Full Text CA-92-16


NIH Guide, Volume 21, Number 16, May 1, 1992

RFA:  CA-92-16

P.T. 34

  Blood Diseases 
  Data Management/Analysis+ 

National Cancer Institute

Letter of Intent Receipt Date:  June 17, 1992
Application Receipt Date:  September 16, 1992


The Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer
Treatment (DCT) and the Cancer Diagnosis Branch (CDB) of the Division
of Cancer Biology, Diagnosis and Centers (DCBDC) at the National Cancer
Institute (NCI) invite applications for cooperative agreements (U01)
from institutions or consortia, such as DCT Clinical Trials Cooperative
Groups, capable of and interested in performing hypothesis driven
clinical correlative studies relevant to the cancer treatment or
clinical outcome of patients with hematologic malignancies.  It is
essential for institutions to have access to biologic samples and
outcome data for a sufficient number of patients on phase III clinical
protocols to be able to test correlative hypotheses.  Hematologic
malignancies that are relevant to this Request for Applications (RFA)
include leukemias, lymphomas, myelomas and myelodysplastic syndromes.
Awards will be made as cooperative agreements which create an
assistance relationship with substantial NCI programmatic involvement
with the recipients during the performance of the project, as outlined
in this RFA.  The cooperative agreement mechanism is used to stimulate
investigator interest and proposes to advise or assist in an important
and opportune area of research.


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,
Hypothesis Driven Clinical Correlative Studies in Hematologic
Malignancies, is related to the priority area of cancer.  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, DC  20402-9325 (telephone (202)


Domestic and foreign for-profit and not-for-profit organizations,
governments and their agencies are eligible to apply.  Applications
from minority individuals and women are encouraged.

It is essential for institutions to have access to biologic samples and
outcome data for a sufficient number of patients on phase III clinical
protocols to be able to test correlative hypotheses.  The applicant
institution must have access to a Central Operations Office and a
Statistical Center for coordination of research activities and data
analysis as defined below (see Definitions).  The Central Operations
Office and the Statistical Center need not reside at the Principal
Investigator's institution.


Support of this program will be through the cooperative agreement
(U01), an assistance mechanism in which substantial NCI programmatic
involvement with the recipients during performance of the planned
activity is anticipated.  The nature of NCI staff involvement is
described below.  Applicants will be responsible for the planning,
direction, and execution of the proposed project.  Except as otherwise
stated in this RFA, awards will be administered under PHS grants policy
as stated in the Public Health Service Grants Policy Statement, DHHS
Publication No. (OASH) 90-50,000, revised October 1, 1990.

This RFA is a one-time solicitation.  If it is determined that there is
a sufficient continuing program need, the NCI will invite recipients of
awards under this RFA to submit competitive continuation cooperative
agreement applications for review according to the procedures described


Approximately $2,000,000 in total costs per year for four years will be
committed to fund applications submitted in response to this RFA.  This
funding level is dependent on the receipt of a sufficient number of
applications of high scientific merit.  It is anticipated that 10-12
awards will be made. The total project period for applications
submitted in response to the present RFA may not exceed four years.
The earliest feasible start date for the initial awards will be August
1, 1993.  Although this program is provided for in the financial plans
of the NCI, the award of cooperative agreements pursuant to this RFA is
also contingent upon the availability of funds for this purpose.


A.  Background

Insights into the biologic function and clinical relevance of growth
factors, genes that promote or suppress neoplasia, mechanisms of
treatment sensitivity and resistance, and functions of the immune
system provide important new clinical research opportunities for
investigators studying patients with hematologic malignancies.  While
advances have been made relating biological characteristics to clinical
behavior of the more common hematologic malignancies, fewer clinical
correlations have been explored for the rarer disease types.
Historically, defining prognostic factors has been a major effort in
correlative research.  In the case of acute leukemias, age, cell type,
cytogenetic abnormalities, leukemic cell burden, and CNS involvement at
presentation are commonly used as prognostic guides and treatment
indicators.  Currently, several well-defined laboratory tests are ready
for inclusion in clinical correlative studies to determine their
clinical relevance and value.  For example, levels of bcr/abl
transcripts are currently being evaluated as a marker for minimal
residual disease in Philadelphia chromosome-positive chronic
myelogenous leukemia.  Technological advances in methodologies such as
polymerase chain reaction (PCR), flow cytometry, immunohistochemistry,
and in situ hybridization allow laboratory investigators to do numerous
analyses on tumor specimens and to study tumor heterogeneity in a
variety of tumor types.  They allow investigators to address the
biology of the disease in a much more detailed manner and to
refine/develop biology-based tests that are/would be of prognostic
value.  Recently, new treatment regimens using differentiating agents
and growth factors have been developed for certain leukemias (i.e.,
trans-retinoic acid for APL).  While the precise mechanism by which
these agents act and how these agents affect the biology of the disease
remain to be eluciated, the significant progress in the molecular
biology of retinoid and growth factor function indicates that this is
a fertile area for correlative studies.  Such correlative laboratory
studies may be immediately relevant to cancer treatment.

The NCI supports an extensive network of clinical and laboratory
research studies related to cancer therapy through contracts, grants
and cooperative agreements.  CTEP supports a program of integrated
national networks of clinical investigators and institutions (Clinical
Trials Cooperative Groups) for the conduct of large scale,
multi-institutional clinical trials.  The primary goal of these trials
is the definitive evaluation of clinical treatment programs.
Presently, the Clinical Trials Cooperative Groups (CTCG) conduct
approximately 500 clinical trials evaluating more than 23,000 patients
per year.  The CTCG have access to tumor specimens from large numbers
of patients with hematologic malignancies.  They maintain statistical
databases and are capable of correlating laboratory data with the
clinical outcome of patients.  NCI also supports Cancer Centers that
conduct phase III clinical trials and have access to statistical
operations, headquarters, and consortia arrangements with other
institutions and hospitals.

This RFA is intended to promote collaborations and interactions between
basic researchers and clinical investigators to advance research on
clinical correlations that can improve therapeutic approaches.  NCI is
seeking to encourage hypothesis driven correlative laboratory studies
linked to large scale clinical trials.  In many instances the potential
participants are already recipients of R01 or P01 support for their
basic research and have developed preliminary data supporting a large
scale analysis of a new prognostic factor.  Likewise, many clinical
investigators are supported through Cancer Centers (P30) and the
Clinical Trials Cooperative Group mechanism (U10) for clinical research
and have access to patient specimens with clinical follow-up.  This
initiative proposes to link these activities and provides a mechanism
to obtain definitive data on the relationship of biological features
and the clinical behavior of the tumors.

B.  Research Goals And Scope

The objectives of this RFA are to foster collaborations and
interactions between basic researchers and clinical investigators to
advance therapeutic clinical research and conduct hypothesis driven
correlative studies in hematologic malignancies that are ready for
large scale evaluation.  The CTEP and the CDB invite cooperative
agreement applications (U01) from institutions or consortia, such as
the DCT Clinical Trials Cooperative Groups and the NCI Cancer Centers,
capable of and interested in performing hypothesis driven clinical
correlative studies relevant to cancer treatment or clinical outcome in
patients with hematologic malignancies.

Hematologic malignancies relevant to this RFA account for significant
cancer incidence, morbidity, and mortality.  Special consideration will
be given to studies with acute promyelocytic leukemia, multiple
myeloma, chronic lymphocytic leukemia, acute myeloid leukemia, and
acute lymphocytic leukemia.  Each application is expected to be focused
on a specific hematologic malignancy.  Applicants may propose to
undertake several correlative studies relevant to the specific
hematologic malignancy during the grant funding period (up to four
years). An individual scientist or a consortium of institutions may be
included on more than one application.

The correlative studies should be based on strong and testable
hypotheses.  A clear rationale should be given for the experimental
design and technical methodologies selected.  The hypotheses tested
must relate to potential clinical applications such as development of
new treatment strategies or identification of patient subsets for
specific treatment approaches.  Preliminary data from appropriate tumor
models or analysis of patient specimens should be provided to support
the feasibility of each study.  This RFA is not for developing new
techniques or assays.  Assays must have already been demonstrated to be
applicable to tissue samples and/or body fluids.  The laboratory assays
must utilize tumor specimens from patients receiving defined treatments
in large clinical trials such as phase III clinical protocols.
Applications must include a statistical section describing plans for
analysis of data designed to test the hypotheses.  Investigators must
have access to sufficient numbers of patient specimens and patient
outcome data from phase III clinical trials.  All investigators are
encouraged to work with multi-center organizations or form a consortium
of institutions in order to access sufficient numbers of patients and
clinical information to test the proposed hypotheses.  To coordinate
the above activities, each Institution must have a Central Operations
Office and Statistical Center as defined below (see Definitions).

Examples of therapeutic laboratory correlates of interest include, but
are not limited to:  (1) phenotypic or genotypic alterations that
appear to correlate with the development of therapy resistance; (2)
loss or inactivation of tumor suppressor genes related to prognosis;
(3) studies of chromosomal rearrangements or deletions that may be used
as prognostic indicators; (4) correlation of expression of tumor growth
factors or oncogenes with response to therapies; (5) characterization
of tumor- associated antigens that may lead to new immunotherapies; (6)
evaluation of use of serum or tumor markers that correlate with tumor
progression; (7) analyses of expression of cellular receptors for
growth factors or differentiating agents; (8) defining and targeting
specific populations of cells for therapy; and (9) analysis of in vitro
response of tumor cells to growth factors/differentiating agents.

The cooperative approach outlined in this RFA allows for interactions
among successful applicants and is designed to optimize use of patient
resources, tissues, reagents and methods.  Applicants must describe how
they might interact with NCI and other awardees in the sharing of data
and improvements in laboratory techniques and study design


A.  Definitions

COOPERATIVE AGREEMENT - An assistance mechanism in which substantial
NCI programmatic involvement with the recipient is anticipated during
performance of the planned activity.

APPLICANT INSTITUTION - An Applicant Institution may consist of a
single institution or a consortium of institutions for the purpose of
accessing a sufficient patient population for biologic samples and
outcome data.  An Applicant Institution functions as an integrated unit
with a common goal and is under the guidance and direction of a single
Principal Investigator.  Each Applicant Institution is composed of
investigators with expertise in clinical research and laboratory
analyses.  In this RFA, the terms Applicant Institution and Institution
are used synonymously.

PRINCIPAL INVESTIGATOR (PI) - The person from the Applicant Institution
who submits the single application in response to this RFA and who is
responsible for performance of the key personnel.  The Principal
Investigator is responsible for coordinating the Institution's
activities scientifically and administratively.

CENTRAL OPERATIONS OFFICE - An administrative unit that coordinates all
Institution activities.  Responsibilities include coordinating protocol
development, study conduct, and quality control and study monitoring.
The Central Operations Office need not be at the PI's institution.

STATISTICAL CENTER - The consortium of institutions must have a
Statistical Center for collection and analysis of patient and
laboratory data.  Responsibilities will include participation in the
planning and coordination of study design methodologies, data
management and analysis, data monitoring, and reporting of data. The
Statistical Center need not be at the PI's institution.

NCI PROGRAM DIRECTORS - The CTEP Program Director for this RFA from
CTEP, DCT or the Chief, CDB, DCBDC who will be coordinating their
Division's interactions and providing guidance for the overall program
within the NCI (see INQUIRIES).

NCI COORDINATOR - The Head, Medicine Section, Clinical Investigations
Branch, CTEP, DCT who interacts scientifically with the Institutions.

B.  Terms Of Cooperation

The cooperative agreements will require cooperation between an NCI
Coordinator and the Principal Investigator of each of the Applicant
Institutions.  The NCI Coordinator will assist in coordinating the
activities of the Institutions as defined below and in facilitating
exchange of information.

Nature Of Participation By NCI Staff

The role of the Program Director, CTEP, and the Chief, CDB, as
described throughout these terms of cooperation, is to assist and
facilitate but not to direct research activities.  The NCI Coordinator
will interact scientifically with all the Institutions.  Two levels of
coordination are anticipated.

The first level involves interactions between the NCI Coordinator and
the individual Institution.  During the period of the award, the
awardee institution(s) will have the primary authority to determine
research priorities and statistical needs.  The NCI Coordinator may
provide appropriate assistance by participating in the design of
research activities, review of protocols, coordination of the tissue
utilization, establishment of priorities, and review of progress.
Although the Institution(s) are responsible for statistical analysis of
data, computer processing and statistical evaluations may be provided
from NCI resources if requested by the awardee.

The second level of coordination involves interactions between the NCI
Coordinator and Institutions funded for research on the same
hematologic disease.  It is expected that Institutions working on the
same disease will participate in joint activities. The NCI Coordinator
would facilitate such activities by coordinating the sharing of patient
specimens, new reagents, improved laboratory techniques, data, and
study design methodologies.  Although investigators will have to
demonstrate that they have access to the necessary numbers of patients
and/or specimens to answer specific questions, other important
correlations identified during the course of the funded research may
require patient resources from more than one Institution. Because the
size and numbers of tumor specimens are often limited, priorities would
need to be set for the most effective use of available specimens.  The
awardee institution(s) will have the primary authority in setting these
priorities.  The NCI Coordinator can assist in this process by
providing information on other ongoing studies and on NCI priorities.

Responsibilities Of Awardees

The Awardee is responsible for the proposed research projects to
advance the goals of the RFA and to define its approaches to attain
these goals.  It is the primary responsibility of the PI to state
clearly the objectives of the Institution, to direct the research
stipulated in the application, and to ensure that the results obtained
are published in a timely manner.  It is anticipated that decisions in
all activities will be reached by consensus of the collaborators of an
Institution under the leadership of the PI and that the NCI Coordinator
will have the opportunity to offer input to this process.  Awardees are
required to have access to appropriate tumor tissue and clinical
follow-up on patients receiving defined treatments in phase III
clinical trials.  Awardees must have the appropriate clinical and
laboratory expertise to accomplish their objectives within the
Applicant Institution.

The Awardee(s) and the NCI Coordinator will meet initially to discuss
research plans and establish priorities.  Subsequent periodic meetings
will be scheduled to review progress and coordinate research
activities.  It is envisioned that more than one Institution may be
funded for research on the same hematologic disease.  For these
Institutions, sharing of data and reagents will be expected.  In
addition, new studies that may require the sharing of patient specimens
or assays/reagents and the prioritization of research studies among the
Awardees are envisioned.  Therefore, each Institution should anticipate
the need to attend two meetings per year to coordinate activities.

The Government, via the NCI Coordinator, will have access to data
generated under this cooperative agreement and may periodically review
the data.  However, the awardee institution will retain custody and
primary rights to the data developed under these awards, and timely
publication of major findings by the awardees is encouraged.
Publication or oral presentation of work done under this agreement will
require appropriate acknowledgement of NCI support.

Arbitration Committee

An arbitration panel of external consultants will be created as needed
to resolve any irreconcilable differences of opinion between the NCI
coordinator and the Institution(s) related to scientific/programmatic
matters or implementation of a proposed operating policy.  The panel
will include one member selected by the Institution(s), one member
selected by the NCI, and a third member chosen by the other two members
of the arbitration panel. The NCI arbitration process for the
cooperative agreement in no way affects the rights of awardees to
appeal selected post award administrative decisions in accordance with
PHS regulations at 42 CFR part 50, subpart D and HHS regulations at 45
CFR part 16.



NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to include
minorities and females 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 females 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
females 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 the Research Plan, 1-4, AND summarized
in Section 5, Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However, NIH
recognizes that it may not be feasible or appropriate in all research
projects to include representation of the full array of United States
racial/ethnic minority populations (i.e., Native Americans (including
American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,
Hispanics). The rationale for studies on single minority 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 females 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 females 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

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
females 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.


Prospective applicants are asked to submit, by June 17, 1992, a letter
of intent that includes a descriptive title of the proposed research,
the name and address of the Principal Investigator, the names of other
key personnel, the 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 subsequent applications, it is requested
in order to provide an indication of the number and scope of
applications to be reviewed.

The letter of intent is to be sent to:

Dr. Roy S. Wu
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
Bethesda, MD  20892
Telephone:  (301) 496-8866
FAX:  (301) 480-4663


The PHS 398 research grant application form (rev. 9/91) is to be used
in applying for cooperative agreements.  These forms are available at
most institutional business offices; from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of Health,
Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892,
telephone (301) 496-7441; and from the NCI Program Director named

The RFA label available in the PHS 398 research application form 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.  In addition, the
RFA number and title must be typed on line 2a of the face page of the
application form.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, exact photocopies, in one package to the
address below.  The photocopies must be clear and single sided.

National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, send two additional copies of the
application to:

Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 838
5333 Westbard Avenue
Bethesda, MD  20892

Applications must be received by September 16, 1992.  If an application
is received after that date, it will be returned to the applicant.  If
the application submitted in response to this RFA is substantially
similar to a research grant application already submitted to the NIH
for review, but has not yet been reviewed, the applicant will be asked
to withdraw either the pending application or the new one.
Simultaneous submission of identical applications will not be allowed,
nor will essentially identical applications be reviewed by different
review committees.  Therefore, an application cannot be submitted in
response to this RFA that is essentially identical to one that has
already been reviewed.  This does not preclude the submission of
substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous

Special Instructions for Preparation of Cooperative Agreement

The general instructions, e.g., for format and budget issues, included
in the PHS 398 application packet must be followed.

Because the Terms of Cooperation discussed above will be included in
all awards issued as a result of the RFA, it is critical that each
applicant include specific plans for responding to these terms.  Plans
must describe how the applicant will comply with staff involvement.

Travel funds for two meetings per year for two representatives from an
institution (one basic researcher and one clinician, one of whom must
be the PI) must be included in the budget.  This budget item will be


A.  Review Procedure

Upon receipt, applications will be reviewed by the Division of Research
Grants (DRG) for completeness.  Incomplete applications will be
returned to the applicant without further consideration.  Evaluation
for responsiveness to the program requirements and criteria stated in
the RFA is an NCI program staff function.  Applications that are judged
non-responsive will be returned to the applicant by the NCI.  An
application judged to be non-responsive to this RFA may be submitted as
an investigator-initiated research grant (R01) or program project grant
(P01).  The application would require modification in accordance with
either the R01 or P01 guidelines. The revised application would not be
considered an application for a cooperative agreement nor would it be
considered a response to an RFA.  Questions concerning the
responsiveness of proposed research to the RFA are to be directed to
program staff (see INQUIRIES).

If the number of applications submitted is large compared to the number
of awards to be made, the NCI may conduct a preliminary scientific peer
review (triage) to eliminate those that are clearly not competitive.
The NCI will remove from competition those applications judged to be
noncompetitive for award and notify the applicant and institutional
business official.

Those applications judged to be both responsive and competitive will be
further evaluated according to the review criteria stated below for
scientific and technical merit by an appropriate peer review group
convened by the Division of Extramural Activities, NCI.  The second
level of review will be by the National Cancer Advisory Board.

B.  Review Criteria

The factors considered in evaluating the scientific merit of each
application will be:

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  demonstrated expertise in both the appropriate basic and clinical
sciences particularly relating to the responsibilities of the PI and
key personnel;

o  adequacy of plans for effective collaboration among laboratory,
clinical, and statistical investigators;

o  demonstration of availability of and access to appropriate patients
receiving defined treatments on phase III clinical trials and/or to
human tissue with the associated pathological data and clinical

o  adequacy of the available facilities and data management resources.
Evidence of the competence of the Central Operations Office and
Statistical Center with regard to the mechanisms for quality control,
study monitoring, data management and reporting, and data analysis;

o  plans for effective interaction and coordination among cooperating
institutions within the applicant institution, with other institutions
working on the same hematological malignancy, and with the NCI;

o  adequacy of provisions for the protection of human subjects;

o  adequacy of the plans for inclusion of females and minorities.

The reviewers will also judge the appropriateness of the proposed
budget and duration in relation to the proposed research.


The anticipated date of award is August 1, 1993.  In addition to the
technical merit of the application, the NCI will consider how well the
applicant institution met the goals and objectives of the program as
described in the RFA, availability of resources, and study populations.


Written and telephone inquires concerning the objectives and scope of
this RFA and inquires about whether or not specific proposed research
would be responsive are encouraged and must be directed to Dr. Roy S.
Wu or Dr. Sheila Taube at the addresses below.  The NCI Program
Directors welcome the opportunity to clarify any issues or questions
from potential applicants.

For technical information:

Dr. Roy S. Wu
NCI Program Director
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
Bethesda, MD  20892
Telephone:  (301) 496-8866
FAX:  (301) 480-4663


Dr. Sheila E. Taube
Chief, Cancer Diagnosis Branch
Division of Cancer Biology, Diagnosis and Centers
National Cancer Institute
Executive Plaza South, Room 638
Bethesda, MD 20892
Telephone: (301) 496-1591
FAX: (301) 402-1037

For business information:

Ms. Mable Lam
Grants Management Specialist
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 48
FAX:  (301) 496-8601


This program is described in the Catalog of Federal Domestic Assistance
No. 93.395, Cancer Treatment Research.  Awards are made under the
authorization of the Public Health Service Act, Title IV Sections 301,
410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public
Law 99-158, 42 USC 285a) and administered under PHS grants policies and
Federal Regulations at 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.


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