and Human Services (HHS)
EXPIRED
NATIONAL TECHNOLOGY CENTERS FOR NETWORKS AND PATHWAYS
RELEASE DATE: September 30, 2003
RFA Number: RFA-RM-04-005 (formerly RFA-RR-04-003, see NOT-OD-04-008)
(see addenda NOT-RM-04-005 and NOT-RM-04-009)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
This RFA is developed as a roadmap initiative. All NIH Institutes and
Centers participate in roadmap initiatives.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.389
LETTER OF INTENT RECEIPT DATE: February 15, 2004
APPLICATION RECEIPT DATE: March 16, 2004
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
Participating Institutes and Centers (ICs) of the National Institutes
of Health invite applications for NIH National Technology Centers for
Networks and Pathways (TCNP). These centers will cooperate in a
networked national effort to develop highly novel, integrated, and
broadly applicable proteomics technologies, to include instrumentation,
biophysical methods, reagents, and infrastructure. These technologies
will be specifically directed at the fundamental technological
challenges inherent in acquiring quantitative information at the high
anatomic resolution (subcellular) and biologically relevant timescales
necessary for temporal and spatial characterization of complex
biochemical pathways and molecular interactions. Beyond cataloging of
proteins and their binary interactions, these methods will be directed
toward quantitatively defining the dynamics of complex systems.
The establishment of the TCNPs was called for in the NIH Roadmapping
Initiative in 2003. TCNPs will be supported by U54 awards. The U54
awards will principally support technological innovation. However, in
addition it is expected that the TCNPs will commit substantial
resources to collaboration with and education of biomedical
researchers, as well as the transfer of technologies to other
laboratories. It is anticipated that there will be strong, vibrant
interactions between the centers themselves and related individual
investigator projects focused on a broad range of significant
biomedical research questions. The centers should foster original and
creative contributions to scientific understanding over and above that
which would be obtained if each component of the center existed
independently.
RESEARCH OBJECTIVES
Proteomics experiments have consistently been characterized as falling
into two broad classes, either directed at defining the physical
interactions of proteins, or concerned with characterizing changes in
the expression of proteins corresponding to internal or external
perturbations of cells or systems. The methodological issue that has
largely driven this distinction is the inherent difficulty of
quantitation of individual molecules in complex systems. The
distinction is artificial, since in either instance, the goal is to
define the roles and functions of proteins in inherently dynamic
systems, whether considered as networks of interactions or steps in a
biochemical pathway.
As the results of biophysical experiments are assembled into coherent
models of these systems, temporal, spatial, and quantitative resolution
all become increasingly critical factors. While substantial and rapid
progress has been made over the past decade in the development of
analytical technologies for proteomics, the greatest successes have
overwhelmingly resided in the realm of tightly bound protein complexes.
In this case, definition of protein identity and interaction are the
two critical analytical tasks, addressed through the creative
application of molecular and cellular biological methods, often
followed by separation and mass spectrometry. However, despite
advances, current tools and reagents are still largely inadequate to
address the larger challenges of quantitative, temporal, and spatial
resolution of dynamic systems.
Similarly, it will be impossible to fully define dynamic biological
systems strictly on the basis of proteomic data. Protein interaction,
modification, translocation and expression level will need to be
considered in the context of gene transcription upstream and metabolic
products downstream. The same necessity for quantitative, temporal,
and spatial resolution applies to these analyses. Acquisition and
integration of these data are significant challenges, and substantial
difficulties remain with respect to the fundamental tasks of profiling
and cataloging biomolecules in complex systems. While efforts continue
in development of these fundamental technologies, it is important that
parallel efforts build technologies directed specifically to the
dynamics of complex systems. To facilitate the development of these
technologies and build infrastructure for support of biomedical
research, the NIH is embarking on a program to build National
Technology Centers for Networks and Pathways.
This Request for Applications (RFA) is intended to encourage
development of highly sensitive tools to measure the dynamics of
quantity, activity, translocation, or interactions of molecules in
cells. Preference will be given to applications that have promise to
be quantitative, capture information at timescales relevant to the
study of pathways and networks, and that have promise to be applied at
subcellular resolution. It is anticipated that approaches will be
valuable which can be scaled, facilitating capture of information about
a comprehensive set of molecules or with the potential for broad,
flexible application to a range of specific molecules.
These issues are deliberately discussed with respect to fundamental
analytical challenges, rather than in relation to specific
technologies, in order to emphasize the overriding importance of
surmounting these obstacles, irrespective of the analytical strategy
adopted to pursue those solutions. This solicitation encourages
unconventional or alternative approaches as a balanced portion of the
overall center effort.
Regardless of the system under study or specific experimental
approaches of proteomics, a common theme in this field is the need for
synergy among three principal domains: (1) biological issues, including
study design, sample collection and processing, sample complexity and
prefractionation; (2) analytical chemistry, including the challenges of
quantitation, maximization of separation space, and improving dynamic
range; and (3) informatics, including data handling, statistical
analyses, validation and curation, integration of results from multiple
platforms used in the center, and development of improved tools for
data analysis. These three domains should each inform the development
of tools and methods in their counterpart areas. Accomplishing this
goal in a climate of specialization demands a fundamentally
collaborative approach. It is anticipated that investigators will
assemble interdisciplinary teams from multiple laboratories.
It is not required that all participating investigators and
laboratories be located either at a single institution or in the same
local geographic area. However, because of the need for integration of
technologies at a fundamental level, it is considered critical that
participating investigators be in a position to work closely together
in an iterative manner. This is seen as particularly important for
example in the effective interfacing of analytical instrumentation.
These issues should be addressed in detail in the application. The
project will be administered through the principal investigator and
his/her institution.
The TCNPs will focus on technology development, but three features of
the program will ensure that the technology developed can be applied to
relevant biological problems. First, each TCNP is encouraged to select
a biological focus or model system that will provide a thematic focus
or context for technology development. Second, each TCNP will support
a set of Driving Biological Projects (DBPs), which will provide an
internal biological context for technology development. Third, after
the initial TCNPs have been funded, NIH anticipates releasing a new
program announcement that will support additional partnerships between
individual investigators and these centers. These awards will leverage
and complement the research activities of the U54 centers in building
comprehensive technologies for molecular networks and pathways research
focused around biological processes, cellular organelles, organs, or
diseases. It is anticipated that the announcements for partnering
projects will include both new R01's and R21's as well as competitively
reviewed supplements to existing projects. These awards will be made
by a variety of participating NIH ICs.
All applications in response to this announcement will be evaluated
primarily for the potential of the proposed activities to address the
broad challenges discussed above, where it is clear that the technology
to be developed can be used to obtain the data required to elucidate
and test models of a molecular network or pathway. However, it is
anticipated that these challenges are too broad for a single center to
address comprehensively. Investigators will be expected to clearly
define the scope of their technical and biological activities.
The funding mechanism for the TCNPs will be a U54 center. Each TCNP
will be required to perform or facilitate six different core functions:
(1) conducting core research in technology development, (2)
establishing Driving Biological Projects (DBP) to allow biomedical
researchers to interact with and drive research in the TCNP, (3)
providing infrastructure to biomedical researchers (hardware, software,
and personnel as appropriate), (4) enhancing the training for
biomedical researchers in appropriate proteomics tools and techniques,
(5) disseminating newly developed tools, reagents, and techniques to
the broader biomedical research community, and (6) providing formal
project leadership and management to ensure that these large centers
achieve their goals within the 5 to 10 year funding lifetime of the
center.
The technological research in core 1 will be the largest component of a
TCNP, focused on development of cutting edge technology and methods for
proteomic characterization of networks and pathways.
The technological R&D component consists of investigations that are at
the cutting edge of the technological field with a goal of increasing
its usefulness in biomedical research. A minimum of three technological
research projects constitutes this section of the application. An
element of high risk (high payoff) should be present in one or more of
these projects and is appropriate for this component. Investigators
should, however, present alternative approaches to solving
technological problems in the event that their main conceptual thrust
should prove unfeasible.
The technological R&D projects to be conducted must be presented in
detail. For each project describe the background, objectives,
rationale, methods and procedures, significance, and facilities
available to conduct the project. If research activities involve
support at more than one location through a consortium/contractual
arrangement, the application should provide a separate description,
detailed budget and budget justification for the consortium/contractual
component(s).
In addition to the individual technology development projects, the
interrelationships of these technologies should be described, as well
as plans for maximizing connectivity and synergy both in the
technologies and between participating groups. These discussions
should be placed in the context of the overall strategic goals of the
center's research program.
Development of complex, integrated approaches to formulating networks
and pathways will require a context within which methods development
can proceed. Investigators should consider selection of a model system
(such as a cellular process, an already characterized network or
pathway where the connections are mostly known but none of the dynamic
information), or define a thematic biological research topic that will
serve as a framework for the technological research and development
activities of the resource. Investigators should propose to tackle a
problem that is both technically challenging and relevant to biomedical
research. These projects should be structured to achieve their goal in
a 5 to 10 year timeframe.
Through collaborations, infrastructure development, training, and
dissemination, TCNPs will be expected to have a broad-based,
significant impact on a variety of biological problems. However, the
most important deliverables will be the state-of-the-art technology,
reagents and methods for proteomics research developed in Core 1.
In the context of this solicitation, technology development should be
interpreted broadly to encompass all aspects from proof of principle of
an innovative idea through development of practical instruments and
systems. It is anticipated that as innovative technology is developed,
to the extent possible, it will be optimized and brought to bear in
application to challenging biomedical research problems. It will be
considered appropriate to balance evolutionary technology development,
the refinement and optimization of current technologies, with the more
challenging development of revolutionary new approaches.
In core 2, an applicant will propose a minimum of 4 projects that
address cutting edge biological questions within the thematic
biological research topic of the Center. The projects will involve
collaborations with biomedical researchers who would use proteomic
approaches under development in the TCNP. It is not essential that the
biomedical researchers have expertise in analytical chemistry or
proteomics, but each DBP must have a question that will drive one or
more specific research projects in core 1. That linkage must be made
explicit in the description of each DBP.
The purpose of this core is twofold. The selected biomedical research
problems should provide both a driver and a test-bed for the
technological research and development carried out in core 1. In
addition, interactions with these projects should serve to ensure that
the research carried out in core 1 has direct relevance to biomedical
research. These collaborations will last for at most three years
without separate funding. It is anticipated that some DBPs will begin
during the first year, while others may be phased in over the lifetime
of the award. If appropriate, the PI and collaborating researchers
must present plans to use these DBPs as a foundation for the
collaborators to compete for independent funding for continuation of
the work. Plans must also be presented to select additional DBPs in an
ongoing manner as these are completed. It is anticipated that
independently funded biological projects, either pre-existing or
matured DBPs, will form strong continuing interactions with the TCNPs
It is expected that many of the biomedical researchers in core 2 will
not be at the same institution as the parent TCNP.
It is anticipated that technologies proposed in applications will be at
different stages of maturity, both among and between centers. It
therefore may be appropriate that the proposed function of a DBP
collaboration may be limited at least initially to helping the center
appropriately define a specific problem.
The new tools, reagents, and methods that are being developed are
likely to require substantial infrastructure to implement them. Core 3
will provide that infrastructure. This infrastructure will be used to
develop appropriate components and to provide the biomedical community
with access to these components. It is appropriate to request
hardware, software, and associated personnel in this core.
It is expected that demand may outstrip available resources. Specific
plans should be presented for the following: ongoing selection and
prioritization of new DBPs, other biological collaborative projects,
and routine service work.
The NIH's long-term goals in proteomics recognize the need to develop a
new generation of multi-disciplinary scientists. In core 4, each
center should develop mechanisms for ensuring that graduate students
and postdoctoral fellows receive broad, relevant training beyond the
specific contributions they make to the infrastructure and research
projects of the center. In addition, there should be plans for
workshops, training courses, or other mechanisms to train the larger
biomedical research community about the new tools and techniques that
the TCNP is developing.
The focus of core 5 is to disseminate new discoveries, reagents,
methods and technology to the biomedical community and to participate
in an effort to develop standards for data sharing and integration.
Publications and a genuinely useful web site are excellent ways to
broadcast some of the discoveries of the TCNP, but those routes may not
be sufficient to inform biomedical investigators who require guidance
in pursuing solutions to their questions. Innovative plans to
disseminate discoveries to the biomedical community should be presented
in core 5. It is also appropriate to discuss how hardware, analytical
methods, or software will be made available to the community in this
core and to justify possible restrictions. Finally, where appropriate,
plans to make data sets and databases available on a continuing basis
should be presented. The development of data standards and ontologies
is extremely important for sharing and communicating data and
information. It is expected that multiple TCNPs will participate
actively in an effort to develop standards for data sharing and
integration.
It is essential to provide appropriate project leadership and
management for these large centers. In core 6 the investigator should
describe management plans. Investigators are strongly encouraged to
consider proposing a project manager for the TCNP. The investigators
should undertake a planning process and document an action plan.
Elements of an action plan include determining which cores will be
established; establishing overall policies and procedures for
management of cores and Center resources. In addition, outcome
measurements should be determined and include how progress on action
plans will be measured. In addition to a project manager, it is
expected that the TCNP will interact with an advisory panel to the
program, selected by investigators and program staff after awards are
made. This committee will meet on an at least an annual basis to
review progress and offer advice. Program directors will attend these
meetings.
Multiple institutes and centers at NIH continue to support programs to
develop centers in proteomics. Recipients of those awards or contracts
are welcome to apply for the U54 centers in this announcement. It is
anticipated that in those cases, the U54 application may be tailored to
complement the center's existing mission while addressing the
additional unique features of this program. No preference will be
given either to recipients or non-recipients of previous proteomics
center awards or contracts.
MECHANISM OF SUPPORT
This RFA will use the NIH U54 award mechanism. 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 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, 2004.
This RFA uses just-in-time concepts. It also uses the non-modular
budgeting formats. This program does not require cost sharing as
defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
The NIH U54 is a cooperative agreement award mechanism in which the
Principal Investigator retains the primary responsibility and dominant
role for planning, directing, and executing the proposed project, with
NIH staff being substantially involved as a partner with the Principal
Investigator, as described under the section "Cooperative Agreement
Terms and Conditions of Award". The initial period of support for a
U54 center will be five years. NIH may reissue this RFA and allow
competitive renewals for a second period of up to five years. If
competing segments of a U54 award are shorter than five years, grantees
may apply for more than one renewal, but no center will receive more
than ten years total of NIH funding.
FUNDS AVAILABLE
The participating ICs intend to commit approximately $7.4 million in FY
2004 to fund 2 to 4 new centers in response to this RFA. An applicant
should request a project period of 5 years. The budget (direct costs)
may not exceed $2 million per year. Because the nature and scope of
the proposed research will vary from application to application, it is
anticipated that the size of each award will also vary. Although the
financial plans of the ICs 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 Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Eligible agencies of the Federal government
o Domestic institutions/organizations
o Foreign institutions are not eligible to apply
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
Applicants are encouraged to contact program staff well in advance of
the letter of intent submission date, in order to discuss the proposed
research program, budget, organization of the center, and its potential
biomedical impact. These contacts help to assure that applicants have
a clear understanding of program policies and priorities, especially
with respect to any special situations, such as the inclusion of
consortia, subcontracts, etc. It will also allow staff to assess
responsiveness to this RFA and provide appropriate guidance as needed.
Principal investigators and key personnel as appropriate are expected
to participate in an annual meeting in the Washington, DC area. Funds
for travel to the meeting should be requested in the budget.
The annual progress report for the U54 award will use the standard 2590
form. In addition, to the basic information in that form, the annual
progress report for the U54 centers will be more involved. Additional
information in the progress report will include both the progress made
in the center as well as the relationship between the center and the
individual investigator awards. Details of the U54 progress report are
spelled out in the notice of grant award and in the Terms and
Conditions section of this RFA. Applications for U54 centers should
contain appropriate personnel to collect the needed information and to
prepare this progress report.
Because of the complexity of the TCNP, program staff from NIH will
likely want to visit periodically to conduct an administrative site
visit. U54 centers should be prepared for annual visits and should
budget appropriately (including travel for collaborators and other
necessary costs).
The complexity of these centers necessitates a project manager(s). U54
centers should budget appropriately for these manager(s). One of the
review criteria for these centers will be the qualifications of these
project managers as well as whether the institution has an appropriate
career pathway for these individuals. Because of their important role,
it is recommended that the project manager be listed as one of the key
personnel.
A principle underlying this program is that substantial benefits in
technology development and biological problem solving will accrue
through successful integration of the biological, analytical, and
informatics domains of the center. The application should articulate a
specific organizational plan. This plan should describe anticipated
interactions between key personnel in support of the overarching goals
of the resource. It should also maximize synergy between the component
technologies. Ultimately, a successful center will function as a
coherent whole, rather than a collection of individual technological
capabilities. In cases where geographically distributed collaboration
is essential, the management plan should include provisions for
teleconferencing or videoconferencing as appropriate. The applicant
may include these provisions in the budget if appropriate.
To address the joint interests of the government in the availability
of, and access to, the results of publicly funded research, NIH
requires applicants who respond to this RFA to propose detailed plans
for sharing the research resources generated through the grant. It is
expected that the resources to be shared include all materials
developed in projects funded under the RFA. A reasonable time frame for
release of materials should be specified in the application and will be
considered during the review of the plan for sharing.
It is expected that the investigator's data and biomaterials sharing
plan will include the access to biomaterials and methods not currently
available to the wider scientific community. In other words, plans
for the development of resources for use by the biomedical community
should have the appropriate timeliness and mileposts. For example
software development should include plans and timeliness for alpha
testing, beta testing, production release, interface development, bug
reporting, integration with other codes, extension to multiple
platforms, etc.
Data sharing will be as important as software sharing for many National
Programs. All awards made under this RFA are subject to the Final NIH
Statement on Sharing Research Data
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).
The scientific review group will evaluate the adequacy of the proposed
plan for sharing and data access. Comments on the plan and any concerns
will be presented in an administrative note in the Summary Statement.
The adequacy of the plan will be considered by NIH program staff and
will be important in determining whether the grant shall be awarded.
The sharing plan approved by program staff, after negotiation with the
applicant when necessary, will become part of the terms and conditions
of the award. NIH program staff will evaluate the compliance with the
sharing plan and scientific progress in the non-competing continuation
of the grant award application.
INTELLECTUAL PROPERTY RIGHTS
NIH is interested in ensuring that the research resources developed
through this PA become readily available to the research community.
With regard to patentable research results, such as genetically encoded
reporters, cell lines, and vectors, the NIH requires applicants who
respond to this RFA to develop a plan addressing if, or how, they will
exercise their intellectual property rights while making available to
the broader scientific community research resources produced in
projects funded under this RFA. This is expected to include an
elaboration of the applicant's anticipated plans to generate, or not
generate, patents and/or exclusive or non-exclusive licensing of
biomaterials and other patentable subject matter created in projects
funded under this RFA. This plan should be consistent with the
applicant's institution's policies on intellectual property rights.
This plan is also expected to include disclosure of any pre-existing
agreements involving intellectual property rights, including options to
for-profit research sponsors that are associated with biomaterials and
data that may be generated. The requirement for this plan is in
addition to the requirement for the plan for sharing and disseminating
research resources described in the previous section.
The majority of transfers to not-for-profit entities should be
implemented under terms no more restrictive than the Uniform Biological
Materials Transfer Agreement (UBMTA). In particular, recipients are
expected to use the Simple Letter Agreement provided at
http://www.nih.gov/od/ott/RTguide_final.htm, or another document with
no more restrictive terms, to readily transfer unpatented tools
developed with NIH funds to other recipients for use in NIH-funded
projects. If the materials are patented or licensed to an exclusive
provider, other arrangements may be used, but commercialization option
rights, royalty reach-through, or product reach-through rights back to
the provider are inappropriate.
Similarly, when for-profit entities are seeking access to NIH-funded
tools for internal use purposes, recipients should ensure that the
tools are transferred with the fewest encumbrances possible. The Simple
Letter Agreement may be expanded for use in transferring tools to for-
profit entities, or simple internal use license agreements with
execution or annual use fees may be appropriate.
The scientific review group will evaluate the adequacy of the proposed
plan for handling intellectual property rights. Comments on the plan
and any concerns will be presented in an administrative note in the
Summary Statement. NIH program staff in determining whether the grant
shall be awarded will consider the adequacy of the proposed plan. The
plan as approved, after negotiation with the applicant when necessary,
will be a condition of the award. Evaluation of non-competing
continuation applications will include assessment of the awardee's
adherence to the proposed plan.
Applicants also are reminded that the grantee institution is required
to disclose each subject invention to NIH within two months after the
inventor discloses it in writing to grantee institutional personnel
responsible for patent matters. The awarding institute reserves the
right to monitor awardee activity in this area to ascertain if patents
or patent applications on mutagenesis protocols, cell lines, vectors,
or other patentable subject matter are adversely affecting the goals of
this RFA.
Principles and guidelines for recipients of NIH research awards on
obtaining and disseminating biomedical research resources can be found
at http://www.nih.gov/od/ott/RTguide_final.htm. A reasonable time frame
for release of materials should be specified in the application and
will be considered during the review of the plan for sharing.
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD
The following Terms and Conditions will be incorporated into the award
statement. The following special terms of award are in addition to,
and not in lieu of, otherwise applicable OMB administrative guidelines,
HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92
is applicable when State and local Governments are eligible to apply),
and other HHS, PHS, and NIH grant administration policies:
1. The administrative and funding instrument used for this program will
be the U54, an "assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH scientific and/or programmatic
involvement with the awardees is anticipated during performance of the
activities. Under the cooperative agreement, the NIH purpose is to
support and/or stimulate the recipients' activities by involvement in
and otherwise working jointly with the award recipients in a
partnership role. The NIH purpose is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with
this concept, the dominant role and prime responsibility resides with
the awardees for the project as a whole, although specific tasks and
activities may be shared among the awardees and designated NIH Science
Officers.
2. PI Rights and Responsibilities
The PI will coordinate project activities scientifically and
administratively at the awardee institution. The PI will have primary
responsibility for defining the details for the projects within the
guidelines of this RFA, and for performing all scientific activities.
The PI will agree to accept the close coordination, cooperation, and
participation of the NIH Science Officer(s), Molecular Pathways and
Network Steering Committee (MPANSC) and Molecular Pathways and Network
Scientific Panel (MPANSP) in those aspects of scientific and technical
management of the project as described below. Specifically, the PI
will:
o Determine experimental approaches, design protocols, direct
experiments, and work cooperatively to set project milestones, in
consultation with the Molecular Pathways and Network Steering
Committee (MPANSC).
o Release data according to the approved plans for sharing research
resources generated through the award, and publish results, as agreed
upon by the Molecular Pathways and Network Steering Committee
(MPANSC).
o Submit periodic progress reports in a standard format, as agreed
upon by Molecular Pathways and Network Steering Committee (MPANSC).
o Accept and implement the common guidelines and procedures approved
by Molecular Pathways and Network Steering Committee (MPANSC)and
Molecular Pathways and Network Scientific Panel (MPANSP).
o Share with other Molecular Pathways and Network facilities research
resources, tools, and data of interest to those facilities, as directed
by MPANSC and MPANSP.
o The PI and other critical staff should participate in MPANSC
meetings held in the metropolitan Washington, DC area at least twice
per year.
3. NIH Program Staff Responsibilities
The NIH Science Officer(s) will have substantial scientific/
programmatic involvement during the conduct of this activity through
technical assistance, advice, and coordination above and beyond normal
program stewardship for grants. This includes functioning as a peer
with the PIs, facilitating the partnership relationship between NIH and
the facilities funded under this RFA, helping to maintain the overall
scientific balance in the program commensurate with new research and
emerging research opportunities, and ensuring that the activities of
the centers are consistent with the missions of the participating
Institutes.
The role of NIH will be to facilitate and not to direct activities. It
is anticipated that decisions will be reached by consensus of the PIs
and that NIH staff will be given the opportunity to offer input to this
process as members of MPANSC.
Specifically, the NIH Science Officer(s) will:
o Provide relevant scientific expertise and overall knowledge.
o Participate with other MPANSC members in the group process of
setting research priorities and milestones, deciding optimal research
approaches and protocol designs, and contributing to the adjustment of
research protocols or approaches as warranted.
o Provide information about ongoing NIH-supported research and
resource collections.
o Attend MPANSC meetings as one voting member, and assist to develop
operating guidelines, quality control procedures, and consistent
policies for dealing with recurrent situations that require coordinated
action. The Science Officer(s) must be informed of all major
interactions of members of MPANSC. The MPANSC will be responsible for
preparing within 30 days a concise summary of each MPANSC meeting.
o Serve as scientific liaison between the awardees and other NIH
program staff.
o Assist in promoting the centers to the scientific community at
large.
o Assist in developing timetables for the wide distribution of
biomaterials and data to the scientific community.
o Coordinate the activities of facilities to ensure the efficient long-
term storage and timely release of biomaterials and data to the wider
scientific community.
o Help determine the most appropriate mechanisms for storage and
distribution of biomaterials and data to the scientific community,
i.e., storage and distribution by one of the facilities funded under
this RFA and/or by another NIH-funded facility.
o Retain the option to recommend re-allocating NIH support among
awardees, as scientific goals evolve.
o Participate in data analyses and, where warranted, co-authorship of
papers resulting from projects funded under this RFA.
NIH Program Director
NIH will appoint a Program Director who will have responsibility for
normal program oversight and stewardship of the award. The Program
Director may also serve as the designated Science Officer. The Program
Director will:
o Have the option to recommend withholding support to a participating
institution if technical performance requirements are not met.
o Carry out continuous review of all activities to ensure objectives
are being met.
o Appoint the MPANSC Chair based on a recommendation from MPANSC
committee members.
o Serve as a non-voting member of MPANSC if not also participating as a
Science Officer.
Serve as administrative liaison to MPANSP, attending MPANSP meetings as
a non-voting member, to help coordinate activities of facilities funded
under this RFA other NIH molecular pathways and network initiatives.
The Program Director(s) will also coordinate the activities of
facilities funded under this RFA with other US and international
efforts.
4. Collaborative Responsibilities - MPANSC Functions
MOLECULAR PATHWAYS AND NETWORK STEERING COMMITTEE (MPANSC): A committee
that is the main governing board of all of the molecular pathways and
network facilities funded under this RFA, and the committee through
which the NIH interacts and collaborates with the facilities. Voting
membership includes the NIH Science Officers(s) (one vote total), the
PI of each awarded cooperative agreement, and three scientists with
relevant expertise who are not affiliated with any of the funded
projects.
NIH will interact and collaborate with the facilities principally
through the MPANSC. After appointment by NIH, the Science Officer(s)
will schedule the first meeting and set the agenda, following which the
Chair of MPANSC will rotate among the PIs and will be responsible for
developing meeting agendas and chairing meetings. MPANSC will meet at
least twice per year, but may use video or teleconferencing rather than
face-to-face meetings, at the discretion of the committee members.
Additional MPANSC members may be added by action of MPANSC. Other NIH
staff may attend MPANSC meetings, when their expertise is required for
specific discussions.
MPANSC will coordinate the activities of the centers and the exchange
of information and biomaterials with the wider scientific community.
MPANSC will discuss scientific progress, make recommendations regarding
how the centers achieve their scientific goals. MPANSP recommendations
will be addressed by MPANSC.
5. Molecular Pathways and Networks Scientific Panel (MPANSP)
MOLECULAR PATHWAYS AND NETWORK SCIENTIFIC PANEL (MPANSP): A committee
that is advisory to NIH. MPANSP ensures coordination among TCNP
projects funded under this RFA and evaluates their progress in relation
to the evolving goals for trans-NIH initiatives on proteomics,
molecular pathways and networks.
MPANSP will use its knowledge of the activities of all of the
participating facilities to ensure adequate investigation,
communication and sharing, and to avoid redundant activities. It will
advise NIH with respect to the coordination of all activities that
involve molecular networks and pathways. MPANSP will evaluate and make
recommendations regarding the coordination of the activities of the
facilities that are funded by the molecular pathways and networks
initiative, and other related activities such as computation and data
management that may be developed in the future.
It will be the responsibility of MPANSP to make recommendations that
will lead to exchanging research tools, research resources, adopting
common policies on data sharing, creating compatible databases, and
other activities that will make these facilities of maximal utility to
the scientific community. MPANSP will also recommend standards for
data format and nomenclature, as well as develop common guidelines and
procedures for deposition of the primary data.
The committee will consist of about 10 scientists (advisors) who are
not affiliated with any of the molecular pathways and network centers.
They will be appointed by NIH. These advisors will be selected for
their broad expertise in relevant topics. MPANSP will meet at least
once each year. A schedule for subsequent meetings will be prepared at
the first meeting.
NIH will select one member to be the committee chair, after considering
MPANSP's recommendations. The chair will schedule the first meeting,
will be responsible for developing meeting agendas and chairing the
meetings. Additional MPANSP members may be added by an action of the
original MPANSP members. The MPANSC Chair and Science Officer(s) will
attend MPANSP as non-voting members and will act as representatives of
MPANSC. Other NIH staff and MPANSC members may attend MPANSP meetings,
when their expertise is required for specific discussions.
6. Milestones and Evaluations
The progress of the TNCPs will be reviewed annually by the NIH Program
Director(s) and MPANSP to assure that satisfactory progress is being
made in achieving the project objectives. During the first year of
funding, and during subsequent years if deemed necessary by the Program
Director, reviews may be more frequent. Should problems arise in the
conduct of the study, the NIH Program Director may require that the
awardee submit quarterly reports on progress and fiscal matters.
The progress report will have two components. The first will be the
standard NIH progress report (Form 2590). The second will be a more
specialized report that will go to the NIH Science Officer(s) and the
NIH Program Director. This specialized report should be included as an
attachment to the standard progress report. The contents or the report
may be changed according to programmatic needs, based on discussion
between NIH program officials, the PI and MPANSC.
The awardees' yearly milestones will be provided to MPANSC and MPANSP.
It is expected that the milestones should be adjusted annually at the
award anniversary dates, both to incorporate a group's scientific
accomplishments and progress in the field in general, as well as to
reflect MPANSC and MPANSP recommendations. Following the evaluation of
milestones, NIH program staff may recommend augmenting any project or
reducing or withholding funds for any project that substantially fails
to meet its milestones or to remain state-of-the-art.
7. Arbitration Process
Any disagreements that may arise in scientific or programmatic matters
within the scope of the award between recipients and the NIH may be
brought to arbitration. This special arbitration procedure in no way
affects the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with PHS regulations 42 CFR Part 50,
Subpart D and HHS regulation at 45 CFR Part 16. An Arbitration Panel
will help resolve both scientific and programmatic issues that develop
during the course of work that restrict progress. The Arbitration
Panel will be composed of three members: a designee of MPANSC chosen
without the NIH staff voting, one NIH designee, and a third designee
with expertise in the relevant area who is chosen by the other two (in
the case of an individual disagreement, the first member is chosen by
the individual awardee rather than by MPANSC).
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:
Douglas M. Sheeley
Division of Biomedical Technology
National Center for Research Resources
6701 Democracy Boulevard, Room 968
Bethesda, MD 20892-4874
Telephone: (301) 594-9762
FAX: 301-480-3659
Email: [email protected]
o Direct your questions about financial or grants management matters
to:
Ms. Mary Niemiec
Office of Grants Management
National Center for Research Resources
6701 Democracy Boulevard, Room 1036
Bethesda, MD 20892-4874
Telephone: (301) 435-0842
FAX: 301-480-3777
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 including those involved with the
Driving Biological Projects and other collaborations
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 (and the subsequent proposal itself) should NOT
include the names of potential members of the proposed center's
External Advisory Committee if it chooses to form one.
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:
Douglas M. Sheeley
Division of Biomedical Technology
National Center for Research Resources
6701 Democracy Boulevard, Room 968
Bethesda, MD 20892-4874
Telephone: (301) 594-9762
FAX: 301-480-3659
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 document 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].
SUPPLEMENTARY INSTRUCTIONS
It is recognized that the proposals in response to this RFA will be
longer and more complex than many other NIH proposals. In order to
ensure effective review, the Research plan should be divided into
sections according to the cores defined below, and separate page limits
should be observed for each section of up to 25 pages each. If a core
has research projects, up to 25 pages are allowed for each research
project in cores 1 and 2. See the RFA sections on RESEARCH OBJECTIVES
and SPECIAL REQUIREMENTS for additional application instructions for
the cores.
The U54 center will be required to have six cores: (1) conducting core
research in technology development, (2) establishing Driving Biological
Projects (DBP) to allow biomedical researchers to interact with and
drive research in the TCNP, (3) providing infrastructure to biomedical
researchers (hardware, software, and personnel as appropriate), (4)
enhancing the training for a field of biomedical researchers in
appropriate tools and techniques, (5) disseminating newly developed
tools and techniques to the broader biomedical research community, and
(6) providing formal project leadership and management to ensure that
these large National Programs achieve their goals within the 5 to 10
year funding lifetime of the center.
Form Pages 4-5: The budget should be completed as described in the
instruction sheet for Application for a Public Health Service Grant
(Form PHS 398). Form page 4 (the detailed budget) should be provided
for each of cores 1,2,4,5,6,and 7. Form page 4 should be provided for
each of the DBPs (core 3). A separate total budget for the entire
center should also be prepared using form page 4.
The budget justification beginning on PHS Form Page 5 should include a
detailed justification for key personnel. As part of the justification,
the percent effort that all staff are spending on each core should be
specified. For example, a particular postdoctoral fellow might spend
75% effort on core 1 and 25% effort on one of the DBP in core 2.
A detailed justification should also be supplied for equipment over
$25,000 requested for the TCNP. Details of the physical location for
this equipment should be provided. Existing equipment should also be
described.
Form page 4 (the detailed budget) should be provided for any sub-
contractual or consortium arrangements. A detailed budget
justification should also be provided for such arrangements. Use
continuation pages as needed.
Section 9, Research Plan D: Each of the six cores should be described.
It will be best if the applicant uses separate headings for each of
these cores. Cores 1 and 2 should be broken into appropriate
subheadings.
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/labels.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 on or before 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.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
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. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the ICs. Incomplete and/or unresponsive
applications will not be reviewed.
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 NIH in accordance with the review criteria
stated below. As part of the initial merit review, all applications
will:
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 written critique
o Receive a second level review by an appropriate National Advisory
Council or Board.
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 evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application's overall score, weighting them
as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The 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, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
SIGNIFICANCE: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project? Does the applicant acknowledge potential problem areas and
consider alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
ENVIRONMENT: Does the scientific environment in which the 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, the
following items will be considered in the determination of scientific
merit and the priority score:
Some of the cores for the TCNPs have specific additional review
criteria.
CORE 1: This solicitation seeks to build a program in which a
significant fraction of the effort is aimed at developing highly novel
technologies that have the potential to provide quantitative
information at high anatomic resolution (subcellular) and biologically
relevant timescales needed to elucidate the function of molecular
pathways and networks. This RFA therefore encourages the inclusion of
the more challenging development of revolutionary new approaches as a
component of the application. The degree of novelty of this component
or components, and its potential impact, will be an important review
criterion.
CORE 2: Do the investigators have appropriate plans to obtain support
for the DBPs after their support from the TCNP has terminated?
CORES 1-2: Will the work proposed in these cores help establish an
integrated approach to characterization of pathways and networks? Is
the proposed work essential to establishing this approach?
CORE 3: Are the infrastructure requests adequate to meet the demands
that are likely to come from biomedical researchers?
CORES 4 and 5: Will the proposed training and dissemination tools help
create a new group of multi-disciplinary or interdisciplinary
investigators?
CORE 6: The reviewers will be asked to address the proposed management
of the project. Will the proposed management structure allow the TCNP
to achieve its goals? Does the institution have an appropriate career
path for the project manager? Is the mechanism to terminate old DBPs
and choose new ones adequate? Will the plans to incorporate individual
investigator awards work?
Reviewers will be instructed to consider all six components of the
project as important, even if a particular component is only a
relatively small part of the budget. For example outreach and
training, while not as costly as the core development of the
technologies, is considered to be critically important for the TCNP to
have the appropriate impact on biomedical research.
SOFTWARE AVAILABILITY: Does the plan for distributing the software
reasonable allow wide and easy access? Are any fee structures
appropriate?
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the
sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of
the proposed research must include a data-sharing plan in their
application. The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the
reviewers. However, reviewers will not factor the proposed data-sharing
plan into the determination of scientific merit or priority score.
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 15, 2004
Application Receipt Date: March 16, 2004
Peer Review Date: June 2004
Council Review: September 2004
Earliest Anticipated Start Date: September 2004
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
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is
required for all types of clinical trials, including physiologic,
toxicity, and dose-finding studies (phase I); efficacy studies (phase
II); efficacy, effectiveness and comparative trials (phase III). The
establishment of data and safety monitoring boards (DSMBs) is required
for multi-site clinical trials involving interventions that entail
potential risk to the participants. (NIH Policy for Data and Safety
Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 "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
applications 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 applications 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://stemcells.nih.gov/index.asp
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, in the project description and elsewhere in the
application as appropriate 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the "Standards for Privacy of Individually Identifiable
Health Information", the "Privacy Rule," on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on "Am
I a covered entity?" Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
applications 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 at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284)and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm.
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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