kristoff@NET.BIO.NET (Dave Kristofferson) (11/19/89)
Vol. 18, No. 41, November 17, 1989
NOTICES
MORATORIUM ON CERTAIN FETAL TISSUE RESEARCH ...............(84/103).......... 1
Public Health Service
Index: PUBLIC HEALTH SERVICE
REMINDER - ASSURANCES REGARDING PROCEDURES FOR DEALING WITH
POSSIBLE MISCONDUCT IN SCIENCE ............................(106/166)......... 1
Public Health Service
Index: PUBLIC HEALTH SERVICE
REMINDER - LETTERS OF REFERENCE ...........................(169/197)......... 2
Division of Research Grants
Index: DIVISION OF RESEARCH GRANTS
DATED ANNOUNCEMENTS (RFPs AND RFAs)
DCT SMALL GRANTS TO STIMULATE CORRELATIVE LABORATORY STUDIES AND
INNOVATIVE CLINICAL TRIALS (RFA) ....................(203/333, 644/994)...... 2
National Cancer Institute
Index: CANCER
GENETICS AND BIOCHEMISTRY OF CELL FATE DETERMINATION IN DEVELOPMENT:
CYTOPLASMIC DETERMINANTS, CELLULAR INDUCTION AND GENOMIC
IMPRINTING (RFA) ....................................(336/410, 997/1242)..... 4
National Institute of Child Health and Human Development
Index: CHILD HEALTH, HUMAN DEVELOPMENT
SPECIALIZED CENTERS OF RESEARCH IN ARTERIOSCLEROSIS (RFA) ................... 5
National Heart, Lung, and Blood Institute (413/452, 1245/1881)
Index: HEART, LUNG, BLOOD
ONGOING PROGRAM ANNOUNCEMENTS
SMALL GRANTS PROGRAM IN LABORATORY ANIMAL SCIENCES ..(458/578, 1884/1959).... 5
Division of Research Resources
Index: RESEARCH RESOURCES
NOTICES
MORATORIUM ON CERTAIN FETAL TISSUE RESEARCH
P.T. 34; K.W. 0783005, 0745065
Public Health Service
The Secretary for Health and Human Services (HHS), has continued
indefinitely the moratorium, instituted initially in March 1988 (NIH Guide for
Grants and Contracts, May 9, 1988, Vol. 17, Special Notice), on research
funded by the Public Health Service (PHS) utilizing human fetal tissue,
obtained from induced abortions, for therapeutic transplantation research in
human beings. No PHS funds (grant, cooperative agreement, or contract) may be
expended on such research. Similar restrictions apply to research conducted
by PHS scientists.
These restrictions do not apply to human therapeutic research using human
fetal tissue from spontaneous abortions or stillbirths, nontherapeutic human
research uses of any legally acquired human fetal tissue, or use of human
fetal tissue in animal or in vitro research (HHS regulations require that
applicable State and local laws be followed).
REMINDER - ASSURANCES REGARDING PROCEDURES FOR DEALING WITH POSSIBLE
MISCONDUCT IN SCIENCE
P.T. 34; K.W. 1014004, 1014006
Public Health Service
As soon as possible after November 8, 1989, but NO LATER THAN JANUARY 1, 1990,
each institution that applies for or receives assistance under the Public
Health Service (PHS) Act, for any project or program which involves the
conduct of biomedical or behavioral research, research training, or related
research activities, must complete and submit to the Office of Scientific
Integrity (OSI) an assurance regarding procedures for dealing with and
reporting possible misconduct in science.
The Office of Scientific Integrity (OSI) has mailed an Initial Assurance Form
(Form PHS 6315) and Instructions to the President or Director of each
institution that has received PHS research support in Fiscal Year 1988 or
later, or had an application for support under consideration at the time the
form was mailed. This form must be used to comply with the Final Rule
published in the Federal Register on August 8, 1989. The Rule requires each
institution to certify that it has (1) established policies and procedures for
investigating and reporting instances of alleged or apparent scientific
misconduct, and (2) will comply with its own administrative process and the
requirements of the Rule.*
Only one assurance is to be submitted for each organization or institution.
Where major components (e.g., college of life sciences, school of medicine,
department of pathology, research institute, etc.) have their own uniquely
tailored scientific misconduct policies, the overall institutional or
organizational assurance certifies that ALL the various policies are in
compliance with the Final Rule.
If you have not received a form, but believe you should have, please check
with the central administration of your institution to determine if your
organization is covered under an already submitted assurance. If it is not,
you may request a form.
FOR FORMS AND INSTRUCTIONS CONTACT:
ASSURANCE PROCESSING SECTION
Office of Scientific Integrity, PHS
National Institutes of Health
Building 31, Mailroom
Bethesda, Maryland 20892
QUESTIONS AND ASSISTANCE
Requests for assistance, copies of the Final Rule, or help with any questions
on the assurance process should be directed to the address listed above. You
may also contact the assurance section on (301) 496-7948.
Vol. 18, No. 41, November 17, 1989 - Page 1
* Responsibilities of Awardee and Applicant Institutions for Dealing With and
Reporting Possible Misconduct in Science, 54 Federal Register 32446, August 8,
1989; amending Title 42, Subchapter D, of the Code of Federal Regulations, to
add a new Subpart A to part 50 consisting of sections 50.101 through 50.105.
[This rule was also published as a special issue of the NIH Guide for Grants
and Contracts, Vol. 18, No. 30, September 1, 1989.]
REMINDER: LETTERS OF REFERENCE
P.T. 22, 34; K.W. 1014006
Division of Research Grants
We are reminding applicants for the Research Career Development Award (RCDA),
the First Independent Research Support and Transition (FIRST) Award, and the
individual and senior National Research Service Award (NRSA) Fellowship to
submit three letters of reference WITH THEIR APPLICATION. Applicants
submitting REVISED applications for RCDA, FIRST, and NRSA fellowships, must
AGAIN submit letters of reference, or their applications will be returned
without review.
For RCDA applications, both new and revised, reference letter guidelines to be
sent to referees are included in the PHS 398 kit (revised 10/88). For NRSA
fellowship applications, new and revised, the reference form (PHS 416-3) is
included in the PHS 416-1 kit (revised 7/88 or 4/89). For FIRST Award
applications, new and revised, there are no special reference forms to be sent
to the referees, although printed guidelines are available from the Office of
Grants Inquiries: (301) 496-7441.
Applicants should contact their referees well in advance of the application
submission date, advising referees to use a typewriter with a black ribbon or
a pen with black ink (to allow for better reproduction), and to return the
letters of reference to the applicant in sealed envelopes as soon as possible.
To protect the utility and confidentiality of reference letters, applicants
are asked not to open the sealed envelopes. The sealed envelopes MUST be
attached to the front page of the original copy of the application.
DATED ANNOUNCEMENTS (RFPs AND RFAs)
DCT SMALL GRANTS TO STIMULATE CORRELATIVE LABORATORY STUDIES AND INNOVATIVE
CLINICAL TRIALS
RFA AVAILABLE: 90-CA-03
P.T. 34; K.W. 0755015, 0715035
National Cancer Institute
Application Receipt Date: February 9, 1990
The Division of Cancer Treatment (DCT) of the National Cancer Institute (NCI)
invites grant applications from interested investigators for tightly focused
innovative laboratory studies which are related to clinical trials or for
innovative clinical trials which take advantage of new developments in the
laboratory.
BACKGROUND
The NCI supports an extensive network of clinical and laboratory research
studies related to cancer therapy through contracts, grants and cooperative
agreements. It has been difficult for investigators to obtain complementary
funding through either the traditional basic research grant (R01) mechanism or
through the cooperative agreement (U10) mechanism for either: (1) innovative
pilot clinical trials that take advantage of new developments in the
laboratory or (2) correlative laboratory studies to existing clinical trials.
The Cancer Therapy Evaluation Program, DCT, NCI, has targeted the use of the
small grants mechanism (R03) to support single or multiple institutions
(individual institutions, consortia, cancer centers, etc.) to perform
innovative pilot clinical trials or correlative studies of relevance to
clinical trials. Some examples of categorical areas for R03 studies include:
(1) oncogenes and growth factors, (2) antigen expression on tumor cells, (3)
biochemical modulation, (4) biological response modifiers, and (5)
pharmacology and cell kinetic studies.
Vol. 18, No. 41, November 17, 1989 - Page 2
RESEARCH GOALS AND SCOPE
The aims of this initiative are two-fold: (1) to provide a mechanism for
accelerated review and funding of innovative correlative studies relevant to
clinical trials, and (2) to stimulate pilot clinical studies with novel
laboratory correlations so as to foster the development of interactions
between basic science laboratories and clinicians performing clinical trials.
Studies should be proposed for a tightly focused, integrated research program
at the interface of laboratory experimentation and concurrent clinical trials.
The laboratory studies must have been demonstrated to be applicable to tissue
samples and/or body fluids, etc. from patients entered onto clinical trials.
Evidence of statistical support should be included to insure proper
correlation of assay parameters with clinical outcome. Some examples of
support that would qualify under this RFA would be: (1) salary for an
additional technician; (2) funds for additional supplies or small equipment
required for the project; (3) salary support for data management, data entry
and coordination of sample procurement; (4) funds for the collection and
shipment of specimens.
MECHANISM OF SUPPORT
This Request for Applications (RFA) will use the NIH grant-in-aid. Small
grants are designated as R03 grants. Approximately $750,000 in first year
total costs will be committed to specifically fund applications submitted in
response to this RFA. This funding level is dependent on the receipt of a
sufficient number of applications of high scientific merit. NCI plans to make
multiple awards for project periods up to two years. The total direct costs
per year must not exceed $48,000. The earliest feasible start date for the
initial award will be June 1, 1990. Although this program is provided for in
the financial plans of the NCI, the award of grants pursuant to this RFA is
also contingent upon the continuing availability of funds for this purpose.
ELIGIBILITY
Domestic non-profit and for-profit institutions are eligible to apply.
Foreign institutions are not eligible to apply. Although NCI funded
Cooperative Groups are ineligible to be the principal investigator, individual
institutions or consortia which may or may not be members of Cooperative
Groups may apply. Awards will be made only to institutions with either a
funded clinical or laboratory component of the proposed study. These awards
are to complement a previously existing source of support. These pre-existing
resources need not be at a single institution, but may exist within a
consortium. The sources of funding must be documented in the application.
Applications without this documentation will be returned to the applicants
without further review.
STUDY POPULATION
NCI encourages the applicant to recruit women and minorities into their study
population. Applicants should address the study population issue in their
application.
INQUIRIES
A copy of the complete RFA describing the research goals and scope, the review
criteria and the method of applying can be obtained by contacting:
Dr. Roy S. Wu
Health Scientist Administrator
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
Bethesda, Maryland 20892
Telephone: (301) 496-8866
FAX: (301) 496-9384
Written or telephone inquiries concerning the objectives and scope of this RFA
or inquiries about whether or not specific proposed research would be
responsive are encouraged and should be directed to Dr. Roy S. Wu at the above
address.
LETTER OF INTENT
Prospective applicants are asked to submit by January 8, 1990 a letter of
intent that includes a DESCRIPTIVE TITLE of the proposed research, the name
and address of the principal investigator, the names of other key personnel,
Vol. 18, No. 41, November 17, 1989 - Page 3
the participating institutions, the number and title of this RFA. The letter
of intent is requested in order to provide an indication of the number and
scope of applications to be reviewed. This letter of intent does not commit
the sender to submit an application, nor is it a requirement for submisssion
of an application.
This program is described in the Catalog of Federal Domestic Assistance No.
13.395, (Clinical Treatment Research). Awards are 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 241 and 285) and administered under PHS Grant
Policies and Federal Regulations 42 CFR 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.
GENETICS AND BIOCHEMISTRY OF CELL FATE DETERMINATION IN DEVELOPMENT:
CYTOPLASMIC DETERMINANTS, CELLULAR INDUCTION AND GENOMIC IMPRINTING
RFA AVAILABLE: 89-HD-08
P.T. 34; K.W. 1002019, 1003002, 1002004, 1002059
National Institute of Child Health and Human Development
Application Receipt Date: February 8, 1990
The Genetics and Teratology Branch (GTB) of the Center for Research for
Mothers and Children (CRMC) of the National Institute of Child Health and
Human Development (NICHD) invites research grant applications for studies on
the genetics and biochemistry of cell fate determination in development. This
initiative has important implications for both basic science and clinical
studies. The information expected from these investigations will further our
understanding of the specific molecules involved in establishing cell fate,
how they are regulated, and how they function. In addition, underlying
principles that direct normal patterns of growth differentiation and
morphogenesis and against which aberrations of these processes can be
understood will be further defined. In a clinical context these studies
provide the basis for an improved understanding of the possible causes of
birth defects and other developmental abnormalities that lead to early
embryonic wastage and spontaneous abortion.
The primary goal of this Request for Applications (RFA) is to support a group
of projects that are devoted to defining the underlying genetic basis,
biochemical nature, and molecular mode of action of the processes that can
influence cell fate, including cytoplasmic determinants, induction, and
genetic imprinting. While our major interest rests in how such processes
operate during mammalian development, other experimental model systems that
can contribute to our understanding of the fundamental principles that apply
to human development are strongly encouraged. The National Institute of
General Medical Sciences (NIGMS) also supports research leading to an
understanding of fundamental principles underlying genetics and cell biology,
especially in model systems. Therefore, a secondary assignment to NIGMS for
applications responsive to this RFA might be appropriate. It is expected that
the latest molecular biological and molecular genetic technologies will be
employed, including the generation of all appropriate and necessary reagents.
Applications should be submitted on Form PHS 398 (rev. 10/88), available in
business or grants offices at most academic research institutions or from the
Division of Research Grants, NIH. Insert the title and number of this RFA
(GENETICS AND BIOCHEMISTRY: 89-HD-08) on line 2 of the face page of the
application. The RFA label available in the October 1988 version of 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.
This program will be funded through the traditional indivi-dual research award
program of NICHD. Grant applications will be reviewed at a single competition
by an initial review group convened by NICHD. It is anticipated that four (4)
grants will be awarded under this program, contingent upon receipt of a
sufficient number of meritorious applications and the availability of funds.
Vol. 18, No. 41, November 17, 1989 - Page 4
Requests for copies of the full RFA should be addressed to:
Joel M. Schindler, Ph.D
Genetics and Teratology Branch
Center for Research for Mothers and Children
National Institute of Child Health
and Human Development
Executive Plaza North, Room 643C
Bethesda, Maryland 20892
Telephone: (30l) 496-5541
SPECIALIZED CENTERS OF RESEARCH IN ARTERIOSCLEROSIS
RFA AVAILABLE: 90-HL-4-H
P.T. 04; K.W. 0715040, 0710030, 0755030, 0745027
National Heart, Lung, and Blood Institute
Application Receipt Date: December 3, 1990
The Division of Heart and Vascular Diseases of the National Heart, Lung, and
Blood Institute (NHLBI), National Institutes of Health, announces the
availability of a Request For Applications (RFA) for Specialized Centers of
Research (SCOR) in Arteriosclerosis. This RFA solicits a variety of research
areas relevant to interdisciplinary investigations focusing on
arteriosclerosis. The goals of the program are to advance understanding of
the causes and mechanisms of atherogenesis, to develop and exploit new
technologies, and to foster new approaches to disease prevention, diagnosis
and treatment.
Women and minority individuals should be included in the study population,
otherwise a clear rationale for their exclusion must be provided in the
application.
It is anticipated that approximately 10 SCORs will be funded under this RFA.
In keeping with the criteria for Centers, applicants must propose both basic
and clinical research. New applications and applications for renewal of
existing programs are invited. Copies of the RFA and Instructions for the
Preparation of Applications are currently available from:
Momtaz Wassef, Ph.D.
Deputy Chief
Lipid Metabolism-Atherogenesis Branch
Division of Heart and Vascular Diseases
National Institutes of Health
Federal Building, Room 4A12
7550 Wisconsin Avenue
Bethesda, Maryland 20892
Telephone: (301) 496-1978
ONGOING PROGRAM ANNOUNCEMENTS
SMALL GRANTS PROGRAM IN LABORATORY ANIMAL SCIENCES
P.T. 34; K.W. 0201058, 1002002, 0201011, 0755030, 0745027
Division of Research Resources
Application Receipt Date: February 1
BACKGROUND
The Animal Resources Program (ARP) of the Division of Research Resources
(DRR), National Institutes of Health (NIH), assists institutions in developing
and improving animal resources for biomedical research and research training
through the award of research and resource grants. For the purpose of this
program, animal resources are defined as all animals, their associated
facilities, and the staff which support biomedical research activities. The
ARP supports various activities which assist in meeting the animal resource
needs of investigators, and the requirements for proper care and use of
laboratory animals. To enhance this program, the ARP announces the initiation
of a small grant award for support of pilot studies. Up to four awards per
Vol. 18, No. 41, November 17, 1989 - Page 5
year may be made, pending the receipt of meritorious applications and
appropriated funds.
PURPOSE
This is a one-year, non-renewable award intended to provide support for pilot
projects, testing of new techniques, or feasibility studies of innovative
research in the area of laboratory animal medicine which would provide a basis
for more extended research. Appropriate areas of study include but are not
limited to the etiology, detection or prevention of laboratory animal disease;
methods to decrease pain and distress associated with the use of animals in
research; and optimal housing requirements.
ELIGIBILITY
Any domestic non-profit or for profit institution may apply for grant support
through this program. The Principal Investigator must be a new or established
investigator who is actively working in laboratory animal medicine at the time
of the award. However, investigators receiving funds from grants for
Laboratory Animal Diagnostic and Investigational Laboratories or Regional
Primate Research Centers from the Division of Research Resources, NIH, may not
act as Principal Investigators in this program.
APPLICATION AND REVIEW PROCEDURE
Applications should be submitted on Form PHS 398 (Rev. 10/88), available at
most institutional business offices or from the Division of Research Grants,
NIH. Because the format for preparing the Small Grant application is
different from that used for regular research grants, the Supplementary
Instructions attached to this announcement must be followed. Applicants must
adhere to this format to be responsive. Unresponsive applications will be
returned to the applicant without review. There will be a single annual
receipt date of February 1. The initial scientific review will be conducted
by the Office of Review, DRR, and final review by the DRR National Advisory
Research Resources Council.
Receipt Date Institute Committee Council Earliest Date
Annually Review Review For Funding
February 1 February-March May-June July 1
Applications not funded by September 30 will be administratively inactivated.
REVIEW CRITERIA
Applications will be evaluated with respect to the following criteria: the
significance and scientific merit of the proposed project as it relates to
laboratory animal medicine, its characterization as an innovative pilot
project, or the probability that the study will provide a basis for more
extended research. The methodology and experimental design will be evaluated
including the experimental groups, data to be collected, procedures of data
analysis, and potential problems that may be encountered in the study and how
they will be addressed. The investigator's background and training for
carrying out the project, the adequacy of the facilities, and the adequacy of
the justifications for the budget requested will also be considered.
TERMS OF THE AWARD
The award will be for one year and will provide a maximum of $25,000 (direct
costs) for technical assistance, supplies, small equipment, and travel.
Support for professional salary should be obtained from another source. The
award may not be used to supplement projects currently supported by Federal or
non-Federal funds, or to provide interim support for projects under review by
the Public Health Service.
INSTRUCTIONS FOR APPLICANT
Additional information on submitting a Small Grant application, supplementary
to that given with PHS 398 (Rev. 10/88), can be obtained from the Laboratory
Animal Sciences Program at the address given below.
Vol. 18, No. 41, November 17, 1989 - Page 6
STAFF CONTACT
Director
Laboratory Animal Sciences Program
Animal Resources Branch
Division of Research Resources
National Institutes of Health
5333 Westbard Avenue, Rm. 853
Bethesda, Maryland 20892
Telephone: (301) 496-5175
This program is described in the Catalog of Federal Domestic Assistance No.
13.306, Laboratory Animal Sciences and Primate Research. Awards will be made
under the authority of the Public Health Service Act, Title III, Section 301
(Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant
policies and Federal Regulations 42 CFR Part 52, and 45 CFR Part 74. This
program is not subject to the intergovernment review requirements of Executive
Order 12372 or Health Systems Agency review.
Vol. 18, No. 41, November 17, 1989 - Page 7
FULL TEXT OF RFAs FOR ONLINE ACCESS
RFA NUMBER: 90-CA-03
DCT Small Grants to Stimulate Correlative
Laboratory Studies and Innovative Clinical Trials
P.T. 34; K.W. 0755015, 0715035
NATIONAL CANCER INSTITUTE
Application Receipt Date: February 9, 1990
Letter of Intent Receipt Date: January 8, 1990
I. INTRODUCTION
The Division of Cancer Treatment (DCT) of the National
Cancer Institute (NCI) invites grant applications from
interested investigators for tightly focused innovative
laboratory studies which are related to therapeutic clinical
trials or for innovative clinical trials which take
advantage of new developments in the laboratory.
Grants are awarded to non-profit and for-profit
organizations and institutions, governments and their
agencies, and occasionally to individuals. This type of
grant solicitation (the Request for Applications (RFA)) is
utilized when it is desired
to encourage investigator-initiated research projects in
areas of special importance to the National Cancer Program.
Applicants funded under the RFA are supported through the
customary National Institutes of Health (NIH) grant-in-aid,
in accordance with Public Health Service (PHS) policies
applicable to research project grants. However, the RFA
solicitation represents a single solicitation, with specific
deadlines for receipt of applications. All applications
received in response to the RFA will be reviewed by the same
NCI initial review group.
The present RFA announcement is for a solicitation in FY90
with a specified deadline (February 9, 1990) for receipt of
applications. Applications should be prepared and submitted
in accordance with the aims and requirements described in
the following sections:
II. BACKGROUND INFORMATION
III. RESEARCH GOALS AND SCOPE
IV. MECHANISM OF SUPPORT
V. ELIGIBILITY
VI. REVIEW PROCEDURES AND CRITERIA
VII. METHOD OF APPLYING
VIII. INQUIRIES
II. BACKGROUND INFORMATION
The NCI supports an extensive network of clinical and
laboratory research studies related to cancer therapy
through contracts, grants and cooperative agreements. At
present there is no mechanism targeted to stimulate the
communication of promising and potentially relevant
innovative developments between the laboratory and the
clinical setting. It has been difficult for investigators
to obtain complementary funding through either the
traditional basic research grant (R01) mechanism or through
the cooperative agreement (U10) mechanism for either: (1)
innovative pilot clinical trials that take advantage of new
developments in the laboratory or (2) correlative laboratory
studies relevant to existing clinical trials.
The small grants (R03) mechanism provides research support
specifically limited in time and amount for studies in
categorical program areas. Small grants provide flexibility
for initiating studies, which are generally for preliminary
short-term projects and are non-renewable. Furthermore, the
time interval from application to funding is shortened under
the R03 mechanism, thus allowing new ideas to be
investigated or pursued in a more expeditious manner. The
Cancer Therapy Evaluation Program, DCT, NCI, has targeted the
use of the small grants mechanism to support single or
multiple institutions (individual institutions, consortia,
cancer centers, etc.) to perform innovative pilot clinical
trials or correlative studies of relevance to clinical
trials. Some examples of categorical areas for R03 studies
include: (1) oncogenes and growth factors, (2) antigen
expression on tumor cells, (3) biochemical modulation, (4)
biological response modifiers, and (5) pharmacology and cell
kinetic studies.
III. RESEARCH GOALS AND SCOPE
The aims of this initiative are two-fold: (1) to provide a
mechanism for accelerated funding of innovative correlative
studies relevant to clinical trials and (2) to stimulate
pilot clinical studies with novel laboratory correlations so
as to foster the development of interactions between basic
science laboratories and clinicians performing clinical
trials.
Studies should be proposed for a tightly focused, integrated
research program at the interface of laboratory
experimentation and concurrent clinical trials. The
laboratory studies must have been demonstrated to be
applicable to tissue samples and/or body fluids, etc. from
patients entered onto clinical trials. Evidence of
statistical support should be included to insure proper
correlation of assay parameters with clinical outcome. Some
examples of support that would qualify under this RFA would
be: (1) salary for an additional technician; (2) funds for
additional supplies or small equipment required for the
project; (3) salary support for data management, data entry
and coordination of sample procurement; (4) funds for the
collection and shipment of specimens.
IV. MECHANISM OF SUPPORT
This RFA will use the NIH grant-in-aid. Responsibility for
the planning, direction, and execution of the proposed
research will be solely that of the applicant. Except as
otherwise stated in this RFA, awards will be administered
under PHS grants policy as stated in the Public Health
Service Grants Policy Statement, DHHS Publication No.(OASH)
82-50,000, revised January 1, 1987. Small grants are
designated as R03 grants.
This RFA is a one-time solicitation. Applications received
after the deadline receipt date will be returned.
Competitive renewals (type 2's) must be prepared and
submitted as traditional research grant applications (R01's)
to be considered along with other non-solicited investigator-
initiated applications in Division of Research Grant (DRG)
study sections.
Approximately $750,000 in first year total costs will be
committed to specifically fund applications submitted in
response to this RFA. This funding level is dependent on
the receipt of a sufficient number of applications of high
scientific merit. NCI plans to make multiple awards for
project periods up to two years. The total direct costs per
year must not exceed $48,000. The total project period for
applications submitted in response to the present RFA should
not exceed two (2) years. The earliest feasible start date
for the initial award will be June 1, 1990. Although this
program is provided for in the financial plans of the NCI,
the award of grants pursuant to this RFA is also contingent
upon the continuing availability of funds for this purpose.
V. ELIGIBILITY
Domestic non-profit and for-profit institutions are eligible
to apply. Foreign institutions are not eligible to apply.
Although NCI funded Cooperative Groups are ineligible to be
the principal investigator, individual institutions or
consortia which may or may not be members of Cooperative
Groups may apply. Awards will be made only to institutions
with either a funded clinical or laboratory component of the
proposed study. These awards are to complement a previously
existing source of support. These pre-existing resources
need not be at a single institution, but may exist within a
consortium. The sources of funding must be documented in
the application. Applications without this documentation
will be returned to the applicants without further review.
VI. REVIEW PROCEDURES AND CRITERIA
A. REVIEW PROCEDURE
Upon receipt, applications will be reviewed by the DRG for
completeness. Incomplete applications will be returned to
the applicant without further consideration. Applications
will be evaluated by NCI Program staff to determine whether
they are responsive to the program requirements and criteria
stated in this RFA. Applications which are judged non-
responsive will be returned to the applicant. Questions
concerning the responsiveness of proposed research to the
RFA should be directed to program staff as described in
section VIII.
In cases where the number of applications is large compared
to the number of awards to be made, the NIH will conduct a
preliminary scientific peer review to eliminate those which
are clearly not competitive. The NIH will administratively
withdraw from competition those applications judged to be
non-competitive and notify the applicant and institutional
business official.
Those applications judged to be both competitive and
responsive will be further evaluated, using the review
criteria stated below, for scientific and technical merit by
an appropriate peer review group convened by the Division of
Extramural Activities, NCI. The second level of review by
NCI program staff considers the application in light of the
special needs of the Institute and the priorities of the
National Cancer Program.
B. REVIEW CRITERIA
The factors considered in evaluating the scientific merit of
each response to this RFA will be:
1. The importance of the proposed clinical trial in
developing new treatment regimens or in addressing issues of
therapy in highly prevalent or scientifically exploitable
diseases.
2. The relevance of the proposed laboratory studies to the
clinical trials.
3. Originality of the research from a scientific and
technical viewpoint.
4. Feasibility of research and adequacy of study design.
5. Quality of the assay methodology and laboratory research
and experience of the laboratory with the assay methodology
proposed.
6. Experience, training, time commitment and clinical and
research competence of the investigators involved.
7. Adequacy of plans for effective communication between
laboratory, clinical and statistical investigators.
8. Adequacy of available facilities, statistical
collaboration and patient population.
9. Provision for the adequate protection of human subjects
and the humane treatment of animals.
The review group will critically examine the submitted
budget and will recommend an appropriate budget and period
of support for each approved application.
C. STUDY POPULATION
NCI encourages the applicant to recruit women and minorities into
their study population. Applicants should address the study
population issue in their application.
VII. METHOD OF APPLYING
The USPHS 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;
or from the Office of Grant Inquiries, Division of Research
Grants, National Institutes of Health, Room 449, Westwood
Building, 5333 Westbard Avenue, Bethesda, MD 20892; or from
the NCI Program Director named below.
The RFA label contained in the 10/88 revision of Application
Form 398 must be affixed 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. In addition, the RFA number
and title (to the extent that space permits) should be typed
on line 2 of the face page of the application form.
Submit a signed, typewritten original of the application,
including the Checklist, and four (4) signed, exact
photocopies, in one package to the Division of Research
Grants at the address below. The photocopies must be clear
and single sided.
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
At the time of submission, two (2) additional copies of the
application should also be sent to:
REFERRAL OFFICER
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 848
5333 Westbard Avenue
Bethesda, MD 20892
Applications should be received by February 9, 1990. If an
application is received after the indicated date, it will be
returned. Also, the Division of Research Grants (DRG) will
not accept any application in response to this announcement
that is the same as one currently being considered by any
other NIH awarding unit.
Letter of Intent
Prospective applicants are asked to submit by January 8,
1990, a letter of intent that includes a descriptive title of
the proposed research, the name and address of the principal
investigator, the names of other key personnel, the
participating institutions, the number and title of the RFA
in response to which the application is being submitted.
Although a letter of intent is not required, is not binding,
and does not enter into the review of subsequent
applications, the information which it contains is extremely
helpful in planning for the review of applications. It
allows NCI staff to estimate the potential review workload
and to avoid possible conflict of interest in the review.
Program staff may be able to assist applicants by phone in
several areas such as scientific content and appropriate use
of consultants as well as ascertain whether they have
understood the objectives of the RFA and opted for an
appropriate funding mechanism. Therefore, NCI would like to
emphasize the benefits to the applicant of the letter of
intent.
The letter of intent should be sent to:
BY US POSTAL
Dr. Roy S. Wu
Health Scientist Administrator
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
Bethesda, MD 20892
Telephone: (301) 496-8866
FAX: (301) 496-9384
BY DIRECT DELIVERY
Dr. Roy S. Wu
Health Scientist Administrator
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
6130 Executive Blvd.
Rockville, MD 20852
Telephone: (301) 496-8866
FAX: (301) 496-9384
VIII. INQUIRIES
Written or telephone inquiries concerning the objectives and
scope of this RFA or inquiries about whether or not specific
proposed research would be responsive are encouraged and
should be directed to Dr. Roy S. Wu at the above address.
The program director welcomes the opportunity to clarify any
issues or questions from potential applicants.
This program is described in the Catalog of Federal Domestic
Assistance No. 13.395, (Clinical Treatment Research).
Awards are 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 241 and 285) and administered
under PHS Grant Policies and Federal Regulations 42 CFR 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.