Subject: (Copy) NIH GUIDE - V21(12) 03/27/92 - P1/3
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Mon, 30 Mar 92 08:41 EST

Hi,
   Please post to the NIH LIstserver as:
    NIHGUIDE.920327
 ---------------------------- Text of forwarded message -----------------------
 
$$XID NIHGUIDE 19920327 V21N12 P1O3 ************************************
X-comment: RFAs described: HS-92-03, DE-92-03, CA-92-17
 
NIH GUIDE - Vol. 21, No. 12 - March 27, 1992
 
$$INDEX BEGIN *******************************************************
 
                                   NOTICES
 
$$INDEX N1 **********************************************************
 
ELECTRONIC ACCESS TO NIH GUIDE FOR GRANTS AND CONTRACTS
National Institutes of Health
INDEX:  NATIONAL INSTITUTES OF HEALTH
 
                      NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
$$INDEX R1 **********************************************************
 
ONCOGENE ANALYSIS FOR MOLECULAR TOXICOLOGY STUDIES (RFP NIH-ES-92-25)
National Institute of Environmental Health Sciences
INDEX:  ENVIRONMENTAL HEALTH SCIENCES
 
$$INDEX R2 **********************************************************
 
OPERATION OF AN EXPERIMENTAL VIRUS VACCINE PRODUCTION LABORATORY (RFP
NIH NIAID-DIR-93-03)
National Institute of Allergy and Infectious Diseases
INDEX:  ALLERGY AND INFECTIOUS DISEASES
 
$$INDEX R3 07/15/92 *************************************************
 
THE STUDY OF PATIENT OUTCOMES ASSOCIATED WITH PHARMACEUTICAL THERAPY
(RFA HS-92-03)
Agency for Health Care Policy and Research
INDEX:  HEALTH CARE POLICY, RESEARCH
 
$$INDEX R4 09/16/92 *************************************************
 
PERIODONTAL DISEASES RESEARCH CENTERS (RFA DE-92-03)
National Institute of Dental Research
INDEX:  DENTAL RESEARCH
 
$$INDEX R5 06/09/92 *************************************************
 
5-A-DAY FOR BETTER HEALTH (RFA CA-92-17)
National Cancer Institute
INDEX:  CANCER
 
                         ONGOING PROGRAM ANNOUNCEMENTS
 
$$INDEX P1 **********************************************************
 
NATIONAL DIGITAL MAMMOGRAPHY DEVELOPMENT GROUP (PA-92-57)
National Cancer Institute
INDEX:  CANCER
 
$$INDEX P2 **********************************************************
 
CLINICAL RESEARCH ON HUMAN DEVELOPMENT AND DRUG ABUSE (PA-92-58)
National Institute on Drug Abuse
INDEX:  DRUG ABUSE
 
$$INDEX P3 **********************************************************
 
GENOME INFORMATICS PROGRAM (PA-92-59)
National Center for Human Genome Research
INDEX:  HUMAN GENOME RESEARCH
 
$$INDEX P4 **********************************************************
 
PREVENTION OF INSULIN DEPENDENT DIABETES MELLITUS BY IMMUNOMODULATION
(PA-92-60)
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Allergy and Infectious Diseases
National Institute of Child Health and Human Development
INDEX:  DIABETES, DIGESTIVE, KIDNEY DISEASES; ALLERGY, INFECTIOUS
DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT
 
$$INDEX P5 **********************************************************
 
CANCER PREVENTION AND CONTROL RESEARCH (PA-92-61)
National Cancer Institute
INDEX:  CANCER
 
$$INDEX P6 **********************************************************
 
CAUSES AND EFFECTS OF ELDERLY POPULATION CONCENTRATIONS (PA-92-62)
National Institute on Aging
Agency for Health Care Policy and Research
INDEX:  AGING; HEALTH CARE POLICY RESEARCH
 
$$INDEX P7 **********************************************************
 
CHEMISTRY-BIOLOGY INTERFACE PREDOCTORAL TRAINING (PA-92-63)
National Institute of General Medical Sciences
INDEX:  GENERAL MEDICAL SCIENCES
 
$$INDEX P8 **********************************************************
 
RESEARCH ON HERITABLE DISORDERS OF CONNECTIVE TISSUE (PA-92-64)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
INDEX:  ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CHILD HEALTH, HUMAN
DEVELOPMENT
 
                                      ERRATUM
 
$$INDEX E1 **********************************************************
 
BI-COMPARTMENT TRANSDERMAL CONTRACEPTIVE DELIVERY SYSTEM (RFP NICHD-CD-
92-12)
National Institute of Child Health and Human Development
INDEX:  CHILD HEALTH, HUMAN DEVELOPMENT
 
This publication is also available electronically to institutions via
BITNET or INTERNET.  Alternative access is through the NIH Grant Line
using a personal computer.  Contact Dr. John James at 301/496-7554 for
details, or send an E-mail message to ZNS@NIHCU.
 
$$INDEX END *********************************************************
 
                                  NOTICES
 
$$N1 BEGIN **********************************************************
 
ELECTRONIC ACCESS TO NIH GUIDE FOR GRANTS AND CONTRACTS
 
NIH GUIDE, Volume 21, Number 12, March 27, 1992
 
P.T. 16; K.W. 1004017, 1014002
 
National Institutes of Health
 
The NIH Guide for Grants and Contracts can be obtained electronically
by the extramural community in two ways:
 
o  Electronic Networks to Institutional Hubs (E-Guide)
 
o  NIH Grant Line, an Electronic Bulletin Board
 
The advantage of both of these methods is that announcements are
available to the extramural community immediately upon publication,
without the delay due to mailing the print version.  In addition, the
full length version of each Request for Applications (RFA) may be
obtained from both of the electronic means of dissemination.  Use of
these means is encouraged.
 
INSTITUTIONAL HUBS
 
Institutional subscriptions to the E-Guide, which includes the NIH
Guide, the full text of RFAs, indices, and directories, are available
upon request.  The subscriber, usually located in the Office of
Sponsored Research or equivalent, receives the E-Guide via an
electronic network (BITNET or INTERNET) once per week, concomitant with
the publication of the print version of the NIH Guide.  From the point
of receipt, the E-Guide may be forwarded in print or electronically, at
the discretion of the recipient, to researchers and administrators at
that institution.
 
To express interest in serving as an Institutional Hub, send an E-mail
message that includes the name of the designated person, the E-mail
address, title, and location of that person, and the estimated number
of individuals to whom the E-Guide will be distributed locally.  Send
the request to Ms. Rebecca Duvall, Program Analyst for the NIH Guide,
at BITNET Q2C@NIHCU or INTERNET [email-masked].
 
NIH GRANT LINE
 
Contents
 
The purpose of NIH Grant Line (known also as DRGLINE) is to make
program and policy information of the Public Health Service (PHS)
agencies rapidly available to the biomedical research community.  Most
of the information available on this bulletin board is derived from the
weekly publication, the NIH Guide for Grants and Contracts, and
consists of Notices, Notices of Availability of RFAs and Requests for
Proposals, Program Announcements, and statements of PHS policy.
 
The information to be found on the NIH GRANT LINE is grouped into three
main sections:  (1) short News Flashes that appear without any
prompting shortly after logon, (2) Bulletins that are for reading, and
(3) Files that
are intended mainly for downloading.
 
The Files section is grouped into ten Directories as follows:
 
Name     Entries    Description
 
GENINFO        2   General NIH info, acronyms, receipt dates
GUIDENDX      10   Various indexes to NIH Guide and RFA schedule
GUIDE90       26   Weekly issues of NIH Guide for 1990
GUIDE91       49   NIH Guide, 1991, New Electronic Format
GUIDE92        7   E-GUIDE, 1992, Weekly Electronic Editions
PROGUIDE      13   NIH program announcements and guidelines
RFAS90        42   Full text of 1990 RFAS available electronically
RFAS91       150   Full Text of 1991 RFAs available electronically
RFAS92        15   Full Text of 1992 RFAs available electronically
TELDIR         2   NIH telephone directory, for extramural use
 
Directories whose names are of the form GUIDEyy (where yy is the year)
contain the weekly issues of the NIH Guide for that year.  Directories
whose names are of the form RFASyy contain the full text of RFAs
distributed during that year.  Program announcements and guidelines are
found in both GUIDEyy and PROGUIDE, but the ones in PROGUIDE are
usually applicable to all of NIH, are often grant mechanism oriented,
and will be effective for longer periods of time than those in GUIDEyy.
Newly announced programs would first appear in the GUIDEyy directories.
 
To access the NIH GRANT LINE:
 
1.  Configure the terminal emulator as:  1200 or 2400 baud, even
parity, 7 data bits, 1 stop bit, Local Echo on.
 
2.  Using the procedure specified in the communication software, dial
1-301-492-2221.  When you get a response indicating that you have been
connected, type ",GEN1" (don't type the quotes) and press ENTER; you
will be prompted for "INITIALS?".  Type BB5 and press ENTER.  You will
then be prompted for "ACCOUNT?".  Type CCS2 and press ENTER.
 
Messages and a menu will be displayed that will allow you to read
Bulletins or download Files.  On the NIH GRANT LINE, back issues of the
NIH Guide are found in two different directories.  GUIDE90 has issues
going back to July 6, 1990; GUIDE91 has all of the issues in 1991; and
GUIDE92 has all of the issues to date in 1992.
 
The Q (Quit) command returns the user to the Main menu.  From there the
F (Files) command is used to enter the file processing facility of the
bulletin board.  Use the D (Directory) command to see general
descriptions of the various Directories.  Selection of a given
Directory, (GUIDENDX for example), will display the names and
descriptions of files.
 
The T (Transfer) command downloads the selected file.  After the file
has been named and ENTER pressed, one of the downloading options may be
selected.  To download the file to a personal computer, Option 1 should
be selected to obtain instructions in the preparation for downloading.
 
Although the access to NIH GRANT LINE is through a modem, users who
have a Bitnet or Internet address may use Option 2 to mail a file
instead of downloading it through the modem.  Mailing files can greatly
reduce the length of the online interactive session and long distance
telephone charges.  When a file to be "downloaded" has been selected,
chose option 2 to transmit via a network and then respond with the
desired E-mail address.
 
INQUIRIES
 
Additional information about subscribing as an Institutional Hub may be
obtained from:
 
Ms. Rebecca Duvall
Institutional Affairs Office
National Institutes of Health
9000 Rockville Pike
Building 31, Room 5B31
Bethesda, MD  20892
Telephone:  (301) 496-5366
 
Additional information about the NIH GRANT LINE may be obtained from:
 
Dr. John James
Division of Research Grants
National Institutes of Health
Westwood Building, Room 109
Telephone:  (301) 496-7554
 
$$N1 END ************************************************************
 
$$R1 BEGIN NIH-ES-92-25 *********************************************
 
                   NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
ONCOGENE ANALYSIS FOR MOLECULAR TOXICOLOGY STUDIES
 
NIH GUIDE, Volume 21, Number 12, March 27, 1992
 
RFP AVAILABLE:  NIH-ES-92-25
 
P.T. 34; K.W. 1007009, 1002019, 0785140, 0755045
 
National Institute of Environmental Health Sciences
 
The primary purpose of this project will be to provide laboratory
support by the application of assays to screen for and verify mutations
in oncogenes, such as ras or p53, in samples of frozen or fixed tissues
using a variety of molecular techniques.  Specific methods to be in
place include polymerase chain reaction (PCR) amplification,
oligonucleotide hybridization, restriction fragment length polymorphism
(RFLP) analysis, direct sequencing of PCR products, and single stranded
conformation polymorphism (SSCP).  Specific tasks include, but are not
limited to, DNA extraction, amplification of regions of p53 or other
genes, screening for mutational activities of ras or other genes or
mutational deactivation of tumor suppressor genes, and assay for loss
of heterozygosity.  All responsible sources may submit a proposal that
will be considered.  The Request for Proposals (RFP) for this estimated
five-year competitive procurement will be released on or about March
27, 1992.  Proposals will be approximately 40 days thereafter.  The
institute expects to made one award from this solicitation.
 
Requests must reference RFP NIH-ES-92-25 and must be forwarded to:
 
National Institute of Environmental Health Sciences
Contracts and Procurement Management Branch
ATTN:  Thomas M. Hardee, Contracting Officer
79 T.W. Alexander Drive, 4401 Building
P. O. Box 12874
Research Triangle Park, NC  27709
Telephone:  (919) 541-7893
 
$$R1 END ************************************************************
 
$$R2 BEGIN NIH-NIAID-DIR-93-03 **************************************
 
OPERATION OF AN EXPERIMENTAL VIRUS VACCINE PRODUCTION LABORATORY
 
NIH GUIDE, Volume 21, Number 12, March 27, 1992
 
RFP AVAILABLE:  NIH-NIAID-DIR-93-03
 
P.T. 34; K.W. 0740075, 1002045, 0715125
 
National Institute of Allergy and Infectious Diseases
 
The National Institute of Allergy and Infectious Diseases (NIAID), NIH,
has a requirement for an Experimental Virus Vaccine Production
Laboratory.  The Division of Intramural Research, NIAID is soliciting
contract proposals from organizations having the capabilities and
facilities to prepare experimental virus vaccine suspensions for
submission to the Center for Biologic Evaluation Research, Food and
Drug Administration, using the Code of Federal Regulations (CFR),
Number 21, April 1, 1990, as a guide.  The viruses will include, but
not be limited to:  influenza, paramyxoviruses, hepatitis, rotavirus,
and vaccinia viruses.  The successful offeror must meet the
requirements listed in the CFR for an establishment engaged in the
preparation of live virus vaccines licensed for human use.  The offeror
will also be subject to inspection under the "Good Laboratory Practices
Act" and "Good Manufacturing Practices Act."  The NIAID-sponsored
project will take approximately five years to complete.  One contract
is anticipated.
 
This is an announcement for an anticipated Request for Proposal (RFP).
RFP NIH-NIAID-DIR-93-03 shall be issued on or about March 31, 1992,
with a closing date tentatively set for May 29, 1992.  Requests for the
RFP shall be directed in writing to:
 
Sylvia Cunningham, Contracting Officer
Contract Management Branch
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3C07
6003 Executive Boulevard
Bethesda, MD  20892
 
To receive a copy of the RFP, supply this office with two
self-addressed labels.  All responsible sources may submit a proposal
that will be considered.  This advertisement does not commit the
Government to award a contract.
 
$$R2 END ************************************************************
 
$$R3 BEGIN HS-92-03 FULL-TEXT ***************************************
 
THE STUDY OF PATIENT OUTCOMES ASSOCIATED WITH PHARMACEUTICAL THERAPY
 
NIH GUIDE, Volume 21, Number 12, March 27, 1992
 
RFA AVAILABLE:  HS-92-03
 
P.T. 34; K.W. 0745005, 0795005
 
Agency for Health Care Policy and Research
 
Application Receipt Date:  July 15, 1992
 
THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS
ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION.  POTENTIAL
APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACTS NAMED IN INQUIRES,
BELOW.
 
PURPOSE
 
The purpose of this announcement is to solicit applications from non-
profit organizations to conduct research on the outcomes of
pharmaceutical therapy.  The Agency for Health Care Policy and Research
(AHCPR) is encouraging innovative and timely health services research
on the effectiveness of pharmaceutical treatment and care.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA, The
Study of Patient Outcomes Associated with Pharmaceutical Therapy, is
related to the section on "Food and Drug Safety" (Objectives 12.5 and
12.6).  Potential applicants may obtain a copy of "Healthy People 2000"
(Full Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign non-profit
organizations, public and private, including universities, clinics,
units of State and local governments, non-profit firms, and non-profit
foundations.  For-profit institutions are not eligible for AHCPR
grants.  Applications from minority and women investigators are
encouraged.
 
MECHANISM OF SUPPORT
 
The RFA will use the research grant mechanism (R01).  Planning,
direction, and execution of the proposed project will be solely the
responsibility of the applicant.  The RFA is a one-time solicitation.
The total project period for applications submitted in response to this
RFA may not exceed five years; continuation of each awarded project
will depend on an annual progress review and availability of funds.
 
FUNDS AVAILABLE
 
AHCPR expects to commit up to $3 million for six to ten competitive
awards under this RFA.  The issuance of awards will be contingent on
the availability of funds and the quality of the applications.
 
RESEARCH OBJECTIVES
 
The enabling legislation for the AHCPR (P.L. 101-239) authorizes the
study of the appropriateness and effectiveness of the use of services
and procedures in the prevention, diagnosis, treatment, and management
of clinical conditions.  The law recognizes drug therapy as an
important form of treatment and refers specifically to the need to
investigate the appropriate use of prescription drugs.  The purpose of
this RFA is to encourage studies on the outcomes of pharmaceutical
therapy.
 
This RFA emphasizes the relationship between prescription drugs,
related services, and patient outcomes in ambulatory care settings.  Of
particular importance is the need to increase the availability and use
of data and empirical methods in research on the patient outcomes of
pharmaceutical therapy.
 
Three general areas of research are of interest:
 
o  data and analytic methods;
o  factors affecting the appropriateness of drug prescribing; and
o  the role of the patient.
 
Described below, the issues and questions raised are illustrative only,
and other study topics relevant to this RFA are welcome.
 
Data and Analytic Methods
 
There is a critical need for comprehensive, comparative assessment of
the appropriateness and effectiveness of alternative pharmaceutical
therapies.  Researchers should consider using existing data collected
for either administrative or research purposes.  These sources can be
supplemented with primary data collection.  Emphasis is to be given to
the study of clinical conditions that meet the following criteria:
 
o  the predominant mode of therapy is pharmaceutical;
o  a large number of patients are affected;
o  the use of health care resources is substantial; and
o  a variety of therapeutic choices exist.
 
The AHCPR encourages studies of the following:
 
o  What is the feasibility of using and/or developing comprehensive
databases to address questions concerning the outcomes of
pharmaceutical treatment?
 
o  Accurate ascertainment of drug exposure is essential.  How valid are
currently used measures of drug exposure?
 
o  How can the association between pharmaceutical treatment to achieve
surrogate endpoints and patient outcomes be validated?
 
o  Comparative cost-effectiveness studies that can be used by the
industry and research community as models or standards for analysis
would be especially useful.
 
o  What hypotheses on the outcomes of pharmaceutical therapy can be
tested using international sources of data?
 
Factors Affecting the Appropriateness of Drug Prescribing
 
Previous studies have explored the effects of policy and educational
interventions on drug prescribing.  Many questions remain about the
long-term effects of private and public programs that monitor and
intervene in the prescribing process.  The AHCPR is interested in
research on the effects on patient outcomes of programs designed to
improve the appropriateness of drug prescribing.
 
The AHCPR encourages studies of the following:
 
o  Of particular interest to this RFA are questions dealing with the
link between drug utilization review (DUR) and patient outcomes in
Medicaid or other programs in the ambulatory care setting.
 
o  Evaluative questions regarding the relationship of pharmaceutical
care, specifically pharmacists' cognitive services, and patient
outcomes are encouraged.
 
o  Interventions to change prescribing behavior range from academic
detailing to less costly computer-generated letters.  Further study of
the effects of these interventions on prescribing behavior and on
patient outcomes is needed.
 
The Role of the Patient
 
Therapeutic goals are condition- and patient-specific, and desired
outcomes will vary by disease, severity of illness, consequences of
therapy, and associated treatment costs.  In addition to objectively
measured consequences of treatment, outcomes of importance include
subjective measures of patients' quality of life, satisfaction, and
perceived functional status.
 
The AHCPR is interested in studies that will address the following:
 
o  How does patient compliance with a drug regimen vary with respect to
changes in quality of life and functional status?
 
o  What is the association between objective and subjective measures
for specific conditions?
 
o  To what extent can existing databases, or new primary data
collection, be used to examine the relationship between self-care and
patient outcomes?
 
o  How can existing models and instruments measuring patient
satisfaction, quality of life, functional status, and utility be used
to compare outcomes among alternative therapies?
 
SPECIAL REQUIREMENTS
 
Applications should specifically address the appropriateness and/or
effectiveness of pharmaceuticals or related services.  Projects should
include investigator(s) and key staff who reflect the multidisciplinary
nature of outcomes research.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN STUDY
POPULATIONS
 
The AHCPR adheres to NIH and ADAMHA policy that requires applicants for
research grants and cooperative agreements to include minorities and
women in study populations.  If minorities or women are excluded or
inadequately represented in proposed research, a clear and compelling
rationale must be provided.  The application must reflect this policy,
or it will be returned without review.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev.9/91) is to be used in
applying for these grants.  State and local government agencies may use
form PHS 5161.  These forms are available from:  Office of Scientific
Review, Agency for Health Care Policy and Research, 2101 East Jefferson
Street, Suite 602, Rockville, MD, 20852, telephone:  (301) 227-8449.
 
The RFA contains further details regarding the application procedures.
Applications must be received by July 15, 1992.
 
CONFERENCE FOR PROSPECTIVE APPLICANTS
 
The AHCPR plans to convene a conference in Chicago on April 30, 1992,
prior to the application receipt date.  Attendance is not a
prerequisite for applying.  All personal travel costs and
accommodations are the responsibility of the attendees.  Individuals
with questions concerning this announcement, or unable to attend the
conference, may call or write the AHCPR staff members listed below for
further technical and/or administrative assistance.
 
REVIEW PROCEDURES
 
Upon receipt, applications will be reviewed by AHCPR staff for
completeness and responsiveness.  All responsive applications will
undergo initial peer review for scientific merit by an AHCPR chartered
review committee of non-Federal experts.  Applications that are
recommended for further consideration for funding and that request
total direct costs in excess of $250,000 will be reviewed by the
National Advisory Council for Health Care Policy, Research, and
Evaluation.
 
Initial peer review will take into account the following review
criteria:
 
o  significance and originality of goals;
o  adequacy of methodology proposed to carry out the project;
o  availability of data or proposed plan to collect data;
o  adequacy of plans for organization and implementation;
o  qualifications of the Principal Investigator and staff;
o  reasonableness of the proposed budget in relation to the project;
o  adequacy of facilities and resources available; and
o  adequacy of the proposed means for protecting against or minimizing
adverse effects of project-related activities upon humans, animals, or
the environment.
 
The RFA contains additional information regarding the review procedures
and criteria.
 
INQUIRIES
 
Written and telephone requests for and inquiries concerning this RFA
are encouraged.
 
Direct inquiries regarding programmatic issues to:
 
Lynn Bosco, M.D. or Eleanor M. Perfetto, Ph.D.
Center for Medical Effectiveness Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD  20852
Telephone:  (301) 227-8485
 
Direct inquiries regarding administrative and budgetary matters to:
 
Ralph L. Sloat
Chief, Grants Management Branch
Office of Planning and Resource Management
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852
Telephone:  (301) 227-8447
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.180.  Awards are made under authority of Title IX of the Public
Health Service Act (42 U.S.C. 299-299c-6) and section 1142 of the
Social Security Act (42 U.S.C. 1320b-12); and administered in
accordance with PHS grants policies, program regulations (42 CFR, Part
67, Subpart A), and other applicable Department regulations.  The
requirements of Executive Order 12372, "Intergovernmental Review of
Federal Programs," are not applicable to AHCPR research grant programs.
 
$$R3 END ************************************************************
 
$$R4 BEGIN DE-92-03 FULL-TEXT ***************************************
 
PERIODONTAL DISEASES RESEARCH CENTERS
 
NIH GUIDE, Volume 21, Number 12, March 27, 1992
 
RFA AVAILABLE:  DE-92-03
 
P.T. 04; K.W. 0715157, 0765033, 0755030, 0785055, 0745020, 0745027
 
National Institute of Dental Research
 
Letter of Intent Receipt Date:  August 17, 1992
Application Receipt Date:  September 16, 1992
 
THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS
ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION.  POTENTIAL
APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES,
BELOW.
 
PURPOSE
 
The National Institute of Dental Research (NIDR) invites applications
for support of categorical Periodontal Diseases Research Centers to
conduct multidisciplinary research on the etiology, epidemiology,
prevention, risk assessment and diagnosis, pathogenesis, and treatment
of the periodontal diseases.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Periodontal Diseases Research Centers, is related to the priority area
of improving oral health. Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC  20402-9325 (telephone 202-783-3238).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by United States non- profit, public and
private organizations, such as dental and medical schools, universities
and research institutions.  Applications from foreign institutions are
not eligible.
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health specialized center
grant (P50).  Awards will be made for five years and the earliest
funding date is August 1, 1993.  This RFA is a one-time solicitation;
issuance of a subsequent request for new and competing continuation
applications is dependent on program needs and the availability of
funds.  Responsibility for the planning, direction, and execution of
the proposed project will be solely that of the applicant institution.
 
FUNDS AVAILABLE
 
The NIDR expects that $2.5 million in total costs will be available to
fund grant applications submitted in response to this RFA.  If a
sufficient number of highly meritorious applications are received, it
is anticipated that two or three awards will be made.  However, none
will exceed $500,000 in direct costs for the first year.  Where
indirect costs are assigned to a subcontract and counted as direct
costs on the parent grant, the allowable direct cost may be exceeded by
the amount of the indirect costs assigned to the subcontract.
 
RESEARCH OBJECTIVES
 
The primary objective of the Periodontal Diseases Research Centers
program is to support multidisciplinary basic and clinical research
that combines existing research knowledge with new innovative
approaches, ultimately leading to the prevention and control of the
periodontal diseases.  Research areas that may be particularly
appropriate for inclusion in the application for support are cited in
the RFA.  However, no priorities are implied and the examples should
not constrain applicants from proposing other research topics or
investigative approaches.
 
STUDY POPULATIONS
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
The NIH policy is that applicants for NIH clinical research grants will
be required to include minorities and women in study populations.  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. Applications without
such documentation will not be accepted for review.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by August 17, 1992, a
letter of intent that includes a descriptive title of the proposed
center, the name, address and telephone number of the center director,
the identities of other key personnel and the number and title of this
RFA.  Although a letter of intent is not required, is not binding, and
does not enter into the review of subsequent applications, the
information that it contains is helpful in planning for the review of
applications.  It allows NIDR staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.
 
The letter of intent is to be addressed to:
 
Matthew Kinnard, Ph.D.
Acting Director, Periodontal Diseases Program
Extramural Program
National Institute of Dental Research
Westwood Building, Room 509
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7784
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional business offices; from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Room 449, Bethesda, MD 20892; and from the program
administrator named above.
 
Applications must be received by September 16, 1992.  If an application
is received after that date, it will be returned to the applicant.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed initially by NIDR staff for
completeness and responsiveness. Subsequently, they will be evaluated
by a special review committee convened by the Scientific Review Office,
NIDR, for technical and scientific merit.  Applications may be
subjected to triage by the review committee to determine the scientific
merit relative to other applications received in response to this RFA.
The NIDR will withdraw from further competition those applications
judged by triage to be noncompetitive for award and notify the
applicant and institutional official.  Applications judged to be
competitive will undergo further scientific merit review.  This review
may involve an applicant interview or site visit.  The second level of
review will be provided by the National Advisory Dental Research
Council.
 
Major factors to be considered in the evaluation of applications are
detailed in the RFA.
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged in
order to clarify any issues or questions from potential applicants.
Direct requests for the RFA and inquiries regarding programmatic issues
to Dr. Matthew Kinnard at the address under LETTER OF INTENT.
 
Direct inquiries concerning fiscal matters to:
 
Theresa Ringler
Grants Management Officer
Extramural Program
National Institute of Dental Research
Westwood Building, Room 518
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7437
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.121.  Awards are made 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 grants
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.
 
$$R4 END ************************************************************
 
$$R5 BEGIN CA-92-17 FULL-TEXT ***************************************
 
5-A-DAY FOR BETTER HEALTH
 
NIH GUIDE, Volume 21, Number 12, March 27, 1992
 
RFA AVAILABLE:  CA-92-17
 
P.T. 34; K.W. 0710095, 0715035, 0404000, 1010013
 
National Cancer Institute
 
Letter of Intent Receipt Date:  April 24, 1992
Application Receipt Date:  June 9, 1992
 
THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS
ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION.  POTENTIAL
APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES,
BELOW.
 
PURPOSE
 
The Division of Cancer Prevention and Control of the National Cancer
Institute (NCI) invites applications for grants to develop, implement,
and evaluate interventions in specific community channels and/or for
specific target populations to increase the consumption of fruits and
vegetables, using the 5-A-Day message.  The 5-A-Day message is "Eat 5
servings of fruits and vegetables a day for better health."  (Products
promotable through the program and serving sizes are defined in
Appendix A; available from the NCI program contact listed under
INQUIRIES.)  Fruits and vegetables are promoted in the program in a
manner that retains their integrity as low-fat foods and as part of an
overall healthy eating pattern that is low in fat and high in fiber.
 
A channel is defined for this application as a specific means or route
for reaching consumers with messages and/or food for the purpose of
creating the desired dietary behavior change.  Examples are schools,
food service (may include restaurants, and cafeterias) worksites, and
food assistance programs.  Within the channel, a target population must
be selected.  For example, if schools are selected as the channel, all
students may be targeted or students in specific grades may be
targeted.
 
Whenever it seems appropriate, applicants will be expected to utilize
the mass media as a part of the intervention.  In addition,
complementary partnerships with the fruit and vegetable industry are
encouraged.
 
The intent of the announcement is two-fold:  (1) to encourage research
in the development of effective community level interventions for
changing dietary patterns, using a simple, positive, actionable
message; and (2) to develop the community-level component of the
national 5-A-Day program, providing the complementary and necessary
interactive and environmental elements of successful behavioral change
interventions, such as skills development, local media placement,
social support, and modifications of foods offered in local food
systems.
 
These community interventions are an important component of the larger
national program, that will provide national media coverage and
industry-initiated activities.  The national program is a partnership
between the fruit and vegetable industry and the NCI, discussed below,
in the section entitled "Background" in the RFA.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA, 5-A-
Day for Better Health, is related to the priority area of nutrition,
specifically objective 2.6.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202/783-3238).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as units of State and local
governments, universities, colleges, hospitals, research institutions,
consultant firms, or combinations thereof.  Universities, colleges,
research institutions, hospitals, and consultant firms must involve
either a public health agency or some other public agency with a
mandate to protect public health and the ability to access and
intervene appropriately in the channel or community chosen.  All
applications will be expected to incorporate appropriate research
design and analysis expertise, most frequently provided by
universities, colleges, research institutions, and consultants.
Interdisciplinary teams of applicants are encouraged.  Among a team of
applicants, one institution must be proposed as the lead institution.
Foreign applicants are not eligible.  Applications from minority
individuals and women are encouraged.
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) individual
research grant (R01).  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant.
However, it is anticipated that a network of grantees will be formed to
share design and evaluation strategies, compare results whenever
possible, and distill lessons learned from all grants combined.  (See
SPECIAL REQUIREMENTS section.)  The total project period for
applications submitted in response to the present RFA may not exceed
four years.
 
This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed according to the customary peer review
procedures.
 
FUNDS AVAILABLE
 
The NCI anticipates that $4,000,000 in total costs per year for four
years will be available for this RFA.  Up to 10 awards are planned.
This funding level is contingent upon receipt of a sufficient number of
applications of high scientific merit and availability of funds.  The
total project period for each award will be up to four years.
Applicants should determine what resources are required to achieve
their scientific objectives and budget accordingly.
 
RESEARCH OBJECTIVES
 
The goal of this research is to develop, implement and evaluate
interventions in specific community channels and/or for specific target
populations to increase the consumption of fruits and vegetables using
the 5-A-Day message.
 
The primary objectives of this research are:
 
(1) To increase awareness in the target population of the importance of
eating at least five servings of fruits and vegetables every day for
better health.
 
(2) In channels chosen, whenever appropriate, to increase the
supportiveness of the environment for increased fruit and vegetable
consumption, either through increasing the offering of foods that meet
the criteria for the 5-A-Day program, policy changes, or other
structural or educational changes that would promote fruit and
vegetable consumption.  (Criteria are listed in Appendix A of the RFA.)
 
(3) To increase the daily consumption of fruits and vegetables in the
target population significantly more than in the control population.
 
Applications must address one of the following two design options.
Designs other than those described below are allowed but will require
justification:
 
(1) Interventions focused on a specific channel:
 
The major research question to be answered is:  Will the target groups
(e.g., schools, worksites) in a specific channel receiving a 5-A-Day
intervention, based on a selected model of dietary behavior change,
demonstrate a significantly greater increase in fruit and vegetable
consumption than the groups in the same channel not receiving the
intervention?  (The unit of randomization is most likely to be a group.
See the section on sample size considerations in the RFA.)  Other
research questions of interest are:  Will the target groups in a
specific channel receiving a 5-A-Day intervention demonstrate greater
changes in dietary awareness, knowledge, attitudes, and behavior than
the control groups?  Will the organizations or entities in a specific
channel receiving a 5-A-Day intervention (e.g., schools, school
cafeterias, worksites, worksite cafeterias) demonstrate greater
environmental support for increased fruit and vegetable consumption
than the organizations or entities in the same channel not receiving
the intervention?  Other innovative research questions are invited.
 
(2) Interventions focused on a specific hard-to-reach population:
 
The major research question to be answered is:  Will the groups in a
specific hard-to-reach population receiving a 5-A-Day intervention,
based on a selected model of behavioral change, demonstrate a
significantly greater increase in fruit and vegetable consumption than
groups in the same target population, not receiving the intervention?
Choice of a single channel is preferable for this research question.
However, more than one channel may be used with adequate justification
of the specific channels as more appropriate for reaching the target
population than a single channel.  Examples of appropriate target
populations might be ethnic groups, such as Blacks, Hispanics, and
Asians, low income groups, low literacy groups, and groups at high
risk.  Other research questions of interest are the same as those
enumerated in design option (1) above, applied to the hard-to-reach
target population.  Other innovative research questions are invited.
 
SPECIAL REQUIREMENTS
 
Networking among investigators will be expected.  Thus, each grantee
should include in her/his budget enough funds for at least two
investigators to attend two meetings per year in Washington DC with
fellow grantees.
 
Investigators will be expected to supply a final report in a specific
format that summarizes both successes and failures to contribute to the
dissemination of community intervention research.  In addition,
grantees will be expected to participate in a joint summary of results
of all grants.  Grantees will be licensed to use the 5- A-Day logo.
 
STUDY POPULATIONS
 
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.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by April 24, 1992, a letter
of intent that includes a descriptive title of the proposed research,
the name, address, and telephone number of the Principal Investigator,
the identities of other key personnel and participating institutions,
and the number and title of the RFA in response to which the
application may be submitted.
 
Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of applications.
It allows NIH staff to estimate the potential review workload and to
avoid conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Jerianne Heimendinger, Sc.D., M.P.H., R.D.
National Cancer Institute
Division of Cancer Prevention and Control
Executive Plaza North, Room 330
9000 Rockville Pike
Bethesda, MD  20892
Telephone:  (301) 496-8520
FAX:  (301) 402-0816
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional business offices; from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441;
and from the NIH program administrator named in INQUIRIES below.
 
Applications must be received by close of business, June 9, 1992.  If
the application is received after that date, it will be returned to the
applicant.
 
REVIEW CONSIDERATIONS
 
Upon receipt applications will be reviewed by NCI staff for
completeness and responsiveness.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NCI staff will contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.
 
Those applications that are complete and responsive will be evaluated
for scientific/technical merit by an appropriate peer review group
convened by the NCI.  The second level of review will be provided by
the National Cancer Advisory Board.
 
The review group will recommend an appropriate budget and period of
support for each application that is recommended for further
consideration.
 
INQUIRIES
 
Written and telephone requests for and inquiries concerning this RFA
are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Jerianne Heimendinger, Sc.D., M.P.H., R.D.
National Cancer Institute
Division of Cancer Prevention and Control
Executive Plaza North, Room 330
9000 Rockville Pike
Bethesda, MD  20892
Telephone:  (301) 496-8520
FAX:  (301) 402-0816
 
Direct inquiries regarding fiscal matters to:
 
Catherine Blount
National Cancer Institute
Grants Administration Branch
Grants Management Section
Executive Plaza South, Room 243N
9000 Rockville Pike
Bethesda, MD  20892
Telephone:  (301) 496-7800
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.399.  Awards are made 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 grants
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.
 
$$R5 END ************************************************************
 
                     ONGOING PROGRAM ANNOUNCEMENTS
 
$$P1 BEGIN PA-92-57 *************************************************
 
NATIONAL DIGITAL MAMMOGRAPHY DEVELOPMENT GROUP
 
NIH GUIDE, Volume 21, Number 12, March 27, 1992
 
PA NUMBER:  PA-92-57
 
P.T. 34; K.W.0715035, 0745020, 0706030, 1004000
 
National Cancer Institute
 
PURPOSE
 
The National Cancer Institute (NCI) through the Diagnostic Imaging
Research Branch (DIRB) of the Radiation Research Program seeks grant
applications through Interactive Research Project Grants (IRPGs) in
order to form a National Digital Mammography Development Group (NDMDG)
that will consist of six major components:  (1) software and hardware
for digital mammography; (2) image processing; (3) computer-aided
diagnosis; (4) telemammography; (5) pre-clinical and clinical
technology evaluation; and (6) Headquarters for the scientific
leadership (development of experimental design and data processing).
The objective of this program announcement (PA) is to establish a
multi- institutional, multi-disciplinary scientific group to facilitate
integrated development and evaluation of digital mammography and
related technologies, such as image processing, computer-aided
diagnosis (CAD), and tele-mammography, for improved breast cancer
imaging and characterization.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This PA,
National Digital Mammography Development Group, is related to the
priority area of cancer.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign and domestic, for-profit and
non-profit, public and private organizations, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal Government.
Applications from minority individuals and women are encouraged.
 
MECHANISM OF SUPPORT
 
This program will be supported through the research project grant (R01)
mechanism.  The NCI encourages the coordinated submission of related
research project grant applications from investigators who want to
collaborate on a common cancer research theme but do not require
extensive shared physical resources or core functions.  A minimum of
three independent investigators with related research objectives are
encouraged to submit concurrent, collaborative, cross-referenced
individual research project grant applications (R01) that share a
common research focus.  Applications may be from either a single
institution or a consortium of institutions. Applications will be
reviewed independently for scientific merit.  Meritorious applications
will be considered for funding both as independent awards and in the
context of the overall proposed collaboration.
 
Applicants will be responsible for the planning, direction, and
execution of the proposed projects.  One Principal Investigator out of
the group MUST be identified as the "Program Coordinator," and must be
cited in all applications on page 2 of form PHS 398.  Individual
investigators may request funds for the time and effort contributed
toward the coordination of the overall research and for collaborative
resource activities.
 
Additional information about the interactive R01 mechanism may be found
in the NIH Guide for Grants and Contracts, January 10, 1992, in
Interactive Research Project Grants for Cancer, PA-92-29."
 
Awards will be administered in accordance with Public Health Service
Policy as described in the PHS Grant Policy Statement, DHHS.
Publication No. (OASH) 90-50,000 revised October 1, 1990.
 
RESEARCH OBJECTIVES
 
Background Information
 
The goal of this announcement is to stimulate research in the area of
digital mammography and related technologies to improve breast cancer
detection and staging.  The scope of the proposed research will
encompass technologic developments in digital mammography integrated
with basic research in critical avenues that can be opened by digital
mammography, such as image processing for improved lesion
visualization, computer-aided diagnosis (CAD) for enhanced image
interpretation and teleradiology, or electronic image transmission, as
a potential mechanism to bring world expertise to community hospitals.
To achieve the above-stated goals, the NDMDG will be established to
ensure comprehensive collaboration among industry (e.g., design of
receptor or display systems), the academic community, and the NCI for
an integrated, multi-component approach to digital mammography
development.  The NDMDG will be supported by the interactive program by
using the R01 funding mechanism (as described in the NIH Guide for
Grants and Contracts, January 10, 1992) and will consist of six major
components:  (1) digital mammography; (2) image processing; (3) CAD;
(4) teleradiology; (5) pre-clinical and clinical technology evaluation;
and (6) Headquarters for the scientific leadership (centralized
development of experimental design and data processing).
 
Research Goals and Scope
 
The major thrust of this initiative is to facilitate integrated
technologic development of digital mammographic systems.  This PA
encompasses a full range of studies from basic technology and
instrumentation development through pre-clinical and clinical
evaluation.  The research agenda for the NDMDG encompasses the
following goals:
 
o  To develop and evaluate new technologic advances to increase image
quality in digital mammography (e.g., spatial/contrast/time
resolution);
 
o  To develop and validate new digital imaging methodology (dynamic or
"real time" imaging);
 
o  To develop and validate new image processing techniques to increase
the sensitivity of the detection of lesions;
 
o  To develop and validate new algorithms, neural networks, and other
forms of machine intelligence for CAD; and
 
o  To develop and validate practical methods of data compression,
storage, and image transmission for telemammography.
 
STUDY POPULATIONS
 
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 must 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 following is a statement of NIH and ADAMHA policy regarding he
inclusion of women and minorities in study populations.  Applications
that are responsive to this PA will, by definition, meet the
requirement for inclusion of women,  However, the inclusion of racial
and ethnic minorities must be addressed in applications submitted
responding to this PA.
 
The composition of the proposed study population must be described in
terms of gender and racial/ethnic group, together with 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 must be
included in the form PHS 398 in Section 2, 1-4 of the Research Plan AND
summarized in Section 2, E, Human Subjects.
 
Applicants 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 is defined as 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.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for this program announcement.  These forms are available
at most institutional business offices, from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of Health,
Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892,
telephone (301) 496-7441, and from the NCI program director named
below.
 
The PA number and title must be typed on line 2a of the face page of
the application form.
 
The use of the IRPG mechanism must be mentioned briefly in form PHS
398, Sections 1-4 of the Research plan.  The goal of the collaborative
efforts MUST be identified in the specific aims of each application,
with the major rationale and explanation for the use of the IRPG
mechanism to be given in Section G, Consultants/ Collaborators.  A
complete list of applications in the IRPG must be provided in Section
G, and an indication of the specific collaborations to be established
for the individual application under consideration.
 
Requests for limited shared resources, if any, must be proportionally
budgeted in each application based on anticipated use, with a full
explanation given in the budget.  Personnel Time and Effort requests
for management of shared resources are allowable.  If consortium
arrangements between independent institutions are proposed that would
make transfer of funds for required new equipment impractical, the
entire equipment request may be budgeted by the responsible laboratory.
This must be clearly justified.
 
All PHS and NIH grants policies will apply to applications received in
response to this announcement.
 
If the applicant has an approved assurance covering the research
(multiple project assurance for human subjects/full assurance of
compliance for animal subjects), the applicant should provide with the
application certification of institutional review board (IRB) approval
if humans are involved and verification of the institutional animal
care and use committee (IACUC) approval if animals are involved.  These
reviews and approvals should occur PRIOR TO SUBMISSION of the
applications and the certifications and verifications should be
SUBMITTED WITH the applications.  If animals or humans will be subjects
of research at PERFORMANCE SITES OTHER THAN THE APPLICANT ORGANIZATION,
the applicants must identify, with the application, the assurance
status of each participant.
 
Submit a signed, typewritten original of the application, including the
Checklist, and five signed, exact photocopies, in one package to 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**
 
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 study sections of the Division of
Research Grants, NIH in accordance with the standard NIH peer review
procedures.  Following scientific-technical review, the applications
will receive a second-level review by the appropriate national advisory
council.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
decisions:
 
o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program balance among research areas of the announcement
 
INQUIRIES
 
Written and telephone inquires concerning the objectives and scope of
this PA and inquiries about whether or not specific proposed research
would be responsive are encouraged and are to be directed to:
 
Faina Shtern, M.D.
Chief, Diagnostic Imaging Research Branch
Radiation Research Program
National Cancer Institute
Executive Plaza North, Suite 800
Bethesda, MD  20892
Telephone:  (301) 496-9531
 
Dr. Shtern welcomes the opportunity to clarify any issues or questions
from potential applicants.
 
Direct inquiries regarding programmatic issues to:
 
Joan Metcalfe
Grants Management Specialist
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, extension 28
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
Number 93.395, Cancer Treatment Research.  Awards are made under the
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 grants policies and Federal Regulations
42 CFR Part 52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.
 
$$P1 END ************************************************************
 
$$P2 BEGIN PA-92-58 *************************************************
 
CLINICAL RESEARCH ON HUMAN DEVELOPMENT AND DRUG ABUSE
 
NIH GUIDE, Volume 21, Number 12, March 27, 1992
 
PA AVAILABLE:  PA-92-58
 
P.T. 34; K.W. 0404009, 0775000, 0775025, 0755020
 
National Institute on Drug Abuse
 
PURPOSE
 
The National Institute on Drug Abuse announces the availability of a
program announcement on the above subject. The purpose of this
announcement is to stimulate clinically relevant research to improve
the ability to identify, measure, intervene, track, and prevent
dysfunctional human development resulting from prenatal exposure to
drugs, environmental exposure to drugs, growing up in a drug abusing
environment, child abuse and neglect by drug abusing care providers,
and related factors associated with developmental and intergenerational
patterns of drug abuse and transmission of AIDS.  Research studies
using animal models to investigate clinical questions are included as
are studies of clinical and legal issues related to drug screening,
risk assessment, parent and child rights, drug treatment, child
custody, and interventions for the child.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) urges applicants to submit applications
that address specific objectives of "Healthy People 2000."  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0; or Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by public and private, non-profit and
for-profit organizations such as universities, colleges, hospitals,
laboratories, units of State or local governments, and eligible
agencies of the Federal government.  Women and minority investigators
are encouraged to apply.  Individual fellowship applicants must be
citizens or noncitizen nationals of the United States for permanent
residence and have in their possession an Alien Registration Receipt
Card (I-151 or I-155) at the time of application.  Individuals on
temporary or student visas are not eligible.  See National Research
Service Awards for Individual Postdoctoral Fellows, October 1990, for
additional information, available from the contact listed under
INQUIRIES.
 
RESEARCH OBJECTIVES
 
In 1989, national random surveys and clinical studies indicated that
approximately 11 percent of pregnant women abused drugs during
pregnancy.  Considering that the average drug abusing career lasts 14