COOPERATIVE CONTRACEPTIVE RESEARCH CENTERS

Release Date:  April 2, 2001

RFA:  RFA-HD-01-011 (This RFA has been reissued, see RFA-HD-06-014)

National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov)

Letter of Intent Receipt Date:  August 15, 2001
Application Receipt Date:       September 26, 2001

PURPOSE

The National Institute of Child Health and Human Development (NICHD) invites 
applications from investigators interested in participating with NICHD in an 
ongoing multicenter cooperative research program termed the Cooperative 
Contraceptive 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, both basic and applied, with the ultimate 
goal of developing knowledge that may lead 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 research to discover 
and/or develop promising new leads in regulating fertility.  The focus of 
individual projects may include basic, preclinical or clinical research or a 
combination of these areas. The Centers will also serve as a national resource 
for career development of young scientists electing to pursue research in 
fertility regulation.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas.  This Request for Applications (RFA) is 
related to one or more of the priority areas.  Potential applicants may obtain 
"Healthy People 2010" at http://www.health.gov/healthypeople.    

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, non-profit and for-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, and units of State or local governments and eligible agencies of 
the Federal government.  The need for continuous and active communication among 
sites dictates that only institutions in the United States are eligible to 
apply.  Racial/ethnic minority individuals, women, and persons with disabilities 
are encouraged to apply as Principal Investigators.  Applications prepared for 
this competition may propose multi-institutional consortium arrangements.  
Applications eligible for award include those for new Cooperative Contraceptive 
Research Centers or for renewal of existing Centers.  

MECHANISM OF SUPPORT

The RFA will use the National Institutes of Health (NIH) specialized cooperative 
research center (U54) award mechanism, 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 studies to be funded under 
cooperative agreements are discussed below under Terms and Conditions of Award.  
Potential applicants may obtain the NICHD U54 Specialized Cooperative Research 
Center Grant Guidelines at http://www.nichd.nih.gov/funding/mechanism/u54_guide.cfm.

FUNDS AVAILABLE

The NICHD intends to commit approximately $5.9 million in total costs [Direct 
plus Facilities and Administrative (F & A) costs] in FY 2002 to fund up to three 
new and/or competing continuation awards in response to this RFA.  An applicant 
for a competing continuation grant may request a project period of up to five 
years and a budget for direct costs of up to120 percent of the direct costs 
awarded for the final competitive segment of the preceding project period as 
stated in the Notice of Grant Award.  Applications exceeding the budgetary 
limits specified above will be returned to the applicant without peer review.  
Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of the awards will also vary.  Although the financial 
plans of the 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 meritorious applications.  At this time, it is not known if the RFA 
will be reissued.  

RESEARCH OBJECTIVES

Background

Over 50 percent of pregnancies in the United States are unintended.  Thus, there 
is a critical need for fertility regulation that fits the needs of women and men 
throughout their reproductive lives.  The ideal contraceptive should be safe and 
highly effective.  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 Research Program 
described in this RFA is to identify new leads for regulation of fertility.  
There are three phases to development of new contraceptive methods:  basic 
discovery, proof of concept, and clinical development.  New products are needed 
that act not only as contraceptives, but that prevent or limit transmission of 
sexually transmitted diseases 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 fertility regulation.  Approaches to both male and 
female targets are encouraged.  Research on abortion will not be funded.

Research Scope

Research projects can be directed to male or female targets of fertility 
regulation.  The Center should consist of projects and/or core facilities 
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 projects.  
Examples of possible projects include, but are not limited to: 

o  Research on a particular gamete-specific target for drug design.

o  The definition of the transcriptome or proteome of gametes.

o  Development of genomic or proteomic screens designed to identify and define 
the functional role of proteins in fertilization.

o  The characterization of a macromolecule(s) involved in fertilization, the 
perturbation of which with a pharmacological reagent results in reversible 
infertility.

o  Research on the processes of gamete maturation with the goal of defining 
specific targets involved in control of fertility.

o  Hormonal or pharmacologic methods that control gamete production or 
maturation.

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 a novel formulation or delivery vehicle (implant, 
transdermal patch, vaginal ring, microsphere, etc.) to deliver contraceptive 
drugs would be considered a separate project.

A Center application can build its research strategy primarily on one broad 
approach to fertility regulation within which the projects are embedded.  
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 
progress. 

Description of a Center:

The minimal requirements for a Center as described in this RFA are as follows:

o  Competent and experienced Principal Investigator to oversee cooperation 
within the Center and to coordinate career development opportunities within the 
Center.

o  Competent and experienced investigators to direct individual research 
projects or core facilities associated with the proposed Center.

o  Availability of the technical resources and facilities for the conduct of the 
proposed projects, including appropriate animal facilities.

o  Research environment conducive for the development of new investigators in 
contraceptive research.

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. 

SPECIAL REQUIREMENTS

Minimum Application Requirements

The Centers are expected to work together in a cooperative manner.  It is 
expected that access to the core facilities will be open to all of the Centers.  
Meetings of the Steering Committee 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.  Each Center should provide career development opportunities 
for new investigators to encourage research in fertility regulation.

The research priorities of the projects within the approved research scope will 
be established after discussions between the awardee and the NICHD Research 
Coordinator.  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 will interact throughout the 
duration of the award in order to facilitate progress and resolve any problems 
that may arise.

A response to this RFA 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 Center’s career development opportunities to encourage 
new investigators to participate in research directly related to fertility 
regulation.  The description should include a justification of the plan, the 
goals of the program, the anticipated number of participants, eligibility 
criteria for participants, selection criteria, budget, 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 contraceptives.

o  Competing continuation applications should include a detailed report of 
research progress during the past funding period.  A description of how the 
Center has met the special cooperative agreement terms and conditions of award, 
including its interaction with other Centers and the NICHD Research Coordinator, 
should be included.

Meetings

An annual meeting of the Centers will be conducted and applicants are advised to 
include funds for travel to these meetings in the budget request.  The purpose 
of the meeting is to exchange scientific information and to discuss 
collaborations within and between Centers.  It is expected that Principal and 
Project Investigators from each of the participating Centers will attend the 
annual meeting.  In addition, core supervisors and research fellows 
participating in the projects should attend the meeting.

Terms and Conditions of Award

The following Terms and Conditions of Award and details of the arbitration 
procedures pertaining to the scope and nature of the interaction between the 
NICHD staff and the participating awardees will be incorporated into the Notice 
of Grant Award and provided to the Principal Investigator and the institutional 
official at the time of award.  These procedures will be in addition to the 
customary programmatic and financial negotiations that occur in the 
administration of grants.  

Cooperative agreements are assistance mechanisms subject to the same 
administrative requirements as grants.  The special Terms and Conditions 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 and 
procedures.  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. 
Facilities and Administrative Cost (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), 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.  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 Research Coordinator.  

1.  Awardee Rights and Responsibilities

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 primary responsibilities of the awardees 
are to:

o Define the research objectives,

o Design the necessary research protocols,

o Conduct specific studies,

o Analyze and interpreting research data,

o Modify protocols as required,

o Interact with the FDA concerning clinical investigations,

o Provide information to the NICHD Research Coordinator concerning progress:

o Maintain career development opportunities to encourage new investigators to 
work in the field of fertility control.

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. 

2.  NICHD Staff Responsibilities

NICHD Research Coordinator:

The NICHD Research Coordinator will have substantial scientific-programmatic 
involvement during the conduct of this activity, through technical assistance, 
advice and coordination above and beyond normal program stewardship for grants.  
The degree of involvement by the NICHD Research Coordinator will include the 
following:

o Assist in setting research priorities and in avoiding unwarranted duplication 
of effort,

o Review and comment on critical stages in the research program before 
subsequent stages are implemented,

o Assist in the interaction between the awardee and the FDA,

o Assist in the interaction between the awardee and investigators of other 
institutions as well 
as between the awardee and potential commercial sponsors,

o Retain 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 manner,

o Retain the option to recommend additional research endeavors within the 
constraints of the approved research and negotiated budget.

NICHD Project Officer:

NICHD will appoint a Project Officer, apart from the Project Scientist, who 
will:

o Have the option to withhold support to a participating institution if 
technical performance requirements are not met.

o Carry out continuous review of all activities to ensure objectives are being 
met.

3. Collaborative Responsibilities

Overall coordination of the Program, consistent with the stated intent of the 
RFA, will be done by a Steering Committee consisting of the Principal and 
Project Investigators from each of the participating Centers and one NICHD staff 
member from the CRHB, CPR, NICHD, who will be the Research Coordinator.  A 
member of the NICHD grants management staff will serve as a nonvoting advisor to 
the Committee.  The Steering Committee meetings will be convened at least once 
yearly. The purpose of these meetings is to assess scientific progress, identify 
new research opportunities, establish priorities, and discuss strategies that 
will accelerate the translation of preclinical findings into clinical 
applications.  Outside consultants/experts may be asked to participate in these 
discussions as nonvoting advisors.

4. Arbitration Process

When agreement between an awardee and NICHD staff cannot be reached on 
scientific/programmatic issues that may arise after the award is made, an 
arbitration panel will be formed.  The arbitration panel will consist of one 
person selected by the Principal Investigators of the three Centers, one person 
selected by the NICHD, and a third person selected by both NICHD staff and the 
Principal Investigators.  The decision of the arbitration panel, by majority 
vote, will be binding.  The special arbitration procedure in no way affects the 
right of an awardee to appeal adverse action in accordance with PHS regulations 
at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their 
sub-populations 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 indicating 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 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete 
copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH-defined Phase III clinical trials and require:  a) all 
applications or proposals and/or protocols to provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender and/or 
racial/ethnic groups, including subgroups if applicable, and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

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/or 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," published in the NIH Guide for Grants and 
Contracts, March 6, 1998, and available at:  
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.   

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

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information necessary 
for the review because reviewers are under no obligation to view the Internet 
sites.  Reviewers are cautioned that their anonymity may be compromised when 
they directly access an Internet site. 

LETTER OF INTENT

Prospective applicants are asked to submit 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 this RFA.  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 
NICHD staff to estimate the potential review workload and plan the review.  

The letter of intent is to be sent to Dr. Diana Blithe at the address listed 
under INQUIRES, below, by August 15, 2001.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research, on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html, 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, 
E-mail: [email protected]. 

Application Instructions

Applications for the U54 grant are to be prepared in a manner consistent with 
the information presented in the NICHD U54 Cooperative Specialized Research 
Center Grant Guidelines, available from the contacts listed under INQUIRIES, 
below, and at:  http://www.nichd.nih.gov/funding/mechanism/u54_guide.cfm.  

Submission Instructions

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
stapled to the bottom of the face page of the application and must display the 
RFA number HD-01-011.  A sample RFA label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.   Please note this is 
in the pdf format.  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 and number must be typed on line 2 of the 
face page of the application form 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:

CENTER FOR SCIENTIFIC REVIEW
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 should be 
sent to:

L.R. Stanford, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)

Applications must be received by September 26, 2001.  If an application is 
received after that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) 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 CSR 
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.  

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and for 
responsiveness to this RFA by the NICHD.  Incomplete and/or nonresponsive 
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, assigned a priority score, and receive a 
second level review by the National Advisory Child Health and Human Development 
(NACHHD) Council.

A site visit is not a required part of the review process.  Applicants should 
ensure that their applications are complete as written and can stand on their 
own.
 
Review Criteria

The scientific and technical merit peer review focuses on three areas:  (1) 
review of the component research subprojects, (2) review of the core units, and 
(3) review of the overall center as an integrated effort.  Applications 
submitted in response to this RFA will be evaluated according to the review 
criteria described in the NICHD U54 Cooperative Specialized Research Center 
Grant Guidelines, available from the contacts listed under INQUIRIES, below, and 
at http://www.nichd.nih.gov/funding/mechanism/u54_guide.cfm.
 
SCHEDULE

Letter of Intent Receipt Date:    August 15, 2001
Application Receipt Date:         September 26, 2001
Peer Review Date:                 February/March 2002
Council Review:                   June 2002
Earliest Anticipated Start Date:  June 2002

AWARD CRITERIA

Criteria that will be used to make award decisions include:

o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities.

INQUIRIES

Inquiries concerning this RFA are encouraged. The opportunity to clarify any 
issues or answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Diana Blithe, Ph.D.
Contraception and Reproductive Health Branch,
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B13, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 435-6990
FAX:  (301) 480-1972
Email:  [email protected] 

Direct inquiries regarding fiscal matters to:

Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development 
6100 Executive Boulevard, Room 8A17M, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 402-0915
Email:  [email protected] 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.864.  Awards are made under authorization of Sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered under 
NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 
92.  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 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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