Full Text HL-96-003

TUBERCULOSIS ACADEMIC AWARD

NIH GUIDE, Volume 24, Number 38, October 27, 1995

P.T. 34

Keywords: 
  Pulmonary Diseases 
  Infectious Diseases/Agents 


RFA:  HL-96-003

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  November 13, 1995
Application Receipt Date:  December 12, 1995

PURPOSE

The primary objective of this Request for Applications (RFA) is to
stimulate the development and/or improvement of the quality of
medical curricula, physician/patient/nurse/and community education,
and clinical practice for the prevention, management, and control of
Mycobacterium tuberculosis (TB) in the United States.

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,
Tuberculosis Academic Award, is related to the priority areas of
immunization and infectious diseases and HIV infection.  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 202-512-1800).

ELIGIBILITY REQUIREMENTS

Institutions

Applications may be submitted by domestic schools of medicine or
osteopathy.  In this competition, there is an interest in a diversity
of types of applications.  These include, but are not limited to,
applications from any of the following:

o  established researchers and/or faculty specializing in the field
of tuberculosis;

o  minority faculty members interested in medical education;

o  minority medical institutions;

o  institutions serving a high proportion of minority medical
students or minority patients;

o  institutions having other tuberculosis research projects to which
this award would be complementary;

o  institutions located in those areas where there is a high
incidence of TB;

Candidates

A candidate for an award must:

o  be an established physician and a medical faculty member in an
accredited school of medicine or osteopathy in the United States, its
territories or possessions;

o  have the unqualified support of the Dean and the educational
leadership at the institution and demonstrate knowledge and
commitment to medical education for medical students, physicians,
patients, nurses, and the public;

o  have sufficient clinical training and practical experience in the
control of TB to develop and implement a high quality curriculum in
TB encompassing current knowledge and methods applicable to the
control of tuberculosis in individuals of all ages and to provide
leadership in applied research in control of TB;

o  be aware of the training and educational needs of health care
professionals at all levels who are working in the area of TB control
and be a leader in providing the appropriate instructional programs
for these individuals;

o  be a citizen or non-citizen national of the United States or have
been lawfully admitted to the United States for permanent residence
at the time of application;

o  commit 30-50 percent effort for a five year period.

Individuals who have held another NIH career development award (K
series) or a regular research grant (R01) are eligible to apply for
the Tuberculosis Academic Award. Applications from minority
individuals and women are encouraged.

MECHANISM OF SUPPORT

This RFA is part of the Academic Award Program (K07) of the National
Heart, Lung, and Blood Institute.  Responsibility for the planning,
direction, and execution of the proposed project will be solely that
of the applicant.  The total project period may not exceed five years
and is non-renewable.  It is anticipated that support for this
program will begin July 1, 1996.

FUNDS AVAILABLE

Awards will be limited to a maximum of $62,000 for the salary of the
Principal Investigator, plus applicable fringe benefits, and a
maximum of $20,000 for technical support.  Indirect costs may not
exceed eight percent

The estimated funds (total costs) for this fiscal year will be
$300,000.  It is anticipated that three new grants will be awarded.
The specific number, however, will depend upon the merit and scope of
the applications received and the availability of funds.  The total
TBAA program will be advertised for competition each year through
1997.

RESEARCH OBJECTIVES

Background

Despite major advances in the understanding of the pathogenesis,
detection and treatment of tuberculosis, in the early 1990s, more
than 25,000 cases/year were reported in the United States.  TB was
spreading rapidly, especially in some population groups.  From 1985
through 1990, the number of TB cases increased by 44 percent in the
25-44 year old age group.  There was a 12 percent increase among
Asians, a 25 percent increase among non-Hispanic whites, a 55 percent
increase among blacks, and a 77 percent increase among Hispanics.
There is also a high prevalence of TB among HIV infected patients.
It is estimated that about 12 percent of all AIDS cases develop TB.
HIV-associated TB has occurred in virtually all age groups, both men
and women, all race/ethnic groups and in all HIV-transmission
categories, although the largest numbers of cases have occurred in
intravenous drug users and homosexual/bisexual men.  Other groups at
high risk for TB include persons living or working in a group or
institutional settings such as hospitals and correctional facilities.
Frequent outbreaks of multidrug resistant TB continues to occur.
These outbreaks are a dramatic manifestation of serious underlying
problems in public and private efforts to control TB.

Very recently, the numbers of TB cases have begun to show a slight
decline, probably, in large measure, because of the increased efforts
in prevention and control.  In order to ensure that this encouraging
trend continues, efforts to educate health care professionals about
TB must also continue.

Although considered "curable" since the development of effective
chemotherapy in 1950, the TB problem has not been dealt with
adequately.  This has been attributed to a lack of sufficient
awareness of the problem and inadequate resources, as well as
clinical management errors and patient nonadherence to treatment
regimens.  The management errors include failing to diagnose and
treat the cases in a timely manner, relying heavily on Isoniazid
(INH) therapy, even in patients likely to have INH-resistant
organisms, using a single drug therapy, prescribing inappropriate
drug dosages, and failing to isolate patients appropriately with
infectious TB, thereby missing opportunities to prevent the spread of
the disease.  Surveillance has often been slow or incomplete.
Noncompliance with treatment regimens for chronic diseases has been a
major problem with approximately 50 percent not taking their
medicine.  A study in 1988 in New York City reported 89 percent of
the patients at one hospital failed to complete therapy, more than
half failed to keep their first clinic appointment, and within twelve
months of discharge, 27 percent of the patients had been readmitted
at least once with confirmed active TB.

The concept for this initiative originated with the Tuberculosis
Education Planning Committee convened by the NHLBI in December 1991,
which emphasized the need for increased efforts to educate health
care workers, patients, and the public on tuberculosis.  They also
recommended that public health officials identify populations and
geographic areas in the community where tuberculosis screening
programs should be intensified as well as conduct public education
campaigns targeted to high risk populations to encourage symptomatic
patients to seek prompt treatment.  In addition, in 1987 the
Department of Health and Human Services established an Advisory
Council for the Elimination of TB (ACET), and in 1992 a "National
Action Plan to Combat Multidrug Resistant Tuberculosis" was published
to complement and supplement the "Strategic Plan for the Elimination
of Tuberculosis."  These plans indicate the urgency to improve the
control of TB in the United States.

In summary, in spite of major advances in the ability to diagnose,
treat, and prevent TB, this disease remains a major health problem in
the U.S. today, largely because of inadequate education of health
professionals, patients, their families, and the larger community.

Objectives

The objectives of the Tuberculosis Academic Award are to:

o  encourage the development of high quality curricula in schools of
medicine or osteopathy that will significantly increase the
opportunities for students, house staff, and others, including
practicing physicians and nurses, to learn the principles and
practice of preventing, managing, and controlling TB;

o  develop and implement interdepartmental programs with common goals
and standardized diagnostic and therapeutic approaches;

o  promote interdepartmental communication between primary care and
other specialists to ensure appropriate control and treatment
strategies;

o  encourage applied research in the control of TB;

o  promote the development of a faculty capable of providing
appropriate instruction in diagnosis and management of TB, with
special emphasis on minority faculty, nursing, and infection control
personnel;

o  promote coordinated clinical approaches to the care of patients of
various ages and ethnic groups who have TB;

o  provide for outreach programs from medical centers to health
practitioners in the community, especially home care agencies, to
enhance optimal care, especially in areas of high TB morbidity;

o  contribute to updating the knowledge and skills of practicing
physicians, nurses and other health care providers in the community;

o  enhance the awareness of health care providers of the unique
ethnic, cultural, socioeconomic, and medical dimensions of TB;

o  coordinate and collaborate with other community organizations to
control TB in areas with a high incidence of TB;

o  facilitate an interchange of ideas and methods between awardees
and institutions;

o  enhance tuberculosis education programs in minority medical
schools and promote TB education in the communities served by these
institutions.

Of particular interest are programs targeted to inner city
populations and to rural areas that may be in need of education about
tuberculosis, and among physicians, nurses, and other health care
workers, who are or who will be caring for medically underserved
populations.

Because this is a medical education program, funds may be requested
for technical support staff who have complementary expertise to the
principal investigator.  Such personnel may include medical
educators, curricula specialists, program evaluators, or other
specialists.

SPECIAL REQUIREMENTS

Use the following modifications in completing the standard PHS 398
application:

o  BUDGET INFORMATION - No current/future year budgets or
justifications (Form Pages 4 and 5) are required in the application.
However, the anticipated level of effort in all years and a brief
description of responsibilities for the Principal Investigator and
all key personnel must be specifically stated at the beginning of the
research plan.  Necessary budget information will be requested by
NHLBI staff if there is a possibility for an award.

o  BIOGRAPHICAL SKETCH - In addition to the standard information
requested on Form Page 6, the applicant has the option of providing
the title and source of any sponsored support relevant to the
proposed research.

o  OTHER SUPPORT - No other support information is required on the
"Other Support" page (Form Page 7).  Selected other support
information relevant to the proposed research may be included in the
Biographical Sketch as indicated above.  Complete other support
information will be requested by NHLBI staff if there is a
possibility for an award.

o  CHECKLIST - No "Checklist" page is required as part of the initial
application.  A completed Checklist will be requested by NHLBI staff
if there is a possibility for an award.

o  FACE PAGE - Currently, the Division of Research Grants requires
that requested costs be reflected on the face page for computer
system tracking purposes.  Because no budgetary information is
required as part of the "streamlined" application, we are requesting
that standard amounts be shown on the face page.  IT IS UNDERSTOOD
THAT THESE LEVELS ARE STRICTLY FOR ADMINISTRATIVE PURPOSES AND THAT
ACTUAL AWARD LEVELS ARE SUBJECT TO NEGOTIATION, PRIOR TO AWARD.  The
following amounts should be reflected on the face page:  7a. Direct
Costs for Initial Budget Period - $70,000; 7b. Total Costs for
Initial Budget Period - $75,000; 8a. Direct Costs for Proposed Period
of Support - $350,000 and; 8b. Total Costs for Proposed Period of
Support - $375,000.

The applicant should be prepared to provide the name and phone number
of the individual to contact concerning fiscal and administrative
issues if additional information is necessary following the initial
review.

In the event that budget information, Other Support pages and/or
Checklist pages are submitted with the application, they will be
removed prior to review to allow for consistency with other
applications.

The following sections are specific cost guidelines that will apply
to those applications selected for award consideration.

1.  Principal Investigator's Salary

The salary for the principal investigator must not exceed the actual
institutional salary rates for the effort being devoted to the
Academic Award.  In addition, salary rates must not exceed an annual
salary level of $125,000 plus fringe benefits (a maximum of $62,500
for 50 percent effort).  A candidate must devote at least 30 percent
effort and no greater than 50 percent effort to this award.

A principal investigator may devote up to a total of 100 percent
combined effort on the Academic Award and as an investigator on any
other NIH-supported grant(s) or contract(s) and may receive
remuneration from such sources accordingly.

2.  Program Support

Technical support will be provided up to a maximum of $20,000 per
year for the following:

personnel other than the Principal Investigator if requested for the
development, implementation, and evaluation of the program.  Salaries
will be allowable for technical and support staff and consultants,
e.g., educational and evaluation specialists.

consumable supplies essential to the proposed program are allowable,
but equipment costs are not allowable;

funds for educational development to enable the awardee to develop
educational skills;

funds for travel for the Principal Investigator to meet with other
investigators and NHLBI staff to exchange ideas, to develop
collaborative projects, and to provide for some needed technical
support.  (Investigators may be requested to meet as a group up to
two times a year; $2,000 should be allocated for this purpose.)

3.  Indirect Costs

Awards will be provided for the reimbursement of actual indirect
costs at a rate up to, but not exceeding, 8 percent of the total
direct costs of each award.

4.  Conditions of the Award

Institutions must provide documentation that the applicant would have
the necessary time and resources to implement the proposed plan.  In
some cases, it may be necessary for the applicant to be relieved of
some responsibilities for the five years of the grant award in order
to implement the proposed plan.

An institution may apply for an award on behalf of a named individual
meeting the criteria for this award.  Awards will be limited to one
from each eligible school over the life of the award.  After the
first year, grants will be renewed for a maximum of four years on a
noncompetitive basis depending upon progress being made in meeting
the program's objectives.  An annual report will be required that
summarizes activities relevant to curriculum development at the
institution and other elements of the program plan and outlines
future plans.  This report will serve as the principal basis for
renewal of the grant.

Awards may not be transferred from one institution to another.  If an
awardee moves to another institution, the award will continue at the
original institution only upon acceptance by the Division of Lung
Diseases of a suitable replacement proposed by the grantee
institution.  Such a replacement will not lengthen the overall term
of the award.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 4922B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (59 FR 14508-14513), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

Although the TB Academic Award is not primarily a mechanism to
support research, human subjects may be involved.  If so, protection
for human subjects must be addressed, and the approximate percent of
women and each minority group that you expect in the total population
must be included.

LETTER OF INTENT

Prospective applicants are asked to submit, by November 13, 1995, a
letter of intent that includes 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 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 Dr. C. James Scheirer, at the address
listed under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 5/95).  These forms are available at most institutional
offices of sponsored research and from the Office of Grants
Information, Division of Research Grants, National Institutes of
Health, 6701 Rockledge Drive MSC 7762, Bethesda, MD 20892-7762,
E-MAIL: GIRG@DRGPO.DRG.NIH.GOV., or telephone (301) 435-0714.  To
identify the application as a response to this RFA, check "YES" in
item 2 of page 1 of the application and enter the title "Tuberculosis
Academic Award" HL-96-001.

The RFA label found in form PHS 398 (rev. 5/95) application kit must
be affixed to the bottom of the face page of the original completed
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.

Application instructions have been modified to reflect "just in time"
streamlining efforts being examined by the NIH.  This concept allows
applicants to submit certain information only when there is a
possibility for an award.  It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers and
NHLBI staff.  For this RFA, no budgetary information is required in
the initial application.  However, the anticipated level of effort in
all years and a brief description of responsibilities for the
Principal Investigator and key personnel must be included in the
research plan.  In addition, instructions for completing the
Biographical Sketch have been modified and no "Other Support"
information or "Checklist" page is required in the initial
application.  If there is a possibility for an award, necessary
budget, Other Support, and Checklist information will be requested by
NHLBI staff following the initial review.  The SPECIAL REQUIREMENTS
section of this RFA provides specific modifications to standard PHS
398 application kit instructions.

Send or deliver the completed application and three signed
photocopies in one package to:

DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC-7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

Send two additional copies of the application to the Chief, Review
Branch, DEA at the address listed under INQUIRIES.  It is important
to send these two copies at the same time as the original and three
copies are sent to the Division of Research Grants, otherwise, the
NHLBI cannot guarantee that the application will be reviewed in
competition for this RFA.

Applications must be received by December 12, 1995.  If an
application is received after this 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 RFA 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 the
DRG and responsiveness to this RFA by the NHLBI. Incomplete
applications will be returned to the applicant without further
consideration.  If the application is not responsive to the RFA,
NHLBI staff will return the application to the applicant.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit in accordance with the
review criteria stated below by an appropriate peer review group
convened by the Division of Extramural Affairs, NHLBI.

As part of the initial merit review, a process may be used by the
initial review group in which applications will be determined to be
competitive or noncompetitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be
noncompetitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.

Review Criteria

Applications for this Tuberculosis Academic Award will be evaluated
in terms of the following criteria:

o  description of the magnitude of the tuberculosis problem and the
need for the program in the area to be served;

o  the overall merit of the proposed five year plan for improving the
institution's interdepartmental curricula in tuberculosis control;

o  the qualifications and background of the candidate, including
experience in teaching, curriculum development, and administration in
a medical school, planning and conduct of research, and level of
effort;

o  the ability and commitment to work cooperatively with other
investigators to make innovative tuberculosis curricula, materials,
and programs available;

o  the institution's commitment to implement the proposed curriculum
and to maintain a program in education about tuberculosis control
after the termination of the award;

o  the significant involvement of appropriate disciplines in the
development, implementation, and evaluation of the program;

o  design and evaluation of educational interventions for health care
providers and for patients with tuberculosis in areas with high
incidence of TB;

o  plans for communication and cooperation between specialists in
adult and pediatric pulmonary medicine, infectious disease, and
community medicine to ensure optimal treatment;

o  plans for collaborative projects with other organizations that
have responsibility for and interest in tuberculosis control, for
example, health departments, medical and nursing associations,
voluntary health agencies, and home care agencies;

o  plans for and availability of expertise to implement and evaluate
the proposed program, including strategies for both process and
impact evaluation;

o  the potential of the program for making an impact on the control
of tuberculosis among populations served;

o  the potential for replication or adaptation of the program at
other sites.

AWARD CRITERIA

The anticipated date of award is July 1, 1996.  Factors that will be
taken into consideration in making awards include the scientific
merit of the proposed program as evidenced by the priority score and
the availability of funds.  Subject to the availability of necessary
funds and consonant with the objectives of the Tuberculosis Academic
Award, the Division of Lung Diseases will provide funds for a project
period up to five years.

INQUIRIES

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:

Mary S. Reilly, M.S.
Division of Lung Diseases
National Heart, Lung, Blood Institute
Two Rockledge Centre, Suite 10018
6701 Rockledge Drive, MSC-7952
Bethesda, MD  20892-7952
Telephone:  (301) 435-0222
FAX:  (301) 480-3557
Email:  ReillyM@NIH.GOV

Inquiries regarding review matters, the letter of intent, and two
copies of the PHS 398 may be directed to:

C. James Scheirer, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Two Rockledge Centre, Room 7220
6701 Rockledge Drive, MSC 7924
Bethesda, MD  20892-7924
Telephone:  (301) 435-0266
FAX:  (301) 480-3541
Email:  ScheireJ@NIH.GOV

Direct inquiries regarding fiscal matters to:

Raymond L. Zimmerman
Grants Operations Branch
National Heart, Lung, and Blood Institute
Two Rockledge Centre, Room 7154
6701 Rockledge Drive
Bethesda, MD  20892-7926
Telephone:  (301) 435-0171
FAX:  (301-480-3310)
Email:  ZimmermR@NIH.GOV

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.838.  Grants are made under the authorization of
the Public Health Service Act, Title III, Section 301 (Public Law
78-410, as amended by Public Law 99-158, 42 US 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.

The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.

.

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