From: kristoff@NET.BIO.NET (Dave Kristofferson)
Newsgroups: bionet.sci-resources
Subject: NIH Guide, vol. 22, no. 3, pt. 2a, 22 January 1993
Date: 22 Jan 93 00:20:02 GMT
Distribution: bionet


$$XID NIHGUIDE 19930122 V22N03 P3O3 ************************************
infrastructure, particularly in urban areas; and the development of
drug resistant strains of tuberculosis.

Recently, there have been reported outbreaks of multi-drug resistant
tuberculosis (MDR-TB), with high case fatality rates. The majority of
cases have occurred in HIV-infected persons, with primary infection
of MDR-TB occurring in several cases.  Factors contributing to
outbreaks include the convergence of highly susceptible, HIV
immunocompromised patients and patients with tuberculosis, as well as
delayed recognition of tuberculosis infection and disease, delayed
recognition of drug resistance, delayed initiation of effective
anti-tuberculosis treatment, and failure of treatment compliance,
resulting in prolonged infectiousness and the development of drug
resistance.

Historically, tuberculosis has been identified as a prevalent
condition among drug users, with very large reservoirs of latent
infection reported.  Drug users are at high risk for contracting and
spreading tuberculosis, due to high HIV seroprevalence, low
socioeconomic status and poor environmental conditions, and problems
of access to primary health care.  Major areas of concern among drug
users both in- and out-of-treatment are diagnosis and treatment of
tuberculosis infection and disease, identification of strain, control
of transmission, and compliance with therapy.

Areas of Research Interest

Areas of research interest that examine the factors influencing the
transmission and treatment of tuberculosis among drug abusers that
would be responsive to this announcement include, but are not limited
to, the following:

1.  Epidemiologic investigations which document the occurrence of and
risk factors for tuberculosis infection and disease, including
MDR-TB, among drug users both in- and out-of treatment and in drug
users with and without HIV infection; the prevalence of latent
tuberculosis infection both in- and out-of treatment drug users.
Epidemiologic investigations which utilize DNA fingerprinting
techniques to document the occurrence of specific tuberculosis
strains, changes in strains over time, and transmission patterns
within populations of drug users.  Investigations of drug
susceptibility patterns in populations of drug users.

2.  Research on the interactions of tuberculosis medications with
drugs of abuse, such as cocaine, alcohol, and heroin, and with
methadone treatment.  Investigation of differential effectiveness of
long-term prophylaxis and treatment in relation to substance abuse
and substance abuse treatment.

3.  Studies of the relationship of skin test anergy, PPD tuberculin
reactivity, and active tuberculosis in HIV co-infected drug users.
Longitudinal research on the natural history of and risk for the
development of anergy in HIV co-infected and uninfected drug users;
the impact of repeated tuberculin testing; the incidence of
tuberculin conversions.  Studies of anergy in relation to development
of HIV disease and decline in immune status; studies on the role of
primary infection on risk of developing active tuberculosis in
anergic drug users.

4.  Research on the clinical side effects of tuberculosis preventive
and treatment therapy in HIV-infected and uninfected drug users, such
as studies on combined toxicity of zidovudine and antituberculosis
chemotherapy.

5.  Investigation of the relationship of tuberculosis prophylaxis and
treatment compliance to the risk of developing active tuberculosis in
drug users, and the risk of developing active disease relative to
tuberculosis therapy and co-infection with HIV; studies of
differences in case rates for active tuberculosis between treated and
partially treated or untreated HIV-infected tuberculin reactors.
Evaluation of the effectiveness of isoniazid prophylaxis in anergic
patients.

6.  Development and evaluation of new or innovative antituberculosis
immunization strategies in drug users.

7.  Studies of characteristics of the health care environment which
enhance screening for tuberculosis and promote compliance with
treatment and prophylaxis for in-and out-of treatment drug users.
Studies to expand research on cultural characteristics and gender
differences which influence utilization of health care and
tuberculosis therapy adherence among at-risk drug users.

8.  Studies of the behavioral issues related to compliance with
tuberculosis treatment and prophylaxis regimens; development and
testing of compliance predictor instruments to identify patient
factors associated with poor compliance.

9.  Studies to evaluate the effectiveness of adherence interventions,
such as directly observed therapy, both in the field and in
treatment, incentives, supports, and provision of social and health
care services.

10.  Research on beliefs, attitudes, and knowledge of drug users and
substance abuse treatment staff regarding prevention, appropriate
management, compliance with and adverse reactions to treatment of
tuberculosis, and development and testing of educational strategies
to prevent transmission among treatment staff and drug users.

11.  Evaluation of the effectiveness of linking antituberculosis
therapies and drug abuse treatment in a single setting to enhance
treatment compliance.

12.  Evaluation of the effectiveness of outreach and contact tracing,
e.g., of household contacts of drug users known to be exposed to
tuberculosis.

13.  Development and evaluation of innovative community-based HIV and
tuberculosis educational and screening programs with linkages to
appropriate treatment or prophylaxis for tuberculosis.

14.  Research on prevention which utilizes epidemiologic studies of
tuberculosis in drug users to target behavioral risk factors for
infection and transmission; development and testing of theory-based
prevention interventions which target the spread of tuberculosis
among drug users.

STUDY POPULATIONS

NIH POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS
IN RESEARCH

Applications for grants and cooperative agreements that involve human
subjects are required to include minorities and both genders 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 applies
to all research involving human subjects and human materials, and
applies to males and females of all ages.  If one gender and/or
minorities are excluded or are inadequately represented in this
research, particularly in proposed population-based studies, a clear
compelling rationale for exclusion or inadequate representation
should be provided.  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.

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., American
Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks,
Hispanics).  Investigators must provide the rationale for studies on
single minority population groups.

Applications for support of research involving human subjects must
employ a study design with minority and/or gender representation (by
age distribution, risk factors, incidence/prevalence, etc.)
appropriate to the scientific objectives of the research.  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,
and racial/ethnic groups, with regard to the hypothesis under
investigation, applicants should include an evaluation of these
gender and minority group differences in the proposed study.  If
adequate inclusion of one gender and/or minorities is impossible or
inappropriate with respect to the purpose of the research, because of
the health of the subjects, or other reasons, or if in the only study
population available, there is a disproportionate representation of
one gender or minority/majority group, the rationale for the study
population must be well explained and justified.

The NIH funding components will not make awards of grants,
cooperative agreements or contracts which do not comply with this
policy.  For research awards which are covered by this policy,
awardees will report annually on enrollment of women and men, and on
the race and ethnicity of subjects.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91) and will be accepted at the standard application
deadlines as indicated in the application kit.  The receipt dates for
applications for AIDS-related research are found in the application
instructions.

Application kits are available at most institutional offices of
sponsored research and may be obtained from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 449, Bethesda, Maryland  20892,
telephone 301/496-7441.  The number and title of the announcement
must be typed in item 2a of the face page of the application.

FIRST award applications must include at least three sealed letters
of reference attached to the face page of the original application.
FIRST award applications submitted without the required number of
reference letters will be considered incomplete and will be returned
without review.

The completed original application and five legible copies must be
sent or delivered to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

REVIEW CONSIDERATIONS

Applications received under this announcement will be assigned on the
basis of established Public Health Service referral guidelines.
Applications will be reviewed for scientific and technical merit by
initial review groups, in accordance with the standard NIH peer
review procedures.  Following scientific-technical review, the
applications will receive second-level review by the appropriate
national advisory council.  Small grants (R03) applications do not
receive a second-level review.

Criteria for scientific/technical merit of applications will include
the following:

o  Potential significance of the concept
o  Originality of the concept
o  Feasibility of the proposed research

AWARD CRITERIA

Applications will compete for available funds with all other
applications recommended for further consideration assigned to that
Institute.  The following will be considered in making funding
decisions:

o  Quality of the proposed project as determined by the peer review;
o  Availability of funds; and
o  Program balance among research areas.

INQUIRIES

Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is
welcomed.

Direct inquiries regarding programmatic issues to:

Katherine Davenny, MPH
Division of Clinical Research
Clinical Medicine Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 11A-33
Rockville, MD  20857
Telephone:  (301) 443-1801

Direct inquiries regarding fiscal matters to:

Mrs. Shirley A. Denney
Grants Management Branch, OPRM
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.279.  Awards are made under authorization of  the
Public Health Service Act, Section 301 (42 U.S.C. 241).  Title 42 of
the Code of Federal Regulations (CFR), Part 52, "Grants for Research
Projects," Title 45 CFR Part 74, "Administration of Grants," and 45
CFR Part 92 are applicable to these awards.

Applications submitted in response to this announcement are not
subject to the intergovernmental review requirements of Executive
Order 12372, as implemented through Department of Health and Human
Services regulations at 45 CFR Part 100.  Grants must be administered
in accordance with the PHS Grants Policy Statement, revised October
1, 1990.

$$P5 END ************************************************************

                               ERRATUM

$$E1 BEGIN R19 19930108 APPEND RFA DK-93-15 BOTH ***********************

PATHOGENESIS OF INFLAMMATORY BOWEL DISEASE AND CELIAC DISEASE

NIH GUIDE, Volume 22, Number 3, January 22, 1993

RFA:  DK-93-15

P.T. 34; K.W. 0715085, 0710070, 1002019, 1002004, 1002008, 0785055

National Institute of Diabetes and Digestive and Kidney Diseases

The erratum is issued to correct the Letter of Intent Receipt Date as
published in the NIH Guide for Grants and Contracts, Vol. 22, No. 1,
January 8, 1993.

The Letter of Intent Receipt Date should read March 24, 1993.

$$E1 END ************************************************************

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Date:         Thu, 21 Jan 1993 16:51:10 EST
From: Q2C@NIHCU.BITNET
Subject:      NIH GUIDE - RFA CA-93-17 - V22(03) 01/22/93
To: Multiple recipients of list NIHGDE-L <NIHGDE-L@JHUVM.BITNET>

$$XID RFA CA9317 CA-93-17 P1O1 *****************************************

BREAST CANCER EDUCATION SUMMITS

NIH GUIDE, Volume 22, Number 3, January 22, 1993

RFA:  CA-93-17

P.T. 34; II; K.W. 0715035, 0403004, 0502017

National Cancer Institute

Application Receipt Data:  May 7, 1993

PURPOSE

The purpose of this Request for Applications (RFA) is to provide
support for the planning, implementation, and evaluation of Breast
Cancer Education Summits.  The summits are intended to convey
information and educational materials about breast cancer to
community organizations and businesses and to stimulate these
organizations and businesses to establish breast cancer education and
screening programs in the community.  The aim is to motivate these
organizations and businesses to reach women in the community, to
inform them about the risks of breast cancer and the methods to
achieve early detection, and how to seek the best treatment.  The
summits are intended ultimately to reach all women in the community
placing special emphasis on women at high risk of breast cancer and
populations that are medically underserved and/or hard-to-reach.

The RFA is intended for (1) NCI-Designated Cancer Centers with P30
grants, (2) institutions with NCI P20 planning grants for prospective
cancer centers, and (3) other institutions with a broad base of
grant-supported research in basic, clinical and prevention and
control science.  Relevant medical and scientific expertise, and the
information and education resources, in place and operational, will
best qualify institutions to (1) plan and conduct the summit with the
content that is of greatest practical value and educational benefit
and (2) reach the largest cross section of organizations and
businesses in the region.  The applicant institution should have
strong ties within the community with voluntary community
organizations, corporate leaders, state and local health departments,
and other intermediaries that can reach medically underserved and
hard-to-reach populations.  This access ensures the widest possible
dissemination of information and the greatest possibility for impact
in establishment of new education and screening programs in the
communities.

Qualified institutions are invited to submit applications for hosting
Breast Cancer Education Summits with NCI and other national and
regional sponsors of the initiative.  Applicants should also include,
when possible, the local Cancer Information Service (CIS) in the
plans for the summit; the CIS can be used as an information resource
for questions concerning early detection and treatment.  The local
and/or divisional chapter of the American Cancer Society should also
be included in the summit plans.  The planning committee for the
summit must include minority representatives as well as
representatives from community organizations with access to the
medically underserved.

NCI will provide for the attendees at each summit written materials
to assist organizations in promoting early detection, to guide
businesses in developing worksite programs, to encourage women to
follow NCI recommended breast cancer screening guidelines and, if
needed, to seek state-of-the-art treatment.  To assist in preparing
applications for the summit, NCI has available a "how to host a
summit" guide, which can be obtained from the NCI Program Directors.
Also, individuals from institutions eligible to apply may attend a
workshop on conducting breast cancer summits that will be held in
Washington, DC on February 23, 1993.  Pre-registration is required
through the contacts named in inquiries below.  Experiences and
"lessons learned" from some breast cancer education summits will be
provided.

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,
Breast Cancer Education Summits, is related to the priority area of
cancer.  Potential applicants may obtain a copy of "Healthy People
2000" (Full (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

Eligibility for this RFA is limited to institutions with NCI P30
Cancer Center Support Grants, institutions with NCI P20 planning
grants for prospective cancer centers and other institutions with a
broad base of grant-supported research in basic, clinical and
prevention and control science.  NCI-designated comprehensive cancer
centers that received awards, or co-hosted summits with awardees in
1992 from applications in response to RFA CA-91-27 are not eligible
to apply under this RFA, but are encouraged to apply for RFA
CA-93-18, Breast Cancer Education Mini-Summits.

MECHANISM OF SUPPORT

The administrative and funding mechanism to be used to support these
summits will be the conference grant award (R13).  Responsibility for
the planning, direction, and execution of the proposed project will
be solely that of the applicant.  The total project period for
applications submitted in response to the present RFA may not exceed
one year.  No more than $20,000 in direct costs will be awarded to a
single Institution.  The anticipated award date is July 30, 1993.

This RFA is a one-time solicitation.

Except as otherwise stated in this RFA, awards will be administered
under PHS Grants Policy as stated in the Public Health Service Grants
Policy Statement, DHHS Publication No. (OASH) 90-50-000, revised
October 1, 1990.

FUNDS AVAILABLE

Approximately $140,000 in total costs will be committed specifically
to fund applications which are submitted in response to this RFA.  It
is anticipated that seven to eight awards will be made.  This funding
level is dependent on the receipt of a sufficient number of
applications of high scientific merit.  The project period for
applications submitted in response to the present RFA should not
exceed one year, with the summit conferences to be held between
October 1993 and July 1994.  The earliest feasible start date for the
initial awards will be July 1993.  Although this program is provided
for in the financial plans of the National Cancer Institute (NCI),
the award of grants pursuant to this RFA is also contingent upon the
availability of funds for this purpose.

RESEARCH OBJECTIVES

Background Information

Embodied in the NCI's mission to carry out the National Cancer
Program is the responsibility for conducting basic and clinical
cancer research; cancer prevention and control research; and public
information, education and community outreach.  Moreover, reducing
the mortality rate from breast cancer is a top priority.  While
research in prevention, diagnosis and control is proceeding,
concomitant attempts must be made to educate women about the
advisability of seeking breast cancer screening at appropriate
intervals and, when cancer is detected, to obtain the most up-
to-date treatment available.

The NCI previously sponsored two national summits to encourage
provision of breast cancer screening services and to provide
information on how to obtain the most up-to-date treatment.  The
first summit targeted leaders of large women's organizations; the
second summit targeted corporate medical directors and unions.  These
summits resulted in increased interest and activity in breast cancer
screening within the large organizations and corporations and the
establishment of new education and screening programs.

Eight regional breast cancer education summits, following the pattern
of the national summits, were hosted by nine NCI-designated
comprehensive cancer centers in 1992.

Goals and Scope

The aim of these additional regional Breast Cancer Education Summits
is to bring the important messages about mammography, clinical breast
examinations, and up-to-date treatment to minorities and to those
hard-to-reach, medically underserved populations that are of highest
priority to the NCI, as well as to the smaller organizations and
businesses in metropolitan areas.  The aim of the program is to
impact on the widest possible array of community organizations, to
provide increased information and education, to stimulate access to
high quality mammography, and to encourage the establishment of new
mammography screening programs where they are needed.  Special
attention should be given to encouraging the establishment of readily
available, low-cost, high-quality mammograms for underserved
populations, such as at the worksite, or off-site with accommodations
made for time and cost considerations.

These regional summits should follow the model of the national and
regional summits, including educational sessions, and panel
discussions featuring successful community-based programs and
worksite screening efforts.

It is expected that grants awarded under this RFA will be used to
partially fund planning, implementation and evaluation of the summit
conference.  The summits will be sponsored by the NCI and other
non-profit organizations.  Centers are encouraged to obtain
additional funding from local sources for any costs not met by this
grant.

SPECIAL REQUIREMENTS

The institutions that receive grants will be asked to coordinate
their meeting dates to ensure that the summits are well-spaced within
the time frame of October 1993 to July 1994.

Applicants are invited to attend a one-day workshop on planning and
conducting a breast cancer summit meeting that will be held in
Washington, DC on February 23, 1993.  Pre-registration is required
through the contacts named in inquiries below.

The funds and resources provided by NCI must be used for information
and education purposes only and not for fund-raising activities.

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 of sponsored research; from the office
of Grants Inquiries, Division of Research Grants, National Institutes
of Health, Westwood Building, Room 449, Bethesda, Maryland 20892,
telephone 301/496-7441; and from the NCI Program Director named
below.  Applicants may find information on the requirements for
conference grants and supplemental instructions for application form
PHS 398 in the publication on "Support of Scientific Meetings,"  U.S.
Department of Health and Human Services, August 1988, 8pp. which can
be obtained from the Office of Grants Inquiries or the Grants
Management contact noted below.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA number and title must be typed on
line 2a of the face page of the application form, and the YES box
must be marked.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At time of submission, send two additional copies of the application
to:

Ms. Toby Friedberg, Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 650
6130 Executive Boulevard
Rockville, MD  20892

Applications must be received by May 7, 1993.  If an application is
received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this announcement that is
essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The DRG will not
accept any application that is essentially the same as one already
reviewed.  This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NCI.  Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration.

Those applications judged to be responsive will be further evaluated
according to the review criteria stated below for technical merit by
an appropriate peer review group convened by the Division of
Extramural Activities, NCI.  The second level of programmatic review
will be conducted by the Executive Committee of NCI which considers
the special needs of the Institute and the priorities of the National
Cancer Program.

Applications responsive to this competitive solicitation will be
reviewed in accordance with the criteria stated below.

1.  The technical merit of the proposed summit conference, including
the organization and agenda, as well as the proposed evaluation and
follow-up after the summit.

2.  The institutional base of grant-supported research in basic,
clinical and prevention and control science.

3.  The institutional expertise available for state-of-the-art cancer
treatment, follow-up, information and education.

4.  The qualifications and experience of the Principal Investigator
and staff.

5.  The applicant's plans for, and demonstrated access to, minorities
and hard-to-reach medically underserved populations in the community
and at work sites.

6.  The demonstrated ability of the Institution to evaluate the
breast cancer-related needs of underserved and hard-to-reach
populations in its region.

7.  The demonstration of established channels for reaching
intermediary organizations that are effective in communicating and
providing services to the community.

8.  Demonstration of an established relationship with the state
and/or local health department.

9.  Demonstrated affiliation or cooperation with a Cancer Information
Service Office.

10.  Demonstrated cooperation and involvement with the local and/or
divisional unit of the American Cancer Society.

The review group will critically examine the submitted budget and
will recommend an appropriate budget and period of support for each
approved application.  No more than $20,000 in total direct costs
will be awarded to a single institution.

AWARD CRITERIA

The anticipated date of award is July 30, 1993.  Although the primary
criteria for award will be the technical merit reflected in the
priority score, the geographic location of the cancer centers will
also be considered, along with other priorities of the National
Cancer Program to allow for the broadest coverage of the U.S.
population.

Applications will be selected for funding based primarily on their
technical merit.  However, location of the cancer centers will also
be considered to assure balanced geographic distribution of the seven
or eight summits funded under this RFA and the more focused
mini-summits to be funded under RFA CA-93-18, allowing the broadest
coverage of the U.S. population.

INQUIRIES

Written and telephone 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:

Linda M. Muul, Ph.D.
Special Assistant to OCC
Program Director, Cancer Centers Branch
Division of Cancer Biology, Diagnosis and Centers
National Cancer Institute
Executive Plaza North, Room 308
Bethesda, MD  20892
Telephone:  301-496-8531

Direct inquiries regarding fiscal matters to:

Cynthia Mead
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800  Ext. 54

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No 93.397.  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.

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Date:         Thu, 21 Jan 1993 16:50:56 EST
From: Q2C@NIHCU.BITNET
Subject:      NIH GUIDE - RFA DA-93-02 - V22(03) 01/22/93
To: Multiple recipients of list NIHGDE-L <NIHGDE-L@JHUVM.BITNET>

$$XID RFA DA9302 DA-93-02 P1O1 *****************************************

SERVICES RESEARCH IN DRUG ABUSE TREATMENT

NIH GUIDE, Volume 22, Number 3, January 22, 1993

RFA:  DA-93-02

P.T. 34; K.W. 0404009, 0730050, 0408006

National Institute on Drug Abuse

Letter of Intent Receipt Date:  March 1, 1993
Application Receipt Date:  April 16, 1993

PURPOSE

This Request for Applications (RFA) will support a program of health
services research in the field of drug abuse treatment.  Research
should be directed toward any of the following: (1) understanding the
impact of organization, structure, financing, management, and
staffing on the availability and accessibility of treatment service
resources, upon program content and function, and upon treatment
effectiveness; (2) understanding the role of treatment program
environment, organization, structure, and operation on mechanisms of
service delivery as these are related to access to treatment,
retention in treatment, or compliance with treatment; and (3)
improving the ability of treatment programs to match clients with
appropriate levels of treatment and appropriate treatment services,
to measure the cost-effectiveness of treatment, and to deal with
special populations.

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,
Services Research in Drug Abuse Treatment, is related to the priority
area of alcohol and other drugs.  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 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.  Women
and minority investigators are encouraged to apply.  Applications are
especially encouraged from State and municipal governments with
research units and/or State and municipal governments collaborating
with university-based research units.

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.  Support will be provided for a period of up to five years
(renewable for subsequent periods) subject to continued availability
of funds and progress achieved.  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.  Because the
nature and scope of the research proposed in response to this RFA may
vary, the size of an award will also vary.

FUNDS AVAILABLE

It is anticipated that approximately $3.0 million will be available
to support the first year of the services research program.  However,
it is anticipated that approximately 8 to 10 new awards will be made
under this announcement.

If required in support of research objectives, funds may be expended
on drug abuse treatment costs, rental and operation of facilities,
approved renovation and modification of facilities (subject to limits
and conditions specified in Public Health Service grant policy), and
other costs normally allowable under existing Public Health Service
grants policy.  Funds may not be used for new construction or to
replace existing treatment funding.

RESEARCH OBJECTIVES

Background

Section 4640(d)(2) of the ADAMHA Reorganization Act of 1992 directs
NIDA to develop a program of health services research, and defines
health services research as "... research endeavors that study the
impact of the organization, financing, and management of health
services on the quality, cost, access to, and outcomes of care."

Estimates of treatment services and funding sources are available
from the National Drug and Alcoholism Treatment Unit Survey
(NIDA/NIAAA, 1990), the State Alcohol and Drug Abuse Profile study
(NIDA/NIAAA, 1992).  However, these studies are deficient in
describing treatment service delivery systems, factors influencing
availability and accessibility of services, the influence of
financing and health care coverage, and the impact of these factors
upon treatment effectiveness and cost-effectiveness.  Compared with
publicly-funded treatment, clients with private funding pay more per
visit on average ($2,450 vs. $1,240) and stay in treatment for
shorter durations (Gerstein and Harwood, 1990:203).  Anecdotal
reports on the impact of private funding for treatment suggest that
the accessibility of drug abuse treatment services may often be more
dependent upon availability of funding than upon need.  Whether this
is true or not, research indicates that treatment services vary
widely from program to program in quality and effectiveness (Ball and
Ross, 1991:243; D'Aunno and Vaughn, 1992).

There is evidence that retention, which has been linked to positive
treatment outcomes, is influenced by the availability and quality of
services.  Dennis et al. (1992) reports higher retention among
eligible methadone maintenance clients who received augmented
vocational and educational services than among those who received the
standard levels of service.  Joe, Simpson, and Hubbard (1991) found
that treatment tenure was related to professional diagnosis of
problems, to more structured treatment, and to the type and frequency
of services provided.  Recently, research has focused on improving
treatment by providing more and better treatment services in order to
improve retention and treatment outcomes (Simpson, Chatham, and Joe,
1993).

McLellan and others (1982) have stated that drug abuse treatment is
most effective when treatment services are matched to individual
needs.  However, augmented treatment services may not always be cost
effective.  In the context of limited treatment resources, there is
also a need to determine the relative costs and benefits of
individual treatment services.  In a study conducted by McLellan et
al. (1983), improvement was related both to client characteristics
(the severity of the patient's psychopathology) and to the services
received. Regardless of additional treatment services received,
patients with the most severe psychopathology improved the least,
while patients with little psychopathology improved the most.  An
additional treatment service, psychotherapy, significantly affected
the outcomes only of the middle group, those with mild to moderate
psychopathology in addition to their substance abuse problem.

The assessment of potential benefit for treatment services is
important for problem areas other than psychopathology.  Dennis et
al. (1992) reports that methadone maintenance clients who have a
moderate level of marketable skills but who lack training, a high
school diploma, appropriate work tools or clothes, or entre into the
job market benefit to a greater extent from vocational and employment
services than clients with severely impaired employability.  Although
a clear need exists to maximize the effectiveness of limited
treatment resources, little research has been carried out to
determine the relative costs and benefits of providing augmented
treatment services.

These and other studies suggest that treatment effectiveness may
depend on the availability, accessibility, cost, and quality of
treatment services as much as on the particular treatment model
employed.  However, there is relatively little knowledge regarding
what service delivery systems exist or how these may be improved to
increase the effective delivery of treatment.

Program Description

Applicants are advised to review existing information relevant to
drug abuse treatment health services research and to design studies
using the most rigorous methodological and analytic designs feasible
to investigate the impact of treatment service structure and
organization, staffing, standards, financing, and management upon the
content, suitability, quality, cost, availability and accessibility,
and effectiveness of drug abuse treatment services.  A variety of
research strategies are appropriate, including those involving
primary data collection at the clinic, local area, or system level,
studies that make use of existing data bases, such as provider/payor
data bases (e.g., Medicaid or HMO), treatment outcome studies (e.g.,
Treatment Outcome Prospective Study), or clinic data archives, and
conceptual and methodological work.  A range of approaches is
appropriate, including individual and multi-disciplinary approaches
from fields including, but not limited to, economics, sociology,
criminal justice, psychology, public health, and other relevant
social sciences. It is intended that this program of research
encourage innovation in research strategies, use of existing data in
ways that maximize its usefulness, and studies that have both
scientific and public policy relevance.  This program of research
emphasizes timely transfer of results.  Awardees will be encouraged
to participate in research coordination activities to maximize the
utility of the research, including review and dissemination
activities.  Areas of particular research interest include the
following:

Treatment Services Structure, Organization, and Delivery

o  Studies to define and characterize the organization, financing,
management, and quality of treatment services, in relation to
treatment content and the client populations and subgroups served.

o  Development and testing of models to improve the availability,
accessibility, and delivery of appropriate treatment services within
typical treatment contexts and environments.

o  Investigation of treatment program environment, organization,
structure, staffing, and operation on mechanisms of service delivery
as these are related to access to treatment, retention in treatment,
compliance with treatment, quality and comprehensiveness of services
received, and treatment outcomes.  For example, are outcomes better
for drug treatment combined with comprehensive services, and is it
more effective to deliver comprehensive services in the treatment
program than to provide referral to outside sources for such
services?

Financing of Services

o  Investigation of the effects of different models/mechanisms of
funding and financing on treatment service resources, on the
organization, structure, management, staffing and function of
treatment programs, on treatment content, on treatment service
utilization, on the populations and subgroups served, on the
assessment of client/patient need for services, and on treatment
effectiveness and cost-effectiveness.

o  Investigation of minimally necessary services.  What is the
incremental value of increased levels of care and different
combinations of services, how do these differ among the populations
and subgroups served, and how may this be optimized with regard to
client characteristics?

Quality and Effectiveness of Services

o  Studies to describe the relationship between client/patient
characteristics and treatment program structure, organization, and
operation with regard to delivery of appropriate treatment services.
Development and testing of models to improve the appropriateness of
the services delivered and to increase the effectiveness of matching
and referral processes.

o  Investigation of availability, accessibility, suitability,
content, quality, cost, and effectiveness of drug abuse treatment
services and delivery systems for special populations, including
women, adolescents, and minorities.

o  Effectiveness of the structure and organization of outreach
services on entry into treatment.

o  Effectiveness of outreach service delivery systems explicitly
directed to reducing HIV risk behaviors of drug abusers.

o  Development and testing of measures of cost, effectiveness,
cost-benefits and cost-effectiveness of treatment services, including
standardized models which could be incorporated in a range of
research activities.

The importance of a sound research plan and qualified research staff
cannot be over-emphasized.  It is recommended that investigators use
the most rigorous methodology consistent with the purposes of the
research.  Where controlled trials are not feasible, other types of
controls may be used, including case controls, equivalent comparison
groups, regression-discontinuity, or other designs.

Where appropriate, investigators are encouraged to offer HIV testing
and counseling in accordance with current guidelines to subjects
identified during the course of the research as being at risk for HIV
acquisition or transmission.  In high risk populations, investigators
are encouraged to assess the effects of new interventions on the
acquisition and transmission of infectious diseases, including HIV.

STUDY POPULATIONS

NIH POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS
IN RESEARCH

Applications for clinical research grants and cooperative agreements
that involve human subjects are required to include minorities and
both genders 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
applies to all research involving human subjects and human materials,
and applies to males and females of all ages.  If one gender and/or
minorities are excluded or are inadequately represented in this
research, particularly in proposed population-based studies, a clear
compelling rationale for exclusion or inadequate representation
should be provided.  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.

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., American
Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks,
Hispanics).  Investigators must provide the rationale for studies on
single minority population groups.

Applications for support of research involving human subjects must
employ a study design with minority and/or gender representation (by
age distribution, risk factors, incidence/prevalence, etc.)
appropriate to the scientific objectives of the research.  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,
and racial/ethnic groups, with regard to the hypothesis under
investigation, applicants should include an evaluation of these
gender and minority group differences in the proposed study.  If
adequate inclusion of one gender and/or minorities is impossible or
inappropriate with respect to the purpose of the only study
population available, there is a disproportionate representation of
one gender or minority/majority group, the rationale for the study
population must be well explained and justified.

The NIH funding components will not make awards of grants,
cooperative agreements or contracts that do not comply with this
policy.  For research awards which are covered by this policy,
awardees will report annually on enrollment of women and men, and on
the race and ethnicity of subjects.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 1, 1993, 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 allows NIDA 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:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room l0-42
Rockville, MD  20857
Telephone:  301-443-2755

APPLICATION PROCEDURES

Applications received after April 16, 1993, will be returned to the
applicant without review.

The RFA label in the PHS form 398 application kit must be affixed to
the bottom of the original face page.  Failure to use the RFA label
and to follow instructions could result in delayed processing of the
application such that it may not reach the review committee in time
for review.

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91).  Application kits are available at most
institutional offices of sponsored research and may be obtained from
the Office of Grant Inquiries, Division of Research Grants, National
Institutes of Health, Westwood Building, Room 240, Bethesda, MD
20892, telephone (301) 496-7441.  The title and number of this
announcement, "Services Research in Drug Abuse Treatment, DA-93-02"
must be typed in item 2a on the face page of the application, and the
"YES" box must be marked.

Submit a signed, typewritten original of the application and three
signed photocopies in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room l0-42
Rockville, MD  20857

REVIEW PROCEDURES

Applications received under this announcement will be assigned to an
NIDA initial review group (IRG) in accordance with established PHS
referral guidelines.  The IRGs, consisting primarily of non-Federal
scientific and technical experts, will review the applications for
scientific and technical merit in accordance with the standard NIH
peer review procedures.  Notification of the review recommendations
will be sent to the applicant after the initial review.  Applications
will receive a second-level review by an appropriate Advisory
Council, whose review may be based on policy considerations as well
as scientific merit.  Only applications recommended for further
consideration by the Council may be considered for funding.

AWARD CRITERIA

Applications recommended for further consideration by an appropriate
Advisory Council will be considered for funding on the basis of
overall scientific and technical merit of the proposal as determined
by peer review, appropriateness of budget estimates, program needs
and balance, policy considerations, adequacy of provisions for the
protection of human subjects, and availability of funds.

The anticipated date of award is September 30, 1993.

INQUIRIES

Written and telephone 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:

Frank M. Tims, Ph.D.
National Institute on Drug Abuse
5600 Fishers Lane, Room l0A-30
Rockville, MD  20857
Telephone:  (301) 443-4060

Direct inquiries regarding fiscal matters to:

Ms. Shirley Ann Denney
Chief, Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710

Schedule

Applications will be reviewed according to the following review
schedule:

Application Receipt Date:  April 16, 1993
Initial Review:            June 1993
Advisory Council:          September 1993
Earliest Date of Award:    September 1993

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.279.  Awards are made under authorization of the
Public Health Service Act, Section 301, and administered under PHS
policies and Federal Regulations at Title 42 CFR 52 "Grants for
Research Projects", Title 45 CFR Part 74 & 92, "Administration of
Grants" and 45 CFR Part 46, "Protection of Human Subjects". Title 42
CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient
Records" may also be applicable to these awards.  This program is not
subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.

References

Ball, J.C., and A. Ross.  The effectiveness of methadone maintenance
treatment.  New York:  Springer-Verlag, 1991.

D'Aunno, T., and T.E. Vaughn.  Variations in methadone treatment
practices: Results from a national study.  Journal of the American
Medical Association, 1992, 267, 253-258.

Dennis, M.L., G.T. Karuntzos, and J.V. Rachal.  Accessing additional
community resources through case management to meet the needs of
methadone clients.  In R.S. Ashery (Ed.), Progress and issues in case
management. National Institute on Drug Abuse Research Monograph 127.
DHHS Pub. No. (ADM) 92-1946.  Washington, DC:  U.S. Government
Printing Office, 1992, pp. 54-78.

Gerstein, D.R., and H.J. Harwood (Eds).  Treating drug problems.
Vol. 1. Washington, DC:  National Academy Press, 1990.

Joe, G.W., D.D. Simpson, and R.L. Hubbard.  Treatment predictors of
tenure in methadone maintenance.  Journal of Substance Abuse, 1991,
3, 73-84.

McLellan, A.T., L. Luborsky, C.P. O'Brien, G.E. Woody, and K.A.
Druley.  Is treatment for substance abuse effective?  Journal of the
American Medical Association, 1982, 247, 1423-1428.

McLellan, A.T., G.E. Woody, L. Luborsky, C.P. O'Brien, and K.A.
Druley. Increased effectiveness of substance abuse treatment:  A
prospective study of patient-treatment "matching."  J Nervous and
Mental Disease, 1983, 171, 597-605.

NIDA/NIAAA.  State resources and services related to alcohol and
other drug abuse problems, fiscal year 1990:  An analysis of state
alcohol and drug abuse profile data.  DHHS Pub. No. (ADM) 92-1905.
Washington, DC: U.S. Government Printing Office, 1992.

NIDA/NIAAA.  National Drug and Alcoholism Treatment Unit Survey
(NDATUS): 1989 Main Findings Report.  DHHS Pub. No. (ADM) 91-1729.
Washington, DC:  U.S. Government Printing Office, 1990.

Simpson, D.D., L.R. Chatham, and G.W. Joe.  Cognitive enhancements to
treatment in DATAR:  Drug abuse treatment for AIDS risk reduction.
In J. Inciardi, F. Tims, and B. Fletcher (Eds.), Innovative
approaches to the treatment of drug abuse:  Program models and
strategies.  Westport, CT: Greenwood Press, 1993.