and Human Services (HHS)
EXPIRED
RESEARCH OPPORTUNITIES IN TISSUE ENGINEERING
RELEASE DATE: December 30, 2002
RFA: EB-03-010
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib1.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
LETTER OF INENT RECEIPT DATE: February 14, 2003
APPLICATION RECEIPT DATE: March 14, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of Biomedical Imaging and Bioengineering (NIBIB)
and the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) issue this Request for Applications (RFA) to address
key research challenges in the field of tissue engineering. The full
promise of tissue engineering as a means to develop functional tissue
or organ substitutes in vitro for implantation in vivo, or to remodel
and regenerate tissue in vivo for the purpose of repairing, replacing,
maintaining, or enhancing organ function, is only beginning to be
realized. Tissue engineering also offers a potential source of human
tissues for use as biosensors or for the development of drugs including
screening for novel drug candidates, identifying novel genes as drug
targets or therapeutic agents, and testing for drug toxicity. As an
emerging multidisciplinary field in which ideas, concepts, and
techniques are developing at an exceedingly rapid pace, there is
significant interest and demand for government agencies to provide
additional resources in this and related areas for fostering the basic
and applied science needed for this field to mature and important
breakthroughs to transition from basic and pre-clinical research to
clinical studies. The overall goal of this solicitation is to provide
resources to address the issues that must be overcome in order to
continue to move this field forward rapidly. It is structured to
provide an opportunity where clinicians, engineers, and scientists from
a variety of disciplines can establish research collaborations that
will hasten the development of tissue engineering.
RESEARCH OBJECTIVES
Tissue engineering is a rapidly growing area that seeks to create,
repair and/or replace tissues and organs by using combinations of
cells, biomaterials, and/or biologically active molecules. It is an
interdisciplinary field that integrates aspects of engineering, and
other quantitative sciences, with biology and medicine. Research and
technology development in tissue engineering promises to revolutionize
current methods of health care treatment and significantly improve the
quality of life for millions of patients. As one indication of the
scope of the problem that tissue engineering addresses, worldwide organ
replacement therapies utilizing standard organo-metallic devices
consume 8 percent of medical spending, or approximately $350 billion
per year. Organ transplantation is another option for replacing
damaged or diseased tissue, but one that is severely limited by donor
availability. Tissue-engineered products hold the promise for true
functional replacement at affordable cost. However, despite early
successes, few functional tissue engineered products are currently
available for clinical use.
As described in the January 2002 World Technology Evaluation Center
(WTEC) report, "Tissue Engineering Research", it is clear that critical
advances in engineering and design are needed and key regulatory issues
must be addressed if the promises of this field are to be fulfilled.
The report is based on findings of the WTEC study supported by member
agencies of the Multi-Agency Tissue Engineering Science (MATES) Working
Group http://www.tissueengineering.gov/. These include the National
Institutes of Health (NIH), National Science Foundation (NSF), National
Institute of Standards and Technology (NIST), National Aeronautics and
Space Administration (NASA), Defense Advanced Research Projects Agency
(DARPA), and the Food and Drug Administration (FDA). The research
areas covered and described in this solicitation represent a collective
effort of the MATES Working Group. In addition, as discussed in
several other recent forums such as the 2001 NIH/BECON sponsored
meeting on "Reparative Medicine: Growing Tissues and Organs"
http://www.becon.nih.gov/becon_symposia.htm and the 2001 NIST sponsored
workshop on "Standards for Biomedical Materials and Devices," there are
a number of areas in tissue engineering requiring additional research.
These include: improved methods for the identification and
characterization of cells; development of novel biomaterials; new
approaches to the design and delivery of three dimensional constructs;
and development of enabling technologies and methods to ensure the
safety and quality assurance of engineered tissues as well as methods
for the stable storage of these products prior to clinical use. As the
field evolves from initial proof-of-principle demonstrations of
feasibility to the development of products intended for widespread
clinical use, the NIBIB and the NIDDK are in a unique position to
foster developments in this area by providing resources to ensure that
these obstacles are successfully overcome and that these revolutionary
products move from the research bench to the clinic.
Strengthening research programs of relevance to tissue engineering and
eventual clinical utilization of products developed by this field are
important areas of emphasis for the NIBIB and NIDDK. Areas in which
such scientific opportunities exist include, but are not limited to:
1. Identification/Characterization of Cells and Development of Novel
Biomaterials
The identification of an optimal cell source for a particular tissue
engineering application will depend on rigorous characterization with
regards to plasticity, propagation, and control of differentiation both
in vitro and in vivo. To guide the organization, growth, and
differentiation of cells in tissue engineered constructs, a variety of
biomaterials are needed to provide mechanical support as well as
physical, chemical, and mechanical cues in forming functional tissues.
These materials and their degradation products must be non-toxic and
non-immunogenic, as well as possess other properties specific for a
given tissue construct and the site of implantation. It is clear that
the continued development of this field will depend upon identification
and characterization of additional sources of cells as well as the
development of new biomaterials and increased understanding of their
interactions with cells.
Specific areas of interest include but are not limited to:
o Isolation of stem and progenitor cells and methods to promote
targeted stimulation of proliferation and controlled
differentiation, including evaluation of signaling pathways in
differentiation and dedifferentiation.
o Development of novel scaffolds and delivery vehicles that combine
bioactive molecules, such as growth factors or DNA, to coordinate
the temporal and spatial distribution of biomolecules in relation to
the desired cellular response.
o Incorporation of new biomaterials and polymer classes of interest to
tissue engineering into material libraries as reference standards or
tools for validation purposes.
o In addition to the above the NIDDK is specifically interested in
engineering tissues to replace the function of pancreatic beta
cells, liver, kidney and bladder.
2. Engineering Design and Functional Assessment of Constructs:
Advances are needed in the application of rational engineering design
principles to tissue engineered constructs and the design must span
multiple hierarchical scales, from the macroscopic level, directed at
satisfying the clinical requirements of the product, to the microscopic
level, directed at satisfying the cell and molecular requirements for
long-term functional success. Determining the fate and function of
implanted constructs is also of critical importance.
Specific areas of interest include but are not limited to:
o Novel approaches to materials processing to create scaffolds, which
allow composition variation to accommodate divergence in evolving
tissue structures.
o Development of strategies to promote vascularization and/or
innervation within engineered tissues or in vivo.
o Model systems to understand physical, chemical and biomechanical
aspects of cell signaling
o Consideration of multiple design and delivery approaches for in
vitro tissue preparations and in situ tissue regeneration, such as
methods to direct self assembly/maturation of bioscaffolds leading
to in situ generation of constructs
o Achievement of immunological tolerance for engineered constructs
o Increased understanding of the basic principles governing tissue
formation, function, and failure, including the assembly of multiple
cell types and biomaterials into multi-dimensional structures that
mimic the architecture and/or function of native tissue.
o Methodologies, such as various imaging modalities, to track the fate
and allow the assessment of implanted engineered constructs in a
non-invasive or minimally invasive manner.
3. Enabling Technologies
If the benefits of tissue engineering are to be realized, the field
must deliver products that can be commercialized. Therefore, a wide
range of enabling technologies, such as techniques for use in growing
tissues/organs on a commercially relevant scale; new, relevant, pre-
clinical models; methods to establish biosafety, quality assurance and
performance; strategies for preserving living-cell products with off-
the-shelf availability and determining the fate of the implanted
constructs will be required.
Specific areas of interest include but are not limited to:
o New sensitive and rapid test methods to address biosafety, function
and stability of the final engineered construct.
o Development of appropriate in vitro and in vivo pre-clinical models
to address biocompatibility, toxicity, immunogenicity and
inflammatory responses.
o Development of relevant in vitro tests to predict the in vivo
performance of tissue engineered medical products, both for product
development and quality control in manufacturing.
o Cost effective approaches for the production of tissues and organs,
that can meet regulatory requirements for good manufacturing
practices (GMP).
o Techniques and technologies for preserving both cells and engineered
tissues to permit the stable storage of these products prior to
clinical utilization.
o Three-dimensional tissue production including development of
bioreactor and organ support systems.
MECHANISM OF SUPPORT
This RFA will use the NIH research grant award mechanism (R01) and the
development/exploratory grant award mechanism (R21). As an applicant
you will be solely responsible for planning, directing, and executing
the proposed project. This RFA is a one-time solicitation. Future
unsolicited, competing-continuation R01 applications based on this
project will compete with all investigator-initiated applications and
will be reviewed according to the customary peer review procedures.
The anticipated award date is September 30, 2003.
The R01 mechanism is recommended for applications that emphasize basic
discovery or crosscutting research that addresses specific aspects of
tissue engineering. Research periods associated with the R01
proposals are limited to five years with no cap on budget amount.
The R21 Exploratory/Developmental Award supports exploratory or
developmental research aimed at proof-of-principle for high-risk
projects where no or very little preliminary data is available. An R21
application can be for up to two years with a maximum budget request of
$275,000 direct costs for the 2-year period and a maximum page limit of
15 pages. R21 applications are not renewable. Investigators are
encouraged to use data generated from the R21 application to apply for
further funding through the R01 mechanism (or other appropriate
mechanisms).
This RFA uses just-in-time concepts. It also uses the modular as well
as the non-modular budgeting formats
(see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs
(including total costs of consortium arrangements) in each year of
$250,000 or less, use the modular format. Otherwise follow the
instructions for non-modular research grant applications.
FUNDS AVAILABLE
The NIBIB intends to commit a total of approximately $8,000,000, and
the NIDDK intends to commit a total of approximately $350,000 in FY
2003 to fund 20 to 30 new and/or competitive continuation grants in
response to this RFA. An applicant may request a project period of up
to 5 years for an R01 and a project period of up to 2 years for an R21.
Budgets for direct costs of up to $275,000 for the 2-year period will
be accepted for an R21. There is no budget limitation for R01
applications.
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of
the NIBIB and the NIDDK provide support for this program, awards
pursuant to this RFA are contingent upon the availability of funds and
the receipt of a sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
General Clinical Research Centers: Applicants from institutions that
have a General Clinical Research Center (GCRC) funded by the NIH
National Center for Research Resources may wish to identify the GCRC as
a resource for conducting the proposed research. If so, a letter of
agreement from either the GCRC program director or principal
investigator should be included with the application.
Grantee Meetings: Principal Investigators will be required to attend
an annual meeting in the Bethesda, MD region organized by NIBIB.
Investigators must include travel to this meeting as part of the budget
request and state a willingness to participate in this meeting.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
two areas: scientific/research and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Christine A. Kelley, Ph.D.
Acting Director
Division of Bioengineering
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
Suite 200
6707 Democracy Blvd.
Bethesda, MD 20892-5469
Telephone: (301) 451-4778
Fax: (301) 480-4973
Email: [email protected]
Maren R. Laughlin, Ph.D.
Director, Metabolism Program
NIDDK
NIH/DHHS
6707 Democracy Blvd, Rm. 6101, MSC 5460
Bethesda, MD 20892-5460
Telephone: (301) 594-8802
Fax: (301) 480-3503
Email: [email protected]
o Direct your questions about financial or grants management matters
to:
Ms. Nancy Curling
Division of Extramural Activities
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
Suite 900
6707 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 451-4782
Fax: 301-480-4974
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
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 IC staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
Meredith D. Temple, Ph.D.
Health Scientist Administrator
Division of Extramural Activities
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
Suite 200
6707 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 451-4792
Fax: (301) 480-4973
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: [email protected].
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in
a modular grant format. The modular grant format simplifies the
preparation of the budget in these applications by limiting the level
of budgetary detail. Applicants request direct costs in $25,000
modules. Section C of the research grant application instructions for
the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information
on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and five signed,
photocopies, in one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be received by the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an Introduction addressing
the previous critique.
Please Note: As of November 27, 2001, all applications and other
deliveries to the Center for Scientific Review must come via courier
delivery or the USPS. Applications delivered by individuals to the
Center for Scientific Review will no longer be accepted. For
additional information, see the NIH Guide Notice
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIBIB. Incomplete applications will be
returned to the applicant without further consideration. And, if the
application is not responsive to the RFA, CSR staff may contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next appropriate NIH review cycle.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the CSR in accordance with the review criteria
stated below. As part of the initial merit review, all applications
will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate National Advisory
Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the
following aspects of your application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these
criteria in assigning your application's overall score, weighting them
as appropriate for each application. Your application does not need to
be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example,
you may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the
aims of your application are achieved, how do they advance scientific
knowledge? What will be the effect of these studies on the concepts or
methods that drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, and appropriate to the
aims of the project? Do you acknowledge potential problem areas and
consider alternative tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project
challenge existing paradigms or develop new methodologies or
technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to your
experience level as the principal investigator and to that of other
researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work
will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will be reviewed with respect to the following:
o TEAM-APPROACH: The inclusion of researchers with divergent
backgrounds, for example, the partnering of an engineer, a physiologist
and/or a clinician.
o R21 REVIEW CRITERIA: Since the R21 mechanism is intended to
encourage exploratory/developmental research, proposals submitted as an
R21 will also be reviewed based on their high risk/high impact
potential and whether or not the proposal is significantly distinct
from those traditionally submitted through the R01 mechanism. For
example, R21 projects designed to produce incremental advances in
knowledge will not be considered.
o PROTECTIONS: The adequacy of the proposed protection for humans,
animals, or the environment, to the extent they may be adversely
affected by the project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both
genders, all racial and ethnic groups (and subgroups), and children as
appropriate for the scientific goals of the research. Plans for the
recruitment and retention of subjects will also be evaluated. (See
Inclusion Criteria included in the section on Federal Citations, below)
o BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 14, 2003
Application Receipt Date: March 14, 2003
Peer Review Date: May/June, 2003
Council Review: September, 2003
Earliest Anticipated Start Date: September 30, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1,
1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide the official NIH identifier(s)for the hESC line(s)to be used in
the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to
view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet
site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.286 & 93.287 (NIBIB) and 93.847,
93.848 & 93.849 (NIDDK) and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review. Awards are made under authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and
administered under NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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