Subject: (Copy) NIH GUIDE - Vol. 20, No. 10, March 8, 1991 - RFA HD9106
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 08 Mar 91 08:39 EST

Hi,
   #4 of l5  Please post as RFAHD-91-06.910308
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA HD9106 HD-91-06 P1O1 *****************************************
 
REQUEST FOR COOPERATIVE AGREEMENT APPLICATIONS
 
RFA:  HD-91-06
 
P.T. 34; K.W. 0413002, 0745020, 0745070
 
COOPERATIVE SPECIALIZED INFERTILITY RESEARCH CENTER PROGRAM
 
National Institute of Child Health and Human Development
 
Letter of Intent Receipt Date:  March 29, 1991
Application Receipt Date:  June 17, 1991
 
OVERVIEW
 
The National Institute of Child Health and Human Development
(NICHD) invites applications from investigators willing to
participate with the NICHD under a cooperative agreement in
a multicenter cooperative research program aimed at
developing new approaches for the diagnosis and/or treatment
of infertility.  Recognizing that the complexity of
infertility research severely limits the progress that can
be achieved by individual investigators working alone, the
NICHD will establish at least two (2) Specialized
Infertility Research Centers to conduct accelerated
preclinical and clinical research and development studies on
promising new leads in infertility research.  The
cooperating Specialized Infertility Research Centers will
also serve as national resources for the career development
of young scientists electing to pursue research in high
priority areas of infertility research.  Grantee
institutions in the Continental United States that meet the
requirements stated are eligible to participate.
 
It is the overall goal of this Request for Applications (RFA)
to establish a program of
biomedical research actively involving the NICHD and two
extramural Centers in specialized research and development
projects directed at the medically assisted alleviation of
infertility.  The Chief of the Reproductive Sciences Branch (RSB),
serving as the Institute staff Research Coordinator, will
cooperate with the project investigators of the selected
Centers in the identification of research priorities,
determination of the research approaches to be pursued, and
the evaluation and dissemination of the research results.
It is expected that the research approaches and directions
will change with time as new information is gathered.  It is
anticipated that the overall program will consist of three
(3) general phases over the five-year program period.  These
are defined as follows (phase durations are estimates only
and overlap):
 
Phase I  (2 months) - Refinement, by consensus, of the
experimental approaches, protocol design(s), end-points,
evaluation methods, and, as necessary, determination of the
intersite standardization of experimental methods and
procedures to be included in the Specialized Infertility
Research Centers program.
 
Phase II (48 months) - Conduct of research, acquisition of
data, evaluation of data, modification of project research
directions, and reporting of completed results.
 
Phase III  (18 months) - Initiation of planning regarding
the need for termination or addition of studies by the
program.  Determination of future research needs of the
program.  Concluding analyses and dissemination of results
as various research segments are completed.
 
It is recognized that these phases will require flexibility
in accommodating the continuously evolving nature of the
progress achieved by the various component projects in the
program.
 
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 for a Cooperative
Specialized Infertility Research Centers Program is related
to the priority area of Family Planning.
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, D.C. 20402-9325 (telephone 202-783-3238).
 
BACKGROUND
 
One of the most basic of human rights--the right to
procreate--is frustrated or denied by the occurrence of
infertility in a couple desiring children.  It has been
estimated that infertility affects between 35 and 70 million
married couples around the world (World Health Organization,
1988 data).  In U.S. studies described nearly fifty years
ago, it was stated that 10 percent of married couples were
"sterile" while the remaining 90 percent possessed varying
degrees of fertility.  More recent studies in the U.S. have
conservatively indicated that there are about 2.3 million
infertile couples, which is about 8 percent of the domestic
married couple population base with wives aged 15 to 44.  In
addition, it has been observed that about 4.9 million U.S.
women in this age range had an impaired ability to have
children (National Center for Health Statistics, 1988 data).
While analyses of the U.S. population base has not found
alarming increases in either the number of infertile couples
or the overall incidence of infertility, physician office
visits for infertility services have markedly increased from
1968 (600,000) to 1988 (1,350,000).  Of the infertile
couples seeking medical treatment, it has been estimated
elsewhere that up to one-half will be unsuccessful in
achieving their desired outcome.
 
The need for accelerated basic and clinical research on the
diagnostic and therapeutic aspects of infertility
alleviation has been extensively considered in several
recent reports ("Infertility: Medical and Social Choices,"
the Office of Technology Assessment of the Congress of the
United States, OTA - BA-358, May 1988; "Infertility in
America:  Why is the Federal Government Ignoring a Major
Health Problem?," Report of the House of Representatives
Committee on Government Operations, December 1989," and
"Medically Assisted Conception:  An Agenda for Research,"
Report of the Institute of Medicine of the National Research
Council, 1989).  Directives included in the deliberations of
the 101st U.S. Congress have also stressed the need to
enhance support for research on the diagnostic and
therapeutic aspects of infertility alleviation (Resolution
HJ 173, Bill HR 2956).  In its report for the current fiscal
year, the Senate Appropriations Committee directed the NICHD
to support a "program to provide new approaches for
overcoming infertility" and provided funds "to create five
new centers, two focused on infertility research and three
focused on contraceptive research."  The Committee noted in
its directive to the NICHD that infertility research and
development problems are so complex that they cannot be
solved by individual investigators working alone.  The
Committee concluded that "without specialized centers,
promising new leads may never be translated into new methods
or ever made available to the public."  It is the goal of
the cooperative research program described in this RFA to
meet the nationally identified need for an infertility
research program which will accelerate the translation of
promising new preclinical or clinical leads into new
clinical methods available to the public.
 
RESEARCH GOALS AND OBJECTIVES
 
Current therapy results for male factor infertility have
been discouraging.  One recent British study reported only a
20 percent chance of a successful pregnancy within two years
and no significant improvement of this chance with the use
of therapeutic insemination, husband (TIH).  In reproductive
aged females, it has been estimated that the general
incidence of endometriosis is 5-15 percent.  For women being
surgically treated for infertility, the incidence is 30-50
percent.  Among infertile females with no other known cause
for their infertility, the incidence has been reported at
40-70 percent.  Optimal diagnosis and treatment of
endometriosis remains enigmatic at present.  Ovulation
failure has been reported to be the underlying reason for
about 25 percent of female factor infertility.  A specific
cause for anovulation is usually not able to be determined.
Chronic anovulation predisposes the female to infertility
and compromises fecundity if not detected and treated early.
Uterine myomata occur in nearly 20 percent of all
reproductive aged women, are the single most common
diagnosis from gynecological hospital admissions, may be the
only clinical abnormality observed in an infertile couple,
and represent the most common medical indication for
hysterectomy.  Mechanistically, it remains unclear how
myomata contribute to infertility and detection is usually
by presentation for medical intervention.
 
The research goals expected to be pursued by a proposed
Center's research plan should address studies organized with
an orientation to either female factor infertility research
or male factor infertility research.  Although it is
anticipated that the overall cooperative research program
may be expanded in the future by the addition of one or more
Centers to accommodate a broadened range of studies, the
initial two (2) Centers are expected to be oriented toward
research on the early diagnosis and/or therapy of those
female factors that most often contribute to infertility or
undesired surgical sterility (endometriosis, chronic
ovulatory dysfunction, or uterine dysfunction--including
myomata-related dysfunctional uterine bleeding) or those
male factors associated with ineffective sperm production
(quality or quantity).  Research proposals directly
involving human in vitro fertilization and/or embryo
transfer should not be submitted in these Center
applications.
 
Each Center should organize its overall research plan to
include a mix of preclinical and clinical research
activities.  Applicants should note, however, that the NICHD
currently supports a separately established cooperative
research program for conducting clinical research trials of
experimental protocols and it is not the intent of the
present Specialized Infertility Research Center program to
support additional large-scale clinical trials.  It is
anticipated, however, that collaborating interactions with
the existing Reproductive Medicine Clinical Trial
Network may evolve from and outside of the activities of the
Specialized Infertility Research Centers.
 
Within the requirement for three (3) funded projects to
constitute a Center award, an applicant's research plan
design might, for example, include a set of research
projects using an animal model, a clinical model, or both
approaches to study infertility-related aspects of
endometriosis.  Alternately, an applicant's research design
strategy may include projects involving animal and/or
clinical investigations of several different types of
infertility-associated ovulation failure.  These examples
are only indicative of general strategy designs and should
not be taken as a preference of the NICHD.
 
DESCRIPTION OF A CENTER
 
The minimal requirements for the Centers described in this
RFA are as follows (see also Review Criteria and Procedures
below):
 
   o  Competent and experienced Principal Investigator who
is committed to and involved in human infertility research;
 
   o  Availability of competent and experienced scientific
experts to direct individual research projects or cores
associated with the proposed Center;
 
   o  Availability of the technical resources and facilities
necessary for the conduct of the experiments;
 
   o  Access to properly managed animal facilities for
projects conducting animal studies;
 
   o  Access to inpatient and outpatient reproductive health
care units providing adequate numbers of patients for
clinical research projects (Applicants from institutions
which 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.  In such a case, a letter of agreement
from either the GCRC Program Director or Principal
Investigator should be included with the application);
 
   o  A research environment conducive to the training of
young investigators in infertility research;
 
   o  Willingness to cooperate in a coordinated cooperative
research program involving two or more Centers with
interacting research projects and, if required, service
cores;
 
   o  Substantive evidence of departmental and institutional
support for and commitment to the proposed Center.
 
Optional components of the Centers Organization include the
mix of local and external projects or cores to be included
in the Center as follows:
 
   o  Investigators may consider attacking a problem from
different disciplines using collaborations within the same
institution or, where justified, by consortium subcontract
arrangements with projects at other institutions.  Centers
may seek to maximize their scientific expertise and research
capabilities by including in the application new projects or
technical service cores to be supported at other
institutions through subcontracted consortium arrangements.
 
   o  One or more highly relevant individual NIH research
projects, which are currently ongoing, may be deemed
appropriate for transfer into the Center.  Such a project
may be fully presented in the Center application as a
project and, contingent upon the review outcome, become
eligible for funding through the Center upon relinquishment
of the prior awarded project.
 
ELIGIBILITY
 
Grantee institutions in the continental United States that
meet the requirements stated are eligible to participate.
In order to be eligible for an award, an application must
have three (3) fundable projects of which one must be a
clinical research project.  If the consortium option is
employed, at least one research project and the
administration core must reside at the grantee institution.
 
CONTENT OF APPLICATIONS
 
A response to this RFA should consist
of a proposal which includes:
 
   o  A description of a Specialized Infertility Research
Center consisting of individual research projects and, as
justified, one or more core service facilities.  For
detailed formatting instructions see Appendix A provided
with this RFA.
 
   o  A description of the capabilities of the Center to
meet or exceed the minimal requirements stated earlier (see
DESCRIPTION OF A CENTER above).
 
   o  A proposed five (5)-year research plan that should
present the applicant's perception of the Center's
organization and component functions.  This plan must
demonstrate the applicant's knowledge, ingenuity,
practicality, and commitment in organizing a multiproject
research infrastructure for conducting studies aimed at
developing new approaches to the diagnosis and/or therapy of
human infertility.  The research plan should include plans
for research expansion in the second year to accommodate an
expected increase in funding (see Budget).  For the 02
through 05 years of the overall research plan, the expansion
plan must include (for peer review evaluation) up to two
(2) "New Program Development" research projects related to
the overall research emphasis of the Center which will
provide up to $75,000 total cost per annum to new
investigators who have not been the Principal Investigator of a funded
NIH (or comparable) research award.
 
   o  Each research project or core proposed for inclusion
in the Center must be described independently using the
PHS 398 application format as described in detail in
Appendix A of this RFA (available from Dr. McClure at the address
below).  For the individual projects or
cores, the page limits stated in the PHS 398 instructions
must be followed.  The overall Center application must
also use the PHS 398 format to summarize the Center's
organization and cumulative budgeting for the various
budgetary categories.  In both instances, all essential
information for the evaluation of the proposal must appear
in the body of the proposal rather than in an appendix.
 
MECHANISM OF SUPPORT
 
The funding mechanism to be used to assist the scientific
community in undertaking this program of basic and applied
research will be the U54 cooperative agreement mechanism
between participating Centers and the NICHD.  It is expected
that up to two (2) applications will be funded for a five
(5)-year period, contingent upon the receipt of a sufficient
number of meritorious proposals, within the total cost limit
of $1,000,000 available for the first year of this Program.
The major difference between a cooperative agreement and a
research grant is that there will be substantial
programmatic involvement of the NICHD staff Research
Coordinator above and beyond the levels required for
traditional Program management of grants.  Specifically, the
Chief, RSB, will cooperate with the Principal Investigators
as a partner in the research and serve as the
Research Coordinator.  All parties accepting funding must
agree to accept the participatory and cooperative nature of
the group process.  Awardees will retain custody of and
rights to the data they developed under these awards subject
only to the Government rights of access consistent with
current HHS, PHS and NIH policies.
 
The primary responsibilities of the awardees are to
participate cooperatively in the following activities:
 
   o  Determine experimental approaches
   o  Design protocols
   o  Conduct experiments
   o  Analyze results and interpret the results
   o  Present results and plans to the Steering Committee
   o  Publish results
   o  Modify, delete or add protocols within the Program
 
The degree of programmatic assistance by the NICHD staff
Research Coordinator includes:
 
   o  Participation in setting research priorities, deciding
optimal research approaches and protocol designs, and
contributing to the adjustment of research protocols or
approaches as warranted.  The Research Coordinator will
assist and facilitate the group process and not direct it.
 
   o  Assistance to and review of all transitional phases of
the Centers' activities to assure consistency with required
program goals and compliance with research protocol
priorities.  This includes efforts to improve and strengthen
inter- and intra-Center cooperation amongst the research
projects of the Centers.  The Research Coordinator will, as
required, help redirect program efforts.  In the event of
disagreements among the program participants, the Research
Coordinator will assist in forming an arbitration panel as
discussed below;
 
   o  Retaining the option to recommend the withholding of
support from a Center project materially failing to meet the
technical performance requirements established by the
Program.  This includes identifying jointly with
participants the need to add additional research projects or
service cores to Centers or to phase out a Center project or
core when performance standards have not been met; and
 
   o  Participating in data analyses, interpretations, and,
where warranted, the publication of results of studies
conducted by a Center.
 
The direction and management of the cooperative research
program described in this RFA will be done by a Steering
Committee consisting of the Principal and Project
Investigators from each participating Center, one NICHD
senior staff member (the Chief of the Reproductive Sciences
Branch) who will serve as the Research Coordinator, and an
independent Chairperson.
 
To ensure impartiality, the independent Chairperson will be
a scientist of national stature who is not participating as
a Principal Investigator and who is mutually acceptable to
the participants.  He or she will be selected by a majority
vote of the Committee.
 
The research approaches to be pursued within a Center will
be refined, further developed and/or modified by the
Steering Committee through a consensus advisory process.
Future continuation of the U54 program's projects beyond the
initial five-year segment will require competitive
application reviews and is contingent upon the availability
of funds.
 
A complete statement of the additional terms and conditions
and details of arbitration procedures pertaining to the
scope and nature of the interaction between NICHD and the
participating sites will be incorporated into the Notice of
Grant Award.  These procedures will be in addition to the
customary programmatic and financial negotiations that occur
in the administration of grants.  Arbitration procedures
will be invoked only when agreement cannot be reached on
programmatic issues that may arise between (an) awardee(s)
and the Research Coordinator after the award has been made.
In that event, an arbitration panel will be formed
consisting of one person selected by the Principal
Investigator of each of the two Centers and one person
selected by the Research Coordinator.  The decision of the
arbitration panel, by majority vote, will be binding.  The
special arbitration procedures described above in no way
affect the right of a recipient of a cooperative agreement
assistance grant to appeal an adverse determination in
accordance with PHS regulations at 42 CFR Part 50, Subpart
D, and HHS regulations at 45 CFR Part 16.  The above Terms
of Award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Part 74, and other HHS,
PHS, and NIH grant administration policies.
 
Cooperative agreements are subject to the administrative
requirements outlined in applicable OMB guidelines and
pertinent HHS, PHS, and NIH grant regulations at 42 CFR Part
52 and 45 CFR Part 74.  The indirect cost award procedures
will apply to cooperative agreement awards in the same
manner as for grants.
 
Business management aspects of these awards will be
administered by the NICHD Grants Management Office in
accordance with HHS, PHS, and NIH grant administration
requirements.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION
OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES
IN CLINICAL RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA
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,
together with a rationale for its choice.  In addition,
gender and racial/ethnic issues should be addressed in
developing a research design and sample size appropriate for
the scientific objectives of the study.  This information
should be included in the form PHS 398 in Section 2, A-D of
the Research Plan AND summarized in Section 2, E, Human
Subjects.
 
Applicants/offerors are urged to assess carefully the
feasibility of including the broadest possible
representation of minority groups.  However, NIH recognizes
that it may not be feasible or appropriate in all research
projects to include representation of the full array of
United States racial/ethnic minority populations (i.e.,
Native Americans (including American Indians or Alaskan
Natives), Asian/Pacific Islanders, Blacks, Hispanics).  The
rationale for studies on single minority populations groups
should be provided.
 
For the purpose of this policy, clinical research includes
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.
 
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of
research involving foreign population groups to the United
States' populations, including minorities.
 
If the required information is not contained within the
application, the application will be returned.
 
Peer reviewers will address specifically whether the
research plan in the application conforms to these policies.
If the representation of women or minorities in a study
design is inadequate to answer the scientific question(s)
addressed AND the justification for the selected study
population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be
reflected in assigning the priority score to the
application.
 
All applications for clinical research submitted to NIH are
required to address these policies.  NIH funding components
will not award grants or cooperative agreements that do not
comply with these policies.
 
REVIEW CRITERIA AND PROCEDURES
 
Review Procedure:
 
An administrative review of the content of applications
meeting the above NIH guidelines will also be done by NICHD
staff upon receipt of the application.  Any application that
does not meet the minimal requirements of a center project
as specified (see DESCRIPTION OF A CENTER above) in this RFA
will be judged to be unresponsive to this RFA and will be
returned to the applicant without technical review.
 
Applications that are complete and responsive may be
subjected to a triage procedure by peer review to determine
their general competitiveness.  In accord with NIH policy,
brief summary statements will be provided to the Principal
Investigators of applications judged to be noncompetitive
for award.  Applications judged to be competitive for awards
will be reviewed in detail in accordance with established
NIH peer review procedures for research grants.  Project
site visits are neither planned nor a prerequisite of the
scientific merit review procedure.  Peer review will be
conducted first for scientific and technical merit by a
special review committee convened specifically for this
purpose by the Division of Scientific Review, NICHD.  This
will be followed by a second-level review by the National
Advisory Child Health and Human Development (NACHHD) Council
in September 1991.
 
Criteria for Review
 
Applications will be evaluated on scientific and technical
merit according to the criteria listed below.  During the
review of applications, ethical, human, and animal welfare
issues will be addressed.  If reviewers identify concerns
and problems with respect to these issues, this will be
brought to the attention of appropriate NIH officials as
well as the applicant institution.
 
Evaluation of the proposals will be based upon the
following:
 
  1.  Qualifications, Experience and Commitment of Key
Personnel
 
      o  Scientific and administrative abilities of the
Principal   Investigator and other key participants, as
evidenced by pertinent publications
 
      o  Knowledge and experience of the Principal
Investigator and other key   participants in areas relevant
to the conduct of the experiments proposed
 
      o  Commitment of time for the proposed studies and the
stated willingness of the Principal Investigator and the key
participants to work and collaborate with other Centers and
with NICHD assistance in the manner summarized in this RFA
 
  2.  Protocols and Procedures
 
      o  Scientific merit of the proposal and its component
projects and cores
 
  3.  Facilities and Management
 
      o  Adequacy of administrative and technical
capabilities
 
      o  Adequacy of animal facilities and appropriateness
of animal care  management where animal work is proposed
 
      o  Adequacy of clinical facilities and appropriateness
of patient care management where clinical work is proposed
 
      o  Institutional assurance to provide support to the
study in such areas  as fiscal administration, personnel
management, space allocation, procurement, planning and
budgeting
 
   4. Budgeting
 
      o  Appropriateness of budget
 
METHOD OF APPLYING
 
Interested applicants should contact the Chief,
RSB, at 301/496-6515 for an advisory consultation
regarding the Cooperative Specialized Infertility Research
Center grants.  If an applicant intends to apply, it is
strongly recommended, but not mandatory, that applicants
send a letter of intent to the Chief, RSB at the address
listed below no later than March 29, 1991.  This letter
should indicate the title of the proposed center and the
names of the key investigators for the proposed subprojects.
Applicants are encouraged to send it as soon as they decide
to apply for the grant so that the RSB staff can be of
maximum assistance in the application process.
 
Applications must be submitted on form PHS 398 (revised
10/88, reprinted 9/89), which is available in most
institutional business offices or from the Division of
Research Grants, Office of Grant Inquiries, NIH, Westwood
Building, Room 449, Bethesda, Maryland 20892 or by telephone
(301/496-7441).  The conventional presentation format
described in Appendix A of this RFA (available from Dr. McClure
at the address below) for multiproject
Specialized Center Research Grant applications should be
used, with care taken to address the specific eligibility
requirements and review criteria requirements.
 
Applications should be identified by checking the "yes" box
in Item Number 2 on the face page of the application, and
typing in the RFA Number and the RFA Title. In addition, the
RFA label available in the 10/88 revision of Application
form 398 must be affixed to the bottom of the face page.
Failure to use this label could result in delayed processing
of your application, such that it may not reach the review
committee in time for review.  The original and four (4)
copies should be received by the Division of Research Grants
no later than June 17, 1991.
 
Applications should be sent or delivered to:
 
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
In addition to those applications mailed to the Division of
Research Grants, two (2) copies of the application should be
sent or delivered to:
 
Laurance Johnston, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human
Development
National Institutes of Health
Executive Plaza North, Suite 520
6130 Executive Boulevard
Rockville, MD  20892
 
Deadline for Submission:
 
The deadline for receipt of applications by the NIH Division
of Research Grants is June 17, 1991.  Late applications will
not be accepted.
 
Budget:
 
The format/form/instructions for budget estimates provided
with research grant application kit (PHS 398) should be
followed.  Indirect costs will be awarded in the same manner
as for research grants.  Budgets will be reviewed on the
basis of appropriateness for the work proposed.  Allowable
costs in the requested budget categories for individual
research projects should not be in excess of the amounts
generally requested for a regular research grant.  Cost will
be a factor in the selection for funding.  Include best
estimates for staffing needs, even though it is expected
that some budget modifications will be needed once the final
research project protocol(s) have been developed.
 
Since the final protocol(s) for this study will not be
exactly known at the time of submission of the application,
the budget request should be based on the plan proposed by
the applicant and should reflect the scope of the Center
project as submitted.  The first year budgets requested for
each Center may not exceed $750,000 in total (direct and
indirect) costs for the first (01) year.  It should be kept
in mind that the first year budgets recommended by the
review group for the two Centers may exceed the funding
available and necessitate adjustments by negotiations
between NICHD and each Center.
 
The second (02) year should be structured to accommodate an
anticipated doubling in funding for these Centers as
discussed on page 5.  Budgets from the third (03) year
onward may not exceed 120 percent of the previous year's
budget.  The budget projection should also include estimates
of travel expenses for the Principal and Project
Investigators attending two meetings of two days each of the
Steering Committee per year.  The first meeting will be a
Phase I meeting held in Bethesda, Maryland, in October 1991.
 
A detailed summary of all sources of actual and pending
support for each key investigator participating in the study
with grant or other award number identification and percent
effort committed should be included in the application.
 
Additional Information:
 
      Timetable
 
Application Receipt Date:     June 17, 1991
Initial Review Date:          June/July 1991
Review by NACHHD Council:     September 1991
Earliest Award Date:          September 1991
 
For further information, please contact:
 
Program/Scientific Matters:    Administrative Policy:
 
Michael E. McClure, Ph.D.      Ms. Melinda Nelson
Chief                          Office of Grants & Contracts
Reproductive Sciences Branch   National Institute of Child
Center for Population Research   Health and Human
National Institute of Child      Development
  Health and Human             National Institutes of Health
  Development                  Executive Plaza North,
National Institutes of Health    Room 505
Executive Plaza North,         Bethesda, Maryland  20892
  Room 603                     Telephone:  (301) 496-5481
Bethesda, Maryland 20892
Telephone: (301) 496-6515
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.864, Population Research. Awards will be
made under the authority of the Public Health Service Act
301 (42 USC 241) and 441 (USC 289d) and administered under
PHS Grant 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.