kristoff@GENBANK.BIO.NET (Dave Kristofferson) (02/14/90)
Vol. 19, No. 6, February 9, 1990
NOTICES
ELECTRONIC TRANSMISSION OF THE NIH GUIDE FOR GRANTS AND CONTRACTS ..(84/108). 1
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
AAMC/NIH REGIONAL WORKSHOPS .............................(111/149)........... 1
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
INVENTIONS: IMPORTANT NOTICE FOR RESEARCH GRANTEES AND RESEARCH
CONTRACTORS .............................................(161/382)........... 2
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
NIH/FDA REGIONAL WORKSHOPS - PROTECTION OF HUMAN SUBJECTS ..(385/457)........ 4
National Institutes of Health
Food and Drug Administration
Index: NATIONAL INSTITUTES OF HEALTH
FOOD AND DRUG ADMINISTRATION
DATED ANNOUNCEMENTS (RFPs AND RFAs)
EVALUATION OF CHEMOPREVENTIVE AGENTS BY IN VITRO TECHNIQUES (RFP/MAA) ....... 5
National Cancer Institute (463/532)
Index: CANCER
PHASE I STUDIES OF NEW CHEMOPREVENTIVE AGENTS (RFP/MAA) ....(535/596)........ 6
National Cancer Institute
Index: CANCER
IN VITRO TRANSFORMATION OF ONCOGENE PRIMED CELLS BY GENOTOXIC
CHEMICALS (RFP) ............................................(599/638)........ 7
National Institute of Environmental Health Sciences
Index: ENVIRONMENTAL HEALTH SCIENCES
A RANDOMIZED TRIAL OF SMOKING CESSATION INTERVENTION FOR PREGNANT
WOMEN (RFP) ................................................(641/676)........ 8
National Institute of Child Health and Human Development
Index: CHILD HEALTH, HUMAN DEVELOPMENT
MINORITY DRUG ABUSE PREVENTION RESEARCH CENTERS (RFA DA-90-08) ..(679/848)... 8
National Institute on Drug Abuse
Index: DRUG ABUSE
ONGOING PROGRAM ANNOUNCEMENTS
PREVENTIVE PULMONARY ACADEMIC AWARD .......................(854/951).........10
National Heart, Lung, and Blood Institute
Index: HEART, LUNG, BLOOD
NOTICES
ELECTRONIC TRANSMISSION OF THE NIH GUIDE FOR GRANTS AND CONTRACTS
P.T. 16; K.W. 1004017
National Institutes of Health
In September 1989, the National Institutes of Health began transmitting the
NIH Guide for Grants and Contracts electronically via the computer
communications network BITNET. Those institutions that have been receiving
the electronic Guide are asked to let us know about their experience with this
electronic system. We would appreciate comments concerning the advantages,
disadvantages, and any problems encountered in using the electronic Guide.
This information will be very helpful to us in improving our service to you.
Please send your letters to:
M. Janet Newburgh, Ph.D.
Institutional Liaison Officer
Office of Extramural Programs
National Institutes of Health
Building 31, Room 5B31
Bethesda, Maryland 20892
Telephone: (301) 496-5366
Comments also can be sent to Dr. Newburgh electronically by using the BITNET
address Q2C@NIHCU.
AAMC/NIH REGIONAL WORKSHOPS
P.T. 42; K.W. 1014004
National Institutes of Health
On April 20-21, the George Washington University will host the first of four
regional workshops sponsored by the Association of American Medical Colleges
(AAMC), under contract with the National Institutes of Health (NIH), to
address issues in the promotion of integrity and responsibility in biomedical
research. These regional workshops are designed to serve as a forum for
discussing recent developments within the Public Health Service that include
the establishment of the Office of Scientific Integrity and the new regulation
requiring awardee institutions to assure that policies and procedures are in
place for investigating possible misconduct in science. The workshop will
address special topics such as training and mentoring, peer review and
authorship practices, and data ownership as well as dissemination of the
information developed by the Institute of Medicine study, "Promotion of
Responsibility in Research in the Health Sciences" supported by the NIH. The
workshop is expected to be of interest to program directors, investigators,
and academic administrators involved in behavioral and biomedical research.
CME credits will be available for the workshop through the George Washington
University Office of Continuing Medical Education.
Title: PROMOTION OF INTEGRITY AND RESPONSIBLE PRACTICE IN BIOMEDICAL RESEARCH
Location: Holiday Inn Crowne Plaza, Arlington Virginia
Contact:
Leah C. Valadez
The George Washington University Medical Center
Office of the Dean for Research
2300 Eye Street, N.W., Suite 514
Washington, DC 20037
Telephone: (202) 994-2801
Similar workshops are planned for Boston, Massachusetts; St. Louis, Missouri;
and San Diego, California. Dates will be announced in future notices.
NIH GUIDE - Vol. 19, No. 6, February 9, 1990 - Page 1
INVENTIONS: IMPORTANT NOTICE FOR RESEARCH GRANTEES AND RESEARCH CONTRACTORS
P.T. 34; K.W. 1014016
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
The following comments provide a brief review of current regulations affecting
inventions made with support from the National Institutes of Health (NIH) and
the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) research
grants or related awards (G, H, K, M, P, R, S, and U awards); research and
development contracts (N01 awards); and grants and contracts (N43, N44, R43,
and R44 awards) made under the Small Business Innovation Research Program.
Inventions made solely by trainees or fellows (assisted only by a T or F
award) are not subject to these guidelines.
Congress has long encouraged the use of the patent system by universities,
non-profit organizations, and small business firms. The principal concern is
to protect the public interest in inventions developed with the aid of Federal
funds, while giving due recognition to the legitimate interests of those who
have contributed to the invention. The key provisions of patent law as they
apply to inventions made with NIH and ADAMHA support are contained in several
references cited at the end of this notice under "Citations." The following
comments are based on those sources and describe procedures for the reporting
and subsequent disposition of such inventions.
DISCLOSURE: Federal law requires that any invention arising from
experimental, developmental, or research activities funded by Government
grants and contracts be promptly and fully reported (disclosed) by the
inventor to his or her employer, i.e., the contractor or grantee organization
(non-profit or for-profit, public or private). In turn, the organization must
fully disclose the invention to the NIH or ADAMHA at the address shown
immediately below. This disclosure must be submitted within 60 days of the
inventor's initial report to the organization and it shall be sufficiently
complete in technical detail to convey a clear understanding of the invention.
The disclosure also will identify the inventor, the grant or contract under
which the invention was made, and any publication or manuscript submitted for
publication that describes the invention. NOTE: Many organizations disclose
inventions by providing a single copy of any report form the inventor submits
for the organization's internal use. However, reporting an invention to the
NIH or ADAMHA by merely submitting its title or summary description is NOT an
acceptable disclosure. Since these disclosure reports contain proprietary
information they are not released to the public without the organization's
specific permission.
MAILING ADDRESS: The following office serves as the receipt point for any of
the documents described in this Notice, as well as for any invention-related
inquiries:
Extramural Inventions Reports Office National Institutes of Health ATT: Dr.
Howard Jenerick Building 31, Room 5B-41 Bethesda, Maryland 20892 Telephone:
(301) 402-0850
INVENTION RIGHTS: Most Government grant and contract awards for the
performance of experimental, developmental, or research work incorporate
standard patent rights clauses which state that, subject to certain
limitations, the ownership of rights to any invention is usually left with the
contractor or grantee organization. However, the organization must elect in
writing whether or not to retain title to the invention during the next one or
two years (see below) after the required disclosure to the Extramural
Invention Reports Office. Any organization that elects to retain the title is
thereafter obligated to file an initial patent application within a reasonable
period of time, i.e., one year or prior to any statutory bar date. Thus, the
NIH and ADAMHA strongly discourage organizations from attempting to protect or
license inventions as "trade secrets" without filing for patent protection.
If the organization elects not to file for a patent, it must so inform the NIH
or ADAMHA which then have the right to take title. (The title does not flow
to the inventor by default.) Agency staff will promptly evaluate the invention
and will file a patent application for the Government if this seems in the
public interest and it is practical to do so. If the Government obtains a
patent, the organization may retain a nonexclusive, royalty-free license and
the inventor may receive royalty payments according to a standard formula. If
the agency elects not to exercise the Government's rights in the invention,
these rights may be granted back to the inventor, who may then file for a
patent.
PATENT APPLICATION and ACKNOWLEDGEMENT: At the time the organization or the
inventor submits the formal application to the U. S. Patent Office, a copy
NIH GUIDE - Vol. 19, No. 6, February 9, 1990 - Page 2
also should be sent to the Extramural Invention Reports Office along with the
obligatory license (see below.) The patent application must include the
following statement:
"This invention was made with Government support under (identify the
grant/contract) awarded by the (cite the awarding agency, National Institutes
of Health or Alcohol, Drug Abuse, and Mental Health Administration). The
Government has certain rights in the invention."
TIMELINESS for ELECTION OF RIGHTS and FILING of PATENT APPLICATIONS: Timing
is critical in patent law because there are statutory deadlines that must be
met to avoid loss of valuable patent rights. The laws distinguish between
inventions that are "disclosed" by confidential reporting to the Government
and inventions that are "disclosed" to the public through speeches or
publications. NOTE: Abstracts and posters presented at scientific meetings
are considered as publications, and if abstracts for society meetings are
mailed in early, the POST MARK DATE is considered the publication date.
If the invention has NOT been disclosed to the public, i.e., it has only been
reported to the Government on a confidential basis, there is a two-year open
period for filing a patent application.
Timing for United States Patent Applications after Public Disclosure: Under
U. S. patent law a valid patent application may be filed only within a
one-year grace period after the publication date of a printed article that
discloses the invention.
Timing for Foreign Patent Applications after Public Disclosure: Other
countries usually do not allow a one-year grace period after publication,
unless a U. S. patent application has been filed prior to the publication
date.
NOTE: If no application is filed during these open periods, the invention is
considered to have been dedicated to the public and can no longer be patented.
Since the Government and the inventor have certain rights to the invention as
outlined above, the limited open periods for seeking patent protection makes
it important for the organization to proceed promptly in its evaluation of the
invention and inform the Extramural Invention Reports Office of its decision
in timely fashion.
LICENSE: Every patent applicant (individual or institutional) is required to
provide the Government with a nonexclusive, irrevocable, paid-up license in
the invention. (A sample license form is provided at the end of this Notice.)
A single copy of this license should be sent to the Extramural Invention
Reports Office at the time the patent application is filed.
PATENT: The successful applicant will furnish a copy of the issued patent to
the Extramural Invention Reports Office.
PREFERENCE FOR UNITED STATES INDUSTRY: The patent holder or its assignee will
not license or grant any person the exclusive right to use or sell the
invention in the United States unless the products are manufactured
substantially in the United States.
INVENTION UTILIZATION REPORTS: Periodic utilization reports for each
invention must be filed with the Extramural Invention Reports Office. Such
reports shall be submitted every two years and shall include information
regarding the status of development, date of first sale or use, and gross
royalties received by the organization. These utilization reports are not
releasable to persons outside the Government without permission of the grantee
or contractor, or within the Government except on a need-to-know basis.
SPECIAL NOTE: Chemical compounds having potential medicinal or other
utilities are often synthesized or identified during research financed by
Federal funds. Such a compound is not patentable until a use can be
described. Although the compound need not be tested, the patent application
must "teach" the reader how to use the substance. It is NIH and ADAMHA policy
that such compounds should be screened adequately so that all possible uses
may be ascertained and any promising compounds be developed for widest
possible use. The screening services of the Cancer Chemotherapy National
Service Center and the Walter Reed Army Institute of Research should be
utilized for this purpose, whenever appropriate.
LEGAL CONTACT: It is expected that institutions will rely primarily on their
own legal counsel for advice and interpretation of relevant Governmental laws
and regulations. However, if a technical question arises that requires an
answer from a Government patent attorney please contact:
NIH GUIDE - Vol. 19, No. 6, February 9, 1990 - Page 3
PATENT BRANCH
DHHS Office of the General Counsel
Public Health Division
National Institutes of Health
Building 31, Room 2B-62
Bethesda, Maryland 20892
Telephone: (301) 496-7056
INVENTION REPORTS in GRANT APPLICATIONS and FINAL REPORTS: Please note that
inventions arising out of NIH and ADAMHA supported projects are customarily
reported to the awarding component in competing and non-competing applications
for continuation awards. To insure confidentiality, inventions reported
through this channel should be described by title or summary paragraph only.
It may be wise to discuss these descriptions with the organization's patent
counsel before submission.
At the expiration or termination of each project, the Final Invention
Statement and Certification (Form HHS 568) is sent to the Grants Management
Officer of the awarding component. In the case of terminated contracts any
inventions are identified in the contract close-out letter. (NOTE: Grantees
are reminded that the Statement is required within 90 days following the
expiration or termination of support for the project.) Because of brevity,
these latter reports do not meet the requirements for full disclosure.
CITATIONS: Important changes in public laws in recent years have led to
substantial revisions of the Agency regulations affecting inventions made with
Federal support. The requirements of Public Laws 96-517 and 98-620 have been
implemented in the regulations published in Title 37 Code of Federal
Regulations (CFR) Part 401 and 45 CFR Part 8. The standard patent rights
clauses that are incorporated into all NIH and ADAMHA grants and research
contracts appear in 37 CFR Section 401.14.
SAMPLE License form for use by Institutional Official or individual inventor:
LICENSE TO THE UNITED STATES GOVERNMENT
This instrument confers to the United States Government, as represented by the
Department of Health and Human Services, a nonexclusive, nontransferable,
irrevocable, paid-up license to practice or have practiced on its behalf
throughout the world the following subject invention:
Invention Title :
Inventor(s) :
Patent Application
Serial No. :
Filing Date :
Title :
Country, if other than
United States :
This subject invention was conceived or first actually reduced to practice in
performance of a government-funded project, (National Institutes of Health or
Alcohol, Drug Abuse, and Mental Health Administration grant/contract) No.
_______________________________.
Principal rights to this subject invention have been left with the Licensor:
_____________________________________________________, subject to the
provisions of 37 CFR 401 and 45 CFR 8.
Signed:___________________________________Date:__________________
Typed Name: Title:
NIH/FDA REGIONAL WORKSHOPS - PROTECTION OF HUMAN SUBJECTS
P.T. 42; K.W. 0783005
National Institutes of Health
Food and Drug Administration
The National Institutes of Health (NIH) and the Food and Drug Administration
(FDA) are continuing to sponsor a series of workshops on responsibilities of
researchers, Institutional Review Boards (IRBs), and institutional officials
for the protection of human subjects in biomedical and behavioral research.
The workshops are open to everyone with an interest in research. The meetings
should be of special interest to those persons currently serving or about to
begin serving as a member of an IRB. The current schedule includes:
NIH GUIDE - Vol. 19, No. 6, February 9, 1990 - Page 4
o Dates: March 8-9, 1990
Location: Denver, Colorado
Title of Workshop: "IRB Issues"
Contact:
Ms. Mary Jane Peratt
Secretary, IRB
University of Colorado Health Sciences Center
4200 East 9th Avenue (Box C290)
Denver, Colorado 80262
Telphone: (303) 270-7960
o Dates: June 22-23, 1990
Location: Seattle, Washington
Title of Workshop: "NIH/FDA Regional Human Subjects Protections Workshop"
Contact:
University of Washington
Continuing Medical Education
Washington Building (Suite 2000)
1325 4th Avenue
Seattle, Washington 98101
Telephone: (206) 543-1050
o Dates: July 19-20, 1990
Location: St. Louis, Missouri
Title of Workshop: "NIH/FDA Regional Human Subjects Protections workshop"
Contact:
Ms. Leigh Tenkku
Assistant Director of Research Administration
Jewish Hospital of St. Louis
at Washington University Medical Center
216 South Kings Highway
St. Louis, Missouri 63110
Telephone: (314) 454-8322
NIH/FDA have planned human subjects regional workshops in other parts of the
United States. For further information regarding these workshops, contact:
Darlene Marie Ross
Human Subjects Education Program Coordinator
Office for Protection from Research Risks
National Institutes of Health
Building 31, Room 5B43
9000 Rockville Pike
Bethesda, Maryland 20892
Telephone: (301) 496-8101
DATED ANNOUNCEMENTS (RFPs AND RFAs)
EVALUATION OF CHEMOPREVENTIVE AGENTS BY IN VITRO TECHNIQUES
RFP/MASTER AGREEMENT ANNOUNCEMENT AVAILABLE: NCI-CN-05253-33
P.T. 34; K.W. 0740018
National Cancer Institute
The National Cancer Institute (NCI), Division of Cancer Prevention and Control
(DCPC), Chemoprevention Branch, wishes to award Master Agreement contracts for
Evaluation of Chemopreventive Agents by In Vitro Techniques. The required
services will be defined by Master Agreement Orders (MAOs) issued during the
period of performance.
Pursuant to the MAOs, the contractor shall screen and evaluate the activity of
chemopreventive agents in various in vitro assays of cell transformation.
NIH GUIDE - Vol. 19, No. 6, February 9, 1990 - Page 5
Agents with potential chemopreventive activity are identified by epidemiologic
surveys, initial laboratory (experimental) findings, observations in the
clinical setting, or structural homology with agents having known
chemopreventive activity. A rigorous and systematic evaluation of these
candidate agents is necessary before their efficacy can be examined in
clinical trials for cancer prevention. In vitro screening and evaluation
techniques measuring the ability of these chemopreventive agents to inhibit
transformation provides a relatively rapid and efficient means of qualifying
these agents for further evaluation for the prevention of cancer in humans.
Agents to be investigated by this project are potentially hazardous. The in
vitro systems may involve the use of carcinogens, tumor cells or tumor
viruses. Laboratory practices shall be employed which will keep any element
of risk to personnel at an absolute minimum. Where indicated, tissue and
compound handling must be performed in (at least) Class I laminar flow
cabinets that must meet NIH specifications for work with these agents. The
offeror shall comply with NCI safety standards for research involving chemical
carcinogens (DHHS Publication No. NIH 76-900 and the Food and Drug
Administration Good Laboratory Practices Regulations).
It is estimated that approximately four (4) MAOs per year will be issued
pursuant to the award(s) of the Master Agreement (MA) contracts. The MAs
awarded as a result of this Request for Proposals (RFP) will remain in force
for a period of two years.
The contractor must have or be able to obtain all the equipment necessary to
accomplish the studies, including but not limited to laminar flow hoods, CO(2)
incubators, equipment for sterility testing, isotope counters,
spectrophotometer, hazardous chemical storage cabinets and refrigerators and
equipment such as microscopes and miscellaneous laboratory equipment. The
laboratory shall have or have access to appropriate terminal and computer
facilities and equipment for data collection and storage.
The purpose of this acquisition is to qualify additional contractors for an
existing pool of Master Agreement Holders. There are currently six (6)
qualified contractors in this pool. The period of performance of the Master
Agreement pool runs through May 30, 1992, which would be the expiration date
for any new Master Agreement Holders added as a result of awards from this
Master Agreement Announcement (MAA). It is estimated that up to four (4) MAOs
per year will be issued pursuant to the MA contracts. The MAA will be
available on approximately February 13, 1990. The proposal due date will be
approximately March 30, 1990.
Copies of MAA/RFP NCI-CN-05253-33 may be obtained by sending a written request
to:
Mr. Alan Kraft, Contract Specialist
National Cancer Institute
Research Contracts Branch, PCCS
Executive Plaza South, Room 635
Bethesda, Maryland 20892
Telephone: (301) 496-8603
PHASE I STUDIES OF NEW CHEMOPREVENTIVE AGENTS
RFP/MASTER AGREEMENT ANNOUNCEMENT AVAILABLE: NCI-CN-05254-33
P.T. 34; K.W. 0740018, 0710100, 0755015
National Cancer Institute
The National Cancer Institute (NCI), Division of Cancer Prevention and Control
(DCPC), Chemoprevention Branch, wishes to award Master Agreement (MA)
contracts for Phase I Studies of New Chemopreventive Agents and to perform
pharmacokinetic studies during these Phase I Studies. The objective of these
studies is to determine the parameters and characteristics of toxicity in
humans, the safely delivered dose, and the basic clinical pharmacokinetics of
agents emerging from the NCI chemoprevention agent development program so that
subsequent Phase III risk-reduction trials can be appropriately designed.
The Master Agreement Holder shall develop and conduct the following Task I and
Task II studies:
TASK I: Phase I Studies - Phase I studies shall provide the parameters and
characteristics of drug toxicity, the safely delivered dose and a recommended
Phase II/III dose. Phase I clinical studies with combinations of agents may
NIH GUIDE - Vol. 19, No. 6, February 9, 1990 - Page 6
be performed if mutually agreed upon by the contractor and the Project
Officer.
TASK II: Pharmacokinetic Studies - Pharmacokinetic studies shall provide the
parameters of drug absorption, blood concentration--time profiles,
distribution and excretion. Using classical and non-classical modeling, the
pharmacokinetic data shall be used to determine probable patterns of
distribution, and excretion, compartmentalization and enterohepatic
recirculation, and to include identification as well as distribution and
excretion of metabolites.
The MA shall certify a holder's qualification to compete for both Tasks I and
II. For a given agent tested, qualifications to carry out both Tasks I and II
must exist, although only Task II may be required.
It is estimated that investigators/institutions shall be deemed to be
qualified via peer review to be included in the MA. A maximum of ten master
agreement orders (including both Tasks I and II), requiring approximately 200
subjects, shall be issued annually for studies on specific agents.
The purpose of this acquisition is to qualify additional contractors for an
existing pool of Master Agreement Holders. There are currently six (6)
qualified contractors in the pool. The period of performance of the MA pool
runs through July 26, 1993, which would be the expiration date for new Master
Agreement Holders, too. The Master Agreement Announcement will be available
on approximately February 13, 1990. The proposal due date will be
approximately March 30, 1990.
Copies of MAA NCI-CN-05254-33 may be obtained by sending a written request to:
Mr. Alan Kraft, Contract Specialist
National Cancer Institute
Research Contracts Branch, PCCS
Executive Plaza South, Room 635
Bethesda, Maryland 20892
Telephone: (301) 496-8603
IN VITRO TRANSFORMATION OF ONCOGENE PRIMED CELLS BY GENOTOXIC CHEMICALS
RFP AVAILABLE: NIH-ES-90-05
P.T. 34; K.W. 0785140, 1002019, 0755035, 1007009
National Institute of Environmental Health Sciences
The National Institute of Environmental Health Sciences (NIEHS), National
Institutes of Health (NIH), is soliciting proposals for a project to study in
vitro transformation induced by chemicals in cells that are engineered to
express cellular oncogenes or other genes likely to be involved in neoplastic
processes. The conceptual framework for this project is the hypothesized
cooperation between experimentally activated oncogenes and chemically induced
genetic effects where neither event alone is sufficient to cause
transformation. The genetic manipulation is directed to the activation of
proto-oncogenes, inappropriate expression or transcriptional activation,
rather that somatic mutation in coding sequences. Proto-oncogenes that are
cloned into retroviral derived vectors and introduced into recipient cells
will provide the method for generating target cell populations. The project
will include the following tasks: Task 1 - Recombinant DNA cloning,
construction of proto-oncogene recombinants and generation of retroviral
vectors for nonmutated mouse proto-oncogenes; Task 2 - Introduction of
vectored oncogenes into test cells and characterization of cellular
phenotypes; and Task III - Characterization of vectored subclones exposed to
selected chemicals. A three-year contract is anticipated. The Government
estimates that the project will require approximately 1.5 professional person
years, 1.5 technical person years, and .25 administrative person years of
effort per year. The Request for Proposals (RFP) will be released on or about
February 6, 1990, and responses will be due to be received by the Contracting
Officer sixty (60) days thereafter. All responsible sources may submit a
proposal that shall be considered by the agency.
Requests should reference RFP NIH-ES-90-05 and should be forwarded to:
National Institute of Environmental Health Sciences
Contracts and Procurement Management Branch, OM
ATTN: Mary B. Armstead, Contracting Officer
79 T.W. Alexander Drive, 4401 Building, P.O. Box 12874
Research Triangle Park, North Carolina 27709
NIH GUIDE - Vol. 19, No. 6, February 9, 1990 - Page 7
A RANDOMIZED TRIAL OF SMOKING CESSATION INTERVENTION FOR PREGNANT WOMEN
RFP AVAILABLE: NICHD-PRP-90-12
P.T. 34, II; K.W. 0404019, 0755015, 0755020
National Institute of Child Health and Human Development
The National Institute of Child Health and Human Development (NICHD) is
seeking a contractor to provide assistance in carrying out a randomized
clinical trial to assist pregnant women to stop smoking during pregnancy. The
clinical trial, Smoking Trial of Pregnancy Project (STOP), is evaluating the
effectiveness of a smoking cessation intervention program to be incorporated
as part of routine prenatal care. Private physicians' offices will be
recruited to participate in this randomized controlled clinical trial. The
intervention has been designed as a self-help smoking cessation intervention
with physician endorsement. During the pilot pre-test phase, the incumbent,
Westat, Inc. and their subcontractor, Porter/Novelli, helped to acquire,
design and compile educational materials and protocols for the project. All
materials developed or acquired under the pre-test pilot contract will be
supplied by the government to the awardee of the contract for the STOP main
trial.
The issuance of the RFP will be on or about February 5, 1990 and the proposals
are due 2:00 pm (Local Time), March 15, 1990. Those organizations desiring a
copy of the above RFP may send their written request with two self-addressed
mailing labels to:
Mrs. Carletha Gates
Contract Specialist
NICHD, OGC, CMS
Executive Plaza North, Room 515
Bethesda, Maryland 20892
All responsible sources may submit a proposal which will be considered. This
advertisement does not commit the Government to award a contract.
MINORITY DRUG ABUSE PREVENTION RESEARCH CENTERS
RFA AVAILABLE: DA-90-08
P.T. 04, FF, II; K.W. 0404009, 0745027, 0411005, 0755030
National Institute on Drug Abuse
Application Receipt Date: May 17, 1990
PURPOSE
The purpose of this announcement is to encourage the development of
multidisciplinary research centers that will improve our ability to prevent
drug abuse among minority populations. Minority populations include American
Indian/Alaskan Natives, Asian Americans, Blacks, Hispanics, and/or Native
Hawaiians/Pacific Islanders. The proposed Centers are designed to: 1)
improve our understanding of etiologic factors that predispose individuals
from minority communities to initiate drug use; 2) identify factors involved
in the progression from initial drug use to drug dependence; 3) develop
criteria and early identification methodologies for use with children and
adolescents at high risk for drug abuse; 4) design and test preventive
interventions at the individual and small group level through controlled
randomized studies; 5) assess the progression of drug use through prospective
longitudinal studies of high-risk populations; 6) develop a series of
conferences and workshops addressing prevention research issues of specific
relevance to understanding etiologic factors and intervention strategies among
minority populations; 7) train minority investigators to conduct drug abuse
prevention research; and 8) involve the minority community in the development
and implementation of a research program.
RESEARCH OBJECTIVES
Prevention and intervention strategies demonstrate differential effects within
various ethnic groups and socioeconomic populations. Multiple intervention
strategies are needed within any geographic location to block and delay the
initiation of drug-use behavior and to impede progression to drug dependency
and associated social, psychological, and physiological sequelae.
NIH GUIDE - Vol. 19, No. 6, February 9, 1990 - Page 8
Etiological studies designed to specify deferential causes for initiating,
continuing and discontinuing drug abuse within and among ethnic groups in
urban, suburban and rural geographic areas are needed. For example, are there
selective or other factors associated with blacks who remain in school
compared to blacks who do not graduate that "protect" them from drug abuse?
What is the role of the educational system in reducing, delaying or
eliminating drug use? Given the same environment and equivalent level of
being "vulnerable" to drug abuse, what family, social, environmental
protectors exist to prevent the use of drugs?
Previous surveys of minorities rarely have included high-risk groups such as
school dropouts, runaways, and prisoners, so the current estimates of drug
abuse in minority populations may be inaccurate. Current research indicates
that dropouts have higher rates of illicit drug use than minority youth in
school. Such data suggest the need for community-wide drug abuse education,
prevention and intervention programs in addition to the school-based programs.
More research is needed to explore the relationship between poor school
performance and acculturation-related stress with drug abuse among minority
youth. Areas related to the putative crime/drug connection among blacks needs
further examination to understand more fully the causes and extent of the
relationship within minority populations.
Applications for Minority Drug Abuse Prevention Research Centers are
encouraged but not restricted to any of the four content areas among minority
groups: Families and Multi-Generational Factors; Environmental and Cultural
Factors; High-Risk Children, Adolescents, and Young Adults; and Women and
Drugs.
INCLUSION OF FEMALES IN THE STUDY POPULATION
Applicants are urged to consider the inclusion of females in the study
populations for all clinical research efforts. Exceptions would be studies of
diseases which exclusively affect males or where involvement with pregnant
women may expose the fetus to undue risks. Gender differences should be noted
and evaluated. If females are not to be included, a clear rationale should be
provided for their exclusion.
In order to provide more precise information to the research and practitioner
community, it is recommended that publications resulting from research
sponsored by the Alcohol, Drug Abuse, and Mental Health Administration in
which the study population was limited to one sex for any reason other than
that the disease or condition studied exclusively affects that sex, should
state, in the abstract summary, the gender of the population studied, e.g.,
"male subjects," "female subjects".
MECHANISM OF SUPPORT
The mechanism of support for this announcement will be the specialized center
(P50). Initial center awards are limited to $600,000 (direct costs) for the
first year of the grant and up to $750,000 (direct costs) for each subsequent
year. It is anticipated that approximately three grants will be awarded under
this announcement.
REVIEW PROCEDURES
The Division of Research Grants, NIH, serves as a central point for receipt of
applications for most discretionary Public Health Service grant programs.
Applications received under this announcement will be assigned to an initial
review group (IRG) in accordance with established Public Health Service
Referral Guidelines. The IRG, consisting primarily of non-federal scientific
and technical experts, will review the applications for scientific and
technical merit. Notification of the review recommendations will be sent to
the applicant after the initial review. Applications will receive a
second-level review by the National Advisory Council on Drug Abuse whose
review may be based on policy as well as scientific merit considerations.
Only applications recommended for approval by the Council may be considered
for funding.
APPLICATION PROCEDURES
An application for a Minority Drug Abuse Prevention Research Center grant must
provide the following information within the general proposal: research plan
to include specific information on the Center's research theme, goals, and
objectives; detailed descriptions of the specific research projects and their
relationship to the core program; identification of key scientists and their
roles and responsibilities on specific projects and research teams; and
discussion of the management structure to be employed to organize and
coordinate multidisciplinary scientific research initiatives; the research
NIH GUIDE - Vol. 19, No. 6, February 9, 1990 - Page 9
program plan must be organized around a central research theme and address the
research and administrative requirements established by this announcement.
Furthermore, the proposal must include a description of training of research
personnel; evidence of a strong community relationship with demonstrated
experience of working in the target community; and descriptions of
conferences, publications, and other methods for the dissemination of research
findings.
Applicants should use the research grant application form PHS 398 (rev.
10/88). The RFA number [DA-90-08] and the title of this announcement,
"Minority Drug Abuse Prevention Research Research", should be typed in item
number 2 of the face page of the PHS 398 application form.
When using the PHS 398 application form to Applicants must affix the RFA label
available in the 398 to the bottom of the face page. Failure to use this
label could result in delayed processing of the application such that it may
not reach the review committee in time for review.
Application kits containing the necessary forms and instructions may be
obtained from business offices or offices of sponsored research at most
universities, colleges, medical schools, and other major research facilities.
If such a source is not available, the following office may be contacted for
the necessary application material:
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A54
Rockville, Maryland 20857
Telephone: (301) 443-6710
The signed original and six (6) permanent legible copies of the completed
application should be sent to:
Division of Research Grants, NIH
Westwood Building, Room 240
Bethesda, Maryland 20892**
INQUIRIES
Further information and consultation on program requirements relevant to
prevention research can be obtained from:
Dr. Zili Amsel
Chief, Prevention Research Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A20
Rockville, Maryland 20857
Telephone: (301) 443-1514
ONGOING PROGRAM ANNOUNCEMENTS
PREVENTIVE PULMONARY ACADEMIC AWARD
P.T. 34; K.W. 0715065, 0745027, 0404000, 0404019
National Heart, Lung, and Blood Institute
Application Receipt Date: July 23, 1990
The Division of Lung Diseases (DLD), National Heart, Lung, and Blood Institute
(NHLBI), National Institutes of Health (NIH), announces the fifth and final
competition for the Preventive Pulmonary Academic Award. The dual objectives
of this award are to encourage (1) the development and/or improvement in
teaching prevention of respiratory diseases in both undergraduate and graduate
medical training, and (2) research in methods for the prevention of lung
diseases. It is anticipated that approximately four awards will be made.
ELIGIBILITY: A candidate for this award must be a physician with both
clinical and academic skills who is an established faculty member in an
accredited academic medical institution. The candidate must commit a minimum
of 50 percent effort to the program. An institution sponsoring a candidate
for the award must show commitment to developing and improving the teaching of
prevention of lung diseases, identifying educational resources, allowing time
for the awardee to acquire educational skills, and providing facilities for
research.
NIH GUIDE - Vol. 19, No. 6, February 9, 1990 - Page 10
Applications from faculty members at minority medical schools are especially
encouraged.
PROVISION OF THE AWARD: This award will provide up to $40,000 salary support
for the awardee, plus appropriate fringe benefits and up to $20,000 a year for
related research support. In addition, each awardee may apply for up to
$10,000 for technical assistance (see pages 4-5 of the Guidelines for this
award); the use of these funds will be coordinated among other awardees and
must be approved by the DLD, NHLBI. Funds will be provided for the
reimbursement of actual indirect costs at a rate up to, but not exceeding,
eight percent of the total direct costs of each award, exclusive of tuition,
fees, and expenditures for equipment.
CURRICULA DEVELOPMENT: Curricula topics which might be addressed include
identification of and interventions with populations at risk for respiratory
diseases, prevention of respiratory infections, methods for encouraging
smoking cessation, and respiratory disturbances during sleep.
RESEARCH PLANS: Research topics might include methods of intervening with
populations at risk, methods for teaching prevention, smoking cessation,
self-management of chronic lung diseases, and cost effectiveness of preventive
measures. Educational and/or behavioral approaches to the prevention of
respiratory diseases and/or the promotion of lung health are encouraged.
Letter of intent: Prospective applicants are asked to submit a one-page
letter of intent that includes a descriptive title, name of the principal
investigator(s), and any other participating institutions. Such letters are
requested for the purpose of obtaining an indication of the number of
applications to be received, and therefore the NHLBI usually does not
acknowledge their receipt. A letter of intent is not binding, nor is it a
necessary requirement for application. This letter should be received no
later than June 15, 1990, and sent to:
C. James Scheirer, Ph.D.
Contract, Clinical Trials, and
Training Review Section
Review Branch
Division of Extramural Affairs, NHLBI
Westwood Building, Room 548
Bethesda, Maryland 20892
TIMETABLE:
Letter of Intent June 15, 1990
Application Receipt Date July 23, 1990
Technical Review (which may
include interviews conducted
by the Division of Extramural
Affairs in Bethesda, MD with
applicants) October/November 1990
Advisory Council Review February 14-15, 1991
Award Date June 1, 1991
Requests for Guidelines for the Preventive Pulmonary Academic Award (Revised
1/90) should be directed to:
Joan M. Wolle, Ph.D., M.P.H.
Health Scientist Administrator
Prevention, Education, and Research Training Branch
Division of Lung Diseases, NHLBI
Westwood Building, Room 640
Bethesda, Maryland 20892
Telephone: (301) 496-7668
This program is described in the Catalog of Federal Domestic Assistance number
13.838. 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 most
specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject
to intergovernmental review requirements of Executive Order 12372 or to Health
Systems Agency Review.
NIH GUIDE - Vol. 19, No. 6, February 9, 1990 - Page 11
**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. 19, No. 6, February 9, 1990 - Page 12