Full Text HD-95-014

NONHUMAN IN VITRO FERTILIZATION AND PREIMPLANTATION DEVELOPMENT

NIH GUIDE, Volume 24, Number 21, June 9, 1995

RFA:  HD-95-014

P.T. 34

Keywords: 
  Human Reproduction/Fertility 
  Embryology 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  August 11, 1995
Application Receipt Date:  November 10, 1995

PURPOSE

The National Institute of Child Health and Human Development (NICHD)
invites applications from investigators willing to participate in the
ongoing multisite National Cooperative Program on Culture Conditions
for Nonhuman In Vitro Fertilization and Preimplantation Development
with the assistance of the NICHD through cooperative agreements
(U01).  The principal goal of this Program is to improve the culture
conditions for mammalian oocyte and preimplantation development.  In
order to achieve this goal, it is expected that methods for
evaluation of the quality of mammalian oocytes, eggs and
preimplantation embryos in culture will continue to be an important
feature of the Program.  It is anticipated that a multispecies
approach will also continue to characterize the Program.  The
ultimate beneficiaries of this Program may be people who seek medical
treatment, advice, or assistance with problems of infertility,
contraception, or preimplantation genetic diagnosis.

HEALTHY PEOPLE 2000

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), Nonhuman In Vitro Fertilization and
Preimplantation Development, 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 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public and private such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  Racial/ethnic minority
individuals, persons with disabilities, and women are encouraged to
apply.  The need for continuous and active communications and
interactions among sites dictates that only institutions in the
continental United States will be eligible for participation.

MECHANISM OF SUPPORT

Funding to assist the scientific community in undertaking this
Program of basic and applied science will be through the use of
cooperative agreements (U01) between participating sites and the
NICHD.  The major difference between a cooperative agreement and a
research grant is that there will be substantial
programmatic/scientific involvement of the NICHD staff Research
Coordinator above and beyond the levels required by the traditional
program management of grants.  Specifically, an NICHD staff member
will cooperate with the Principal Investigators as a partner in the
research and serve as Research Coordinator.  The Research Coordinator
will assist the recipient(s) in a cooperative way but without
assuming direction, prime responsibility or a dominant role in the
activity.  In a cooperative agreement, which is an assistance
mechanism and not an acquisition mechanism, the NIH purpose is to
support, stimulate and expedite the recipient's activities through a
partnership role.  All recipients in this Program will agree to
accept the participatory and cooperative nature of the group process.
Details of the responsibilities, relationships and governance of the
activities to be funded under the cooperative agreements to be
awarded for this Program are discussed later in this document under
Direction and Management: The Steering Committee and in Terms and
Conditions of the Award.

The anticipated award date is September 1, 1996.  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 also vary.  Awards
and levels of support depend on the receipt of a sufficient number of
applications of high scientific merit.  Although the 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.

This RFA is a one-time solicitation for the purpose of the present
competition.  At this time, the NICHD has not determined whether or
how this Program will be continued beyond the present solicitation.
Any future determination in this regard will be publicly announced.

FUNDS AVAILABLE

It is anticipated that an estimated total of $1,900,000 (including
direct and indirect costs) will be available for the entire Program
for the first year.  It is also anticipated that up to six awards
(either new and/or competing continuation) will be made with an award
period of four years.

RESEARCH OBJECTIVES

Background

The goal of this Cooperative Program is to improve the culture
conditions for nonhuman in vitro fertilization and preimplantation
development that are necessary for basic and applied reproductive
research on mammalian gametes and preimplantation development.
Indeed, nearly our entire knowledge of mammalian oocytes and
preimplantation embryos depends upon our ability to culture and
manipulate them in vitro.  The basic and applied studies that will
benefit from this Program are at the very center of mammalian,
including human, reproductive biology. Some of these research topics
are:

1.  The mechanisms of oocyte development in vitro, fertilization,
activation of development and implantation, the prevention of
polyspermy, the causes and alleviation of infertility, new
contraceptive leads and genetic assessment of individual oocytes,
eggs or embryos;

2.  the genetic and epigenetic regulation of the program of
preimplantation development that is crucial for the initiation of
placenta formation (i.e., trophectoderm formation) that is, in turn,
the key prerequisite for successful embryo transfer, implantation and
the establishment of pregnancy; and

3.  the initiation and maintenance of normal mammalian embryo
development into blastocysts, as well as the production and culture
of healthy oocytes and eggs that are capable of fertilization and
full development.

Owing to new technology and broad interest, there exists an
opportunity for rapid progress on these critical problems of
mammalian reproductive biology.  This progress will depend upon the
use of more efficient in vitro techniques for the study of mammalian
gametes and preimplantation embryos.  This is the case for many gene
transfer experiments, twinning experiments, and a multitude of
experiments on the genetic assessment, morphology, physiology,
biochemistry and molecular biology of oocytes and eggs and on embryo
development from fertilization through implantation.  In applied
science, in vitro procedures are widely used in commercial endeavors,
such as producing twins of valuable animals and improving the
commercial qualities of livestock for food production.  Knowledge
gained from the animal studies is considered to be a vital step in
making improvements in human in vitro fertilization, preimplantation
development, and embryo transfer.

Those who use in vitro fertilization, oocyte and preimplantation
development and implantation as model systems for reproductive
toxicology studies also need in vitro systems that produce high
quality oocytes, eggs and embryos.  Sensitivity of these systems to
drugs and radiation may be much different in culture media that
support growth better than the previously and currently used media.
A far-reaching benefit of this Cooperative Program will be the
improvement of conditions for the production and genetic assessment
of genetically engineered embryos leading to the establishment of
animals that could be used in many biomedical experiments, including
models for human diseases.  It is also expected that the results of
the Cooperative Program will provide a better understanding of the
general principles of nutrition with regard to the interaction of the
preimplantation embryo with the maternal environment.

Unfortunately, the culture conditions in current use bear little
resemblance to in vivo conditions, our understanding of nutritional
requirements and basic principles of oocyte and embryonic metabolism
and nutrition are practically nonexistent, and oocytes, eggs and
embryos raised under these conditions are inferior.  This inferior
development may be responsible for defects in fertilization, in the
implantation process or during postimplantation development,
resulting in limited success of embryo transfer experiments.

Despite the fact that numerous successful pregnancies have followed
from in vitro procedures, the efficiency and therefore the
cost-effectiveness could be greatly improved by increased basic
knowledge expected from the results of this Cooperative Program.
This would be especially true in the case of in vitro fertilization
and embryo transfer for humans, domestic livestock and of nonhuman
primates, but also for small laboratory animals. Thus, there are both
basic and applied science needs for improvement of culture conditions
for successful in vitro reproductive procedures for a variety of
mammalian species.

The ongoing Cooperative Program was established by NICHD more than
eight years ago.  During that time, significant improvements have
been made in the culture conditions for the production of higher
quality mammalian oocytes and eggs that are capable of fertilization
and subsequent development.  Significant progress has also been made
in solving the problem of in vitro "blocks" for preimplantation
development for several mammalian species. We are just beginning to
make correlations between superior culture media, improved
development and the regulation of specific gene expression that may
be used as one of the criteria for embryo quality.  It is clear that
there is a continuing need for major improvements in the quality of
in vitro-raised oocytes and embryos for mammals and that these
improvements will be critical for successful, cost-effective in vitro
fertilization and subsequent development in vitro and in vivo.  This
Program has been enriched by the multispecies approach that has been
a consistent feature.  This is important since the potential
beneficiaries include not only human reproductive technology and
other biomedical applications, but also reproduction in agricultural
species, endangered species and others.

Objectives

The objectives of this ongoing Program continue to be to improve the
culture conditions for mammalian oocytes and preimplantation embryos.
Implicit in making improvements in culture conditions is to know when
improvements have been made by demonstrating that higher quality
oocytes or embryos have been produced.  For this Program, then, it is
essential to be able to evaluate the quality of individual mammalian
oocytes and preimplantation embryos by a number of parameters during
and after in vitro development.  The need for these assessments has
always been a part of this Program and may include morphological
assessments, biochemical assessments, metabolic assessments, genetic
assessments and molecular assessments.  Of course, these should also
include the generation of live offspring after in vitro development
that would prove that an oocyte or embryo has full developmental
potential.

Scope

The scope of the Program will include research on improved culture
conditions and assessment of quality for:

o  mammalian oocytes developing in vitro;

o  fertilization in vitro; and

o  preimplantation embryos developing in vitro.

Studies on fertilization may be included in proposals only if that is
part of a project in which the primary emphasis is upon oocyte
development and/or preimplantation development in vitro. Of
particular interest will be studies with continuum capabilities,
i.e., those in which oocytes are raised in vitro, fertilized in
vitro, resultant embryos developed in vitro and transferred to the
female reproductive tract for further development.  This enables one
to study the quality or the results of oocyte manipulation of an
individual oocyte in the context of future developmental
potentialities of that oocyte. It is recognized that most applicants
will not have that full capability, but it is anticipated that
capability will exist within the Program.  For oocyte and
preimplantation embryo studies, it is desirable to have the
capability to conduct comparisons between in vivo and in vitro-raised
oocytes and embryos.

The protocols will be approved, developed and/or modified by the
Steering Committee (see Direction and Management, below) through a
consensus process.  The Program is expected to have the following
features:

o  Different sites that emphasize the study of different aspects of
the culture environment and utilize different species; some sites may
study micronutrients, some may emphasize macronutrients, and some
will study other aspects of the environment.  This underscores the
need for coordination and communication.

o  Some investigators may focus strongly on the establishment of
endpoints, that is the evaluation of the quality of individual
oocytes or embryos raised in vitro, using various possible assays,
including morphological, biochemical, metabolic, genetic or molecular
assays and that may include spatial and temporal displays of gene
expression.

o  Principles obtained from research on one species can be rapidly
tested in other species.

o  Approaches will be determined and prioritized.

o  Some sites will place more emphasis on oocyte development, others
on preimplantation development, but the goals of improved quality of
oocytes and embryos and the production of live offspring will be an
important feature.

o  Detailed experimental designs will be established in order to
maximize chances of success and to facilitate statistical analysis.

o  Progress reports will be transmitted to the cooperating sites and
NICHD.

o  Results will be analyzed and disseminated.

o  Meetings will be held at least three times each year to discuss
progress and future plans.

Direction and Management:  The Steering Committee

Planning and implementation of the study will be done by a Steering
Committee consisting of the Principal Investigators from each of the
participating sites, one NICHD staff member from the Reproductive
Sciences Branch who will serve as 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.  The Steering Committee will meet at
least three times per year.  The purpose of these meetings will be to
share scientific information, assess scientific progress, identify
new research opportunities, exploit opportunities for collaboration
within the Program and with outside scientists when appropriate,
establish priorities that will facilitate the translation of basic
research findings to the many beneficiaries of this work, and to
conduct other business of the Program.

SPECIAL REQUIREMENTS

The NICHD invites applications both from current members of the
Cooperative Program (competing continuation applications), and from
prospective members (new applications).  The minimal requirements for
applicants are as follows (See also REVIEW CONSIDERATIONS below):

o  Competent, experienced principal investigators who are committed
to this problem and who are willing to cooperate with the other
Principal Investigators and the NICHD Research Coordinator;

o  access to properly managed animal colonies with breeding
capabilities;

o  demonstration of the capability of producing and evaluating
sufficient numbers of oocytes, eggs or embryos for sound statistical
analysis;

o  experience with in vitro oocyte development, in vitro
fertilization and/or preimplantation development followed by embryo
transfer;

o  excellent technical resources necessary for conduct of the
experiments; and

o  evidence of departmental and institutional support and commitment.

Terms and Conditions of Award

Cooperative agreements are assistance mechanisms subject to the same
administrative requirements as grants.  The special Terms and
Conditions of Award are in addition to, not in lieu of, otherwise
applicable OMB administrative guidelines, HHS, PHS, and NIH grant
regulations, policies and procedures, with particular emphasis on HHS
regulations at 42 CFR Part 74 and 92.  The NIH Information for
Management and Planning Analysis and Coordination (IMPAC) system and
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.

The following terms and conditions of the cooperative agreement
award, and details of the arbitration procedures pertaining to the
scope and nature of the interaction between the NICHD and the
participating awardees will be incorporated into the Notice of Grant
Award and provided to the Principal Investigator as well as to the
institutional official at the time of award.  These procedures will
be in addition to the customary programmatic and financial
negotiations which occur in the administration of grants.

1.  The Steering Committee

The planning and implementation of the study will be done by a
Steering Committee consisting of the Principal Investigators from
each of the participating sites, one NICHD staff member from the
Reproductive Sciences Branch who will serve as Research Coordinator,
and a nonvoting, independent chairperson who is acceptable to the
participants and who is a nongovernment employee.  The Steering
Committee will meet at least three times a year.  The purpose of
these meetings is to share scientific information, assess scientific
progress, identify new research opportunities, exploit opportunities
for collaboration within the Program and with outside scientists when
appropriate, ensure the rapid dissemination of the findings,
establish priorities that will facilitate the translation of basic
research findings to the many beneficiaries of this work, and to
conduct other business of the Program.

2.  Awardee Responsibilities and Rights

The primary responsibilities of the awardees are:

o  Determine experimental approaches
o  Design protocols
o  Conduct experiments
o  Analyze and interpret the results
o  Present results and plans at Steering Committee meetings
o  Publication of results
o  Modify, delete or add protocols
o  Accept and participate in the cooperative nature of the group
process.

Awardees will retain custody of and primary rights to their data
developed under the award, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies.

3.  The degree of programmatic/scientific assistance by the NICHD
staff Research Coordinator includes:

o  Participation in the development of optimal approaches and
protocol designs (and adjustments of protocols and approaches when
needed).  The Research Coordinator will assist and facilitate the
process, rather than directing it.

o  Assistance and review of all phases of the study to assure
consistency of protocol compliance, to improve and strengthen
cooperation between the sites, and to help redirect efforts, if
necessary.  In the event of disagreement among participants, the
Research Coordinator will assist in forming an arbitration panel
acceptable to participants (see below).

o  Participation in data analyses, interpretation and publication of
study results.

o  Identification, jointly with awardees, the need to modify or
terminate a site when technical performance requirements are not met.

4. Arbitration

When agreement between an awardee and NIH staff cannot be reached on
scientific/programmatic issues that may arise after the award, an
arbitration panel will be formed.  The panel will consist of one
person selected by the Principal Investigators, one person selected
by NICHD staff, and a third person selected by these two members.
The decision of the arbitration panel, by majority vote, will be
binding.  This special arbitration procedure in no way affects the
right of an awardee to appeal an 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 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.  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 has been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.  Program staff may also provide additional relevant
information concerning the policy (see INQUIRIES).

LETTER OF INTENT

Prospective applicants are asked to submit, by August 11, 1995, 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 a 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 avoid
conflict of interest in the review.

The letter of intent is to be sent to:

Richard J. Tasca, Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
Building 61E, Room 8B01
Bethesda, MD  20892
Telephone:  (301) 496-6515
FAX:  (301) 496-0962
Email:  TASCAR@HD01.NICHD.NIH.GOV

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these cooperative agreements.  These forms are
available at most institutional offices of sponsored research and
from the Office of Grants Information, Division of Research Grants,
National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC
7762, Bethesda, MD 20892-7762, telephone 301/710-0267.

Content of Applications

Applications in response to this RFA should include:

o  A description of the capabilities of the site to meet or exceed
the minimal requirements (see SPECIAL REQUIREMENTS above).

o  A proposed four-year research plan that should be the applicant's
perception of the study and of his/her cooperative role.  This plan
should demonstrate the applicant's knowledge, ingenuity,
practicality, and commitment to improve the culture conditions for
nonhuman in vitro oocyte development, fertilization and/or in vitro
preimplantation development followed by embryo transfer.

o  All essential information in the body of the application rather
than in the Appendix.

o  Current members who wish to submit competing continuation
applications should prepare a renewal proposal, and are required to
list significant progress they have made in this Program and indicate
how they have met any special cooperative agreement terms and
conditions of their awards including their interaction with other
investigators and the Research Coordinator, if appropriate.  In order
to respond to these requirements, current members may use up to five
additional pages in the Progress Report section of their application.

Budget

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 project.  The requested budget should not be
in excess of the amount generally requested for a regular research
grant.  Include estimates for staffing needs, although it is expected
that some modification will be needed once the final research
protocol(s) have been developed.  The budget must also include
estimates of travel expenses for three meetings of two days each of
the Steering Committee per year. The first meeting will be a planning
meeting held in Bethesda, Maryland in September 1996.

Applications must be identified by typing in the RFA number,
HD-95-014, and the RFA Title, NONHUMAN IN VITRO FERTILIZATION AND
PREIMPLANTATION DEVELOPMENT, on line 2a of the face page of the
application form and the YES box must be checked.  Type U01 in Item
Number 2b.  In addition, the RFA label available in the PHS 398 must
be affixed to the bottom of the face page.  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.

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 also be sent to:

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
Building 61E, Room 5E03
Bethesda, MD  20892

Applications must be received by November 10, 1995.  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.

Schedule

Letter of Intent Receipt Date:  August 11, 1995
Application Receipt Date:       November 10, 1995
NACHHD Council Review:          June 4, 1996
Earliest Award Date:            September 1, 1996

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the
DRG and for responsiveness by NICHD staff.  Incomplete applications
will be returned to the applicant without further consideration.  Any
application that does not meet the minimum requirements (see SPECIAL
REQUIREMENTS above) of this RFA will be judged to be unresponsive to
this RFA and will be returned to the applicant.  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 NICHD, in accordance with the review criteria stated
below.

As part of the initial merit review, a process (triage) may be used
by the initial review group in which applications will be determined
to be competitive or noncompetitive based on their scientific merit
relative to other applications received in response to this RFA.
Applications judged to be competitive will be discussed and assigned
a priority score.  Applications determined to be noncompetitive will
be withdrawn from further consideration and the Principal
Investigator and the official signing for the applicant organization
will be notified.

Review Criteria

In addition to the usual NIH criteria for scientific merit,
evaluation of the applications 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 team members, as evidenced by pertinent
publications.

o  Knowledge and experience in areas relevant to the conduct of the
experiments proposed.

o  Commitment of time for the proposed study and stated willingness
to work and collaborate with other sites and the NIH in the manner
summarized in this RFA.

2.  Protocols and Procedures

o  Appropriateness of the application to the objectives of the study
as outlined in this RFA.

o  Scientific merit of the proposal.

o  Demonstration of cost-effectiveness through improved oocyte and/or
embryo quality.

o  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.

3.  Facilities and Management

o  Adequacy of administrative and technical capabilities.

o  Adequacy of animal facilities and appropriateness of animal care
management.

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.

5. Human Subjects, Animal Welfare, Biohazards, Gender and Minorities

o  The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.

AWARD CRITERIA

The anticipated date of award is September 1, 1996.  Applications
recommended by the NACHHD Council will be considered for award based
upon scientific and technical merit as determined by peer review;
program balance, including in this instance, sufficient compatibility
of features to enhance the likelihood of a successful collaborative
Program; and availability of funds.

INQUIRIES

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

Direct inquiries regarding scientific program issues to:

Richard J. Tasca, Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
Building 61E, Room 8B01
Bethesda, MD  20892
Telephone:  (301) 496-6515
FAX:  (301) 496-0962
Email:  TASCAR@HD01.NICHD.NIH.GOV

Direct inquiries regarding fiscal matters to:

Ms. Melinda Nelson
Office of Grants and Contracts
National Institute of Child Health and Human Development
Building 61E, Room 8B17
Bethesda, MD  20892
Telephone:  (301) 496-5481
FAX:  (301) 402-0915
Email:  NELSONM@HD01.NICHD.NIH.GOV

AUTHORITY AND REGULATIONS

This Program is described in the Catalog of Federal Domestic
Assistance No. 93.864, Population Research.  Awards are made under
authorization of the Public Health Service Act, Title IV,Part A
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routing 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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