Full Text HL-96-006
SLEEP ACADEMIC AWARD

NIH GUIDE, Volume 24, Number 41, December 1, 1995

RFA:  HL-96-006

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  December 29, 1995
Application Receipt Date:  March 12, 1996

THIS RFA USES "JUST-IN-TIME" PROCEDURES.  THIS RFA INCLUDES DETAILED
MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE
FOLLOWED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA.

PURPOSE

The primary objective of this initiative is to encourage 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 sleep
disorders.  A secondary objective is to promote high quality clinical
research on sleep.

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,
Sleep Academic Award, is related to the priority areas of heart
disease and stroke, diabetes, chronic disabling conditions, mental
health and disorders, and clinical prevention services.  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 any domestic university or school of
medicine or osteopathy.

In this competition, there is a special interest in institutions
sponsoring candidates experienced in medical education and sleep and
clinical sleep research.  Also, minority institutions and
institutions with eligible minority faculty members are encouraged to
apply.

Candidates

A candidate for an award must:

o  Individuals who have or have had another NIH career development
award (K series) or a regular research grant (R01) are eligible for a
Sleep Academic Award if the individual meets the requirements of the
Sleep Academic Award program.  Applications from minority individuals
and women are encouraged.

o  have knowledge and skills in sleep and sleep disorders medicine;

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

o  have had formal clinical research training or post graduate
clinical research training;

o  have had experience and sufficient training in clinical sleep
research, clinical practice, and/or medical education to develop and
implement a high quality curriculum in sleep and sleep disorders and
provide leadership in clinical research on sleep;

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  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.

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.  Awards will be limited to a maximum of $62,500
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 8 percent.

It is anticipated that support for this program will begin September
30, 1996.

Application instructions have been modified to implement "just-in-
time" streamlining efforts being considered by the NIH.  This
requires an applicant to submit certain information only when and if
it is likely that an award will be made.  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 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 an award is likely, necessary budget, Other Support,
and Checklist information will be requested by NHLBI staff.  The
SPECIAL REQUIREMENTS section of this RFA provides specific
modifications to the instructions in the PHS 398 application kit.

FUNDS AVAILABLE

The estimated funds (total costs) available for this program for
fiscal year 1996 will be $300,000.  It is anticipated that three to
four new grants will be awarded in FY 96 and in each of the next two
years through an additional competition in each of fiscal years 1997
and 1998. The actual number each year, however, will depend upon the
merit and scope of the applications received and the availability of
funds.

RESEARCH OBJECTIVES

Background

Recent estimates suggest that as many as 40 million people may suffer
from chronic or intermittent disorders of sleep.  Many remain
undiagnosed and untreated, the consequences of which include reduced
productivity, lowered cognitive performance, increased likelihood of
accidents, higher risk of morbidity and mortality, and decreased
quality of life.  It is now apparent that sleep disorders,
disturbances of sleep, and sleep deprivation are major public health
concerns.  Sleep problems occur in both genders, in all races and
socioeconomic groups, and increase with age.

National attention has been directed to this problem.  The National
Commission on Sleep Disorders Research submitted their report
entitled "Wake Up America:  A National Sleep Alert" to the United
States Congress in January 1993.  The Commission's recommendations
include encouraging broader awareness of sleep and training about
sleep and the diagnosis and treatment of sleep disorders, spanning
the full range of health care professions, particularly at the
primary care level.  Several surveys have documented that physician
training and knowledge about sleep and sleep disorders is minimal.
For example, in 1978, the American Sleep Disorders Association (ASDA)
conducted a survey of medical school curricula and found that about
one third of the medical schools provided one to four hours within
the curricula for teaching about sleep.  A more recent (1990) survey
found that less than two hours were allocated to teaching about sleep
at one third of the medical schools and one third of the medical
schools reported no formal teaching about sleep.  It was estimated
that about 30 percent of all medical students receive no instruction
about sleep.  These results would suggest that there actually has
been a decrease in the amount of medical school training about sleep.

The American Thoracic Society (ATS) surveyed pulmonary residency
training programs and found that 70 percent had laboratories, but
only 29 percent had formal training programs about sleep.  Of greater
concern was that 90 percent of the trainees diagnosed patients with
sleep apnea, but only 33 percent had any formal training on how to
conduct sleep studies.  The major obstacles cited for increasing the
attention to sleep in medical schools included low administrative
priority, lack of qualified faculty, and limited curriculum time.

Given the limited medical school training about sleep and sleep
disorders, it is not surprising that several surveys have reported
that health practitioners rarely diagnose sleep disorders.  In fact,
primary care physicians scored less than 50 percent correctly on
factual items for diagnosis and management of sleep disorders.  A
1991 Gallup survey showed that primary care physicians failed to
correctly diagnose one in three adults with insomnia.  Most
narcoleptics contact as many as five physicians before proper
diagnosis is made.  Clearly, physicians are not well trained or
knowledgeable about sleep and sleep disorders.

Sleep disorders cut across several medical specialties (e.g.,
neurology, psychiatry, internal medicine, and otolaryngology), which
complicates the development of effective treatment guidelines and
research.  Although most sleep disorders can be controlled with
medical treatment, many patients are not being diagnosed or receiving
state-of-the-art medical care.  This may be because many people
believe that no effective treatments exist and therefore do not seek
medical help.  Multidimensional research is clearly necessary to
improve clinical practice and patient education.

Therefore, the aim of this program is to stimulate the development
and/or improvement of the quality of medical education, patient and
community education, high quality clinical research programs, and
clinical practice focused on the control of sleep disorders.

Awardees will be encouraged to submit objectives and program plans
for both health provider education and applied research.  Awardees
will be encouraged to develop and evaluate complementary educational
and research projects as indicated below.

Objectives

The objectives of the Sleep Academic Award Program are to:

o  encourage the development of high quality curricula in schools of
medicine that will significantly increase the knowledge and skills of
students, house staff, and others, including practicing physicians,
needed to apply state-of-the-art principles and practice to the
prevention, management, and control of sleep disorders;

o  evaluate the impact of the proposed program and assemble a
curriculum that can be adapted and used by other Institutions;

o  promote communication among specialists in primary care and other
specialties to ensure appropriate treatment strategies;

o  promote an institutional environment that facilitates an
interchange of  information and educational evaluation techniques
about new diagnostic, therapeutic, and behavioral measures in sleep
and sleep disorders;

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

o  enhance the teaching about sleep disorders in minority medical
schools and promote community education about sleep in the
communities served by these institutions, including providing
outreach programs from medical centers to health practitioners in the
community;

o  promote the development of a faculty capable of providing
appropriate instruction in the diagnosis and management of sleep
disorders, with special emphasis on minority faculties;

o  contribute to the public health efforts to address sleep disorders
in the United States;

o  facilitate an interchange of ideas among awardee investigators and
institutions;

o  promote coordinated clinical approaches to the care of patients of
various ages and ethnic groups, such as minorities and the elderly
with sleep disorders;

o  encourage high quality clinical and applied research in the
treatment and control of sleep disorders.

No one application is expected to address all of these objectives.
Applicants should assess the needs in their area and develop a
program that most effectively addresses the objectives of this RFA.

Of particular interest are programs targeted to inner city and rural
populations that may need education about sleep and sleep disorders
for the community and to 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 that
of 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 "just-in-time" application process, 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 must be entered 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 plan to devote at least 30
percent effort and no greater than 50 percent effort to this award.

A Principal Investigator may devote up to a combined total of 100
percent 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:

o  personnel other than the PI 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.

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

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

o  funds for travel for the Principal Investigator to meet with other
investigators and NHLBI staff to exchange ideas, develop
collaborative projects, and provide 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, eight 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.  Only one application may be
submitted from each eligible institution in each competition. 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 that
summarizes to curriculum development at the institution and other
elements of the program plan and outlines future plans will be
required.  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 National Heart,
Lung, and Blood Institute of a suitable replacement proposed by the
grantee institution.  Such a replacement will not lengthen the
overall term of the award.

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 492B 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
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, (F 59 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 these sources
or from the program staff listed under INQUIRIES.  Program staff may
also provide additional relevant information concerning the policy.

Although the Sleep Academic Award is not primarily a mechanism to
support research, it is likely that human subjects will be involved.
Therefore, protection for human subjects must be addressed, and the
approximate percent of women and each minority group expected to be
in the total population must be included.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 29, 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 faxed or 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, Room 3032, MSC 7762, Bethesda, MD
20892-7762, telephone (301) 435-0714, email: GIRG@DRGPO.DRG.NIH.GOV.

The RFA label available in the PHS 398 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, 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 "Sleep Academic Award" HL-96-006.

DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 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 March 12, 1996.  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 and/or
non-responsive applications will be returned to the applicant without
further consideration.  Applications that are complete and responsive
to the RFA will be evaluated for scientific and technical merit by an
appropriate peer review group convened by the Division of Extramural
Affairs, NHLBI in accordance with the review criteria stated below.

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 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 Sleep Academic Award will be evaluated in terms
of the following criteria:

o  the magnitude of sleep and sleep disorders and the need for the
program in the area to be served;

o  the overall merit of the proposed five year plan for developing or
improving the institution's interdepartmental curricula in sleep;

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 develop innovative sleep curricula, materials, and
programs;

o  the institution's commitment to implement the proposed curriculum
and maintain a program in education about sleep and sleep disorders
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 sleep disorders;

o  plans for communication and cooperation among specialists in
internal medicine, psychiatry, pulmonary, neurology, and community
medicine to ensure optimal treatment;

o  plans for collaborative projects with other organizations that
have responsibility for and interest in sleep disorders; 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 sleep disorders;

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

AWARD CRITERIA

The anticipated date of award is September 30, 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 Sleep
Academic Award, the NHLBI will provide funds for a project period up
to five years.

INQUIRIES

Inquiries concerning this RFA are encouraged, and the opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

James P. Kiley, Ph.D.
National Center on Sleep Disorders Research
National Heart, Lung, Blood Institute
6701 Rockledge Drive, Suite 7024, MSC-7920
Bethesda, MD  20892-7920
Telephone:  (301) 435-0199
FAX:  (301) 480-3451
Email:  Kileyj@NIH.GOV

Direct inquiries regarding review matters to:

C. James Scheirer, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7220, 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
6701 Rockledge Drive, Room 7154
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 to
a review by a Health Systems Agency.

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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