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EXPIRED


NANOMEDICINE CENTER CONCEPT DEVELOPMENT AWARDS
 
RELEASE DATE:  May 4, 2004
 
RFA Number:  RFA-RM-04-018 (This RFA has been reissued, see RFA-RM-06-007)
                           (see addendum NOT-RM-04-013)

EXPIRATION DATE:  July 27, 2004

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

This RFA is developed as an NIH roadmap initiative 
(http://nihroadmap.nih.gov). All NIH Institutes and Centers participate 
in roadmap initiatives.  The RFA will be administered by the National Eye  
Institute (NEI) on behalf of the NIH.

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.867

APPLICATION RECEIPT DATE:  July 26, 2004 
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
  o Part 1   Nanomedicine Initiative Description and Research Objectives
  o Part 2   Solicitation of the Concept Development Memo
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Submitting an Application 
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

This RFA has two purposes:  

o Part 1   describes a new initiative to support a network of Nanomedicine
Development Centers.  This part of the RFA includes a description of an 
emerging NIH vision of Nanomedicine and the scientific basis driving this 
initiative.  

o Part 2   presents a solicitation of applications, or more aptly,  white 
papers,  for applicants to request support for planning the Nanomedicine
Development Centers.  

o PART 1   NANOMEDICINE INITIATIVE DESCRIPTION AND RESEARCH OBJECTIVES
Nanomedicine, an offshoot of nanotechnology, is a new term whose definition 
is evolving.  In the present context, it refers to highly specific medical 
intervention at the molecular scale for curing disease or repairing tissue.  
To stimulate work in this field, the NIH will support a major research effort 
to obtain the fundamental knowledge required to make nanomedicine a reality.  
It is at this size scale   about 100 nm or less - that biological molecules 
form the basis of systems that provide structure, control, signaling, 
homeostasis, and motility in cells. There have been many scientific and 
technological advances in both the physical and biological sciences over the 
past several years that make nanomedicine research particularly attractive at 
this time. For example, new tools are being developed that permit imaging of 
structure at this scale, high speed measurement of the dynamic behavior of 
molecular assemblies, and measurement of forces at the molecular scale. These 
advances are complemented, on the biological side, by our knowledge of the 
human genome and a greater understanding of the molecular pathology of some 
diseases.  The future of nanomedicine shows promise for providing us with 
better control of intracellular machinery, leading to better diagnostic tools 
and more specific treatments of disease with fewer side effects.
 
The NIH Nanomedicine Vision

A goal of this initiative is to characterize quantitatively the molecular 
scale components or nanomachinery of the cell and to precisely control and 
manipulate these molecules and supramolecular assemblies in living cells to 
improve human health. There are several other research efforts across the NIH  
in nanotechnology (http://www.becon.nih.gov/nano.htm).  This Nanomedicine 
Initiative is distinguished from the others by its long-term focus on 
characterizing cellular processes and nanomachinery and their interactions at 
a level of precision that has not been achieved to date. This Initiative will 
exploit and build upon other research in nanotechnology, and apply it to 
studies of molecular systems in living cells which contain a multitude of 
nanoscale structures, such as membrane transporters; processes, such as self-
assembly of protein-nucleic acid complexes; and nanomachines, such as 
molecular motors. Well controlled manipulation of these and other 
intracellular processes and structures has not yet been achieved. As a first 
step, this initiative will define what is needed to precisely control 
cellular events at the molecular level including data collection, concept and 
model development, and creation of the physical tools for manipulating the 
processes and components in living cells. We anticipate that this knowledge 
will provide the essential scientific basis required to repair or replace 
damaged or diseased cellular systems.

Another important aspect of this initiative is the recognition that the 
precise control required to manipulate cellular components will require the 
understanding and use of engineering principles. To this end, the approach 
will be informed by the design principles gleaned from the molecular 
processes and structures found in living cells. In other words, biological 
tissues have evolved elegant, intricate pathways, molecular structures, and 
"devices" at the nanoscale. The long-term goal is to exploit these designs to 
build new nanoscale devices for biomedical use.

At present, there are gaps in our knowledge about most of the physical 
characteristics of cellular components such as their exact quantities and 
variations, location, timescales, interactions, affinities, force generation, 
flexibility and internal motion. Progress, using analytical models of 
molecular interactions already in hand, is stymied by this lack of 
information. More comprehensive models describing cellular structures and 
associations will be developed by using the knowledge gained from such 
precise quantitative physical measurements. To do so, new physical methods, 
instruments, and tools must be developed. In addition, computational tools 
for data collection, storage, analysis and dissemination must be refined. 

In examining the long-term horizon, we expect that the next level of 
investigation will identify and define the design principles and operational 
parameters of naturally occurring nanostructures and complexes in cells. This 
knowledge will lead us to develop strategies and fabrication methods to build 
nanostructures, assemblies, and systems that ultimately will lead to specific 
control of various individual cellular components, from the smallest 
molecules to the largest organelles, in order to treat disease or repair 
damage.

If we are to achieve improved health by employing new nanoscale materials, 
then this initiative bears the responsibility to investigate interactions 
between the physical materials and devices that we develop and biological 
tissues. Most existing nanomaterials (e.g., carbon nanotubes and quantum 
dots) were not designed for biocompatibility or biodegradability.  One of our 
goals is to design particles, materials, and devices that can be used in 
vivo.

What do we need to learn in order to engineer molecular-sized components? 
What types of measurements are lacking but, if made, could propel this effort 
forward? The following specific examples are presented only to illustrate 
what we mean by physical, quantitative measurements that may be required to 
fill gaps in our knowledge. We are not suggesting these as topics of 
particular interest to this initiative or as areas that are any more or less 
in need than others, but as examples to convey the ideas presented above.

Protein-Protein Interactions.  Knowledge of protein interactions is crucial 
for understanding the pathways and networks operating within and between 
cells. Collection of protein-protein interaction information on a genome-wide 
basis is now possible. However, most of the approaches available today fall 
short of gathering the needed information. Yeast two-hybrid measurements, for 
example, remove the protein-coding DNA sequences from the cells of origin and 
place them in an artificial environment. In doing so, subtleties of the 
actual intracellular behavior are lost as a consequence of this experimental 
manipulation.  The results are also not quantitative, for instance, with 
respect to binding constants. The next generation of tools will need to 
enable both qualitative and quantitative studies on the precise protein 
interactions in situ.

Intracellular Transport.  The transport systems present in eukaryotic cells 
organize and move organelles within the cytoplasm, orchestrate and implement 
the distribution of replicated chromosomes to daughter cells, and are the 
basic machinery of cellular migration. Years of innovative research have 
generated detailed knowledge of the cellular organization and control of 
these dynamic systems. Mathematical models of their operation have been 
developed, but many key parameters, such as, rates of polymerization, 
nucleation, capping, or dissociation, must be estimated because they cannot 
be measured directly. Indeed, measurements central to the functions of these 
transport systems, such as stresses on the fibers, forces generated by 
assembly of the fibers or by interactions of fibers with the motors or other 
cellular structures, and force and dynamics of adhesion to substrates 
currently cannot be measured in vivo.

Biomolecular Dynamics.  Often, measurements of molecular processes on a 
biologically relevant timescale are inadequate. For example, studies of 
second messenger signaling require harvesting tens of thousands of cells to 
measure significant changes of intracellular concentrations of relevant 
molecules. The methods require substantial time, at least on the order of 
seconds, before the first data points are measured. Is 10 seconds a rapid 
enough measurement? 5 seconds? Are studies with techniques that require such 
large quantities of material feasible or necessary for precision studies of 
nanoscale events? Is the information from these types of studies adequate to 
lead to the precision required for more refined, quantitative models? 
Clearly, a very different set of tools is needed to probe intracellular 
molecular events on the biologically-relevant timescales of milliseconds or 
even microseconds.

These are just a few examples that typify the shortcomings in available 
knowledge and technology. A primary goal of the Nanomedicine Initiative is to 
stimulate development of radically new technologies that might provide novel 
strategies and new insights for cell biological studies of intracellular 
molecular interactions. 

Formulating the Program for a Network of Nanomedicine Development Centers 

Based on discussions with hundreds of scientists early in the planning for 
the NIH Roadmap (Zerhouni, E., 2003, Science 302:63-72), the following 
concepts have been developed for the Nanomedicine Development Centers 
program.  While it is anticipated that the final program will have many of 
the features outlined here, the NIH invites the research community, through 
the processes initiated in this RFA, to help to formulate this program.  

Initially, work at the Centers will determine what additional measurements 
and analytical and computational tools are needed to understand biological 
system design at the molecular level. Next, the Centers will develop, refine,  
and apply them to biological systems. This, in turn, will lead to using the 
knowledge to engineer molecular structures, assemblies, and organelles for 
treating diseased or damaged cells and tissues.  We anticipate that reaching 
all of these goals may require ten years or more.

Each of the Nanomedicine Development Centers will be formed around a specific 
theme that will serve as a model on which to focus studies of broader 
relevance.  For example, a Center may choose a model molecular system or 
pathway, such as a particular signaling pathway, a system of molecular 
motors, a proteasomal degradation pathway, an energy transduction system, or 
the transport of materials across membranes.  Alternatively, a Center may 
choose a cell type or disease as a model.  Regardless of the specific theme, 
the focus will be on the biological system and its relevance to health, not 
on the technological approach, per se, since several technologies will most 
likely be required to acquire the range of physical data types needed to 
solve the biomedical problem.  Nonetheless, the expectation is that the level 
of technology development in the Centers will be high. 

Additionally, each center will develop new tools as well as refine existing 
ones, evaluate materials on which the tools will be based, generate tools 
that can be used at large scale and high throughput, and develop novel 
algorithms and modular systems for analysis and data handling that can be 
merged with tools developed by other groups.  

Another emphasis of this program is to develop new tools and knowledge that 
can be generalized and therefore transcend any individual model pathway, 
molecular assembly, cell type, or disease. Although work may begin with well 
characterized models, greater efforts should be devoted to developing tools 
whose potential for application is broader than the individual model system 
or class of problem (e.g., cytoskeleton vs. signaling pathway vs. ion 
channels vs. machinery for replication, transcription or translation).  
Optimal measurement tools would be sufficiently powerful and generic that 
they would not need to be re-created for each molecule (e.g., today we must 
produce a GFP reporter construct for every gene and gene variant we wish to 
study, or several constructs to conduct FRET studies of molecular 
rearrangements).  Given this approach, it will be essential for the 
Nanomedicine Centers to collaborate on setting priorities and resource 
allocation with other Nanomedicine Centers, in order to maximize the 
resources and capabilities of the Centers.  That is, each Center would not be 
expected to be comprehensive but would operate as part of a network so that 
new capabilities are generated efficiently and without redundancy. 

These Centers will require collaboration by scientists from disciplines that 
may not typically interact with each other. For example, Centers might be 
populated with cell biologists, mathematicians, biochemists, engineers, 
molecular biologists, statisticians, etc. A key to progress in nanomedicine 
is the development of multi- and interdisciplinary teams of scientists who 
together will define the properties, knowledge, and concepts required by this 
initiative.

Implementing this Initiative for Developing a Network of Nanomedicine Centers

This Centers program will be developed and implemented in a different fashion 
from standard NIH procedures. The scientific scope and the administrative 
structure required for the Nanomedicine Development Centers are currently 
only partially defined. The NIH Nanomedicine Roadmap Implementation team has 
devised a novel plan to work with the scientific community to develop the 
scientific and organizational ideas that will lead to a solicitation for 
applications to generate these centers. Our plan will be distinguished by a 
high level of interaction of potential applicants with each other and with 
NIH staff prior to announcing the final solicitation.  This process was 
designed to stimulate new collaborations that will result in more effective 
Centers.  We expect that this high degree of interaction will lead to Centers 
that operate as a network, with each Center working on a unique set of 
problems but cooperating and sharing information with the others.  Once the 
Centers are funded, the NIH will continue to facilitate interaction and 
collaboration among Centers with periodic meetings of key Center scientific 
representatives.

A three-step process for applicants has been developed.  APPLICANTS MUST 
PARTICIPATE IN EACH STEP OF THE PROCESS TO BE ELIGIBLE TO APPLY FOR THE 
CENTER GRANT IN 2005.  

Step 1:  Concept Development Memo (CDM) - the short  white paper  

The CDM will broadly outline the applicant's vision for the content and 
structure for a nanomedicine center, as well as how planning funds would be 
used to further develop this vision. Successful applicants will receive a 
Concept Development Award (CDA) for developing a more extensive plan for a 
Nanomedicine Center.  The specific requirements for preparing the  white 
paper  are outlined in PART 2 of this RFA (see below).

Step 2: Concept Development Plans (CDP)   the long  white paper   

The product of the Concept Development Award is the CDP. The best features 
from the submitted CDPs will be incorporated into the final solicitation for 
the Nanomedicine Development Centers. 

Step 3: Nanomedicine Development Center Application

Only applicant teams who have submitted both the CDM and CDP will be eligible 
to apply for funding for a Nanomedicine Development Center in 2005.  

The NIH Roadmap has set aside $6 million annually for Nanomedicine 
Development Centers beginning in 2005.  It is anticipated that three or four 
awards for up to five years, will be made.  Pending availability of 
additional funds in 2006, the initial Centers may be expanded, or additional 
awards will be made, or both.  If additional awards are to be made, this 
second solicitation would be open to the entire research community. 

o PART 2   SOLICITATION OF THE CONCEPT DEVELOPMENT MEMO (CDM) 

The CDM is a brief  white paper  that outlines the applicant’s vision for a 
Nanomedicine Development Center and the set of problems the center might try 
to solve.  This vision should begin with the concepts described in this RFA, 
and develop them further based upon the applicant’s understanding of the 
science, the technology, and the medical needs.  The applicant should also 
propose a structure for the proposed center and include a budget and 
justification to support activities necessary to prepare a Concept 
Development Plan (CDP, see below).  Concept Development Awards (CDA) will be 
made by September 30, 2004, and the deadline for CDPs will be February 15, 
2005.  Therefore, in their CDM, applicants should propose a budget that can 
be used effectively during this time period to gather key investigators for 
planning meetings, to organize small workshops with members of other 
scientific, clinical or engineering communities, or organize any other 
planning activities that will facilitate the assembly of teams and the 
production of a CDP.  The award notice for the CDA will contain an explicit 
term, requiring submission of a CDP to the NIH by February 15, 2005.

Applicants submitting a CDM for obtaining a Concept Development Award need to 
understand the next steps in this process, because the CDM and CDA lead 
directly to submission of the Concept Development Plan (CDP). Therefore, even 
though this RFA only solicits the CDM, information about the CDP and 
subsequent steps is presented here. 

The Concept Development Plan (CDP) will be a more extensive, substantive, 
 white paper  to (1) describe a vision for the proposed NIH Nanomedicine 
Development Center, (2) describe the specific scientific and technical 
approaches that the applicant team would propose in the subsequent Center 
application, and (3) propose a structure for the overall NIH Nanomedicine 
program, including how each Center, and the network of Centers, should be 
structured and should operate.  The notion that these Centers will operate as 
a network is driven not only by the high value of collaborative interactions 
but also by the benefits derived from sharing essential, expensive resources,  
and avoiding duplication of efforts.

The vision for this Nanomedicine Initiative, expressed in this RFA, is 
intentionally ambitious.  Because this vision may evolve, the scientific 
goals and structural ideas of how these Centers will operate may also change.     
Thus, the CDP components requested in the previous paragraph should be 
written to explicitly address this ambitious vision but in a critical, 
rigorous fashion that might also include refining the vision and ideas 
expressed here.

The CDP will include a 2 to 3 page public abstract that will be shared with 
all participants in a meeting to be held at the NIH in approximately March 
2005, to which all authors of substantive CDPs will be invited.  The CDP will 
also include 15-20 pages that will be held in confidence and used, by NIH 
staff and a group of scientific consultants, in combination with information 
exchanged at the March 2005 meeting, as a basis for the formal solicitation 
for the Nanomedicine Development Centers.  Further instructions for preparing 
the CDP will be provided to CDA awardees.

In summary, the timetable for awarding the first group of Nanomedicine 
Development Centers is as follows:

May 4, 2004          Public meeting to describe this RFA and the overall
                     Nanomedicine Initiative

July 26, 2004        Receipt of Concept Development Memos (step 1)

September 30, 2004   Funding of Concept Development Awards

February 15, 2005    Receipt of Concept Development Plans (step 2)

March 2005           Meeting of submitters of Concept Development Plans

April 2005           Publication of solicitation for Nanomedicine Development
                     Centers

July 12, 2005        Receipt of applications for Nanomedicine Development
                     Centers (step 3)

September 2005       Funding of Nanomedicine Development Centers

MECHANISM OF SUPPORT

This RFA will use a Flexible Research Authority PN1, Nanomedicine Concept 
Development 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.  The anticipated award date is September 30, 2004.

FUNDS AVAILABLE

The NIH intends to commit approximately $1.5 million in FY 2004 to fund 
approximately 20 new awards in response to this RFA. An applicant may request 
a project period of up to 6 months and a budget for direct costs of up to 
$50,000 (plus associated F&A). Although the financial plans of the NIH 
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 (CDMs).  This initiative may be repeated in future 
years depending on the success of the program and the availability of funds.

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 Foreign institutions are not eligible to apply, but may collaborate 
with U.S. institutions and may receive funding.
 
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 (CDM) 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

The CDM is the first of three steps for applicants. In order to be eligible 
to submit an application for a Nanomedicine Development Center in July 2005, 
applicants must have submitted a Concept Development Memo, must have received 
a Concept Development Award, and must have submitted a Concept Development 
Plan.

The principal investigator or any other co-investigators listed in the CDM 
may be the lead author of the CDP, and the lead author or any co-investigator 
listed in the CDP may be designated as the principal investigator of the 
Center application.  Thus, the PI and/or applicant institution may change but 
must meet all eligibility requirements.  However, we expect that each CDA can 
lead to only one CDP, and each CDP can only lead to one Nanomedicine Center 
application.

Submission of a Concept Development Plan (CDP) by February 15, 2005, will be 
an explicit requirement of the Notice of Award for all Concept Development 
Awards.

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/peer review or financial/grants management 
issues:

o Direct your questions about scientific/research/review issues to:

Richard S. Fisher, Ph.D.
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Room 1300
Bethesda, MD  20892-9300
Telephone:  (301) 451-2020
Email:   [email protected]

o Direct your questions about financial/grants management matters to:

Mr. William Darby
Chief, Grants Management Branch
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Room 1300
Bethesda, MD  20892-9300
Telephone:  (301) 451-2020
Email:  [email protected]

SUBMITTING AN APPLICATION

Applications (CDMs) must be prepared using only the specified pages from PHS 
398 research grant application instructions and forms (rev. 5/2001; see 
below, SUPPLEMENTARY INSTRUCTIONS). 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

The Concept Development Memo (CDM) consists of two sections: 

o  Use only the following PHS 398 pages:  Face Page (Form Page 1);  
Description, Performance Sites, and Key Personnel page (Form Page 2); 
Detailed Budget for Initial Budget Period (Form Page 4) including 
justification;  Biographical Sketches for the P.I. and Key Personnel; and 
Checklist Form Page (include as the last page of the application).

o  A white paper, in PHS 398 Continuation Page format using standard font, 
spacing and margin rules.  The white paper should be structured as the 
applicant finds most effective.  The white paper may not exceed five pages 
and must be self-contained including any figures.  No appendix material or 
website links for additional information are acceptable.  The CDM must 
include:

- a broad outline of the applicant’s vision for a Nanomedicine Development 
Center, with emphasis on the set of problems the center might try to solve, 
and a preview of the approaches that might be used.  This vision should 
explicitly address the concepts described in this RFA and should develop them 
further based upon the applicant’s understanding of the scientific, 
technological and medical needs.  Applicants are encouraged to think more 
broadly than their current research program and begin developing 
collaborations that would be further cultivated if the CDM results in an 
award (CDA).  The characteristics of the proposed team, such as expertise and 
other required broad capabilities, should be described even if all of the key 
individuals have not yet been identified.  It would be advantageous if some 
of the potential collaborators contribute to the development of the CDM.

- a plan for using the Concept Development Award to produce the Concept 
Development Plan (described above) including a justified budget.  The budget 
may include funds for travel, workshops, and other activities required to 
facilitate planning for submission of a Concept Development Plan.  Up to 
$1000 each for the P.I. and up to two co-investigators, to participate in the 
March 2005 meeting at NIH, may also be included.

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 (CDM), including the Checklist, and three 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)
 
At the time of submission, two additional copies of the application must be 
sent to:

Richard S. Fisher, Ph.D.
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Room 1300
Bethesda, MD  20892-9300
Email:   [email protected]
 
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. 

REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness and 
responsiveness by NIH staff.  Incomplete applications will not be reviewed.  
If the application is not responsive to the RFA, it will be returned to the 
applicant without review.

Applications that are complete and responsive to the RFA will be evaluated by 
a Nanomedicine Evaluation Panel comprised of the Nanomedicine Roadmap 
Implementation Working Group members and outside scientific review 
consultants.

Applications will be reviewed and ranked in accordance with the review 
criteria stated below. Applicants will receive a brief written summary of the 
outcome of the review.
 
REVIEW CRITERIA

The following topics will be evaluated in the merit review of the CDM. The 
Panel will weight the topics as appropriate for each application.

1. Merit of proposal for the applicant’s vision of a Nanomedicine Development 
Center.  The relevance of the proposed Center to the Nanomedicine Roadmap 
Initiative will be evaluated.  The evaluation of the proposal may include but 
is not limited to:

o  Justification for the model system(s) chosen
o  Toolbox to be applied and developed 
o  Clarity of analysis of the shortcomings of current capabilities and
impediments to be overcome
o  Approach to generalizing results/solutions
o  Anticipated design principles to be learned from the model system
o  Analysis of the need for collaborative areas and interdisciplinary
interactions
o  Approach to efficiently integrating with ongoing efforts and 
existing/emerging resources
o  Qualifications of the investigative team
   
2.  Merit of validity and creativity for using requested planning funds to 
facilitate the planning and writing of the Concept Development Plan (CDP).

The appropriateness of the proposed budget for planning activities will also 
be evaluated but will not be incorporated into the CDM ranking.

RECEIPT AND REVIEW SCHEDULE

Application Receipt Date:               July 26, 2004
Scientific Merit Review Date:           August 2004
Earliest Anticipated Start Date:        September 30, 2004
Receipt of CDP:                         February 15, 2005

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific merit (as determined by review)
o  Availability of funds
o  Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

AUTHORITY AND REGULATIONS: 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), FY 2004 Consolidated 
Appropriations Resolution P.L. 108-199, Sections 221, (a) and (b).  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.



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