Subject: NIH Guide l2/28/90
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 27 Dec 90 08:20 EST

Hello Again,
   Please post this to the NIH Listserver as:
      NIHGUIDE.901228
 Also, please notify me as soon as these are posted.  Thanks.
 Have a nice day.
                 Dottie
 ---------------------------- Text of forwarded message -----------------------
 
X-comment: NIH Guide (including TOC) contained 15 pages (1200 lines)
X-comment: RFAs described:  CA-91-03, AR-91-01, DK-91-05

 

 
NIH GUIDE - Vol. 19, No. 46, December 28, 1990

                                   NOTICES

INSERT FLYER FOR APPLICANTS USING FORM 398 REGARDING IMPLEMENTATION
OF THE NIH/ADAMHA POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES
IN CLINICAL RESEARCH STUDY POPULATIONS .................(84/203)............ 1
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index:  NATIONAL INSTITUTES OF HEALTH
        ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION

ANNUAL ASSURANCE UPDATE AND REPORT ON ACTIVITIES RELATED TO
POSSIBLE MISCONDUCT IN SCIENCE .........................(206/249)........... 2
Public Health Service
Index:  PUBLIC HEALTH SERVICE

NIDCD RESTRICTIONS ON REQUESTED BUDGETS FOR PROGRAM PROJECT AND
CLINICAL RESEARCH CENTER APPLICATIONS ..................(252/292)........... 3
National Institute on Deafness and Other Communication Disorders
Index:  DEAFNESS, COMMUNICATION DISORDERS

                   NOTICES OF AVAILABILITY (RFPs AND RFAs)

SUPPORT FOR THE PREPARATION OF THE ANNUAL REPORTS ON CARCINOGENS (RFP) ..... 3
National Institute of Environmental Health Sciences     (298/335)
Index:  ENVIRONMENTAL HEALTH SCIENCES

CLINICAL TRIALS TO EVALUATE THERAPIES FOR HIV DISEASE (RFP) ..(338/402)..... 4
National Institute of Allergy and Infectious Diseases
Index:  ALLERGY, INFECTIOUS DISEASES

INSTITUTIONAL PHYSICIAN SCIENTIST DEVELOPMENT AWARD PROGRAM (RFA MH-91-02) . 5
National Institute of Mental Health                      (405/461)
National Institute on Drug Abuse
Index:  MENTAL HEALTH, DRUG ABUSE

CLINICAL TREATMENT AND CORRELATES OF UPPER GI CARCINOMA (RFA CA-91-03) ..... 5
National Cancer Institute                        (464/647, 1204/1623)
Index:  CANCER

SPECIALIZED CENTERS OF RESEARCH IN RHEUMATOID ARTHRITIS
SPECIALIZED CENTERS OF RESEARCH IN OSTEOARTHRITIS       (650/819)
SPECIALIZED CENTERS OF RESEARCH IN OSTEOPOROSIS (RFA AR-91-01) .(1626/1992). 8
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Index:  ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES

DIABETES INTERDISCIPLINARY RESEARCH PROGRAM (RFA DK-91-05) ..(822/925)......10
National Institute of Diabetes and Digestive and Kidney Diseases  (1995/2409)
Index:  DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES

PHYSICAL FRAILTY IN MINORITY OLDER POPULATIONS - REVISION (RFA AG-91-03) ...11
National Institute on Aging                              (928/951)
Index:  AGING

                        ONGOING PROGRAM ANNOUNCEMENTS

SURGICAL ONCOLOGY (PA-91-16) ............................(964/1149).........12
National Cancer Institute
Index:  CANCER
                                   NOTICES

INSERT FLYER FOR APPLICANTS USING FORM 398 REGARDING IMPLEMENTATION OF THE
NIH/ADAMHA POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
P.T. 34; K.W. 1014006
 
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
 
The purpose of this notice is to provide special instructions to research
grant and cooperative agreement applicants using Form PHS 398, regarding the
National Institutes of Health (NIH) and the Alcohol, Drug Abuse, and Mental
Health Administration (ADAMHA) policies concerning the inclusion of women and
minorities in clinical research study populations.  These policies were
published in the NIH Guide for Grants and Contracts on September 28, 1990,
Vol. 19, No. 35 for inclusion of minorities in study populations and on August
24, 1990, Vol. 19, No. 31 for inclusion of women in study populations.
 
PRIORITY ANNOUNCEMENT
 
SPECIAL INSTRUCTIONS TO APPLICANTS USING FORM PHS 398 REGARDING IMPLEMENTATION
OF THE NIH/ADAMHA POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
 
NOTE:  THESE INSTRUCTIONS APPLY ONLY TO THE LIMITED NUMBER OF GRANT AND
COOPERATIVE AGREEMENT APPLICANTS WHO PROPOSE CLINICAL RESEARCH STUDIES THAT
INCLUDE HUMAN BIOMEDICAL AND BEHAVIORAL STUDIES OF ETIOLOGY, EPIDEMIOLOGY,
PREVENTION (AND PREVENTIVE STRATEGIES), DIAGNOSIS, OR TREATMENT OF DISEASES,
DISORDERS OR CONDITIONS, INCLUDING BUT NOT LIMITED TO CLINICAL TRIALS.
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research
grants, cooperative agreements, and contracts will be required to include
minorities and women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder, or condition under
study; special emphasis should be placed on the need for inclusion of
minorites and women in studies of diseases, disorders, and conditions which
disproportionately affect them.  If women or minorities are not included or
are inadequately represented in clinical research, particularly in proposed
populations-based studies, a clear compelling rationale should be provided.
 
Applicants are urged to assess carefully the feasibility of including the
broadest possible representation of minority groups.  However, NIH and ADAMHA
recognize that it may not be feasible or appropriate in all research projects
to include representation of the full array of United States racial/ethnic
minority populations (i.e, Native Americans (American Indians or Alaskan
Natives), Asian/Pacific Islanders, Blacks, Hispanics).  The rationale for
studies on single minority population groups should be provided.
 
Beginning immediately, all applications submitted to NIH/ADAMHA will be
required to address this policy.
 
INSTRUCTIONS TO APPLICANTS
 
Applicants must include a description of the composition of the proposed study
population in terms of gender and racial/ethnic group and a rationale for its
choice.  In addition, gender and racial/ethnic issues should be addressed in
developing a research design and sample size appropriate for the scientific
objectives of the study.  This information should be included in the form PHS
398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E,
Human Subjects.
 
Applications must employ a study design with gender and/or minority
representation (by age distribution, risk factors, incidence/prevalence, or
other) appropriate to the scientific objectives of the disease, disorder, or
condition being studied.
 
It is not an automatic requirement for the study design to provide statistical
power to answer the questions posed for men and women and racial/ethnic groups
separately; however, whenever there are scientific reasons to anticipate
differences between men and women with regard to the hypothesis under
investigation, applicants should include an evaluation of gender and minority
group differences in the proposed study.
 
If adequate inclusion of women or minorities is impossible or inappropriate
with respect to the purpose of the research, the health of the subjects, or
 
           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 1
other reasons, or if the only available study population has a
disproportionate representation of one gender or minority/majority group, the
rationale for the study population must be well explained and justified by the
applicant.
 
The usual NIH policies concerning research on human subjects also apply.
Basic research or clinical studies in which human tissues cannot be identified
or linked to individuals are excluded.  However, every effort should be made
to include human tissues from women and racial/ethnic minorities when it is
important to apply the results of the study broadly, and this should be
addressed by applicants.
 
PEER REVIEW
 
Executive Secretaries of the Initial Review Groups (IRGs) will request written
clarification from the applicant when the application does not describe and
justify the gender or minority composition of the study population.  If such
information is not contained within the application, and is not provided upon
request, the application will be deferred without IRG review until it is
complete or will be returned to the applicant.  In the case of responses to
RFAs with single receipt dates, applications that are not brought into
compliance will be returned without review rather than deferred.
 
Executive Secretaries of all scientific IRGs will instruct the IRG members
that the assessment of scientific and technical merit of applications must
include an evaluation of the proposed gender and minority composition of the
study population and its appropriateness to the scientific objectives of the
study and to this policy.  If the representation of women and minorities in a
study design is inadequate to answer the scientific question(s) addressed AND
the justification for the selected study population is inadequate, it will be
considered a scientific weakness or deficiency in the study design and should
be reflected in the assigned score given to the application.  When preparing
the summary statement, the Executive Secretary will summarize the findings and
recommendations of the reviewers on this policy in a special section at the
end of the Critique sub-headed:  Women and Minority Subjects.
 
Regardless of the priority score, percentile ranking, or program relevance of
the proposed research, the NIH and ADAMHA funding components will not
fund/award grants that do not comply with this policy.
 
APPLICANTS SHOULD CONTACT NIH/ADAMHA PROGRAM STAFF FOR ADDITIONAL GUIDANCE IN
INTERPRETING THIS POLICY IN THE CONTEXT OF ANY SPECIFIC INSTITUTE, CENTER OR
DIVISION RESEARCH PROGRAM OF NIH/ADAMHA.

ANNUAL ASSURANCE UPDATE AND REPORT ON ACTIVITIES RELATED TO POSSIBLE
MISCONDUCT IN SCIENCE
 
P.T. 34; K.W. 1014004, 1014006
 
Public Health Service
 
Effective Date:  January 1, 1991
 
The Public Health Service (PHS) scientific misconduct regulations, 42 CFR 50
Subpart A, "Responsibilities of PHS Awardee and Applicant Institutions for
Dealing With and Reporting Possible Misconduct in Science", require
institutions to make an annual report to the Office of Scientific Integrity
(OSI), about the handling of allegations, inquiries, and investigations into
possible scientific misconduct, in connection with research for which PHS
funds have been requested or received, along with an annual update of the
institutional assurance to the OSI.
 
The official forms for the annual report with a signature page for the
required assurance update were mailed by the OSI in December 1990, to the
officials of institutions that filed an assurance with OSI for 1990.  The
completed form must be returned to OSI no later than Janaury 10, 1991.  OSI
staff will review and use the form to update the PHS assurance files.  An
updated, active assurance is required in order for each institution to be
eligible to apply for and receive PHS grants, fellowhsips, and cooperative
agreements for research during calendar year 1991.

 

 

           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 2
For further information contact:
 
Dr. Alan R. Price or Ms. Carolyn Bowman
Office of Scientific Integrity
NIH
Building 31, Room B1C39
Bethesda, MD  20892
Telephone:  (301) 496-2624 (this is not a toll-free number)
Fax:  (301) 402-0238

NIDCD RESTRICTIONS ON REQUESTED BUDGETS FOR PROGRAM PROJECT AND CLINICAL
RESEARCH CENTER APPLICATIONS
 
P.T. 04, 34; K.W. 1014006
 
National Institute on Deafness and Other Communication Disorders
 
The National Institute on Deafness and Other Communication Disorders (NIDCD)
announces a new policy on the maximum amount of direct costs for applications
for program projects and clinical research centers.  Effective for the
submission deadline of June 1, 1991, applications for new program projects and
clinical research centers may not request more than $750,000 direct costs for
the first year of support.  Applications exceeding this limit will be returned
to the applicant without further review.
 
Competing continuation applications for program projects and clinical research
centers already received and awaiting review or award may be awarded at an
amount in excess of $750,000 for the first year of continuation support (when
appropriately recommended by initial review groups and the National Advisory
Council).  current payment criteria).
 
Competing continuation applications for program projects and clinical research
centers received by the October 1, 1991 deadline may request the amount of the
last year of their current project period or $750,000, whichever is greater,
for the first year of renewal support.
 
Principal Investigators (PI) with grants that now exceed or will exceed
$750,000 direct costs must prepare to reduce the size of their grant proposal
when they apply for a renewal at the end of their current project period.  The
Health Scientist Administrator responsible for the grant will work with the PI
to approach the $750,000 limitation.
 
The NIDCD regrets that budgetary constraints have dictated the issuance of
this new policy.  For additional information and for NIDCD Guidelines for the
preparation of program project and clinical research grant applications,
please contact:
 
Acting Director for Extramural Activities
National Institute on Deafness and Other Communication Disorders
6120 Executive Plaza South, Suite 750a
Bethesda, MD  20892

                   NOTICES OF AVAILABILITY (RFPs AND RFAs)

SUPPORT FOR THE PREPARATION OF THE ANNUAL REPORTS ON CARCINOGENS
 
RFP:  NIH-ES-91-07
 
P.T. 34; K.W. 0715035, 0725000
 
National Institute of Environmental Health Sciences
 
The National Institute of Environmental Health Sciences (NIEHS), National
Institutes of Health (NIH), is soliciting a proposal from the source
identified below to procure assistance in preparing the Annual Reports on
Carcinogens for printing.  With respect to chemicals that are known to be or
reasonably anticipated to be carcinogens, the Contractor shall assist the
Government in identifying, gathering, collating, and summarizing existing
data, estimates and information on the nature of exposure, its level, the
number of persons exposed, and the regulatory status for each chemical to be
included in the Annual Reports on Carcinogens.  The Contractor shall provide
support for inclusion of approximately 20 new chemicals per year in the Annual
Report on Carcinogens, as well as updating the information contained in the
immediately preceding report.  Each Annual Report shall be a self-contained
document.  The Government estimates that the project will require
 
           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 3
approximately 1.4 professional person years and .8 technical person years of
effort per contract year.  The proposed contract is set aside for Rao
Enterprises, Inc./dba Integrated Laboratory Systems, P.O. Box 13501, Research
Triangle Park, NC 27709.  The RFP was released on or about December 13, 1990
with the proposal due to be received January 15, 1991.
 
Requests should reference RFP NIH-ES-91-07 and should be forwarded to:
 
National Institute of Environmental Health Sciences
Contracts and Procurement Management Branch, OM
ATTN:  Mr. Donald Gula, Contract Specialist
79 T.W. Alexander Drive, 4401 Research Commons Building
P.O. Box 12874
Research Triangle Park, NC  27709
Telephone:  (919) 541-7893

CLINICAL TRIALS TO EVALUATE THERAPIES FOR HIV DISEASE
 
RFP AVAILABLE:  RFP-NIH-NIAID-DAIDS-91-29
 
P.T. 34; K.W. 0715008, 0755015, 0740012, 0795005
 
National Institute of Allergy and Infectious Diseases
 
The Division of Acquired Immunodeficiency Syndrome (DAIDS) of the National
Institute of Allergy and Infectious Diseases (NIAID) has a need for
organizations having the capability and facilities to conduct Clinical Trials
to Evaluate Therapies for HIV Disease.  The purpose of this requirement is to
evaluate potential therapies for HIV disease and its associated opportunistic
infections and malignancies in Phase I, I/II, and II clinical trials.
 
The DAIDS was established to address national research needs created by the
advent and spread of the acquired immunodeficiency syndrome (AIDS) epidemic.
Integral to the mission of the Division is responsibility for ensuring that
scientific investigation of infection with the human immunodeficiency virus
(HIV) is focused on the most critical biomedical research issues engendered by
the AIDS epidemic.  The Treatment Research Program of the DAIDS directs two
national clinical investigation programs for evaluating new treatments for HIV
infection and its associated opportunistic infections and cancers.  These two
programs are the AIDS Clinical Trials Group (ACTG) and the Community Programs
for Clinical Research on AIDS (CPCRA).
 
The purpose of this Request for Proposals (RFP) is to provide the DAIDS with
an additional clinical trials mechanism, separate and distinct from both the
ACTG and the CPCRA.  This mechanism will enable the Division to rapidly
address critical questions about therapeutic agents or innovative treatment
approaches and to evaluate potentially effective therapies that may fall
outside the immediate priorities of the ACTG or the CPCRA.  This contract
specifically will NOT REPLICATE the research conducted through the existing
ACTG and CPCRA systems but, rather, is expected to complement these research
activities.
 
The successful offeror(s) to this RFP must have the demonstrated scientific,
technical, and operational capabilities to plan, develop, implement, and
manage a clinical trials system to respond to the DAIDS need to rapidly
implement pilot and other early studies of new agents and interventions for
the treatment of HIV infection and its sequelae.  These capabilities include
developing, implementing and analyzing protocols, acquiring and distributing
investigational agents, and monitoring the progress of the ongoing trials in
accordance with Federal regulations and the DAIDS standards, including
reporting adverse drug reactions.
 
This NIAID-sponsored project will take approximately 5 years to complete.  It
is anticipated two completion type contracts will be made.  This is an
announcement for an anticipated RFP.  RFP-NIH-NIAID-DIADS-91-29 shall be
issued on or about January 4, 1991, with a closing date tentatively set for
March 13, 1991.  Requests for the RFP should be directed in writing to:
 
William Roberts
Contract Management Branch
National Institutes of Health
Control Data Corp. Building
6003 Executive Blvd., Room 222P
Bethesda, MD  20892
 
To receive a copy of the RFP, please supply this office with two
self-addressed mailing labels.  All responsible sources may submit a proposal
 
           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 4
that will be considered.  This advertisement does not commit the Government to
award a contract.

INSTITUTIONAL PHYSICIAN SCIENTIST DEVELOPMENT AWARD PROGRAM
 
RFA AVAILABLE:  MH-91-02
 
P.T. 34; K.W. 0710030, 0785035
 
National Institute of Mental Health
National Institute on Drug Abuse
 
Application Receipt Date:  March 20, 1991
 
The National Institute of Mental Health (NIMH) and the National Institute on
Drug Abuse (NIDA) is issuing this Request for Applications (RFA),
Institutional Physician Scientist Development Award Program, MH-91-02, whose
purpose is to develop exceptional research skills in physicians beginning a
research career.  It is designed to enable a research career for junior
faculty from institutions lacking a strong research base by offering
high-quality research career development experience in a research-intensive
environment where a critical mass of scientists are available to provide a
complete developmental experience.
 
Domestic, public or private, nonprofit institutions, and professional
organizations and associations may apply.  For NIMH, junior faculty to be
supported by the program must have an M.D. degree and must have completed at
least 1 year of postresidency training in psychiatry.  For NIDA, junior
faculty who have an M.D. and are currently in residency are encouraged.  This
program should include both women and the broadest possible representation of
minority groups.  If women and minority group members are not represented,
reasons for their exclusion must be explained or justified.
 
Applications will be accepted by NIMH and NIDA on the single receipt date of
March 20, 1991.  A maximum of six awards (three from each Institute) will be
supported initially.  Each Institute will set aside approximately $1,000,000
for this program.
 
Potential applicants may seek additional information and consultation from
NIMH or NIDA:
 
Leonard Lash, Ph.D.
Division of Clinical Research, NIMH
Room 10-99
Telephone:  (301) 443-3264
 
Kenneth Lutterman, Ph.D.
Division of Applied and Services Research, NIMH
Room 118C-26
Telephone:  (301) 443-3685
 
Harold Jones, Ph.D.
Office of Policy and External Affairs, NIDA
Room 10A-43
Telephone:  (301) 443-1801
 
The mailing address for all of the above is:
 
5600 Fishers Lane
Rockville, MD  20857

CLINICAL TREATMENT AND CORRELATES OF UPPER GI CARCINOMA
 
RFA AVAILABLE:  CA-91-03
 
P.T. 34; K.W. 0715035, 0715085
 
National Cancer Institute
 
Letter of Intent Date:  February 25, 1991
Application Receipt Date:  April 8, 1991
 
PURPOSE
 
The Division of Cancer Treatment (DCT) of the National Cancer Institute (NCI)
invites research grant applications (R01) from interested investigators to
 
           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 5
assess new clinical correlates and develop new treatment modalities in upper
gastrointestinal (GI) carcinoma by means of an integrated research program of
laboratory experimentation and concurrent clinical trials.  New, as well as
experienced, investigators in relevant fields and disciplines may apply to
fund new therapeutic clinical trials or new correlative laboratory studies
that are related to clinical trials.
 
BACKGROUND
 
Carcinoma of the organs of the upper GI tract (esophagus and stomach) are
lethal tumors.  Development of resistance to treatment (as manifested by tumor
progression) is rapid even when chemotherapy, with or without radiation
therapy, is effective.  Taken collectively, the incidence of these tumors
represents a major health hazard to 35,000 patients per year.  Except for the
11 percent of patients with gastric cancer limited to the stomach, who are
able to undergo curative resection, and a similar group of patients with
esophageal cancer, the average life span for patients with these cancers is 4
to 6 months.  The reported response rates for cytotoxic therapy range from 5
percent to 40 percent.  Relatively few complete responses are noted and no
patient with metastatic disease is cured.  Recently, however, promising
results utilizing combinations of radiation or surgery and chemotherapy have
been reported for esophageal cancer.
 
The NCI supports basic research efforts to describe and understand the tumor
biology and treatment resistance of malignancies.  Such efforts form the basis
for the development of new treatment modalities.  Relatively few
investigations are supported in upper gastrointestinal carcinoma to move new
advances in the laboratory into the clinic.  This Request for Applications
(RFA) encourages applicants to address their research efforts towards the
upper GI carcinomas and the development of new clinical therapies.  For
example, monoclonal antibodies directed against gastrointestinal tumor
specific antigens have been developed, characterized, and applied for
diagnostic purposes.  The potential of these antibodies to improve clinical
management and/or therapy of these diseases needs further investigation.
Clinical correlations of oncogenes, growth factors, or markers of drug
resistance may prove useful in subsets of patients that would respond to
specific treatment therapies.
 
RESEARCH GOALS AND SCOPE
 
The major goal of this RFA is to foster interactions between basic science
laboratories and clinicians performing clinical trials in upper GI carcinoma
to improve treatment results and clinical outcome.  To accomplish this goal,
two types of studies will be supported:  (1) the development of new
therapeutic clinical trials and (2) new correlative studies relevant to
clinical trials.  Applications should be focused on integrating clinical goals
with laboratory research areas.
 
This RFA envisions funding new therapeutic clinical trials in upper GI
carcinomas that test and exploit basic findings concerning drug resistance or
cellular targets of treatment.  Clinical studies should be designed to improve
cancer treatment.  New clinical studies dealing with treatment using
chemotherapeutic drugs, biologics, radiation, or surgery, whether used as a
single agent/modality or in combination, are appropriate.  Examples of
clinical trials based on new therapeutic approaches include:  (1) treatment
therapies for overcoming drug or radiation resistance; (2) treatment therapies
based on novel mechanisms of action; (3) biologics in combination with drug or
radiation regimens; (4) immunotherapies including monoclonal antibody therapy,
radioimmunotherapy, and the use of new immunotoxins; (5) new therapies
combining endocrine manipulations with chemotherapeutic agents; (6) more
effective combinations of chemotherapy and radiation therapy; or (7) radiation
modifiers to enhance cell kill or protect normal tissue.
 
This RFA has a second research goal of funding new correlative laboratory
studies that are relevant to therapeutic clinical trials.  Some examples of
therapeutic correlates include:  (1) phenotypic or genotypic alterations which
appear to correlate with the development of drug or radiation resistance; (2)
oncogenes, growth factors, and specific antigen expression on tumor cells for
antibody development; (3) pharmacokinetic and pharmacodynamic measurements;
and (4) biochemical pharmacologic parameters.  The therapeutic correlates must
have a future clinical application such as development of new treatment
strategies or identification of patient subsets for specific treatment
therapies.  This RFA does not support research investigations on diagnostic
markers or clinical correlates that will have no impact on the clinical
treatment of patients.  The laboratory assays must utilize patient specimens
from new or ongoing clinical trials and have been demonstrated to be
applicable to tissue samples and/or body fluids, etc.  Investigators are

           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 6
encouraged to obtain patient specimens from multi-institutional clinical
trials to ensure adequate sample size for statistical analysis.
 
Research investigators are not limited to the above areas of potential
studies.  Clinical protocols should be included in the Appendix of the
application.  A section on statistical support should be included in the grant
application to ensure proper correlation of assay parameters with clinical
outcome.
 
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
 
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations.  If women or minorities are not included in the study populations
for clinical studies, a specific justification for this exclusion must be
provided.  Applications without such documentation will not be accepted for
review.
 
MECHANISM OF SUPPORT
 
Support of the program will be through the National Institutes of Health (NIH)
grant-in-aid.  Applicants will be responsible for the planning, direction, and
execution of the proposed project.  Approximately $1,500,000 in total costs
per year for three years will be committed to specifically fund applications
that are submitted in response to this RFA.  It is anticipated that 6 to 8
awards will be made.  This funding level is dependent on the receipt of a
sufficient number of applications of high scientific merit.  The total project
period for applications submitted in response to the present RFA should not
exceed three (3) years.  The earliest feasible start date for the initial
award will be December 1, 1991.
 
Non-profit organizations and institutions, governments and their agencies are
eligible to apply.  For-profit organizations are also eligible to apply.
Applications can be from single institutions or multiple institutions
(collaborating institutions, consortia, cooperative groups).  We encourage
new, as well as experienced, investigators to apply.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by February 25, 1991, 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, it is requested in order to
provide an indication of the number and scope of applications to be reviewed.
 
The letter of intent should be sent to:
 
BY US POSTAL
 
Ms. Diane Bronzert
Program Director
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
 
Ms. Diane Bronzert
Program Director
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
6130 Executive Blvd.
Rockville, MD  20852

 

           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 7
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 Ms. Diane Bronzert at the
above address.  The program director welcomes the opportunity to clarify any
issues or questions from potential applicants.

SPECIALIZED CENTERS OF RESEARCH IN RHEUMATOID ARTHRITIS (RA SCOR)
SPECIALIZED CENTERS OF RESEARCH IN OSTEOARTHRITIS (OA SCOR)
SPECIALIZED CENTERS OF RESEARCH IN OSTEOPOROSIS (OP SCOR)
 
RFA AVAILABLE:  AR-91-01
 
P.T. 04; K.W. 0715010, 0705050, 0710030
 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 
Letter of Intent Receipt Date for RA and OP SCORs:  July 1, 1991
Application Receipt Date for RA and OP SCORs:  October 15, 1991
 
Letter of Intent Receipt Date for OA SCORs:  November 1, 1991
Application Receipt Date for OA SCORs:  February 14, 1992
 
BACKGROUND
 
The National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) invites grant applications from interested institutions for
Specialized Centers of Research (SCORs) in three areas of special importance
to the Institute:  rheumatoid arthritis, osteoarthritis, and osteoporosis.
This represents the first recompetition of the NIAMS SCOR program, begun in
1987.  At this time the number of SCOR grants (nine) and the distribution,
three each in RA, OA, and OP, will remain the same.
 
RESEARCH GOALS AND SCOPE
 
A SCOR consists of a cluster of individual, but interrelated, basic and
clinical research projects, each with high scientific merit and clear research
objectives.  Examples of disciplines that could contribute to a SCOR include,
but are not limited to:  biochemistry, genetics, molecular biology,
immunology, pathology, epidemiology, rheumatology, orthopedic surgery,
bioengineering, and statistics.  Each center has a central research theme that
provides for research on significant problems of etiology, pathogenesis,
diagnosis, prevention, and treatment related to the program area.  Other
characteristics of the SCOR include:  a research plan emphasizing current
multidisciplinary fundamental and clinical research; an environment
encouraging active collaborations among individual clinical and basic research
investigators within the SCOR, and among other SCORs.
 
Support for large clinical trials or for applications that contain exclusively
clinical or exclusively basic studies will not be provided within this SCOR
program.  Applicants from institutions which have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources may
wish to identify the GCRC as a resource for conducting the proposed research.
In such a case, a letter of agreement from either the GCRC program director or
principal investigator could be included with the application.
 
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
 
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations.  If women or minorities are not included in the study populations
for clinical studies, a specific justification for this exclusion must be
provided.  Applications without such documentation will not be accepted for
review.
 
MECHANISM OF SUPPORT
 
The administrative and funding mechanism will be the Specialized Center of
Research (P50) grant award.  Regulations and policies that govern the research
grant programs of the Public Health Service will prevail.  The award will
support research projects and core functions.
 
To be eligible for an award, an application must include both basic
(laboratory-based) and clinical investigation.  Each individual research
project must stand on its own merit and complement other projects.  Thus, a
 
           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 8
project, regarded as highly meritorious in isolation could be recommended for
deletion from the program if it is perceived as being totally independent from
the program as a whole.
 
Separate cores are not a mandatory component, although experience has shown
them to be useful and economic.  A core is defined as a resource shared by
multiple investigators that should enhance research productivity and increase
the functional capacity of the SCOR.  Examples of core functions include
biochemical analysis, electron microscopy, or data management.
 
The award of grants pursuant to this Request for Applications (RFA) is
contingent upon the receipt of applications judged by peer review to be of
excellent to outstanding merit and the availability of appropriated funds for
this purpose.  The yearly direct cost budget requested must not exceed $1
million.  SCOR awards will be issued for a period of five (5) years and may be
renewable on a competitive basis.
 
REVIEW PROCEDURES AND CRITERIA
 
All applications submitted in response to the RFA will be reviewed first for
completeness and responsiveness to this RFA.  A preliminary evaluation
(triage) by a peer review group to determine the relative merit of an
application relative to other applications may be performed.  The further
evaluation of remaining applications for scientific and technical merit will
be by an initial review group which will be convened solely to review these
applications.  A site visit is not planned.  Each proposal should, therefore,
be complete in itself and be prepared as if no site visit is expected.
 
Factors to be considered in evaluation of the scientific merit of each
application will be those used in the review of traditional research project
grants applications, including the scientific merit of each proposed project
and the scientific merit of combining the component parts into a SCOR.
Applications judged to be nonresponsive to the RFA will be returned to the
applicant.
 
Following assessment by the initial review group, applications will be
evaluated by the National Arthritis and Musculoskeletal and Skin Diseases
Advisory Council.
 
METHOD OF APPLYING
 
Prospective applicants should obtain the supplemental program guidelines
developed by NIAMS for its SCOR program from the Centers Program Director
listed below.  Prospective applicants are encouraged to submit to the Centers
Program Director a nonbinding letter of intent to apply by July 15, 1991 (RA
and OP SCORs) or November 14, 1991 (OA SCOR).  The letter should include a
descriptive title, the name and address of the Principal Investigator and
other key investigations, and the names and address of any other participating
institutions.
 
The letter of intent is not mandatory and does not influence review or funding
decisions, but it will assist the NIAMS to plan the review.  It will also
ensure that each potential applicant receives relevant program information
prior to expending considerable effort in preparing the application.
 
Applications must be submitted on the standard PHS 398 application form (rev.
10/88) available at most institutional business offices or from the Division
of Research Grants, NIH (telephone number:  301-496-7441).  On item 2 of the
face page of the application, applicants must enter:  RFA AR-91-01 Specialized
Centers of Research in Arthritis and Musculoskeletal Diseases.  The RFA label
(found in the 10/88 revision of application form PHS 398) must be affixed to
the bottom of the face page of the original copy of the application.  Failure
to use this label could result in delayed processing of your application such
that it will not reach the review committee in time for review.
 
Send the original and six copies of the application to the NIH Division of
Research Grants (DRG), no later than October 15, 1991, for an RA or OP SCOR
and February 14, 1992, for an OA SCOR.

 

 

 

           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 9
IDENTIFICATION OF CONTACT POINTS
 
Inquiries regarding this announcement, the guidelines for structuring a
Specialized Center of Research application, and method of applying should be
directed to:
 
Julia B. Freeman, Ph.D.
Centers Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403
Bethesda, MD  20892
Telephone:  (301) 496-7496
FAX:  (301) 496-7881
 
This program is described in the Catalog of Federal Domestic Assistance, No.
93.846.  Grants are awarded under the authority of the Public Health Service
Act, Section 301 (42 USC 241) and administered under PHS grant policies and
Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74.
This program is not subject to review by a Health Systems Agency.

DIABETES INTERDISCIPLINARY RESEARCH PROGRAM
 
RFA AVAILABLE:  DK-91-05
 
P.T. 34; K.W. 0715075, 0710030, 1002019, 0710070, 1002004, 1002008
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date:  March 15, 1991
Application Receipt Date:  May 17, 1991
 
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
and the Juvenile Diabetes Foundation International (JDFI) invite
investigator-initiated program project grant applications that incorporate an
interdisciplinary research approach to the etiology and pathogenesis of
insulin-dependent diabetes mellitus (IDDM) or to the genetic susceptibility
for the long-term complications of diabetes.  This solicitation is intended to
stimulate the application of advances in basic molecular biology, genetics,
immunology, cell biology, and biophysics to the study of IDDM and its
complications.  It is expected that this will be accomplished by bringing to
the diabetes arena those who are skilled in these approaches by the support of
meritorious, synergistic, multidisciplinary research program project
applications.  Proposals should include the involvement of both basic and
applied scientists in collaborative endeavors.
 
The mechanism of support will be the program project grant award.  A program
project grant is for the support of a broadly-based multidisciplinary or
multifaceted research program that has a specific major objective or central
theme.  The award may support research components and core functions.
Collectively, these components should demonstrate essential elements of unity
and interdependence and result in a greater contribution to program goals than
if each activity were pursued individually.
 
Applications will be submitted to the NIH and will be reviewed by NIH
according to normal NIH peer review procedures.  Applications judged
meritorious but not funded by the NIH may be considered by the JDFI for
possible funding.  Applicants wishing to have their application considered by
the JDFI must authorize the NIDDK to provide a copy of their letter of intent,
application, and NIH-prepared summary statement of the initial review to the
JDFI.
 
The NIDDK plans to make one or two awards in FY 1992 contingent on the receipt
of highly meritorious applications in response to this solicitation.  The JDFI
plans to make two to four awards.  With respect to post-award administration,
the current policies and requirements that govern the research grant programs
of the NIH or the JDFI will prevail depending on the funding source.
Applicants should note that grants funded by the JDFI will be subject to the
indirect cost policy of JDFI.
 
The criteria for review of applications will be those used regularly for the
review of program project grant applications by the NIDDK.  These criteria
concern the scientific and technical merit, originality, and feasibility of
the constituent individual research projects; the utility and quality of the
proposed core facilities; the cohesiveness, synergy, significance, and overall
scientific and technical merit of the entire program project; and the
qualifications, experience, and commitment of the participating personnel.  A
complete and detailed description of these criteria is contained in the
 
           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 10
publication entitled "NIDDK Program Project Grants:  Administrative
Guidelines" that is available by request.
 
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
 
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations.  If women or minorities are not included in the study populations
for clinical studies, a specific justification for this exclusion must be
provided.  Applications without such documentation will not be accepted for
review.
 
Potential applicants are strongly encouraged to submit a letter of intent.
The letter of intent may include only 1) names of the Principal
Investigator/program director and principal collaborators, 2) descriptive
title of the potential application, and 3) identification of the
organization(s) involved.  The letter of intent should be sent to:
 
Dr. Robert D. Hammond
Chief, Review Branch
Division of Extramural Activities
NIDDK, NIH
Westwood Building, Room 406
Bethesda, MD  20892
 
Applicants must submit a brief letter to the NIDDK indicating whether or not
they wish their applications to be considered for funding by the JDFI.  While
applicants may request that their applications be considered only by the NIDDK
and not by the JDFI, it is necessary that the record indicate the applicant's
consideration of this opportunity.  Letters of authorization should be
prepared by the Principal Investigator and co-signed by the official signing
for the applicant organization.  This letter may be combined with Letters of
Intent or may be submitted as cover letters accompanying applications.
 
Requests for the full text of this RFA and inquiries should be directed to the
following NIDDK Program Staff:
 
Joan T. Harmon, Ph.D.
Executive Director, Diabetes Research Program
Diabetes Programs Branch
NIDDK, DDEM
Westwood Building, Room 622
Bethesda, MD  20892
Telephone:  (301) 496-7731

PHYSICAL FRAILTY IN MINORITY OLDER POPULATIONS - REVISION
 
RFA:  AG-91-03
 
P.T. 34, CC, FF; K.W. 0710010, 0715043, 0710095, 1002019, 0745027
 
National Institute on Aging
 
The Notice of Availability for this RFA was published in the NIH Guide for
Grants and Contracts on December 7, 1990, Vol. 19, No. 44.
 
No award will be made in excess of $200,000 in total cost (direct plus
indirect) for first year expenses and, in general, increments no more than
four percent for each succeeding year.
 
For further information, contact:
 
Stanley L. Slater, M.D.
Geriatrics Program
National Institute on Aging
Building 31, Room 5C27
National Institutes of Health
Bethesda, MD  20892
Telephone:  (301) 496-6761

 

 

           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 11
                        ONGOING PROGRAM ANNOUNCEMENTS

SURGICAL ONCOLOGY
 
PA:  PA-91-16
 
P.T. 34; K.W. 0785140, 0785210
 
National Cancer Institute
 
Application Receipt Dates:  June 1, October 1, February 1
 
PURPOSE
 
The treatment of cancer has evolved as a multi-disciplinary effort involving
(but not limited to) the disciplines of surgical oncology, medical oncology,
pediatric oncology, and radiation oncology.  The disciplines of medical
oncology, pediatric oncology, and radiation oncology have developed strong
cadres of academic investigators while academic development in surgical
oncology has not kept pace.  It is believed that surgical oncology is not
keeping pace because of an insufficient number of surgical oncology research
programs and an insufficient number of surgeons undertaking research related
to cancer.  Continued development of superior multi-disciplinary treatment of
cancer is the long-range objective of the Division of Cancer Treatment (DCT)
and the attainment of the goal requires sufficient academic strength in
investigative surgical oncology.
 
RESEARCH OBJECTIVES
 
The DCT, National Cancer Institute, is seeking applications for research
grants (R01, R29, P01) concerned with research in surgical oncology.  Examples
of relevant studies include mechanisms of metastases, effect of surgery on
tumor cell kinetics, and tumor host responses to surgery.  Preclinical and
clinical research is encompassed in this program.  Categories of research
include (but are not confined to) the following:  (1) Pathophysiologic studies
related to surgery and cancer in laboratory models or in humans; (2)
Laboratory and clinical studies that examine the biochemical, cytokinetic,
immunological, or nutritional effects of cancer surgery; (3) Therapeutic
studies in which surgery or a surgical question is the primary treatment
modality; (4) Novel immunotherapy procedures such as assessment of specific
lymphokines, stimulated cells, and autologous vaccines which require surgical
input; (5) New surgical techniques relevant to staging or care of patients;
(6) Studies to identify prognostic factors relevant to the treatment of cancer
patients; (7) Surgical supportive care; (8) Regional chemotherapy or
hyperthermia or radiation in which a surgical approach to the treatment site
is a major aspect of the procedure.  This Program Announcement is not
restricted to the areas of surgical oncology research listed above.
 
MECHANISM OF SUPPORT
 
This program will be supported through the NIH grant-in-aid mechanism (R01,
R29, P01).  Awards will be administered under Public Health Service grants
policy as stated in the PHS Grants Policy Statement, DHHS Publication No.
(OASH) 82-50,000, revised January 1, 1987.  The total project period for
applications submitted in response to the Program Announcement should not
exceed five years.
 
This Program Announcement is a continuous announcement until retracted.
Generally future unsolicited competing renewal applications will compete as
research project applications with all other investigator-initiated
applications.  Applications will compete for available funds with all other
approved applications.
 
ELIGIBILITY
 
Applications may be submitted by public or private nonprofit or for-profit
organizations such as universities, colleges, hospitals, laboratories, units
of State or local governments, and eligible agencies of the Federal
Government.  Applications from minority individuals and women are encouraged.
 
REVIEW PROCEDURES
 
Applications will be assigned on the basis of established Public Health
Service referral guidelines.  Applications will be reviewed for scientific and
technical merit by regular study sections of the NIH, or in the case of P01s,
by the review group of the relevant institute in accordance with the usual NIH
peer review procedures and criteria.  Following study section review, the
 
           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 12
applications will receive a second-level review by the appropriate national
advisory council.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES
CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY
POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research
grants and cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study; special
emphasis should be placed on the need for inclusion of minorities and women in
studies of diseases, disorders and conditions which disproportionately affect
them.  This policy is intended to apply to males and females of all ages.  If
women or minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.
 
The composition of the proposed study population must be described in terms of
gender and racial/ethnic group.  In addition, gender and racial/ethnic issues
should be addressed in developing a research design and sample size
appropriate for the scientific objectives of the study.  This information
should be included in the form PHS 398 in Section 2, A-D of the Research Plan
AND summarized in Section 2, E, Human Subjects.  Applicants/offerors are urged
to assess carefully the feasibility of including the broadest possible
representation of minority groups.  However, NIH recognizes that it may not be
feasible or appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority populations (i.e.,
Native Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics).
 
The rationale for studies on single minority population groups should be
provided.
 
For the purpose of this policy, clinical research includes human biomedical
and behavioral studies of etiology, epidemiology, prevention (and preventive
strategies), diagnosis, or treatment of diseases, disorders or conditions,
including not but limited to clinical trials.
 
The usual NIH policies concerning research on human subjects also apply.
Basic research or clinical studies in which human tissues cannot be identified
or linked to individuals are excluded.  However, every effort should be made
to include human tissues from women and racial/ethnic minorities when it is
important to apply the results of the study broadly, and this should be
addressed by applicants.
 
For foreign awards, the policy on inclusion of women applies fully; since the
definition of minority differs in other countries, the applicant must discuss
the relevance of research involving foreign population groups to the United
States' populations, including minorities.
 
If the required information is not contained within the application, the
application will be returned.
 
Peer reviewers will address specifically whether the research plan in the
application conforms to these policies.  If the representation of women or
minorities in a study design is inadequate to answer the scientific
question(s) addressed AND the justification for the selected study population
is inadequate, it will be considered a scientific weakness or deficiency in
the study design and will be reflected in assigning the priority score to the
application.
 
All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants or
cooperative agreements that do not comply with these policies.
 
METHOD OF APPLYING
 
Applications should be submitted on the grant applications for PHS 398 (Rev.
10/88) and will be accepted at the regular application deadlines.  Application
kits are available at most institutional business and grant/contract offices
or may be obtained from the Division of Research Grants, National Institutes
of Health, Bethesda, MD 20892.  The title and number of this announcement
should be typed in line 2 on the face page of the application.
 
The original application and six (6) signed exact photocopies should be
submitted or delivered to:

           NIH GUIDE - Vol. 19, No. 46, December 28, 1990 - Page 13
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Applicants are strongly encouraged to contact Dr. Wu prior to application
preparation:
 
Roy S. Wu, Ph.D.
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
EPN, Room 734
Bethesda, MD  20892
Telephone:  (301) 496-8866
 
Request for further information should be directed to Dr. Wu at the address
given above.
 
Before submitting a P01 application, please submit a letter of intent to
Dr. Wu.
 
This program is described in the Catalog of Federal Domestic Assistance No
93.395, Cancer Treatment Research.  Grants will be awarded 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 Feral
Regulations at 42 CFR Part 52 and 45 CFR Part 74.  This program is not subject
to the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

**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

 

 

 

 

 

 

 

 

 

 

 

 

 
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