kristoff@GENBANK.BIO.NET (Dave Kristofferson) (06/13/91)
NOTE: The NIH Guide may be split into more than one mail message to
avoid truncation during e-mail distribution. The first message always
begins with the RFP/RFA summary sections followed by the appended
texts of the full RFP/RFAs.
----------------------------------------------------------------------
$$XID NIHGUIDE 19910614 V20N23 P1O1 ************************************
X-comment: RFAs described: AI-91-09
NIH GUIDE - Vol. 20, No. 23, June 14, 1991
$$INDEX BEGIN **********************************************************
NOTICES
$$INDEX N1 *************************************************************
JAMES A. SHANNON DIRECTOR'S AWARD
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
NOTICES OF AVAILABILITY (RFPs AND RFAs)
$$INDEX R1 11/13/91 ****************************************************
PROGRAM PROJECTS ON AUTOIMMUNITY (RFA AI-91-09)
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
ONGOING PROGRAM ANNOUNCEMENTS
$$INDEX P1 *************************************************************
STUDIES ON THE INTERACTIONS BETWEEN ENVIRONMENTAL TOXICANTS AND THE
IMMUNE SYSTEM (PA-91-66)
National Institute of Environmental Health Sciences
National Institute of Allergy and Infectious Diseases
Index: ENVIRONMENTAL HEALTH, ALLERGY, INFECTIOUS DISEASES
$$INDEX P2 *************************************************************
BIOLOGY OF THE BASEMENT MEMBRANE ZONE OF SKIN AND EPIDERMOLYSIS
BULLOSA (PA-91-67)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
Index: ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES,
CHILD HEALTH, HUMAN DEVELOPMENT
$$INDEX END ************************************************************
NOTICES
$$N1 BEGIN *************************************************************
JAMES A. SHANNON DIRECTOR'S AWARD
P.T. 34; K.W. 1014006, 0710030
National Institutes of Health
I. SUMMARY
The National Institutes of Health (NIH) announces a new award, the James
A. Shannon Director's Award, that will be awarded in FY 1991. The award
will provide limited support to scientists whose research applications
fall short of the institute/center funding cutoff but are at the margin
of funding in which high quality grants are not awarded due to lack of
funds. Institutes and centers will recommend pending R0l (traditional
research grant), R29 (FIRST Award), and, to a limited extent, R03 (small
grant) applications to the Director, NIH, for consideration. The
Director intends to make approximately $30 million available for this
award. Each award will consist of up to $80,000 direct costs and up to
$20,000 indirect costs (20 percent of total costs) for a total of up to
$100,000 for a twenty-four-month grant period. Funding for R03
applications will be considerably less. Annual expenditures on these
Awards may not exceed 50 percent of the total allocation. INVESTIGATORS
MAY NOT APPLY FOR THE SHANNON AWARD.
II. BACKGROUND
The NIH has been concerned that its award rate has dropped precipitously
in the last five years from 34.9 percent in 1987 to 26.9 percent in
1991. This has been occurring at a time when there has been increasing
Congressional concerns about technology transfer and sustained
scientific leadership in biomedical science and biotechnology. Highly
meritorious applications have not been funded. Many of these
applications have been from young scientists trying to establish
research careers and experienced scientists frustrated by the ever
increasing difficulty in obtaining grant renewals.
Cognizant of these issues, the new Director of NIH, Dr. Bernadine Healy,
has announced that one of her first initiatives is the James A. Shannon
Director's Awards to provide limited support for investigators whose
applications are on the margin of funding. Approximately $30 million is
available for the awards, with funds derived from two sources--the NIH
Director's Discretionary Fund and the NIH Director's transfer authority
established in P.L. l0l-5l7. Funds ordinarily set aside for
investigator-initiated research projects will not be used. Therefore,
this award will not be a redirection of funds that would have been used
to fund the traditional NIH investigator-initiated research grants.
III. OBJECTIVE
The objective of the Shannon Award is to provide limited research
support for exploration and development based on the merit of a pending
application. These grants will underwrite exciting applications that
are at the cutting edge of science and that would be missed
opportunities if not funded. The Shannon Award is intended to provide
support to test the feasibility of an innovative approach; develop
further tests and refine research techniques; perform secondary analysis
of available data sets; and conduct other activities that are within the
original specific aims of the approved application in order to
demonstrate research capabilities or lend additional weight to an
already meritorious application.
IV. GENERAL FEATURES
A. The Shannon Award will apply to RO1, R29, and a limited number of
outstanding R03 applications. Foreign applications will not be
considered.
B. Investigators may not apply for a Shannon Award. Competing
applications, prepared and submitted in accordance with NIH procedures,
will have been peer reviewed and provided a percentile rating. Nominees
will be from among applications pending FY 1991 funding and reviewed by
the Sept./Oct. 1990, Jan./Feb. 1991, May/June 1991 Advisory Boards and
Councils. Nominees for the award must be in the top half of the
percentile range. Previously approved, but inactivated, applications
from this time period may be considered and, if awarded, will be
converted to a Shannon Award (R55).
C. The application upon which the Shannon Award is funded will remain
active for its entire period of support. However, the investigator is
advised to submit a revised application at the earliest convenient date
to be considered for future funding as either an RO1 or R29.
D. If a competing application (RO1 or R29) is subsequently funded while
the Shannon Award is active, the balance of the Shannon Award will be
deducted from the total approved amount of the competing award.
E. The Shannon Award is a two-year award for up to $100,000 total costs.
The distribution of funds will be $80,000 for direct costs ($60,000 in
personnel and $20,000 in supplies for budgetary flexibility) and a
maximum of $20,000 indirect costs. The level of funding for R03 awards
will be considerably less with the same 20 percent of total costs
limitation on indirect costs. PHS special grants administration
provisions as outlined in the "PHS Grants Policy Statement" interim
update of November 15, 1990 apply to these awards. However,
expenditures during the first year may not exceed 50 percent of the
total award and additional funds may not be rebudgeted into indirect
costs.
F. One final progress report, final financial status report, and final
invention statement (HHS 568) will be required 90 days after the end of
the twenty-four-month grant period. The progress report must identify
those portions of the original proposal pursued with the Shannon Award.
If the awardee is successful with a subsequent application, the progress
report in the amended application will suffice as a progress report for
the Shannon Award and a final invention statement will not be required.
V. REVIEW CRITERIA AND PROCEDURES
A. NIH staff, initial review groups, and Advisory Councils and Boards
will have reviewed all RO1, R29, and R03 applications in the usual
manner. Program administrators will submit to their institute or center
director for further consideration pending applications that have
creative and innovative approaches and meet the mission of the
institute.
B. On July 15, the institutes and centers will submit their nominees for
the Shannon Award to the Office of the Director, NIH. The Deputy
Director for Extramural Research, NIH, will convene a committee of
senior NIH officials to review the nominated applications and make
recommendations to the Director, NIH. The Director, NIH, will make the
final selection.
C. The Director will notify the institutes and centers of her decision
by August 15, 1991. The institutes and centers will issue the FY 1991
Shannon Awards before September 30, 1991.
$$N1 END ***************************************************************
NOTICES OF AVAILABILITY (RFPs AND RFAs)
$$R1 BEGIN AI-91-09 FULL-TEXT ******************************************
PROGRAM PROJECTS ON AUTOIMMUNITY
RFA AVAILABLE: AI-91-09
P.T. 34; K.W. 0715015, 0745027, 0745070, 0710030
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: August 1, 1991
Application Receipt Date: November 13, 1991
BACKGROUND INFORMATION
The Autoimmunity Section of the Division of Allergy, Immunology and
Transplantation (DAIT) of the National Institute of Allergy and
Infectious Diseases (NIAID) supports research aimed at elucidating the
causes and mechanisms of tolerance and autoimmune diseases and to
promote application of this basic biomedical knowledge to the
development and implementation of new preventive and treatment
modalities for these diseases.
This Request for Applications (RFA) is intended to encourage and invite
the development of program projects applications from collaborating
basic science and clinical research investigators who are interested in
developing integrated novel studies on autoimmune diseases.
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, Program
Projects on Autoimmunity, is related to the priority area of diabetes
and chronic disabling diseases. 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).
RESEARCH GOALS AND SCOPE
The major goals of these program projects are: increased understanding
of the etiology and pathogenetic mechanisms involved in autoimmune
diseases; generation of new information and the expansion of the current
knowledge base; and the application of this knowledge to the development
of new or improved measures of risk assessment, prevention, early
diagnosis, and treatment of a wide variety of autoimmune diseases and
disorders in which the autoimmune response is a major contributor to
pathogenesis.
Broad and innovative applications that address all aspects of the immune
responses related to self reactivity may include studies concerned with
relevant areas of genetics, cell and molecular biology, biochemistry,
physiology, microbiology, pathology, and pharmacology. Of special
interest to NIAID are program projects that emphasize new ideas, novel
approaches, and state-of-the-art technology in basic research that
elucidate pathogenetic mechanisms and that show promise for clinical
application in the prevention, diagnosis, and treatment of autoimmune
diseases.
There is overwhelming evidence that implicates immune mechanisms in the
pathogenesis of diseases of the skin, nervous system, endocrine system,
and gastrointestinal tract. Thus, in addition to studies of well
recognized autoimmune disorders, such as systemic lupus erythematosus,
rheumatoid arthritis, antibody-mediated thrombocytopenia, and autoimmune
hemolytic anemia, NIAID encourages investigators to design and develop
studies aimed at establishing the role of the immune system in the
pathogenesis of endocrine, dermatologic, neurologic, and
gastrointestinal diseases and the development of new preventive and
treatment modalities specific for these disorders through the
manipulation of the immune response.
Protocols focused on the study of mechanisms of autoimmune diseases
should be designed based on integrated and coordinated
intra-institutional clinical investigations or experimental studies with
demonstrated relevance to human autoimmune disease. Inclusion of basic
research components utilizing in vitro procedures and samples from human
source materials are encouraged, as are preclinical studies using
appropriate animal models of human autoimmune disease. Inclusion of
clinical investigative components drawing upon immunologically relevant
areas in medicine, pediatrics, surgery, dermatology, neurology,
pathology, and their subspecialties is highly recommended.
SPECIAL INSTRUCTIONS FOR THE INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDIES
The following is a brief statement of the NIH and ADAMHA policy
regarding the inclusion of women and minorities in study populations.
The inclusion of women and minorities should be addressed in
applications submitted in response to this RFA.
For projects involving clinical research, NIH requires applicants to
give special attention to the inclusion of women and minorities in study
populations. If women or minorities are not included or adequately
represented in the study populations for clinical studies, a specific
justification must be provided. Application without such documentation
will not be accepted for review.
MECHANISM OF SUPPORT
Program project (P01) grants are awarded to an institution on behalf of
a program director for the support of a broadly based,
multidisciplinary, long-term research program that has a specific major
goal or basic theme. A program project generally involves the organized
efforts of groups of investigators who conduct research projects related
to the overall program goal. The grant can provide support for the
projects and for certain basic resources shared by individuals in the
program project if sharing facilitates the total research effort. Each
project supported by a program project grant is expected to contribute
to and be directly related to the common theme of the program; the
projects, under the direction of a Principal Investigator, should
demonstrate an essential element of unity and interdependence. In
Fiscal Year 1992 the NIAID plans to award at least two program project
grants submitted in response to this RFA and, depending on availability
of funds and scientific merit, more than two. Budgetary requests must
be limited to no more than $500,000 direct costs per year.
ELIGIBILITY
ONLY DOMESTIC INSTITUTIONS ARE ELIGIBLE TO APPLY. Applications may be
submitted by any domestic, public or private, nonprofit or profit-making
organizations.
METHOD OF APPLYING
Before preparing an application, the prospective applicant should
request a copy of the NIAID Information Brochure on Program Project and
Center Grants from:
Olivia Preble, Ph.D.
Allergy, Immunology and Transplantation Research Committee
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Westwood Building, Room 3A-07
Bethesda, MD 20892
Telephone: (301) 496-3528
THE RFA LABEL AVAILABLE IN THE 10/88 REVISION OF APPLICATION FORM PHS
398 MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE. 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.
LETTER OF INTENT
Prospective applicants are asked to submit by August 1, 1991, a letter
of intent that includes a descriptive title of the overall proposed
research, the name of the Principal Investigator, and a list of the
names of key investigators and their institution(s). The letter of
intent is requested in order to provide an indication of the number and
scope of applications to be reviewed to allow early preparations for
review, as well as to promote early interactions between applicants and
NIAID staff. The letter of intent is not binding and does not commit
the sender to submit an application, nor is it a requirement for
submission of an application. The letter of intent is to be directed to
Dr. Preble at the address given above.
STAFF CONTACT
A more detailed RFA may be obtained from:
Susana A. Serrate-Sztein, M.D.
Chief, Autoimmunity Section
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Westwood Building, Room 755
Bethesda, MD 20892
Telephone: (301) 496-7985
Telefax: (301) 402-0175
Inquiries regarding fiscal matters may be addressed to Mr. Carow:
Mr. Jeffrey Carow
Chief, Immunology Grants Management Section
GMB, DEA, NIAID, NIH
Westwood Building, Room 726
Bethesda, MD 20892
Telephone: (301) 496-7075
This program is described in the Catalog of Federal Domestic Assistance
No. 93.855, Immunology, Allergic and Immunologic Diseases Research.
Awards will be made under the authority of the Public Health Service
Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241)
and administered under PHS grants policies and Federal Regulation 42 CFR
Part 74. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
$$R1 END ***************************************************************
ONGOING PROGRAM ANNOUNCEMENTS
$$P1 BEGIN PA-91-66 ****************************************************
STUDIES ON THE INTERACTIONS BETWEEN ENVIRONMENTAL TOXICANTS AND THE
IMMUNE SYSTEM
PA: PA-91-66
P.T. 34; K.W. 0705040, 1007009, 0715120, 1002004, 1002008
National Institute of Environmental Health Sciences
National Institute of Allergy and Infectious Diseases
Application Receipt Dates: February 1, June 1, October 1
BACKGROUND
The National Institute of Environmental Health Sciences (NIEHS) and the
National Institute of Allergy and Infectious Diseases (NIAID) announce
their interest in receiving individual research grant applications (R01s
and R29s) for support of studies on the interactions between
environmental substances and their effects on immune function. The
objective is to promote research at the molecular and cellular level to
better understand mechanisms of environmentally induced aberrations
within the immune system in order to gain insight into approaches to
mitigate the effects of such agents. These agents are substances that
may be present in the natural environment or have been added by human
activities and are known or or thought to induce illnesses that affect
or involve the immune systems.
NIAID is the principal Federal funding component that supports
fundamental research concerned with the structure and function of the
immune system in health and disease. The acquisition of new and deeper
knowledge about the immune system is requisite to the development of
improved procedures for prevention, diagnosis, and treatment of
immunological diseases and of diseases having a major immunological
component. The interest of the NIAID in environmental toxicology is
predicated on the strong likelihood that the analysis of interactions
between noxious substances in the environment and the immune system can
provide insight, from a largely ignored perspective, on some of the
typical functions of the immune system, the adaptability and plasticity
of the immune system, and the susceptibility of the immune system to
chemical and physical insult.
The NIEHS is the principal Federal funding component for support of
basic research on environmental factors that contribute to human health
problems and disease. Major emphasis by NIEHS is placed upon research
examining those physical and chemical substances resulting from
industrial progress. However, there also are many natural environmental
substances that have been found to have deleterious effects on human
health and are within the purview of the NIEHS mission. Many of these
substances cause human health problems by disrupting normal immune
function that can lead to a disease state.
RESEARCH GOALS AND SCOPE
The effects of environmental toxicants may be divided into three broad
categories: suppression/inhibition of immunological competence;
initiation or triggering of autoimmunity; and stimulation of
allergic/hypersensitivity reactions. Although the NIEHS and NIAID have
overlapping interests with respect to each of these categories of
effect, it is reasonable to state that the interests of NIEHS center on
the effects of chemical/physical agents that suppress or reduce the
capacity of the immune system. The interests of NIAID are more focussed
on the actions of chemical/physical agents that precipitate or lead to
autoimmune and allergic disorders. Interests of the NIEHS are to
identify and characterize the mechanisms of action of substances that
affect the immune system and to determine the magnitude and consequences
of exposure to such substances. NIAID is concerned with understanding
the immuno-physiological processes that are affected by environmental
agents and elucidating the pathogenesis of the disorders that they
cause. Both Institutes are interested in approaches that may mitigate
the noxious effects of environmental agents and in the development of
improved animal and in vitro models for studying the effects of noxious
substances. Examples of projects/topics that would be of primary
interest to each Institute follow:
OF PRIMARY INTEREST TO NIEHS:
o Analysis of the precise effects of toxicants on individual
components of the immune system; e.g., on cellular components such
as antigen-processing cells (APC), B-lymphocytes, and
T-lymphocytes.
o Development of in vitro systems for systematic quantitative
analyses and mechanisms of action of toxicants on individual
cellular components of the immune system: APC, B-cells, and
T-cells.
o Studies on dual effects of toxic agents such as simultaneous
inactivation of certain components of the immune system and
activation of other components.
o Studies on the genetics and pharmacological control of
susceptibility and resistance to the effects of toxic substances on
the immune system.
OF PRIMARY INTEREST TO NIAID:
o Identification of the actual immunogenic components (e.g.,
fragments, molecular conjugates) and epitopes of toxicants that
trigger allergic/hypersensitive responses or autoimmunity, and
detailed analyses of their processing by APC and presentation to T-
and B-cells.
o Comprehensive studies on toxicant-induced allergic/hypersensitive
responses designed to reveal the roles of components such as
T-cells, APC, IgE-producing B-cells, IgE molecules, leukocytes, and
mediator substances in the development and manifestation of those
responses.
o Development of approaches to prevent or reduce the undesirable
effects of toxicants on the immune system; e.g., appropriate
pre-immunization ("vaccination") against toxicants or preparation
of monoclonal antibodies capable of nullifying the effects of
toxicants.
o Studies on the genetic control of susceptibility and resistance to
those effects of toxicants that lead to autoimmune or allergic
disorders.
OF INTEREST TO BOTH INSTITUTES
o Studies on toxicant-triggered expression of stress proteins (e.g.,
heat-shock proteins) and special receptors such as those for
aromatic hydrocarbons controlled by the "Ah" genetic locus and
found in leukocytes; and the roles of such proteins in the effects
of toxicants on immune functions.
o Studies on aberrations in the elaboration and functions of
cytokines and cytokine receptors induced by toxicants.
o Synergistic actions of physical/chemical agents either with each
other (e.g., a chemical and UV-B or two chemicals) or with other
agents such as viruses or oncogenes. NIAID is most interested in
those responses that lead to autoimmune or allergic disorders.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
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, general 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 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 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
review will be deferred until the information is provided.
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.
MECHANISM OF SUPPORT
The mechanism of support for this activity will be the individual
research grant - Research Project Grant (R01) and First Independent
Research Support and Transition (FIRST) Award (R29) as applicable.
APPLICATION AND REVIEW PROCEDURES
A. Deadline: Applications will be accepted in accordance with the usual
receipt dates for new research grant applications; i.e., February 1,
June 1, and October 1. The earliest possible award dates will be
approximately nine months after the respective receipt dates.
Applications received too late for one cycle of review will be held
until the next receipt date.
B. Method of Applying: Applications will be received by the NIH
Division of Research Grants (DRG) and referred to an appropriate study
section for scientific and technical merit review. Institute assignment
decisions will be governed by normal programmatic considerations as
specified in the NIH Referral Guidelines. The review criteria
customarily employed by the NIH for research grant applications will
prevail. Following the initial scientific review, the applications will
be evaluated by the National Advisory Council of the assigned Institute.
Applications must be submitted on form PHS 398 (revised 10/88) which is
available in the business or grants and contracts offices at most
academic and research institutions and from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of Health,
Westwood Building, Room 449, Bethesda, MD 20892, telephone (301)
496-7441. To identify the application as a response to this
announcement, check "yes" in Item 2 on the face page of the application
and enter the announcement title, "Environmental Toxicants and the
Immune System", and PA-91-66.
The original and six copies of the application must be directed to:
Applications Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
ADDITIONAL INFORMATION
Applicants are strongly encouraged to contact one of the Program
Administrators listed below prior to preparing an application.
Inquiries related to this program announcement should be directed to:
Dr. Joseph F. Albright
Program Administrator
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Westwood Building, Room 757
Bethesda, MD 20892
Telephone: (301) 496-7551
Dr. Jerry A. Robinson
Program Administrator
Scientific Programs Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 541-7724
Grants management inquiries should be directed to:
David L. Mineo
Chief, Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 541-1373
This program is described in the Catalog of Federal Domestic Assistance
Numbers 93.112, Characterization of Environmental Health Hazards;
93.113, Biological Response to Environmental Health Hazards; and 93.855,
Allergy, Immunology and Transplantation Research. Awards are made under
the authority of Section 487, Public Health Service Act as amended (42
USC 288) and administered under PHS Grants Policies and Title 42 of the
Code of Federal Regulations, Part 66. This program is not subject to
the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.
$$P1 END ***************************************************************
$$P2 BEGIN PA-91-67 ****************************************************
BIOLOGY OF THE BASEMENT MEMBRANE ZONE OF SKIN AND EPIDERMOLYSIS BULLOSA
PA: PA-91-67
P.T. 34; K.W. 0715185, 0790005, 0765033, 1002058, 0780020
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
I. PURPOSE
The Skin Diseases Program of the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS) supports research on the
structure, function, and diseases of the skin. The Genetics and
Teratology Branch of the National Institute of Child Health and Human
Development (NICHD) supports research on genetic and congenital
malformations of skin. This program announcement is to encourage
submission of research grant applications in the area of basement
membrane zone of the skin in normal and diseased states with particular
reference to epidermolysis bullosa.
II. BACKGROUND
The basement membrane zone of the skin is an area of great biologic
importance. The many structures within this zone mediate not only
attachment of the epidermis to the underlying dermis but also transport
nutrients from the vasculature of the dermis to the nonvascularized
epidermis and, in the reverse direction, chemicals, including drugs,
into the systemic circulation following topical application. Studies of
skin diseases must consider the basement membrane zone in evaluating the
underlying mechanisms of their pathogenesis.
Epidermolysis bullosa is a large group of hereditary and at least two
acquired skin diseases in which the pathologic defect occurs within the
skin basement membrane zone, either within the basal keratinocytes, the
electron microscopically identified basement membrane, or the
superficial papillary dermis. In the past several years many structures
have been identified within this area of skin. Several have been
implicated in the pathogenesis of one or more forms of epidermolysis
bullosa. Thus, these diseases represent an experiment of nature, the
study of which can provide great insights into normal functioning of
molecules of the basement membrane zone of skin, as well as potential
approaches to the diagnosis and treatment of individuals suffering with
these often debilitatiing or even fatal conditions.
The NIAMS supports a National Epidermolysis Bullosa Registry that
consists of four clinical sites and a coordinating center. The first
five years of this Registry will conclude in September 1991. The
Registry facilitates research in epidermolysis bullosa and the biology
of the basement membrane zone by providing tissues from banked sources
and/or obtaining patients interested in participating in research.
RESEARCH GOALS AND SCOPE
The goal of this program announcement is to stimulate research in the
biology of the skin basement membrane zone and into the etiopathogenesis
of epidermolysis bullosa. Some research areas appropriate for inclusion
in applications responsive to this announcement are:
o Studies of the molecules making up the basement membrane zone, in
the normal and/or diseased state;
o Studies seeking early aberrations and biological markers of skin
development at the tissue, cellular, and molecular levels;
o Molecular genetic approaches to understanding basic defects in the
hereditary forms of epidermolysis bullosa utilizing both candidate
gene and anonymous marker approaches;
o Investigations utilizing tissue culture, organ and animal model
systems, and other techniques as appropriate to investigate the
mechanisms by which defects in the skin basement membrane zone
result in disease phenotype;
o Studies leading to clinical trials and the treatment of various
forms of epidermolysis bullosa;
o Epidemiology of subsets of epidermolysis bullosa.
MECHANISM OF SUPPORT
Research mechanisms to support these investigations include individual
research grants (RO1), Clinical Investigator Awards (KO8), and First
Independent Research and Transition (FIRST) Awards (R29).
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. 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 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 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.
APPLICATION AND REVIEW PROCEDURES
Applications in response to this announcement will be reviewed in
accordance with Public Health Service peer review procedures for
research grants. Review criteria include significance and originality
of the research goals and approaches; feasibility of the research and
adequacy of the experimental design; training, research competence, and
dedication of the investigator(s); adequacy of available facilities; and
provision for the humane care of animals. Decisions will be based on
initial review group and National Advisory Council recommendations.
Applications must be submitted on form PHS 398 (rev. 10/88), available
in the business or grants office at most academic or research
institutions and from the Division of Research Grants, National
Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20894,
telephone (301) 496-7441.
Applications will be accepted in accordance with the submission dates
for new applications on a continuing basis.
February 1, June 1, October 1 for research grant applications.
The phrase "BIOLOGY OF THE BASEMENT MEMBRANE ZONE OF SKIN AND
EPIDERMOLYSIS BULLOSA, PA-91-67" must be typed on line 2 of the face
page of the application. The original and six copies must be sent or
delivered to:
Grant Application Receipt Office
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD 20892-4500**
For further information, investigators are encouraged to contact the
following individuals:
Alan N. Moshell, M.D.
Skin Diseases Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 405
Bethesda, MD 20892
Telephone: (301) 496-7326
Delbert H. Dayton, M.D.
Genetics and Teratology Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Executive Plaza North Building, Room 643
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-5541
For fiscal and administrative matters, contact:
Diane M. Watson
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 407-A
Bethesda, MD 20892
Telephone: (301) 496-7495
Douglas Shawver
Supervisory Grants Management Specialist
Grants Management Branch
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 505
Bethesda, MD 20892
Telephone: (301) 496-1303
This program is described in the Catalog of Federal Domestic Assistance
No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research and
No. 93.865, Research for Mothers and Children. Awards will be made
under authorization of the Public Health Service Act, Title III, Section
301(c) (Public Law 78-410, as amended; 42 USC 241) and administered
under PHS grants 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.
$$P2 END ***************************************************************
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS
THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH.
APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO
FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE
ADDRESS FOR THE WESTWOOD BUILDING IS:
5333 Westbard Avenue
Bethesda, Maryland 20816
FULL TEXT OF RFAs FOR ONLINE ACCESS
$$XID RFA AI9109 AI-91-09 P1O1 *****************************************
REQUEST FOR APPLICATIONS
RFA: AI-91-09
PROGRAM PROJECTS ON AUTOIMMUNITY
P.T. 34; K.W. 0715015, 0745027, 0745070, 0710030
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: August 1, 1991
Application Receipt Date: November 13, 1991
BACKGROUND INFORMATION
The Autoimmunity Section of the Division of Allergy, Immunology and
Transplantation (DAIT) of the National Institute of Allergy and
Infectious Diseases (NIAID) supports research aimed at elucidating the
causes and mechanisms of tolerance to potential allergans and to
autoimmune diseases and at the application of this basic biomedical
knowledge to the development and implementation of new preventive and
treatment modalities for these diseases.
This Request for Applications (RFA) is intended to encourage and invite
the development of program project applications by collaborating basic
science and clinical research investigators who are interested in
developing novel integrated studies on autoimmune diseases.
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, Program
Projects on Autoimmunity, is related to the priority area of diabetes
and chronic disabling diseases. 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).
RESEARCH GOALS AND SCOPE
The major goals of these program projects are: increased understanding
of the etiology and pathogenetic mechanisms involved in autoimmune
diseases; generation of new information and the expansion of the current
knowledge base; and the application of this knowledge to the development
of new or improved measures of risk assessment, prevention, early
diagnosis, and treatment of a wide variety of autoimmune diseases and
disorders in which the autoimmune response is a major contributor to
pathogenesis.
NIAID is seeking broad and innovative applications that address all
aspects of the immune responses related to self reactivity and may
include studies concerned with relevant areas of genetics, cell and
molecular biology, biochemistry, physiology, microbiology, pathology,
and pharmacology. Of special interest to NIAID are program projects
that emphasize new ideas, novel approaches, and state-of-the-art
technology in basic research that elucidate pathogenetic mechanisms and
that show promise for clinical application in the prevention, diagnosis,
and treatment of autoimmune diseases.
There is overwhelming evidence to implicate immune mechanisms in the
pathogenesis of diseases of the skin, nervous system, endocrine system,
and gastrointestinal tract. Thus, in addition to studies of well
recognized autoimmune disorders, such as systemic lupus erythematosus,
rheumatoid arthritis, antibody-mediated thrombocytopenia, and autoimmune
hemolytic anemia, NIAID encourages investigators to design and develop
studies aimed at establishing the role of the immune system in the
pathogenesis of endocrine, dermatologic, neurologic, and
gastrointestinal diseases and the development of new preventive and
treatment modalities specific for these disorders through the
manipulation of the immune response.
Protocols focused on the study of mechanisms of autoimmune diseases
should be designed based on integrated and coordinated
intra-institutional clinical investigations or experimental studies with
demonstrated relevance to human autoimmune disease. Inclusion of basic
research components utilizing samples from human source materials in in
vitro procedures are encouraged, as are preclinical studies using
appropriate animal models of human autoimmune disease. Inclusion of
clinical investigative components drawing upon immunologically relevant
areas in medicine, pediatrics, surgery, dermatology, neurology,
pathology, and their subspecialties is highly recommended.
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 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 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.
MECHANISM OF SUPPORT
Program project (P01) grants are awarded to an institution on behalf of
a program director for the support of a broadly based,
multidisciplinary, long-term research program that has a specific major
goal or basic theme. A program project generally involves the organized
efforts of groups of investigators who conduct research projects related
to the overall program goal. The grant can provide support for the
projects and for certain basic resources shared by individuals in the
program project if sharing facilitates the total research effort. Each
project supported under a program project grant is expected to
contribute to and be directly related to the common theme of the
program; the projects, under the direction of a Principal Investigator,
should demonstrate an essential element of unity and interdependence.
The application must clearly explain how the projected multidisciplinary
integrated program can be expected to accomplish the stated goal more
efficiently and effectively than could a series of independent
individual grant-supported studies.
Designation of a program director should be based upon accomplishment
and experience as a scientist, the ability to assume both the leadership
of the research group and the responsibility for scientific,
professional, and administrative functions, and the commitment of a
significant amount of his/her time to the project. Each project in the
program must have a designated project leader with a demonstrable record
of accomplishment in clinical immunology, or one of the basic science
disciplines or clinical specialties relevant to the particular subject
of investigation. However, the participation of one junior investigator
whose project is an integral part of the overall program, and whose work
would be closely related to that of the senior scientist leaders of the
other projects, is encouraged by the NIAID.
Support for a program project in autoimmune mechanisms in disease will
be limited to a maximum of four years. Competing renewals may be
submitted in response to an RFA or as an unsolicited application after
consultation with appropriate NIAID staff. Funding beyond the first and
subsequent years of the grant will be contingent upon satisfactory
progress during the preceding years and availability of funds. In
Fiscal Year 1992 the NIAID plans to award at least two program project
grants submitted in response to this RFA and, depending on availability
of funds and scientific merit, more than two. Budgetary requests should
be limited to no more than $500,000 direct costs. Grant funds may be
utilized to support the research activities of scientific and
professional personnel, administration, consultation services, central
support services, equipment, supplies, travel, and publication costs.
Support for research-related costs of patient involvement and medical
care may be authorized. Since the program cannot provide funds for new
construction, adequate physical facilities must be available for the
primary needs of the project. However, moderate alterations or
renovations to enhance clinical or laboratory facilities may be allowed
if they are necessary to meet objectives of the proposed program.
ELIGIBILITY
ONLY DOMESTIC INSTITUTIONS ARE ELIGIBLE TO APPLY. Applications may be
submitted by any domestic, public or private, nonprofit or profit-making
organizations.
REVIEW PROCEDURES AND CRITERIA
These are outlined in the NIAID Information Brochure on Program Project
and Center Grants that contains special instructions and information for
preparing multiproject applications for program project grants, review
procedures and criteria, and other important information. Before
proceeding, the prospective applicant should first request a copy of
this brochure from:
Olivia T. Preble, Ph.D.
Chief, Microbiology & Immunology Review Section
National Institute of Allergy and Infectious Diseases
National Institute of Health
Westwood Building, Room 3A-10
Bethesda, MD 20892
Telephone: (301) 496-8208
Applications will be examined by NIAID staff to determine administrative
and programmatic responsiveness to this RFA; those judged to be
non-responsive will be returned to the applicant without review.
Those applications that are complete and responsive may be subjected to
a triage by an NIAID peer review group before or during the scientific
review meeting to determine their scientific merit relative to other
applications received in response to this RFA. The NIAID will withdraw
from competition those applications judged to be non-competitive for
award and will notify the applicant and institutional business official.
Those applications judged by the reviewers to be competitive for award
will be further reviewed for scientific and technical merit by a review
committee convened by the Division of Extramural Activities, NIAID,
during February or March 1992. The second level of review will be
provided by the National Advisory Allergy and Infectious Disease Council
in May 1992. July 1, 1992 will be the earliest starting date for
successful applicants.
METHOD OF APPLYING
The receipt date for applications will be November 13, 1991.
APPLICATIONS NOT RECEIVED AS A SINGLE PACKAGE FROM THE APPLICANT
ORGANIZATION BY NOVEMBER 13, 1991, OR THAT DO NOT CONFORM TO THE
INSTRUCTIONS CONTAINED IN FORM PHS 398 (rev. 10/88) APPLICATION KIT,
WILL BE JUDGED TO BE NON-RESPONSIVE AND WILL BE RETURNED TO THE
APPLICANT.
Use the research grant application form PHS 398 (rev. 10/88). For
purposes of identification and processing, the words "PROGRAM PROJECTS
ON AUTOIMMUNITY" and RFA number AI-91-09 must be typed in item 2 on the
face page of the application.
THE RFA LABEL AVAILABLE IN THE 10/88 REVISION OF APPLICATION FORM PHS
398 MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE. 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.
In addition to following the format instructions contained in the
Information Brochure for the development of a program project grant
application, include the expanded material listed below:
o A brief overview of the intended program project as well its
components;
o A description of available laboratory and clinical facilities
available for use by the proposed project;
o Ongoing relevant research studies, identifying existing projects
and sources of support;
o Past research by members of the proposed investigative group
relevant to the proposal;
o Specific information on the institution's present patient load and
projections for patient involvement in clinical investigations;
o The academic positions and major research interests of the program
director and his/her professional staff who will be involved in the
work of the program project;
o Collaborative arrangements with other laboratories and
investigators and delineation of the role and manner of anticipated
participation and interaction of the Principal Investigators,
consultants, and collaborators;
o Justification for the use of the PO1 mechanism as opposed to
submission of individual RO1 projects.
Application kits may be obtained from the institution's office of
sponsored research and from:
Office of Grants Inquires
Division of Research Grants
National Institutes of Health
Westwood Building, Room 449
Bethesda, MD 20892
Submit a signed, typewritten original of the application, including the
checklist, and four signed, exact, single-sided photocopies, in one
package to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892
IN ADDITION mail two exact copies of the application and six copies of
the appendices directly to Dr. Olivia Preble at the address given above.
LETTER OF INTENT
Prospective applicants are asked to submit by August 1, 1991, a letter
of intent that includes a descriptive title of the overall proposed
research, the name of the Principal Investigator, and a list of the
names of key investigators and their institution(s). The letter of
intent is requested in order to provide an indication of the number and
scope of applications to be reviewed so as to allow early preparations
for review, as well as to promote early interactions between applicants
and NIAID staff. The letter of intent is not binding and does not
commit the sender to submit an application, nor is it a requirement for
submission of an application. The letter of intent is to be directed to
Dr. Preble at the address given above.
In addition, it is highly recommended that the Chief of the Autoimmunity
Section be contacted in the early stages of preparation of the
application:
Susana A. Serrate-Sztein, M.D.
Chief, Autoimmunity Section
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Westwood Building, Room 755
Bethesda, MD 20892
Telephone: (301) 496-7985
Telefax: (301) 402-0175
INQUIRIES
Inquiries concerning the programmatic aspects of this RFA may be
addressed to Dr. Serrate-Sztein at the address given above.
Inquiries regarding the review of these applications should be addressed
to Dr. Preble at the address given above.
Inquiries regarding fiscal matters may be addressed to Mr. Carow:
Mr. Jeffrey Carow
Chief, Immunology Grants Management Section
GMB, DEA, NIAID, NIH
Westwood Building, Room 726
Bethesda, MD 20892
Telephone: (301) 496-7075
This program is described in the Catalog of Federal Domestic Assistance
No. 93.855, Immunology, Allergic and Immunologic Diseases Research.
Awards will be made under the authority of the Public Health Service
Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241)
and administered under PHS grants policies and Federal Regulation 42 CFR
Part 74. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.