Full Text HD-96-001
NIH GUIDE, Volume 25, Number 4, February 16, 1996
RFA:  HD-96-001
P.T. 34

  Human Reproduction/Fertility 

National Institute of Child Health and Human Development
Letter of Intent Receipt Date:  April 1, 1996
Application Receipt Date:  July 17, 1996
The National Institute of Child Health and Human Development (NICHD)
invites applications from investigators interested in participating
under a Cooperative Agreement (U54) with NICHD in an ongoing
multicenter cooperative research program termed the Cooperative
Contraceptive Development Research Centers program.  This program is
designed to expedite the development of new methods to regulate
fertility.  The aim of the program is to conduct a wide range of
research leading to clinically useful products.  Recognizing that the
complexity of contraceptive development can severely limit progress
achieved by individual investigators working alone, the NICHD will
support three Centers composed of research projects and technical
service core facilities that are interactively organized to conduct
preclinical and clinical research and development studies on
promising new leads in contraceptive development.  The Centers will
also serve as a national resource for career development of young
scientists electing to pursue research in contraception.
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), Cooperative Contraceptive Development
Research Centers, 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 Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800).
Domestic non-profit and for-profit organizations, public and private,
such as universities, colleges, hospitals, laboratories, and units of
state or local governments are eligible to apply for these Centers.
Applications prepared for this competition may  propose
multi-institutional consortium arrangements.  The need for continuous
and active communications and interactions among the awarded sites
dictates that only institutions in the Continental United States may
apply for these Center grant awards.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as principal investigators.  Applications eligible for award
include those for new U54 Centers or for renewal of existing Centers.
The administrative and funding instrument to be used for this program
will be a cooperative agreement (U54), an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
scientific and/or programmatic involvement with the awardee is
anticipated during performance of the activity.  Under the
cooperative agreement, the NIH purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working
jointly with the award recipient in a partner role, but it is not to
assume direction, prime responsibility, or a dominant role in the
activity.  Details of the responsibilities, relationships, and
governance of the study to be funded under cooperative agreement(s)
are discussed later in this document under the section "Terms and
Conditions of Award."
The total project period may not exceed five years.  The anticipated
award date is March 1, 1997.  Because the nature and scope of the
research proposed in response to this RFA may vary, it is anticipated
that the size of the awards will vary also.
Awards and level of support depend on receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of the NICHD, awards pursuant to
this RFA are contingent upon the availability of funds for this
purpose.  NICHD has not determined whether or how this program will
be continued beyond the present solicitation.  Any future NICHD
determination in this regard will be publicly announced.
The estimated funds (total indirect and direct costs) available for
the first year of support for the entire program are $4,080,000.
Three awards are anticipated, either new or competing continuation.
Over 50 percent of pregnancies in the United States are unintended.
Thus, there is a critical need for contraception that fits the needs
of women and men throughout their reproductive lives.  Whether
dissatisfaction with the current methods leads to misuse or
abandonment of effective methods, or whether available methods are
too inconvenient or difficult to use, too expensive or too
complicated is not clear. The ideal contraceptive should be highly
effective, safe, long-acting but readily reversible, virtually free
of side effects, should reduce the spread of sexually transmitted
diseases and, preferably, not be associated with sexual intercourse.
A variety of contraceptive methods are needed to address the needs of
people of different ethnic, cultural, and religious values; those
with inadequate access to services; and those with changing needs
related to age.
The primary objective of the Cooperative Contraceptive Development
Program described in this RFA is to develop new contraceptives. It is
recognized that adverse reactions may occur with use of presently
available contraceptives and there is concern about long-term safety
and expense of currently available methods.  Because the acquired
immunodeficiency syndrome (AIDS) can be a sexually transmitted
disease, new products are needed that act not only as contraceptives,
but prevent or limit such transmission as well.
The intent of this program is to establish or maintain an
organizational infrastructure that has the scientific and
administrative capabilities to address the broad issue of
contraceptive development.  The proposed research should encompass
ongoing projects in contraceptive development, as well as the
initiation of new projects.  Approaches to both male and female
fertility regulation are encouraged.  Innovative approaches that show
promise, but which are in the early developmental stages, will be
considered for any of the broad categories of family planning
methods, other than those related to abortion.
Research Scope
Research projects can be directed to male and/or female methods of
contraception.  The Center should consist of multidisciplinary
projects and/or cores capable of interacting in a coordinated,
cooperative fashion.  It is expected that activities may require
collaboration with other institutions or other Centers.  By using the
framework of an interdisciplinary approach, the Centers can conduct
activities that are beyond the capabilities of individual
investigators or institutions.  Each Center should organize its
overall research plan to include a minimum of three highly
meritorious research and development (R&D) projects.  Examples of
possible projects include:
o  The pharmacology of a single drug.  Even if this pharmacological
assessment involves animal and clinical studies, it would still be
classified as a single project.
o  The development of a new spermicide would be construed as a single
project even though it would require formulation and preclinical and
clinical studies.
o  The development of an implant, transdermal patch, or vaginal ring
to deliver contraceptive drugs would each be considered a separate
o  Research on a particular gamete antigen for contraceptive vaccine
development would be considered to be a single project.
A Center application can build its research strategy primarily on one
broad approach to fertility regulation within which the projects are
embedded.  For example, a Center could devote its energies to
immunocontraceptive development with projects on specific antigens
and delivery systems.  Alternatively, a Center proposal could be
structured with research representing different approaches to
fertility regulation. The overall Center plan should stress internal
priorities and collaboration and be focused on opportunities for
Description of a Center
The minimal requirements for Centers described in this RFA are as
o  Competent and experienced principal investigator who is committed
to and directly involved in research in contraceptive development;
o  Competent and experienced investigators to direct individual
research projects or cores associated with the proposed Center;
o  Availability of the technical resources and facilities for the
conduct of the proposed projects, including appropriate animal
o  Access to volunteers for clinical studies where appropriate.
(Applicant institutions that have a General Clinical Research Center
[GCRC] funded by the NIH National Center for Research Resources may
wish to identify the GCRC as a resource for conducting the proposed
research.  If so, a letter of agreement from either the GCRC program
director or principal investigator should be included with the
o  Research environment conducive for the development of young
investigators in contraceptive research, a teaching program should be
in place;
o  Willingness to engage in a coordinated cooperative research
program involving two or more Centers with multiple interacting
research projects, and if required, service cores;
o  Substantive evidence of departmental and institutional support for
and commitment to the proposed Center.
The centers are expected to work together in a cooperative manner.
It is expected that access to the cores will be open to all of the
centers. Meetings of the center directors and core leaders, as part
of the annual meeting, will facilitate the development of a plan for
core use by the center members.  The three center directors will work
together to minimize overlap and to facilitate research efforts,
depending upon the research goals of the various funded projects.
The research priorities of the projects within the approved research
scope will be established after discussions between the awardee and
NICHD.  Outside consultants/experts may be asked to participate in
these discussions.  Once priorities have been agreed upon, the
awardee will assume the responsibility for implementation of research
activities.  It is anticipated that the awardee and NICHD Research
Coordinator (Chief of CDB or designee) will interact throughout the
duration of the award in order to facilitate progress and resolve any
problems that may arise.
The following 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 92, and other HHS,
PHS, and NIH grant administration policies.  Cooperative Agreements
are subject to the administrative requirements outlined in pertinent
OMB, HHS, PHS, and NIH guidelines, with particular emphasis on HHS
regulations at 42 CFR Part 52 and 45 CFR Part 74. Indirect cost award
procedures will apply to cooperative agreement awards in the same
manner as for grants.
The administrative and funding instrument used for this program is a
cooperative agreement (U54), and ~assistance~ mechanism (rather than
an ~acquisition~ mechanism) in which substantial NIH scientific
and/or programmatic involvement with the awardee is anticipated
during performance of the activity.  Under the cooperative agreement,
the NIH purpose is to support and/or stimulate the recipient~s
activity by involvement in and otherwise working jointly with the
award recipient in a partner role, but it is not to assume direction,
prime responsibility, or a dominant role in the activity. Consistent
with this concept, the dominant role and prime responsibility for the
activity resides with the awardee(s) for the project as a whole,
although specific tasks and activities in carrying out the studies
will be shared among the  awardees and the NICHD Project Scientist.
Awardees have primary authorities and responsibilities to define
objectives and approaches, and to plan, conduct, analyze, and publish
results, interpretations, and conclusions of their studies.  The
awardees will be responsible for:
o Defining the research objectives;
o Designing the necessary research protocols;
o Conducting specific studies;
o Analyzing and interpreting research data;
o Modifying protocols as required;
o Interacting with the FDA concerning clinical investigations;
o Providing information to the NICHD Research Coordinator concerning
Awardees will retain custody of and primary rights to their data and
intellectual property developed under the award subject to current
government policies regarding rights of access as consistent with
current HHS, PHS, and NIH policies.
The NICHD Research Coordinator will have substantial
scientific-programmatic involvement during conduct of this activity,
through technical assistance, advice and coordination above and
beyond normal program stewardship for grants.  The following lists
the degree of involvement by NICHD Research Coordinator:
o Assisting in setting research priorities and in avoiding
unwarranted duplication of effort;
o Reviewing and commenting on critical stages in the R & D program
before subsequent stages are implemented;
o Assisting in the interaction between the awardee and the FDA;
o Assisting in the interaction between the awardee and investigators
of other institutions as well as between the awardee and potential
commercial sponsors;
o Retaining  the option of recommending  termination of studies if
technical performance falls below acceptable standards, or when
specific lines of research cannot be effectively pursued in a timely
o Retaining the option to recommend additional research endeavors
within the constraints of the approved research and negotiated
The following arbitration procedures will be invoked only when
agreement cannot be reached on programmatic issues that may arise
between (an) awardee(s) and the NICHD after the award has been made.
In that event, an arbitration panel will be formed consisting of one
person selected by the Principal Investigators of the three Centers,
one person selected by the NICHD and one person selected by both
NICHD and the Principal Investigators. The decision of the
arbitration panel, by majority vote, will be binding.  The process to
resolve programmatic differences described above in no way affects
the right of a recipient of a cooperative agreement assistance grant
to appeal adverse determination in accordance with PHS regulations at
42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16.
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.  Adequate plans to include
both genders and minorities and their subgroups as appropriate for
the scientific goals of the research must be included.  Plans for
recruitment and retention of subjects will be evaluated. This new
policy results from the NIH Revitalization Act of 1993 (Section 492B
of Public Law 103-43) and supersedes and strengthens the previous
policies (Concerning the Inclusion of Women in Study Populations and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should
read the NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research,~ which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
for the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
Prospective applicants are asked to submit, by April 1, 1996, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the principal
investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.  Although the letter of
intent is not required, is not binding and does not enter into the
review of a subsequent application, the information that it contains
allows staff to estimate the potential review workload and avoid
conflict of interest in the review.
The letter of intent is to be sent to Dr. Nancy J. Alexander at the
address listed under INQUIRIES.
The research grant application form PHS 398 (rev.5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email:  girg@drgpo.drg.nih.gov; and from the program administrator
listed under INQUIRIES.
Additional suggestions for formatting the application into a Center
grant application are provided in the Supplemental Instructions for
NICHD U54 Grant Applications, which are available from the program
staff listed under INQUIRIES.
A response to this Request for Applications must consist of an
application that includes:
o  A description of the Center consisting of multiple individual
research projects and justified core service facilities (three
approved projects is the minimum for a Center).
o  A description of the capabilities of the Center.
o  A description of the career development program including a
justification of the plan, the goals of the program, the anticipated
number of participants, eligibility criteria for applicants,
selection criteria, budget (no more than 10% of the grant), and other
existing or pending sources of funding that will contribute to a
substantial program.
o  A proposed five-year research plan that presents the applicant's
perception of the Center's organization and component functions.  The
plan should identify  the applicant~s knowledge, ingenuity,
practicality, and commitment in organizing a multi-project research
infrastructure for conducting studies aimed at developing new
o  Competing continuation applications should include a detailed
report of research progress during the entire funding period.  A
description of how the Center has met the special cooperative
agreement terms and conditions of the award, including its
interaction with other Centers and the NICHD Research Coordinator
should be included.
An annual meeting of the centers will be conducted and applicants are
advised to include such a plan in the budget request.
The RFA label, available in the PHS 398 (rev.5/95) application, must
be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title number must be typed on line
2 of the face page of the application form and the Yes box must be
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:
Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
Susan Streufert, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
Building 6100, Room 5E03, MSC 7510
6100 Executive Boulevard
Bethesda, MD  20892-7510
Rockville, MD  20854 (for express/courier service)
Letter of Intent Receipt Date:  April 1, 1996
Application Receipt Date:       July 14, 1996
NACHHD Council Review:          January 1997
Earliest Award Date:            March 1, 1997
Applications must be received by July 14, 1996.  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 currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the (NICHD).  Incomplete or nonresponsive
applications will be returned to the applicant without further
consideration.  If the application is not responsive to the RFA,
NICHD staff will contact the applicant to determine whether to return
the application to the applicant or submit it for review in
competition with unsolicited applications at the next review cycle.
Applications may receive a preliminary scientific peer review to
determine their relative competitiveness by an NICHD peer review
group.  The NIH will withdraw from further competition those
applications judged to be non- competitive for award and notify the
applicant Principal Investigator and institutional official.  Those
applications that are complete and responsive, and judged to be
competitive in triage (if triage is used), will undergo further
scientific merit review in accordance with an appropriate peer review
group convened by the NICHD.  The second level of review will be
provided by the NACHHD Council.
All applications will be judged on the basis of the scientific merit
of the proposed project and the documented ability of the
investigators to meet the RESEARCH OBJECTIVES of the RFA.  Although
the technical merit of the proposed protocol is important, it will
not be the sole criterion for evaluation of the study.  Other
considerations,, such as the importance and timeliness of the
proposed study or clinical trials, access to patients if appropriate,
and multidisciplinary nature of the studies will be part of the
evaluation criteria.  The review criteria are listed below.
o  Scientific, technical, or medical significance and originality of
proposed research of each project;
o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
o  Relevance and usefulness of each core; core should serve several
projects, appropriate scientific expertise should be available; core
should be cost effective; variations in funding requests based on
anticipated load should be considered;
o  Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
o  Plans for coordination and cooperation among projects where
o  Ability to move research toward clinical trials and approval by
the FDA;
o  Availability of the resources necessary to perform the research;
o  Evidence of a detailed plan for career development of young
investigators in contraceptive research and development;
o  Appropriateness of the proposed budget and duration of the
projects in relation to the proposed research;
o  For research involving human subjects, adequacy of plans to
include both genders and minorities and their subgroups as
appropriate for the scientific goals of the research.  Plans for the
recruitment and retention of subjects will also be evaluated.
The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.
Funding decisions will be based on scientific and technical merit as
determined by the peer review group, the recommendations of the
NACHHD Council, program balance and the availability of funds.
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Nancy J. Alexander, Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
Building 6100, Suite 8B13G MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1661
FAX:  (301) 480-1972
Email:  AlexandN@hd01.nichd.nih.gov
For information on budget and fiscal matters, contact:
Ms. Melinda Nelson
Office of Grants and Contracts
National Institute of Child Health and Human Development
Building 6100, Suite 8A17K MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5481
FAX:  (301) 402-0915
Email:  NelsonM@hd01.nih.gov
This program is described in the Catalog of Federal Domestic
Assistance No. 1 3.864, Population Research.  Awards are made under
authorization of the PHS Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
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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