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Full Text DK-93-06


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

RFA:  DK-93-06

P.T. 34

  Molecular Genetics 
  Cell Lines 
  Viral Studies (Virology) 
  Growth Factors 
  Technology Planning/Policy 

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  January 31, 1993
Application Receipt Date:  March 15, 1993


The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites applications for Exploratory Grants for Centers of
Excellence in Molecular Hematology, to be awarded competitively in
Fiscal Year 1993.


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), Exploratory Grants for Centers of Excellence in
Molecular Hematology, is related to the priority areas of diabetes and
chronic disabling conditions.  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 from domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, or medical centers.  Applications from foreign institutions
are ineligible for the center program mechanism.  Applicant
institutions must demonstrate an established research base in areas
related to the RFA.  Minority individuals and women are encouraged to
submit as Principal Investigators.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  If so, a letter of agreement from the GCRC Program Director
must be included with the application.


Support of this program will be through the NIH grant-in-aid
Exploratory Grant (P20) award.  Responsibility for the planning,
direction, and execution of the proposed project will be solely that of
the applicant.  Awards will be administered under PHS grants policy as
stated in the PHS Grants Policy Statement and in this announcement.
Requests for support must be limited to no more than $20,000 in direct
costs.  Any application exceeding this amount will be returned to the
applicant. Under certain circumstances, a no-cost extension of up to
another 12 months can be requested.


The NIDDK anticipates awarding five Exploratory Grants in Fiscal Year
1993 on a competitive basis, the awards will be for one year duration
and contingent upon the availability of appropriated funds.  It is
anticipated that approximately $150,000 in FY 93 funds will be
available for funding these awards.


The objective of Exploratory Grants (P20) is to provide partial funding
for the cost of planning and developing meritorious Centers of
Excellence in Molecular Hematology.  The anticipated awards for full
scale Centers of Excellence in Molecular Hematology (P50) will be made
in Fiscal Year 1994 or Fiscal Year 1995, contingent upon authorization
and appropriation of funds, and will involve a separate nation-wide

It is important to note that the award of an Exploratory Grant does not
imply a commitment by the National Institute of Diabetes and Digestive
and Kidney Diseases to future funding of a Center of Excellence in
Molecular Hematology planned with the support of an Exploratory Grant.
Center applications will be reviewed on the basis of their own merit.
A future announcement will be made for applications for Centers of
Excellence in Molecular Hematology.  At that time, any eligible
institution may apply; funding decisions will not be based on previous
award of an Exploratory Grant.

Guidelines are available from the NIDDK that describe the Centers of
Excellence in Molecular Hematology (P50), and the anticipated
application process for the Centers.  These guidelines should be
requested from the program administrator identified in INQUIRIES before
applying for an Exploratory Grant.


Exploratory Grants are intended to provide partial support for the
planning phase of a Center of Excellence in Molecular Hematology.
Successful applicants thus would be better prepared to formulate
appropriate programs in response to a later announcement by the NIDDK
of a full-scale Centers (P50) announcement.

The planning phase may consist of, but is not limited to:

a. departmental and interdepartmental planning to integrate a broad
spectrum of molecular hematology related activities;

b. planning the establishment of specialized resources and facilities;

c. feasibility surveys to identify special problems and opportunities;

d. use of consultants to assist in developing plans for Center
activities and core resources.

Centers of Excellence in Molecular Hematology will allow development of
the broad range of technologies involved in the investigation of
genetic diseases and genetic therapy to be brought together in a
unified effort.  These technologies will draw on knowledge of viruses,
cell culture, bone marrow cells, growth factors, animal models, and the
molecular basis of genetic diseases.

During the past two decades, major advances have been made in
understanding the molecular basis for inherited diseases.  The clinical
and biochemical effects of diseases have been clarified, and, in an
ever-increasing number of genetic disorders, the molecular defects have
been described.  Notable examples of this new knowledge are the genes
for Cooley's anemia, sickle cell disease, and hemophilia.  Application
of sensitive biochemical and molecular techniques has made molecular
diagnosis of these disorders a reality.  Now, with these important
diagnostic achievements in hand, even greater efforts must be directed
toward development of technologies to formulate specific therapies for
these debilitating disorders.

The development of Centers as an organizational mechanism will promote
the joint efforts both of basic scientists and clinical researchers
toward the study of gene structure and function, the structural biology
of proteins and the complex biochemistry of protein interaction, the
cell and molecular regulation of blood cell formation, and clinical
research to test the efficacy and safety of therapeutic strategies
derived from basic investigation.  These studies will have as their
ultimate goal the development of somatic gene therapy or other means of
treatment of genetic diseases.  Concentration of efforts into the
Center format will allow economies of scale and will generate
technologies that can be applied by other investigators.  The
capability to design and implement strategies for clinical application
of molecular genetic knowledge will be essential for the Centers.
However, Center funds will not be available for full-scale clinical
trials, and investigators will be encouraged to apply for support of
clinical trials by alternative mechanisms.

Due to the breadth of expertise in a variety of disciplines needed for
successful application of molecular genetic technologies to genetic
diseases, it is anticipated that such expertise may not be available at
any one institution.  Therefore, applicants are encouraged to propose
consortium arrangements with other suitable institutions with needed
expertise.  Such consortia may include geographic separation, if
acceptable plans for effective collaboration are proposed.  Where
appropriate, applicant institutions are strongly encouraged to develop
relationships with traditionally minority institutions and


NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and women
in study populations so that research findings can be of benefit to all
persons at risk of the disease, disorder, or condition under study;
special emphasis 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 is intended to apply
to males and females of all ages.  If women or minorities are excluded
or inadequately represented in clinical research, particularly in
proposed population-based studies, a clear compelling rationale should
be provided.

The 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 (rev. 09/91) in
Item 4 (Research Design and Methods) of the Research Plan AND
summarized in Item 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, and

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 without review.


Potential applicants are strongly encouraged to submit a letter of
intent no later than January 31, 1993.  The letter of intent is to
include:  (1) name of the Principal Investigator/program director and
principal collaborators, (2) descriptive title of the potential
application, (3) identification of the organization(s) involved, and
(4) reference to RFA DK-93-06.  The letter of intent is to be sent to
the Chief, Review Branch, NIDDK, at the address noted below.

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 the review of applications.  It
allows NIDDK staff to estimate the potential review workload and to
avoid conflict of interest in the review.


Applications are to be submitted on the form PHS 398 (rev. 09/91)
available at most institutional  offices of sponsored research and from
the Division of Research Grants, National Institute of Health, 5333
Westbard Avenue, Room 449, Bethesda, MD 20892, (301) 496-7441.  For
item 2a of the face page of the application, applicants should enter
RFA:  Hematology Exploratory Grants, RFA number DK-93-06.  The RFA
label available in the form PHS 398 must be affixed to the bottom of
the face page.  Failure to use this label could result in delayed
processing of the application to the extent that it may not reach the
review committee in time for review.

Applications must be received by close of business March 15, 1993.  If
an application is received after this date, it will be returned to the
applicant.  The original and three copies of the application must be
sent or delivered to:

Application Receipt Office
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:

Robert D. Hammond, Ph.D.
Chief, Review Branch, DEA
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
5333 Westbard Avenue
Bethesda, MD  20892

The Division 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.  Nor will the DRG 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.

Special Application Instructions

The written application is the basis for the merit review.  Particular
attention should be given to the format of the application.  The
standard instructions provided with the PHS 398 are designed primarily
for applications for single research projects.  Exploratory Grant
applications require additional information as outlined below.  Page
limitations presented in the PHS 398 instructions should be followed
closely unless otherwise noted.

Program Narrative (PHS 398, Continuation Pages)

The narrative must provide a description and plan of the Exploratory
Grant program, and how the applicant intends to prepare for developing
a Center program.  The narrative must include an overall description of
the envisioned Center as well as a description of each of the Center


Follow instructions on page 24 of PHS Form 398.

Budgetary Considerations - Allowable Costs

Unless otherwise indicated, allowable costs and policies governing the
research grant programs of the NIH will prevail.  Overlapping support
between the Exploratory Grant and other NIH grants and contracts to the
applicant institution will be administratively reviewed and, if
appropriate, will be adjusted to avoid duplication of funding.

Support may be requested for salaries of professional, technical, and
support personnel who contribute to allowable activities under the
Exploratory Grant.

The salaries derived from the Exploratory Grant will depend on the
effort provided and institutional salary policies.  Salaries of
personnel engaged in administrative and planning activities are
allowable cost items.  Stipends for research fellows/trainees are not
allowable.  No overlap of time or effort between the Exploratory Grant
and other, separately funded projects is permitted.

Support for secretarial and administrative staff may be provided to the
extent that their activities relate to administrative management of the
Exploratory Grant activities, providing these costs have not been
included in the institution's indirect cost pool.

Expenditures for major equipment under this RFA will not be considered.
General purpose equipment needs may be included and justified only
after surveying the availability of such items within the institution.

Consumable supplies directly related to the operation of the
Exploratory Grant are allowed.  These supplies principally will include
office materials (if not included in the indirect cost pool).

Research patient care costs are not required for Exploratory Grant
purposes, and will not be provided.

Domestic travel costs of Exploratory Grant personnel directly related
to administrative and planning activities is allowable.  Foreign travel
will not be allowed except under unusual and compelling circumstances,
and will require prior approval by the awarding agency.

Costs for consultant services (consultation fees, per diem, travel) may
be included.  Costs associated with consultation or scientific or
technical assistance, evaluation of planning activities, and
development of new organizational arrangements and consortia  are

Costs for telephone, photocopying, and computer time are permitted.


Upon receipt, applications will be examined initially by the DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation of responsiveness
to the program requirements and criteria stated in this RFA is an NIDDK
staff function.

Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below and in the Centers of
Excellence in Molecular Hematology Guidelines for Scientific/Technical
Merit by an appropriate peer review group convened by the NIDDK.  It is
essential that the written application be in a form that can be
reviewed on its own merit, since no site visit is anticipated.

If the number of applications is large compared to the number of awards
to be made, the NIDDK may conduct a preliminary scientific peer review
to eliminate those applications that are clearly not competitive. The
NIDDK will withdraw administratively from competition those
applications judged to be noncompetitive, and will so notify the
applicant and the institutional business official.  Those applications
judged to be both competitive and responsive to the RFA will be
evaluated further, according to the review criteria stated below.

Following initial merit review, the applications will be given a
second-level review by the National Diabetes and Digestive and Kidney
Diseases Advisory Council.

The review of the Exploratory Grant applications will focus on
scientific merit.  Additionally, the component parts of the Exploratory
Grant will be reviewed for their synergism and contribution to the
future development of a Center.

The evaluation will include the following review criteria:

1.  Overall Program

o  The scientific merit of the program as a whole.  The significance of
the overall program goals and the development of a well-defined central

o  The potential of the identified participants to develop
interdisciplinary research programs of high merit as evidenced by
previous accomplishments.

o  The balance of administrative and planning expenses.

2. Administration and Planning

o  The scientific and administrative leadership ability and experience
of the Exploratory Grant Principal Investigator and his/her commitment
and ability to devote adequate time to the effective management of the
Center planning.

o  Maintenance of internal communication and cooperation among the
investigators involved in planning for a Center.

o  Adequacy of the Advisory Committee to assess the scientific merit of
the proposed Center plans.

o  Inclusion of an adequate mechanism for reviewing the proposed uses
of Center funds.

o  Appropriateness and adequacy of plans for collaboration among the
members of the proposed Center.

o  Appropriateness of the budget for the various components of the
Exploratory Grant.

3. Scientific Expertise of Participants

o  Quality and appropriateness of expertise available at the applicant

o  Nature and degree of interdisciplinary approach proposed to promote
the collaboration of scientists with expertise in hematology with
scientists in other disciplines.

o  Qualifications, experience, and evidence of commitment of the
investigators within the applicant institution, and their willingness
to interrelate with other elements proposed for the proposed Center.

o  Quality and appropriateness of collaborating institutions and
research staff.

o  Proposed plans to recruit new expertise to the proposed Center.

4. Institutional Commitment

o  The institutional commitment to the program, including lines of
responsibility for a Center and the institution's contribution to the
management capabilities of a Center.

o  The degree of institutional contributions for administrative and
planning activities.

o  The academic research environment and resources in which the
activities would be conducted, including the availability of space,
equipment, and facilities, and the potential for interaction with
scientists from other departments and institutions.

o  The institutional commitment to any newly-recruited individuals
responsible for conducting essential planning functions and activities.


Applications will compete for available funds with all other
applications submitted in response to this RFA and recommended by peer
review.  The following will be considered in making funding decisions:

o  Quality of the application as determined by peer review

o  Availability of funds

o  Overall program balance represented by the applications recommended
by peer review


Letter of Intent:     January 31, 1993
Application Receipt:  March 15, 1993
Initial Review:       June-July 1993
Second Level Review:  September 1993
Anticipated Award:    September 30, 1993


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:

David G. Badman, Ph.D.
Hematology Program Director
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-05
Bethesda, MD  20892
Telephone:  (301) 496-7458

Direct inquiries regarding fiscal matters to:

Ms. Nancy Dixon
Grants Management Officer
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 637
Bethesda, MD  20892
Telephone:  (301) 496-7467


This program is described in the Catalog of Federal Domestic Assistance
No. 93.849 for DKUHD.  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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