Full Text HD-94-021


NIH GUIDE, Volume 23, Number 27, July 22, 1994

RFA:  HD-94-021

P.T. 04, AA

  Biomedical Research, Multidiscipl 
  Children (Patients) 

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  October 1, 1994
Application Receipt Date:  January 18, 1995


The National Institute of Child Health and Human Development (NICHD)
supports a program of Child Health Research Centers (CHRC), intended to
provide resources to speed the transfer of knowledge gained through
studies in basic science to clinical applications that will benefit the
health of children.  This will be accomplished by increasing the number
of pediatric medical centers that can stimulate and facilitate the
application of research findings to pressing pediatric problems, as
well as increasing the number and effectiveness of pediatric
investigators who have a grounding in basic science and research skills
that can be applied to the health problems of children.


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), Child Health Research Centers, is related to
several priority areas.  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).


A CHRC grant is awarded to a children's hospital or a department of
pediatrics of an approved medical school in the United States of
America that has as a primary teaching site either a general children's
hospital or a children's program with an identifiable organizational
structure that is part of a larger medical institution.  Recipient
institutions must have the clinical pediatric specialties and
subspecialties and the discrete clinical and research facilities
sufficient to ensure the linkage of basic research and clinical
application that will meet the purposes of the CHRC program.  The
applicant institution must also meet the standard eligibility
requirements for research grants established in the PHS Grants Policy
Statement (rev. 4/94).

The CHRC must have a strong, well-established research base, resting on
the interests of established investigators who make their expertise
available to the junior investigators and act as mentors or senior
collaborators for them.  The research must relate to the current areas
of interest of the research program of the NICHD and should be
broadly-based, not defined by a specific disease category or organ
system.  There should be an adequate pool of junior investigators
likely to benefit from career development under the guidance of
established investigators.  In addition, each Center must have a
scientifically sound and equitable system for choosing which junior
investigators and which projects are to be supported.  Finally, there
should be evidence of an institutional commitment to support of the
Center resources and to the development and retention of pediatric


Support for this program will be through Center Core Grant (P30)
awards, which provide core support for laboratories and administrative
resources applicable to a number of different research projects.
Policies that govern the grants award programs of the PHS will prevail.
The support of grants pursuant to the RFA is contingent upon ultimate
receipt of appropriated funds for this purpose.

Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the size of an award will
vary also.  The maximum will be $400,000 for direct plus indirect costs
in the first year, with no increases for inflation in subsequent years.
The number of awards will be influenced by the amount of funds
available to the NICHD, by the overall merit of applications, and by
their relevance to program goals.

Applications from institutions not previously funded for Child Health
Centers will compete on an equal basis with competing continuation
applications.  It is expected that RFAs similar to this one will be
issued in
FY 1995 and FY 1996.


The estimated total costs awarded will be $2.4 million for the first
year of support.  It is anticipated that six or more awards (new and
competing continuations) will be made.  The maximum amount will be
$400,000 for direct plus indirect costs in the first year, with no
increases for inflation in subsequent years.  The number of awards will
be influenced by the overall merit of applications and by their
relevance to program goals.


A CHRC grant provides pediatric research institutions, both developing
and established, an opportunity to build a greater capacity for
nurturing pediatric investigators.  Established investigators whose
research is already funded by NIH or other sources through
competitively reviewed grants or contracts combine to establish in
their institution a center of research excellence.  Individuals with a
wide range of scientific backgrounds, especially those with basic
science orientation, are encouraged to interact with each other and
with newly trained pediatricians just embarking on their research
careers.  A shared core laboratory, which provides services to
complement and extend the capabilities of the established investigators
to facilitate the career development of new investigators, may be a
major part of the Center.  The established investigators make available
their expertise, guidance, and laboratory facilities, which together
with the shared core laboratory comprise the laboratory resources of
the Center, to be utilized by junior investigators for research
projects which will enhance their basic science knowledge and skills.
Support for conducting these projects is provided by the Center grant.

The CHRC grant may provide funds for three purposes:

A.  Administration of the Center.

B.  Improvements in the child health-related research program of an
institution in an area of scientific excellence through the
establishment and maintenance of a shared core laboratory.

C.  Support for new projects, conducted by junior investigators,
designed to enhance their research skills and produce preliminary data
which could lead to successful competitive grant applications to the
NIH or other agencies (New Project Development Funds), thereby
providing a bridge between formal research training and the receipt of
independent research grants.

The novel feature of these grants is the flexibility in the use of the
funds awarded for research support and career development, so that
decisions about which new projects and which junior investigators are
to be supported are made by the grantee institution.  Both competing
(renewal) and noncompeting continuations of a CHRC grant are contingent
on demonstration of good judgment in these decisions, as indicated by
scientific progress, success in the initiation of new
competitively-supported research grants and contracts, and the
development of new pediatric investigators.

Components of a CHRC

A.  Principal Investigator

The principal investigator of the CHRC is the chairperson of the
department of pediatrics or the chief of the pediatric service.  He or
she is responsible for development and maintenance of the Center as an
institutional resource and for its general oversight, appointing the
program director and members of the advisory committee (see below).  He
or she makes the decisions as to appropriate recipients of the Center
funds for research and career development, taking into consideration
recommendations from the Center advisory committee.  The principal
investigator does not receive salary or fringe benefit support from the
CHRC for this responsibility.

B.  Administrative Staff

The day-to-day administration of the Center grant may be made the
responsibility of a senior faculty member, called the program director,
supported for up to 10 percent time and effort for this activity.  The
program director must be a physician knowledgeable about pediatric
research, with a record of success at laboratory or clinical
investigation and preferably a demonstrated skill in career
development.  The principal investigator may also serve as program
director, with appropriate support.  The program director may be
assisted by a part-time Center-supported secretary.  Administrative
staff funds may also be used for a well-qualified recruitment officer,
supported up to 20 percent time and effort, to enhance participation in
the program by women and by members of minority groups
under-represented in pediatric research (see below).

C.  Advisory Committee

The advisory committee is a group of Center scientists, drawn from the
pediatric department and from other departments or institutions as
appropriate, who have interests and expertise relevant to modern
pediatric research.  The advisory committee should be chaired by the
principal investigator and should include the program director, the
core laboratory director, and some or all of the established
investigators.  It may also include the recruitment officer and any
other persons considered potentially contributory by the principal
investigator.  It is the function of the advisory committee to evaluate
applications for the use of the Center's New Project Development Funds
and make recommendations to the principal investigator as to
appropriate awardees.  It evaluates ongoing activities annually, makes
recommendations as to their continuation, and recommends to the
principal investigator priorities for use of the resources of the core
laboratory. For these functions the committee may utilize institutional
or outside consultants as necessary.

The advisory committee provides expert counsel essential to the
principal investigator for his or her administration of the Center.
Its meetings should be regular and its evaluation activities
formalized.  Minutes of the advisory committee meetings will be
scrutinized as part of any competing continuation application.

D.  Established Investigators

At least six established investigators, supported by NIH or other
competitively-awarded grants, are required for a CHRC.  They should be
expert in the application of new advances in basic science methodology
to problems of human development and pediatric disease that are
relevant to the mission of the NICHD and within its authority to
support.  Their research interests must contribute to areas that
justify their collective designation as a Child Health Research Center,
making the CHRC attractive to recently-trained pediatricians as a place
to develop their investigative careers.  The established investigators
need not be pediatric department members; linkage to other departments
can enhance the power of the CHRC, and is expected to be a key feature
of each Center.  When a junior investigator is to be supported by the
Center through New Project Development Funds, at least one of the
established investigators must agree to provide his or her expertise as
a mentor and collaborator and allow the junior investigator access to
his or her laboratories.  The established investigators do not receive
support for their salaries or fringe benefits from the Center grant.
Established investigators may be added as appropriate to the roster of
an ongoing funded Center.

E.  Laboratory Resources

The laboratory resources of the CHRC comprise the research laboratories
of the established investigators, as well as a shared core laboratory
to be utilized by the established investigators and the
Center-supported junior investigators whose activities they will
supervise.  The justification for the shared core laboratory is its
provision of a cost-effective expansion or centralization of the
research resources that make the Center a magnet for beginning
investigators.  The CHRC grant may support professional supervision of
the shared core laboratory (core laboratory director, maximum 50
percent time and effort), as well as technical assistance, supplies,
and equipment purchase and maintenance.  The principal investigator,
program director, and core laboratory director are responsible for
efficient and equitable utilization of the core laboratory on the basis
of recommendations from the advisory committee.  Core laboratory log
books are subject to review by NICHD staff and outside consultants upon
request of the former.

There must be an institutional commitment to this shared core
laboratory, which may take the form of alterations and renovations to
establish it, the purchase of research equipment, the assignment of
research space, and/or the support of personnel.  Creative approaches
to stimulating interactions between diverse investigators who can
contribute to Center goals are particularly desirable.

The laboratories of the established investigators are not supported
directly by the Center grant.  Funds for supplies, small equipment, and
technical assistance needed for the conduct of Center-supported
research projects in these laboratories are provided through New
Project Development Funds. Support for projects conducted in the core
laboratory by recipients of New Project Development Funds may come
either from those funds, from the core laboratory budget, or from both.

F.  New Project Development Funds

The principal investigator, after considering recommendations from the
advisory committee, is to use Center funds to make annual awards to
junior faculty members for the pursuit of research projects which will
utilize the Center laboratory resources and established investigator
expertise.  The projects may be clinical or non-clinical, as long as
they relate to the goal of the Center.  Each junior investigator must
be under the mentorship of an established investigator who will provide
supervision of the research to be undertaken.

The maximum award to any individual for a project in this category is
$50,000 per year.  These funds may be used to defray the costs of
materials, supplies, technical assistance, and miscellaneous expenses
generated by these projects in the laboratories of the established
investigators who serve as preceptors and collaborators of the
awardees;  for supplies needed for work in the core laboratory which
are beyond the capacity of that laboratory's budget; for small items of
equipment; for travel; and for a portion of the salaries and fringe
benefits of the junior investigators.  These funds may not be used for
patient care costs such as inpatient bed days or outpatient visits,
except for clinical laboratory analyses essential for the research.

The recipient of New Project Development Funds should be a physician
who has completed pediatric training, who has not previously been the
principal investigator of a competitively awarded NIH research grant or
contract* (except for an NICHD-supported R03 grant), and who is no more
than three years beyond fellowship training at the time the first New
Project Development Fund award is made.  The awards are renewable at
the discretion of the principal investigator, contingent upon
presentation of evidence of satisfactory progress to the advisory
committee and the NICHD in the Center annual progress report.  Each
recipient should make a commitment of time and effort to research which
is appropriate for the magnitude of the award.

Institutions with CHRC grants are encouraged to develop novel
mechanisms for recruiting qualified pediatricians to become
grant-supported investigators in the Center.  Such mechanisms could
include, for example, part-time appointments for persons with families
and special efforts to recruit members of minority groups.

*Note:  This restriction does not apply to NIH CIDA (K08) awards or any
of its precursors (CIA, PSA), which are career development awards and
not research grants.  Recipients of New Project Development Funds are
especially encouraged to apply for CIDA awards, which may be held prior
to, concurrently with (subject to the relevant CIDA salary
restriction), or subsequent to New Project Development Funds.

Allowable Budgetary Items and Supportable Activities

Allowable costs in NIH grants are governed by rules set forth in the
Public Health Service Grants Policy Statement and the NIH Guide for
Grants and Contracts unless otherwise stated on the Notice of Grant
Award.  Under these rules the principal investigator may exercise
flexibility in meeting unexpected Center requirements by rebudgeting or
requesting approval to rebudget among categories within the total
direct cost budget of the Center (as shown on the Notice of Grant
Award), within the ceilings set in these guidelines.

CHRC grants are for five years, at a maximum level of $400,000 (direct
plus indirect cost) annually, and are renewable.  Competing
continuation (renewals) are limited by Congressional action to one
five-year period.  No institution will be funded for a CHRC for more
than ten years in any twelve-year period. That is, institutions which
have been funded for a new CHRC and one competing continuation may not
reapply until after a lapse of two years.  An institution not funded
for a competing continuation application may make a new application
when a new RFA is issued.

Items fundable under a CHRC grant include:

A.  Administration

1.  Salaries and support for a Center program director (maximum 10
percent time and effort), a part-time secretary, and a recruiting
officer (maximum 20 percent time and effort).

2.  Administrative support services, including supplies, duplicating
equipment, telephone, or maintenance contracts for equipment when not
covered by institutional overhead charges.

3.  Travel of principal investigator and Center program director to
administrative meetings with NICHD staff and to an annual scientific
meeting of Centers.

B.  Shared Core Laboratory (maximum annually)

1.  Salaries and support for shared core laboratory staff.
2.  Supplies and animals.
3.  Scientific equipment (purchase and maintenance).
4.  Computer facilities.

C.  New Project Development Funds (maximum $200,000 annually)

Up to $50,000 annually can be used to provide support for projects of
individual junior investigators which are pursued in their own
laboratories, in the shared core laboratory, and/or in the laboratories
of the established investigators.  For each person supported in this
category, the maximum expenditure for equipment is $7,000 annually and
for travel $1,500 annually.  The grant application should indicate the
number of awards proposed for each year, and provide evidence that this
number of worthwhile projects is likely to be forthcoming. No
investigator may receive more than one such award per year.

It is not a requirement that any CHRC grant be funded at the allowable
budgetary maximum in any particular year. The number of New Project
Development Awards to be supported  must be commensurate with the
institution's capacity to develop and recruit appropriate candidates.
Small size is not a disadvantage for Center funding, provided the
support for core resources (administration, shared core laboratory) is
in proportion to the activity in new investigator development which is
the Center's primary purpose.  To encourage use of these funds only for
the most deserving candidates, requests will be considered for the
carry-over of unexpended New Project Development Funds into subsequent
budget periods.

Items not fundable under a CHRC grant include:

1.  Direct support of the laboratories, salaries, fringe benefits,
travel, and research projects of the established investigators, except
for reimbursement for costs from New Project Development Funds within
the Center.

2.  Salary and support for central institutional administrative
personnel usually paid from institutional overhead charges, such as
budget officers, grant assistants, and building maintenance personnel.

3.  Salary and support for administrative activities such as public
relations or health and educational services.

4.  Travel of principal investigator, program director, core laboratory
director, or established investigators to scientific meetings.

5.  Costs of clinical care, such as patient bed days or outpatient
visit charges.

6.  Alterations and renovations.

Application Format

A.  Text

Applicants should follow the instructions for applications included in
the "National Institute of Child Health and Human Development Research
Center Programs P30 Center Core Grant Guidelines," except where these
are at variance with these specific guidelines for CHRC grants.  Since
P30 Guidelines were not designed primarily to be used for CHRC-type
applications, considerable flexibility in format will be permitted.
Applicants should take care, however, that adequate information is
provided for evaluation with respect to the eleven review criteria
described above.  Prospective applicants are urged to discuss their
plans with Institute staff.

Specific research projects proposed for support need not be described
in the initial application.  However, a brief description of examples
of junior investigators who might be supported through this award,
their training background, research areas in which they would work, and
established investigators who would supervise them might provide
evidence that enough worthy projects will be available to justify the
requested budget.

B.  Budget

Each application submitted in response to this RFA should include
several separate budget pages (plus any budget justification pages):

1.  A composite budget, the sum of the other budgets, in categories,
for the first year.  New project development funds should be listed
under Other Expenses.

2.  A budget for the administrative core (unless no funds are requested
for this core), including personnel or supplies, travel for the
principal investigator and program director to the Centers' meeting,
and any other expenses requested, for the first year.

3.  A budget for the shared core laboratory (unless no funds are
requested for this laboratory), including personnel, equipment,
supplies, and other expenses.

4.  A budget for New Project Development, providing under Other
Expenses the total dollars and minimum number of positions requested,
according to the following format:

New Project Development Awards:  3 @$ 50,000 or 5 @$ 30,000 = $150,000

The New Project Development Funds budget need not be allocated into
categories, since these will vary with the situations of the
recipients.  However, it should be specified to what extent these funds
will be used for salaries.  The number of such awards planned should be
appropriate for the size of the institution, the number and skills of
the established investigators, and the magnitude of the request for
Center administration and core laboratory resources.

5.  The usual future-year continuation page, listing New Project
Development Awards under Other Expenses.



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 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 9, 1994 (FR 59 11146-11151), and reprinted in the NIH GUIDE
FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the program
staff or contact person listed below.  Program staff may also provide
additional relevant information concerning the policy.


Prospective applicants are asked to submit, by October 1, 1994, a
letter of intent that includes a descriptive title of the proposed
Center, 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 this RFA.

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 NICHD staff to estimate the potential review
workload, to recruit appropriate reviewers, and to avoid possible
conflicts of interest in the review.

The letter of intent is to be sent to Dr. Ephraim Levin at the address
listed under INQUIRIES.


The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and from the Office of
Grants Information, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone

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

The title of the application on page 1 of the grant application must be
RFA HD-94-021" must be typed on line 2a of the face page of the

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, exact 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:

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E01
Bethesda, MD  20892

Applications prepared in response to this RFA must be received by
January 18, 1995.  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 RFA 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.


Applications will be reviewed by NICHD staff for responsiveness to the
RFA.  A non-responsive application will be returned to the applicant.
Responsive applications may be subjected to a triage by a peer-review
group to determine their scientific merit relative to the other
applications received in response to this RFA.  The NICHD will withdraw
from competition those applications judged to be noncompetitive and
notify the applicant and institutional business official.

Applications considered responsive to this RFA and competitive will be
reviewed for technical merit by an Initial Review Group convened by the
scientific review staff of the NICHD solely to evaluate these
applications. Criteria for the initial review are described below.
Following review by the Initial Review Group, applications will be
evaluated by the NICHD Advisory Council for program relevance and
policy issues before awards are made.

Review Criteria

A.  The review criteria for the evaluation of new and competing
continuation CHRC applications include the following:

1.  Relevance of the research at the Institution to programmatic needs
of the NICHD.

2.  Probable impact of the Center on enhancing the capacity of the
grantee institution for developing well-qualified new pediatric
investigators, thereby advancing pediatric research at the grantee
institution, in the local medical environment, and in the nation,
especially with regard to the application of basic research
developments to clinical problems in pediatrics.

3.  Quality and productivity of the research activities of the
participating established investigators, and relevance of their
programs to the NICHD mission.

4.  Nature and quality of the shared core laboratory:  technical merit,
scientific justification, evidence of cost-effectiveness, procedures
for quality control and allocation of resources, qualifications of the
core laboratory director and technical staff, and probable utility to
the investigators.

5.  Institutional commitment to the requirements of the program, such
as recruitment efforts, salaries, equipment, or other forms of cost

6.  Evidence for a pool of prospective investigators, trained locally
or recruited from elsewhere, who could benefit from receiving support
from the Center.

7.  Opportunities for faculty positions emphasizing research for
recipients of New Project Development Funds at the applicant
institution or elsewhere.

8.  Previous success of the institution in developing new pediatric

9.  Efforts to develop novel mechanisms for recruiting candidates for
New Project Development Awards from groups under-represented in
pediatric research.

10.  Procedures established for evaluating candidates for New Project
Development Funds and providing internal quality control of ongoing

11.  For renewal (competing continuation) applications, or subsequent
new applications from an institution with a previously-funded Center,
success of the Center-funded junior investigators in producing research
publications and in obtaining independent, competitively-funded support
for pediatric research.

B.  Non-competing continuations:

Annual progress reports of a CHRC grant will be reviewed by NICHD staff
and outside consultants in order to confirm that the Center is
continuing to meet its goal of recruiting promising new pediatric
investigators and stimulating and facilitating their career
development.  In addition, each Center will be asked to send some of
its recent recipients of research support as well as the principal
investigator and/or program director to an annual meeting.  One purpose
of this meeting will be to allow these junior investigators to present
their Center-supported research to their peers as well as to other
critics.  Center principal investigators and program directors are
expected to make a special effort to attend these meetings to
demonstrate their support of the program and the junior investigators.
In addition, they will have an opportunity at these meetings to
exchange ideas about common problems and make suggestions to NICHD
staff about possible modifications in the program.


The anticipated date of award is September 1, 1995, based on the
following timetable:

Letter of Intent Receipt Date:  October 1, 1994
Application Receipt Date:       January 18, 1995
Initial Review Date:            March 1995
Review by Advisory Council:     June 1995

Scientific merit and technical proficiency, based on the demonstrated
and projected capabilities described in the application will be the
predominant criteria for determining funding priorities.


Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions for potential
applicants is welcome.

Direct inquiries regarding programmatic issues and address the letter
of intent to:

Ephraim Y. Levin, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Building, Room 4B11
6100 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-5593

Direct inquiries regarding fiscal matters to:

Ms. Mary Ellen Colvin
Office of Grants and Contracts
National Institute of Child Health and Human Development
6100 Building, Room 8A17
6100 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-1303


This program is described in the Catalog of Federal Domestic Assistance
No. 93.865, Research for Mothers and Children.  Awards are made under
the authority 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 Part 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 Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use of
all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American


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