Subject: (Copy) NIH Guide Vol. 18, No. 41, November 17, 1989,
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 16 Nov 89 08:07 EST

Paul,
     This is the first of two parts of the NIH GUide for November l7th.
Please post this as NIHGUIDE.111789.
     Thanks.
            Dottie
 ---------------------------- Text of forwarded message -----------------------

     

     
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.

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     
     
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