114, Applied
Toxicological Research and Testing; 93.115, Biometry and Risk Estimation.
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.