Full Text HL-93-09


NIH GUIDE, Volume 21, Number 41, November 13, 1992

RFA:  HL-93-09-L

P.T. 34

  Pulmonary Diseases 
  Medical Education 
  Clinical Medicine, General 

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  December 15, 1992
Application Receipt Date:  February 17, 1993


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


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 Request
for Applications (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 "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).



Applications may be submitted by domestic universities or schools of
medicine.  Minority institutions and urban institutions from areas with
high rates of incidence of TB that have the necessary resources and
facilities and a commitment to providing the awardee with the time to
develop and implement plans consistent with the goals of this
announcement are encouraged to sponsor candidates for these awards.


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, and have competence in tuberculosis and;

o  be employed by a school of medicine or osteopathy that is located in
an area with high TB rates;

o  have sufficient clinical training, research, and teaching 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 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;

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


This RFA is part of the Academic Award Program (K07) of the National
Heart, Lung, and Blood Institute (NHLBI).  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 September 1993.


The estimated funds (total costs) for the first year of support for the
entire program will be $300,000.  It is anticipated that three to four
grants will be awarded each year for five years under this program.
The specific number, however, will depend upon the merit and scope of
the applications received and the availability of funds.

A maximum of $50,000 for the salary of the awardee, plus applicable
fringe benefits, a maximum of $20,000 for technical support, and
indirect costs not to exceed eight percent may be requested.



Despite major advances in our understanding of the pathogenesis,
detection and treatment of tuberculosis, nearly 28,000 cases have been
reported in the United States since 1984, the year when the lowest
number of cases were reported.  Currently, TB is 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
group or institutional settings such as hospitals and correctional
facilities.  More recently, there have been outbreaks of multi-drug
resistant TB.  These outbreaks are a dramatic manifestation of serious
underlying problems in public and private efforts to control TB.

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 non-adherence to treatment regimens.  The management
errors include failing to diagnose and treat the cases in a timely
manner, relying heavily on Isoniazide (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, and recommended that
public health officials identify populations and geographic areas in
the community where tuberculosis screening programs should be
intensified and 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 Committee (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, TB is spreading in the U.S., despite major advances in our
ability to diagnose, treat, and prevent this disease, largely due to
inadequate education of health professionals, patients and their
families, and the community.


The objectives of the Tuberculosis Academic Award are to:

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

o  encourage applied research in the control of TB;

o  encourage the development of a faculty capable of providing
appropriate instruction in TB;

o  contribute to updating the knowledge and skills of practicing
physicians 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 high incidence of TB;

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

o  contribute to public health efforts to control TB in the United


Awardee Salary

The salary requested for the awardee must not exceed the actual
institutional salary rates, and must not exceed $50,000 plus fringe

An awardee may devote up to a total of 100 percent effort as an
Academic Awardee and as principal or participating investigator on any
other NIH supported grant(s) or contract(s) and may receive
remuneration from such grant(s) or contract(s) accordingly.

Technical Support

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

o  personnel other than the awardee when required for the development
of program.  Salaries will be allowable for technical and support staff
and consultants.  Students stipends are allowable for students
conducting projects directly related to the award;

o  equipment costs are not allowable;

o  consumable supplies essential to the proposed program;

o  funds for educational development to enable the awardee to develop
educational skills and to meet with other awardees to exchange ideas,
methods, and program evaluations.

Awardees may be requested to meet as a group up to two times a year.
These meetings will promote collaborative efforts, provide for some
needed technical support, and encourage an exchange of ideas among the
awardees.  Funds should be allocated for travel for the Principal
Investigator to a midpoint in the country and the Principal
Investigator must agree to participate in these meetings.

Indirect Costs

Awards will be provided for the reimbursement of actual indirect costs
at a rate up to, but not exceeding, eight percent of the total direct
costs of each award, exclusive of tuition, fees, and expenditures of

Conditions of the Award

Institutions may apply for awards on behalf of named individuals
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
non-competitive 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.

The grant will be made annually for each of the five annual budget
periods.  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 approval 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.



Although the TB Academic Award is not primarily a mechanism to support
research, some awardees may implement research as part of the overall
Academic Award Program.  If any clinical research is proposed under the
program, the policies of the NIH regarding inclusion of women and
minorities apply.

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are 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 must be

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must 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 Sections 1-4
of the Research Plan AND summarized in Section 5, 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 but not 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.

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 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.


Prospective applicants are asked to submit, by December 15, 1992, 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 is helpful in planning for the review of applications.
It allows the Institute 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:

C. James Scheirer, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 548B
Bethesda, MD  20892
Telephone:  (301) 496-7363


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
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
(301) 496-7441.  The title and number of the request for grant
application 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 the time of submission, two additional copies of the application
must also be sent to:

C. James Scheirer, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 548B
Bethesda, MD  20892

Applications must be received by February 17, 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.


Upon receipt, applications will be reviewed by NIH 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, NHLBI 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.

The review includes an assessment of the written application and the
letters of reference, and may be followed by an interview with the
candidate in Bethesda, MD.  Travel expenses for this interview must be
paid by the applicant institution.  The initial review will be
conducted by a Special Review Committee, managed by the Division of
Extramural Affairs, National Heart, Lung, and Blood Institute.  The
secondary review will be by the National Heart, Lung, and Blood
Advisory Council.

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

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 research;

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

o  the 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, infections, 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, and voluntary
health agencies;

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

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


The anticipated date of award is September 30, 1993.  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.


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:

Joan M. Wolle, Ph.D., M.P.H.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Westwood Building, Room 640
Bethesda, MD  20892
Telephone:  (301) 496-7668

Direct inquiries regarding fiscal matters to:

Raymond L. Zimmerman
Grants Operations Branch
National Heart, Lung, and Blood Institute
Westwood Building, Room 4A17
Bethesda, MD  20892
Telephone:  (301) 496-4970


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.


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