Release Date:  August 13, 1999

RFA:  HD-99-010

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  September 15,1999
Application Receipt Date:  December 10, 1999


The National Institute of Child Health and Human Development (NICHD) supports
a program of Child Health Research Career Development Awards (CHRCDA) intended
to develop resources to speed the transfer of knowledge gained through studies
in basic science to clinical applications that will benefit the health of
children.  The CHRCDA will support research career development of
pediatricians who have recently completed postgraduate clinical training, and
who are commencing basic and/or clinical research relevant to child health. 
The goal of this initiative is to advance research in child health and to
support educational institutions in their ability to stimulate novel research
initiatives and career development experiences for junior investigators.  This
will be accomplished by increasing the number and effectiveness of established
pediatric investigators who have a grounding in basic science and research
skills that can be applied to the health problems of children, as well as by
increasing the number of pediatric medical centers that can stimulate and
facilitate the application of research findings to pressing pediatric


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) is
related to several priority areas.  Potential applicants may obtain "Healthy
People 2000" at


Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
units of State and local governments, and eligible agencies of the Federal
government.  Foreign institutions are not eligible for this institutional
career development award.  Applications from institutions not previously
funded for Child Health Research Career Development Awards are encouraged. 
Racial/ethnic minority individuals, persons with disabilities, and women are
encouraged to apply as Principal Investigators.

A CHRCDA may be awarded to a children's hospital or to 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.  Grantee institutions must have the clinical
pediatric specialties and subspecialties, and the discrete clinical and
research facilities sufficient to meet the purposes of the CHRCDA program,
namely,  to bridge clinical pediatric training with a career in basic and/or
clinical research relevant to child health.  CHRCDA Scholars must have a
clinical degree or its equivalent, must have initiated postgraduate clinical
training, and must be willing to spend 75 percent of full-time professional
effort conducting research and research career development.  Scholars must be
US citizens or noncitizen nationals, or must have been  lawfully admitted for
permanent residence and possess an Alien Registration Receipt Card (I-151 or
I-551).  Individuals on temporary or student visas are not eligible.


Support for this program in the past has been through National Institutes of
Health (NIH) Center Core Grant (P30) awards.  This RFA will use the NIH
Mentored Clinical Scientist Development Program (K12) award mechanism.  This
is an award to an educational institution to support career development
experiences for clinicians, leading to research independence. The award will
provide support for laboratories and administrative resources applicable to a
number of different research projects related to these career development

Responsibility for the planning, direction, and execution of the proposed
program will be solely that of the applicant. The total project period for an
application submitted in response to this RFA may not exceed five years.  The
anticipated award date is December 1, 2000.


NICHD intends to commit approximately $2.6 million in total costs (direct plus
facilities and administrative) in FY 2000.  It is anticipated that six awards
(new and/or competing continuation) will be made.  Applicants may request a
budget of up to $400,000 for direct costs per year.  It is not required that
applications request the allowable budgetary maximum.  Small size is not a
disadvantage for CHRCDA funding, if the support requested for core resources
(administration, shared core laboratory) is in proportion to the activity in
new project development which is the CHRCDA's primary purpose.  Facilities and
administrative costs on K12 awards are limited to eight percent of applicable
direct costs.

Because the nature and scope of the new projects may vary, it is anticipated
that the size of awards also will vary.  Although the financial plans of NICHD
provide support for this program, awards pursuant to this RFA are contingent
upon the availability of funds and the receipt of a sufficient number of
applications of outstanding scientific and technical merit.



A CHRCDA grant provides pediatric research institutions an opportunity to
build a greater capacity for nurturing junior investigators.  Established
investigators, with research  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
asked to mentor 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 an
institution.  The established investigators make available their expertise,
guidance, and laboratory facilities which, with the shared core laboratory,
comprise the laboratory resources of the institution to be utilized by junior
investigators for research projects that will enhance their basic science
knowledge and skills.  Support for conducting these projects is provided by
the K12 grant.


The CHRCDA grant may provide funds for three purposes:

A.  Administration of the CHRCDA career development program.

B.  Enhancement of the child health-related career development 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,
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; decisions about which new projects and which
junior investigators are to be supported are made by the grantee institution. 
Both competing and noncompeting continuations of a CHRCDA grant are contingent
on demonstration of good judgment in these decisions, as indicated by
scientific progress, success of the junior investigators in competing for new
research grants and contracts, and the development of new pediatric

Components of a CHRCDA

A.  Principal Investigator

The Principal Investigator of the CHRCDA must be the chairperson of the
Department of Pediatrics or the chief of the pediatric service.  He or she
should possess the scientific expertise, leadership, and administrative
capabilities required to coordinate and supervise a multidisciplinary research
program of this scope.  The Principal Investigator is responsible for
appointing the Program Director and members of the Advisory Committee (see
below).  He or she makes the decisions regarding appropriate recipients of the
program funds for research and career development, taking into consideration
recommendations from the CHRCDA Advisory Committee.  The Principal
Investigator does not receive salary or fringe benefit support from the CHRCDA
for this activity.  The Principal Investigator is expected to attend the
annual scientific meeting of the CHRCDA centers.

B.  Administrative Staff

The day-to-day administration of the CHRCDA 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 who is knowledgeable about pediatric research and has a record of
success at laboratory or clinical investigation and, preferably, 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 CHRCDA-supported secretary.  Administrative staff
funds also may 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 members of minority groups that are underrepresented in pediatric
research (see below).  The Program Director is expected to attend the annual
scientific meeting of the CHRCDA centers.

C.  Advisory Committee

The Advisory Committee is a group of scientists, selected from the Pediatric
Department and other departments or institutions as appropriate, who have
interests and expertise relevant to pediatric research.  The Advisory
Committee is chaired by the Principal Investigator and must include the
Program Director, the Core Laboratory Director, and some or all of the
participating established investigators.  It also may include the recruitment
officer and any other persons considered essential by the Principal
Investigator.  It is the function of the Advisory Committee to evaluate
applications for the use of the new project development funds and make
recommendations to the Principal Investigator about appropriate awardees.  It
evaluates ongoing activities annually, makes recommendations about their
continuation, and recommends to the Principal Investigator priorities for use
of the resources of the core laboratory.  The committee may utilize
institutional or outside consultants for these functions.  The Advisory
Committee provides expert counsel essential to the Principal Investigator for
his or her administration of the center.  It should meet regularly and its
evaluation activities should be formalized.

D.  Mentors

At least six established investigators, supported by NIH or other
competitively awarded grants, are required as mentors for a CHRCDA.  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.  Their research interests must
contribute to areas that justify their collective designation as a Child
Health Research Career Development Award center, making the CHRCDA attractive
to recently trained pediatricians as a place to develop their investigative
careers.  The mentors need not be pediatric department members; linkage to
other departments can enhance the power of the CHRCDA, and is expected to be a
key feature of each center.  When a junior investigator is to be supported by
the CHRCDA 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.  Annual progress reports of a CHRCDA grant will be reviewed
by NICHD staff and outside consultants in order to confirm that the
institution is continuing to meet its goal of recruiting promising new
pediatric investigators and facilitating their career development.  The
mentors do not receive support for their salaries or fringe benefits from the
career development awards.  Mentors may be added as appropriate to the roster
of an ongoing funded CHRCDA center without prior NICHD approval.

E.  Laboratory Resources

The laboratory resources of the CHRCDA comprise the research laboratories of
the established investigators, as well as a shared core laboratory to be
utilized by the established investigators and the 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 program a magnet for beginning
investigators.  The CHRCDA 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.  Approaches to stimulating interactions between diverse
investigators who can contribute to career development goals are particularly

The laboratories of the established investigators are not supported directly
by the K12 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, the core
laboratory budget, or both.

F.  Career Development Program

The K12 award provides five years of funding to the institution.  The
Principal Investigator, after considering recommendations from the Advisory
Committee, will make CHRCDA Scholar appointments to junior investigators for
the pursuit of research projects that will utilize the institution laboratory
resources and established investigator expertise. The institution will support
CHRCDA Scholars for periods of two to five years consisting of consecutive 12-
month appointments.  Each CHRCDA Scholar must be under the guidance and
supervision of an established investigator.  In addition to research activity,
the program should include an initial didactic phase which may include
training in areas such as biostatistics, scientific writing and oral
presentation, biotechnology, and epidemiology.  At least 75 percent of the
Scholar's time should be devoted to the K12 program.

G.  CHRCDA Scholars

The CHRCDA Scholar should be a physician who has completed pediatric training,
who is no more than three years beyond fellowship training at the time the
first appointment is made, and who has not previously been the Principal
Investigator of an NIH research grant or contract.

The grant application should indicate the number of CHRCDA Scholar
appointments proposed for each year and provide evidence that this number of
worthwhile projects is likely to be forthcoming.  The number of new projects
to be supported must be commensurate with the institution's capacity to
develop and recruit appropriate candidates.  CHRCDA projects may be clinical
or non-clinical, as long as they relate to the goals of the CHRCDA center. 
Support of Scholars is 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 required annual
progress report.  Criteria for selecting CHRCDA Scholars should be described
in the grant application.  Institutions are encouraged to develop novel
mechanisms for recruiting qualified pediatricians to become grant-supported
investigators.  Such mechanisms could include, for example, part-time
appointments for individuals with families and special efforts to recruit
members of minority groups.

CHRCDA Scholars as well as the Principal Investigator and Program Director are
expected to attend an annual CHRCDA centers meeting.  One purpose of this
meeting is to allow Scholars to present their career development award-
supported research to their peers.  Principal Investigators and Program
Directors are expected 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.


Allowable Budgetary Items and Supportable Activities

A.  Administration

1.  Salaries and support for a Program Director (maximum 20 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 if not covered by
institutional overhead charges.

3.  Travel of Principal Investigator and Program Director to an annual CHRCDA
scientific meeting.

B.  Shared Core Laboratory

1.  Salaries and support for shared core laboratory staff.

2.  Supplies and animals.

3.  Scientific equipment (purchase and maintenance).

4.  Computer costs.

C.  New Project Development Support

Up to $100,000 annually may be used per CHRCDA Scholar for projects that are
pursued in their own laboratories, in the shared core laboratory, and/or in
the laboratories of the established investigators.  Individual Scholars are
eligible for up to $75,000 per year in salary.  For each person supported in
this category, the maximum expenditure for equipment is $10,000 annually and
for travel, $3,500 annually.  Awards to CHRCDA Scholars need not all be equal
in size.  These funds may be used for salary and 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 mentors  of the awardees; for supplies needed for
work in the core laboratory that 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.

Items that may not be supported with CHRCDA grant funds include:

1.  Direct support of the laboratories, salaries, fringe benefits, travel, and
research projects of the established investigators, except for reimbursement
of costs from new project development support within the CHRCDA 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 the Principal Investigator, the Program Director, the Core
Laboratory Director, or other established investigators to scientific meetings
except as previously noted.

5.  Patient care costs such as inpatient bed days or outpatient visits, except
for clinical laboratory analyses essential for the research.

6.  Alterations and renovations.


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 are provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research.  This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which was published in the Federal Register of March 28, 1994 (FR
59 14508-14513), and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994, available on the web at:


It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at:

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


Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed application, the name, address, and
telephone number of the Principal Investigator, the identities of other key
personnel (established investigators excepted) 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 and avoid possible conflicts of interest in the

The letter of intent is to be sent to Dr. Karen Winer at the address listed
under INQUIRIES by September 15, 1999.


The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  Applications forms are available at most
institutional offices of sponsored research, on the web at, and from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, Email:

Institutions that have previously submitted unsuccessful CHRCDA applications
should treat applications in response to this RFA as new applications, not as
revisions of the previous submissions.

Budget Instructions

Each application submitted in response to this RFA should include the
following information, using PHS 398 (rev. 4/98) Form Pages 4 and 5, including
appropriate budget justification, as indicated:

following individual budgets, using separate pages for each:

1.  A budget for the administrative core, including Personnel, Supplies,
Travel Expenses for the Principal Investigator and Program Director to the
annual CHRCDA scientific meeting, and Other Expenses, for the first year.

2.  A budget for the shared core laboratory including Personnel, Equipment,
Supplies, and Other Expenses, for the first year.

3.  A budget for new project development funds for the first year, providing
under Other Expenses the total dollars and minimum number of positions
requested.  The new project development funds budget need not be allocated
into categories in the initial application, since these will vary with the
projects supported.  It should be specified to what extent these funds will be
used for salaries.

the following:

A composite budget, reflecting the sum of the individual budgets, in
categories, for the first year and for the entire proposed period of support. 
New project development funds should be listed under Other Expenses.  Provide
budget justification in narrative form.

The RFA label available in the PHS 398 (rev. 4/98) must be stapled to the
bottom of the face page of the application and must display the number of this
RFA, HD-99-010.  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
AWARD) and number (HD-99-010) must be typed on line 2 of the face page of the
application 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:

BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application should be
sent to:

Scott Andres, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)

Applications prepared in response to this RFA must be received by December 10,
1999.  If an application is received after that date, it will be returned to
the applicant without review.  The CSR will not accept any application that is
essentially the same as one already reviewed.


Upon receipt, applications will be reviewed for completeness by the Center for
Scientific Review (CSR) and for responsiveness by the NICHD.  Incomplete 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 NICHD in accordance with the review criteria stated
below.  As part of the initial merit review, all applications will receive a
written critique and may undergo a process in which only those applications
deemed to have the highest scientific merit will be discussed and assigned a
priority score, and receive a second-level review by the National Advisory
Child Health and Human Development Council at its June 2000 meeting.

Review Criteria

1.  Probable impact of the CHRCDA on enhancing the capacity of the grantee
institution to develop 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.

2.  Applicant institution's commitment to appropriate broadly based research,
resting on the interests of established investigators who can act as mentors
or senior collaborators for them.  The research at the institution must be
relevant to the current areas of interest of the research and programmatic
needs of the NICHD.  Research should not be narrowly defined by a specific
disease category or organ system.

3.  Institutional commitment to the requirements of the program, such as
recruitment efforts, salaries, equipment, core laboratory support, or other
forms of cost sharing.

4.  Evidence of the availability of a pool of prospective investigators,
trained locally or recruited from elsewhere, who could benefit from receiving
career development support from the CHRCDA.

5.  Appropriateness of the number of planned awards for the size of the
institution, the number and skills of the established investigators who will
serve as mentors, and the magnitude of the request for administration and core
laboratory resources.

6.  Availability of research-oriented faculty positions at the grantee
institution for new investigators previously trained by the CHRCDA.

7.  Evidence of previous success of the institution in developing new
pediatric investigators.

8.  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

9.  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.

10.  Efforts to develop novel mechanisms for recruiting candidates for new
project development awards from groups under-represented in pediatric

11.  Evidence of a scientifically sound and equitable system for evaluating
candidates for new project development funds and providing internal quality
control of ongoing research.

12.  Quality of the proposed training in the responsible conduct of research.

13.  Adequacy of plans for the recruitment of women and minorities as

14.  Appropriateness of the requested budget.


Letter of Intent Receipt Date:  September 15, 1999
Application Receipt Date:       December 10, 1999
Peer Review Date:               April 2000
Council Review:                 June 2000
Anticipated Date of Award:      December 1, 2000


Criteria that will be used in making funding decisions include scientific and
technical merit, as determined by peer review, availability of funds, and
programmatic priorities.


Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions for potential applicants is welcomed.  Prospective
applicants are urged to discuss their plans with Institute staff.

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

Karen K. Winer, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5593
FAX:  (301) 480-9791

Direct inquiries regarding fiscal matters to:

Ms. Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1304
FAX:  (301) 402-0915


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 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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