Subject: NIH GUIDE - Vol. 20, No. 10, March 8, 1991 - RFA HD9107
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 08 Mar 91 08:30 EST

Hi Paul,
    #3 for the listserver.  Please post as: RFAHD-91-07.910308
       Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA HD9107 HD-91-07 P1O1 *****************************************
 
REQUEST FOR COOPERATIVE AGREEMENT APPLICATIONS
 
RFA:  HD-91-07
 
P.T. 34; K.W. 0413002, 0750020, 0710100
 
COOPERATIVE CONTRACEPTIVE DEVELOPMENT RESEARCH CENTERS
PROGRAM
 
National Institute of Child Health and Human Development
 
Application Receipt Date:  June 17, 1991
Letter of Intent Receipt Date:  March 25, 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 establishing a Centers program designed to conduct
comprehensive research on the development of new
contraceptive products.  It is anticipated that eventually
three Centers will participate in this program and that the
award period will be for five years.  The aim of these
Centers will be to conduct a wide range of research
activities that, with time, may result in the development of
clinically useful modalities.  The Centers should have, or
should be able to develop, a broad range of research
activities normally classified as a research and development
(R & D) program.  It is understood that certain activities
may have to be conducted outside a specific Center via
arrangements with other Centers or other institutions.  By
utilizing the framework of an interdisciplinary approach,
the Centers can conduct R & D activities that are beyond the
capabilities of individual investigators.
 
The Chief of the Contraceptive Development Branch (CDB) will
serve as the Research Coordinator for the Centers' program
and will cooperate with Principal Investigators of the
selected Centers in the identification of research
priorities and the implementation of the required steps in
the overall process of product development.  The Chief of
the CDB may ask on occasions for participation of other CDB
staff members in the interactive process if and when their
scientific and managerial skills can contribute to effective
program management.  The deadline for receipt of
applications is June 17, 1991.
 
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, Cooperative Contraceptive
Development 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
 
The National Institute of Child Health and Human Development
has supported contraceptive development research for the
past two decades.  The program focused on the development of
methods of fertility regulation that were reversible and
acceptable to various segments of the American public.  The
retrenchment of the American pharmaceutical industry in the
area of contraceptive development has had a negative effect
on research, as well as on the availability of products for
American people.  A recent report from the National Research
Council/Institute of Medicine titled "Developing New
Contraceptives - Obstacles and Opportunities" identified
several problems facing the overall area.  Among the
subjects discussed were the rather low funding levels for
applied research in contraceptive development and the
scarcity of institutions carrying out research in this area.
Congressional committees have directed NICHD to establish a
Contraceptive Development Centers program to
promote research in this complex field.  The Senate
Appropriations Committee report stated:  "The Committee has
added $6,000,000 to create five new centers, two focused on
infertility research and three focused on contraceptive
research.  The Committee considers this to be an adequate
amount to initiate all five of these centers and expects to
provide additional funding for these centers in subsequent
years."  The Committee report went on to say: "Research and
development problems within the complex field of fertility
cannot be solved by an individual investigator working
alone; to create a new contraceptive method or treatment for
infertility, the concerted efforts of highly skilled
scientists from a variety of disciplines are required.
Without specialized centers, promising new leads may never
be translated effectively into new methods or ever made
available to the public."  The Committee concluded:  By
establishing these new research centers, the Committee is
taking an affirmative step to regain the United States'
rightful position while at the same time reaffirming its
commitment to those who are trying to plan their families.
 
Thus the intent of the Congressional mandate and the needs
of the field support the concept that the Centers program
should assume a leadership role in contraceptive
development.  The Center will coordinate the research
conducted by the Center's investigators and will attempt to
interact with the pharmaceutical industry in order to bring
the newly developed technologies to the public.
 
The intent of the program is to establish, with time, an
organizational infrastructure that has the scientific and
administrative capabilities to address the broad issue of
method development.  The proposed research should encompass
ongoing projects in contraceptive development, as well as
new projects that can be brought on line.  Approaches to
both male and female fertility regulation are encouraged.
Innovative approaches that show promise for effective
fertility regulation, but which are in early developmental
stages, will be considered for any of the broad categories
of family planning methods, other than those related to
abortion.
 
The scope of the proposed program should involve the
concurrent development of at least three projects.  The
investigators should have a clear understanding of the
complexities of the R & D process.  However, a single
institution need not be capable of conducting all of the
necessary phases of product development.  Consortium-like
arrangements that exploit the capabilities of other research
organizations may be proposed.  The proposed investigational
approaches may represent a mix of R & D phases.  Thus the
overall program can present a variety of approaches
representing the early phases of R and D, such as synthesis
of new compounds, and the more advanced stages, such as
clinical studies.
 
While the initial funding is limited and can support only a
part of the projected activities of each Center, the Center
application should provide sufficient detail with respect to
research activities that will be implemented under
circumstances when additional funding becomes available from
NICHD (see Budget section).  The new or expanded projects
that are proposed must be fully described because they will be
subjected to initial peer review.  Projects funded by
other sources may be incorporated into the overall concept
of the Center if they are related to the projects
requesting NICHD funding.  Projects able to attract
industrial sponsorship are encouraged.  Provision of
financial assistance from NICHD, together with other funding
sources, should permit these new Centers to assume a
leadership role in contraceptive development.
 
ORGANIZATION OF CENTERS AND RESEARCH SCOPE
 
NICHD invites applications from investigators based in
institutions that can provide a scientific and
administrative framework conducive to research directed
toward development of new technologies for fertility
regulation.  The minimum requirements for a Center proposal
will be:
 
     o  Commitment of a Principal Investigator (P.I.) with
experience in the area of contraceptive development.  This
experience can be in research conducted at the different
stages of the overall R & D process.  Consequently the P.I.
may be either a clinician experienced in the development of
fertility regulation methods or a nonclinician who is
familiar with the preclinical aspects of contraceptive
research.
 
     o  Availability of other staff who will be responsible
for both the research and administrative aspects of the
center.
 
     o  Evidence of ongoing applied contraceptive research
projects which, together with new initiatives, represents a
minimum of three distinct fundable projects (see below for
project description).  This research can be represented by
any one of several R&D phases.  Projects involving clinical
studies must provide assurance of implementation of
NIH policies concerning inclusion of women and minorities in
study populations.
 
     o  Ability to attract and train other investigators for
a comprehensive contraceptive development program.
 
     o  Availability of facilities to conduct research
leading to product development.
 
     o  Institutional commitment to the project and
flexibility for implementation of interactions within the
organization and with outside resources.
 
Each Center should focus on a mix of research activities
that are classified as applied R & D, as distinguished from
basic research.  The proposed program should involve
research endeavors that represent a minimum of three
distinct fundable projects.  With respect to the Centers
program, a project is defined as an activity involving, for
example:
 
     o  Research dealing with 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.  The same would hold true if the research
concerned a single sperm or zona antigen.
 
     o  Research dealing with the development of a new
spermicide based on a compound would be construed as a
single project.
 
     o  Development of a transdermal patch, or a vaginal
ring to deliver contraceptive drugs would be considered a
single project.
 
These examples of research activities should not be
construed as indicating a preference on the part of NICHD in
these areas of research.  Investigators are invited to
propose development of methods, other than abortion related,
that can be made available to the American public.  A Center
application can build its research strategy primarily on one
broad approach to fertility regulation within which the
three projects are embedded.  For example, a Center could
devote its energies to the development of barrier methods of
contraception.  Under these circumstances the three Center
projects could be comprised of:
 
     o  New spermicide development
 
     o  Development of devices to block the cervix and
deliver the new spermicide
 
     o  Development of formulations for more effective
delivery of spermicides
 
Alternatively, a Center proposal could be structured to
represent research from different approaches to fertility
regulation.  There could be a project involving drug
development and two projects dealing with barrier methods.
The overall Center plan should stress internal priorities
and be focussed on opportunities for progress.
 
In structuring the Center application, investigators must
take into account two important aspects of the program:
 
     o  Projects that require funding from the proposed
Center grant
 
     o  Projects that are part of the program but do not
require funding from the proposed grant because it is
available from other sources
 
It must also be kept in mind that NICHD is currently
involved in funding of research in the following areas:
 
     o  Synthesis and biological evaluation of GnRH
antagonists
 
     o  Condom development and clinical evaluation
 
     o  Isolation of peptides that can influence
reproductive processes
 
It is not the intent of the NICHD that the Centers should
allocate fiscal resources to duplicate research areas listed
above.  On the other hand, fiscal resources can be allocated
to research that represents a programmatic progression from
what is currently being supported by NICHD.  For example, if
funding is already provided for synthesis and biological
evaluation, funds can be requested for toxicology or
clinical evaluation.  Because phase III multicenter clinical
trials require a substantial investment of funds, they
should not be proposed for funding during initial phases of
the Center program.
 
Proposals that include clinical studies must address the
issue of appropriate and representative inclusion of women
and/or minorities as study participants, when applicable.
If minorities and women are not included, a clear rationale
for their exclusion must be provided.
 
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 could be included with
the application.
 
CONTENT OF APPLICATIONS
 
The application should include the following information:
 
1.  Center Staffing
 
Provide complete description of the qualifications of the
Principal Investigator and the research staff who will be
responsible for the Center's activities.  Specify past and
current involvement of the staff in applied research
directed toward the development of new fertility regulation
technology.  Specify the extent of the commitment that each
investigator can make to the Center's program.  Indicate
possible staff additions in the event of program expansion.
If actual individuals cannot be specified, indicate the
nature of expertise that is needed.
 
2.  Center Research Activities
 
Provide information concerning the details of the proposed
Center's program.  Provide a five (5)-year research plan for
activities that can result in the development of new
contraceptive products.  The plan should include:
 
     o  Information concerning current projects or, in their
absence, information on projects that will become part of
Centers' activities
 
     o  Evidence of understanding of the research that must
be in place for successful implementation of a goal oriented
program
 
     o  Phasing of new studies based on an increase in
fiscal resources to be provided by NICHD ÅConsideration must
be given to budgetary expansion in succeeding years (see
Budget Section)Ì
 
     o  Provision for development of activities for young
investigators interested in contraceptive development
 
3.  Facilities
 
Describe the nature of facilities that will be made
available to the Center.  Describe availability of essential
core facilities and indicate major equipment needs.
 
4.  Departmental and Institutional Commitment
 
Provide letters of commitment from all individuals and
departments that are not currently directly affiliated with
the P.I.  Provide letters of commitment from the institution
to the Center.
 
5.  Collaboration
 
Describe past and current collaborative studies that have
been carried out by the P.I. and the proposed Center staff.
Indicate which projects may require collaboration with other
departments or institutions.
 
6.  Center Management
 
Provide information concerning the scientific and
administrative management of the Center.  Indicate what
decision-making processes will be utilized in order to
optimize successful progression of research.
 
In view of the fact that the overall Center evaluation
process will not include site visits, investigators must
provide sufficient details for the assessment of scientific
and technical merit.
 
MECHANISM OF SUPPORT
 
The funding mechanism to be used will be the Cooperative
Agreement (U54) between each Center and the NICHD.  It is
expected that up to three (3) 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 $2,000,000 available for the first year of
this program.  The major difference between a Cooperative
Agreement and a research grant is that there will be a
substantial programmatic involvement of NICHD staff above
and beyond the levels required for traditional program
management of grants.  Specifically, the awardees will
proceed with peer reviewed and approved projects that result
from discussions and subsequent agreement between the
awardee and NICHD.  Recognizing that the available funding
may be below the level needed to support all of the peer
reviewed and approved projects, research priorities will be
established after in depth 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 staff will interact throughout
the duration of the award in order to facilitate progress
and resolve any problems that may arise.  Awardees will
retain custody and rights to the data developed under these
awards subject only to the Government rights of access
consistent with current HHS, PHS, and NIH policies.
 
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 NICHD Research Coordinator
concerning progress
 
The following lists the degree of involvement by NICHD
Research Coordinator:
 
     o  Assist in setting research priorities and in
avoiding unwarranted duplication of effort
 
     o  Review and comment on critical stages in the R & D
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 to recommend 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
 
The specific terms and conditions of the award, and details
of arbitration procedures pertaining to the scope and nature
of the interactions 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 NICHD 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 three
Centers and one person selected by the NICHD.  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 l6.
 
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 pertinent OMB, HHS, PHS, and NIH
guidelines, with particular emphasis on HHS regulations at
42 CFR Part 52 and 45 CFR Part 74.  The
indirect cost award procedures apply to cooperative
agreement awards in the same manner as for grants.
 
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 recognize
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 population 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
 
A preliminary review will be conducted by NICHD staff upon
receipt of the application.  Any application which does not
meet the minimum requirements (see ORGANIZATION AND SCOPE,
above) of this RFA will be returned to the applicant without
technical review.  Applications meeting the minimum
requirements will be reviewed as a group on a competitive
basis with each other and in accordance with the usual NIH
peer review procedures for research grants.
 
Projects proposing clinical studies must ensure that
adequate representation of minorities and women are included
in the study population in accord with NIH policy.  Failure
to comply with this policy may result in the application
being returned unreviewed.
 
Responsive applications may be subjected to a triage by a
peer-review group to determine their scientific merit
relative to the other applications received in response to
this RFA.  NIH will withdraw from competition those
applications judged to be noncompetitive, and notify the
applicant and institutional official.
 
The 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 Council.
 
Criteria for Review of Center Applications
 
Applications meeting the minimum requirements will be
evaluated on scientific and technical merit according to the
criteria listed below.
 
1.  Scientific, Technical and Programmatic Merit of Proposed
Research
 
    o  Clear understanding of the relationship of the
proposed research to the future of fertility regulation
 
    o  Description of experimental plan, including phasing,
which can maximize progress
 
    o  Appreciation of potential problems that may be
encountered in the conduct of research and how they may be
resolved
 
2.  Qualifications, Experience, and Commitment of Key
Personnel
 
    o  Scientific, clinical, and administrative abilities of
the principal investigator and other team members
 
    o  Knowledge and experience in areas relevant to the
conduct of potential studies in contraceptive development
 
    o  Commitment of staff time for the satisfactory conduct
of the study
 
    o  Experience and qualifications of team members who
would be responsible for internal coordination of activities
 
3.  Adequacy of Facilities, and Availability of Equipment
and Volunteer Population
 
    o  Present facilities
 
    o  Facilities necessary to meet future needs
 
    o  Availability of suitable volunteer population for
clinical investigation
 
4.  Nature of Departmental and Institutional Commitment
 
Institutional assurance to provide support for the study in
such areas as fiscal administration, personnel management,
space allocation, procurement, planning and budgeting
 
5.  Nature of Potential Arrangements Outside of Center
 
    o  Willingness to work with other organizations in the
conduct of contraceptive research
 
    o  Information on how these arrangements are to be
implemented
 
6.  Appropriateness of budget
 
METHOD OF APPLYING
 
Application Procedures
 
Applications must be submitted on form PHS 398 (revised
l0/88, reprinted 9/89), which is available in most
institutional business offices and from the Division of
Research Grants, NIH, at the following address:
 
Division of Research Grants
Office of Administrative Management
Office of Grants Inquiries
Westwood Building, Room 449
Bethesda, MD  20892
Telephone:  (30l) 496-744l
 
Applications must be identified by checking the "yes" box
in Item Number 2 on the face page of the application, and
typing in the words, "In Response to  RFA-91-HD-07."  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 and placed on top of your entire package.  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 must
be received by the Division of Research Grants no later than
June 17, 1991.  Applications must 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 must be
sent to:
 
Laurance Johnston, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
National Institutes of Health
Executive Plaza North, Room 520
Bethesda, MD  20892
 
Each research project that is proposed for inclusion in the
Center should be described independently using the PHS 398
application format. The page limitations stated in PHS 398
instructions must be followed. The overall Center
application should also use the PHS 398 format to summarize
the Center's organization and cumulative budgeting for the
various budget categories. All essential information
necessary for the evaluation of the Center proposal must
appear in the body of the proposal rather than as
appendixes.
 
Budget
 
The instructions for budget estimates provided with the
Research Grant Application form PHS 398 (rev. 10/88) should be
followed.  Indirect costs will be awarded in the same
manner as for research project grants (R01).  Budgets will
be reviewed on the basis of appropriateness for the work
proposed.  Allowable costs and policies governing the
research grants programs of the NIH will prevail.  In
planning the budget section of the proposal investigators
should submit detailed budget estimates for each project.
It should be kept in mind that the requested budget for the
first year may far exceed the total funds ($2,000,000) made
available for this program.  Consequently, the peer reviewed
and approved projects will be subject to negotiations
between each Center and NICHD to bring the overall funding
levels in line with allocated funds.  The second year budget
for each Center may be negotiated at a higher level, two-
fold, but this will depend on the appropriations for this
program.  For subsequent years (3, 4 and 5) a 20 percent increase
should be built into the fiscal projection.  All budgetary
negotiations between individual Centers and NICHD will be
based strictly upon projects that have been peer reviewed.
A summary of sources of actual and pending support for each
investigator participating in the study, with grant or other
award number identification and percent effort, must be in
the application.
 
The intent of the Contraceptive Development Centers program
is to establish scientific/administrative organizations
capable of undertaking the various phases of the R & D
process leading to the development of improved methods of
fertility regulation for both men and women.  It is not the
intent of this program to enable the awardee to merely shift
the funding currently available from a variety of sources to
other projects and to reallocate the Center's funds to the
ongoing projects.  The Center's funds can be used to
supplement ongoing projects if such supplementation is
programmatically justifiable.  Funds can be used in any one
of the accepted budget categories.  With respect to travel,
the budget should include funds for at least one trip to
Bethesda per year as well as a cost estimate for a yearly
meeting of Center Principal Investigators.  It is
anticipated that no more than three individuals from any one
of the Centers will participate in these meetings.
 
Deadline for Submission
 
The deadline for receipt of applications by the NIH Division
of Research Grants is June 17, 1991.  Applications received
after this date will be returned to the applicant.
 
TIMETABLE
 
Application Receipt Date:             June 17, 1991
Review by Initial Review Group:       July 1991
Review by NICHD Advisory Council:     September 1991
Earliest Award Date:                  September 1991
 
Additional Information
 
For further information, investigators are encouraged to
contact the NICHD staff members listed below.
 
Program/Scientific Matters
 
Gabriel Bialy, Ph.D.
Contraceptive Development Branch
National Institute of Child Health and Human Development
Executive Plaza North, Room 600
Bethesda, MD  20892
Telephone:  (301) 496-1661
 
Administrative Policy
 
Ms. Melinda Nelson
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 505
Bethesda, MD  20892
Telephone:  (301) 496-5481
 
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
30l (42 USC24l) and 44l (USC289d) 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.