DEVELOPMENT OF HIGH RESOLUTION PROBES FOR CELLULAR IMAGING     

RELEASE DATE:  September 9, 2003
  
RFA Number:  RFA-RM-04-001 (formerly RFA-GM-03-013, see NOT-OD-04-008)

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:

The National Institutes of Health (NIH)
 (http://www.nih.gov/)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:  

National Institute of General Medical Sciences (NIGMS)
 (http://www.nigms.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.nih.gov)
National Human Genome Research Institute (NHGRI)
 (http://www.genome.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.859 (NIGMS); 93.286, 
93.287 (NIBIB); 93.172 (NHGRI)

LETTER OF INTENT RECEIPT DATE: October 20, 2003 

APPLICATION RECEIPT DATE: November 20, 2003 
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
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 Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of General Medical Sciences (NIGMS), the National 
Institute of Biomedical Imaging and Bioengineering (NIBIB), and the 
National Human Gnome Research Institute (NHGRI) invite applications for 
P20 Exploratory Center Grants to support multi-investigator teams to 
develop new technologies to enable higher sensitivity biological imaging 
in living cells. The purpose of this RFA is to encourage and facilitate 
novel, high-risk strategies to create fundamentally new probes with 
enhanced spectral characteristics with the goal of improving detection 
schemes by a factor of 10 to 100. Parallel improvements in probe 
targeting, cellular delivery, and signal detection will be required. The 
ultimate goal will be to develop probes that can be used to routinely 
achieve single molecule sensitivity for imaging dynamic processes in 
living cells. Although the focus of the RFA is on the development of 
probes for live cell imaging, the NIBIB will accept applications that 
emphasize pre-clinical development of imaging agents for the detection, 
diagnosis, or measurement of treatment efficacy for different disease 
processes.

RESEARCH OBJECTIVES 

Background

Recent growth in atomic level structural information, obtained through X-
ray crystallography and nuclear magnetic resonance (NMR), has greatly 
increased our knowledge of biological structures. Despite the tremendous 
value of these structures, little is known about molecular movement, 
intracellular molecular dynamics, and the formation of transient 
assemblies inside the cell. Temporal or spatial relationships among 
individual molecules as they move within the cell cannot be captured by 
examining isolated static structures in vitro or by analyzing indirect 
biochemical or genetic data. Imaging organelle structure in frozen or 
fixed cells gives information about cellular context but is limited by its 
static 'snapshot' view. Dynamic imaging of molecules in vivo is required 
to track structural changes over time and to obtain direct information 
about native structures within the cell. Despite the increasing demand to 
image cellular processes, however, the tools and reagents are not well 
developed. 

The lack of sufficiently sensitive molecular probes and detection schemes 
for imaging individual molecules in vivo is a significant barrier to 
obtaining real-time information on dynamic cellular processes. A variety of 
probes are currently used for in vivo studies, but their chemical and 
photophysical properties limit their use and resolution within the 3-D 
context of the living cell. Detection in eukaryotic cells using currently 
available probes typically requires signals from tens to thousands of 
molecules. Problems with spectral intensity, photobleaching, isomerization, 
and large size limit their utility. Additional difficulties with probe 
targeting, cell delivery and detection instrumentation contribute to a 
detection sensitivity level that is estimated to be too low by a factor of 
100-1000. The development of improved technology to increase the sensitivity 
of the probe signal 10-100 fold from what is currently possible would be a 
significant step forward. 

Scope of Research

The objective of this RFA is to encourage and enable teams to initiate 
collaborative projects to develop new probes for molecular and cellular 
imaging. The overall goal is to establish programs to create complete 
toolsets for detection of single molecule events in living cells and to 
generate new strategies for dramatically increasing the resolution of 
imaging dynamic cellular processes. It is expected that new principles and 
high-risk approaches will be employed in the construction of probes. 
Although the probes developed under this RFA will be used for the study of 
basic molecular and cellular processes, the technology developed may 
eventually be adapted for clinical use.

Examples of research that are appropriate for support by this RFA include:
1) Addressing the need for higher sensitivity and greater flexibility in 
probes for in vivo imaging
2) Addressing current bottlenecks related to spectral intensity, blinking, 
photobleaching, isomerization, signal-to-noise, and large size of labels
3) Developing new approaches to create genetically encoded probes with 
high quantum yield for routine detection of single molecules in vivo in 
eukaryotic cells; to develop probes that emit the maximum number of 
photons before bleaching  
4) Identifying genetically encoded fluorescent proteins in nature that are 
superior to those currently used
5) Developing new strategies to create genetically encoded domains that 
'capture' optically active, membrane permeable, diffusible probes 
6) Exploiting in vitro evolution strategies to maximize the spectral 
characteristics of genetically encoded probes
7) Exploiting strategies in combinatorial chemistry or coordination 
chemistry to find new ways to intensify the probe signal 
8) Creating multifunctional probes that generate a signal in more than one 
imaging modality (e.g., optical microscopy/electron microscopy, or 
x-ray/optical microscopy) 
9) Developing new approaches to deliver and adapt inorganic materials 
(metallic colloids, magnetic nanoparticles, quantum dots, nanocrystals, or 
other) to the cellular environment; to address problems related to 
membrane permeability
10) Developing strategies for 'multiplexing' probe signals by combining or 
linking optically active molecules 
11) Developing novel strategies for delivering probes into cells and for targeting 
specific molecules without disrupting cell physiology
12) Developing detection strategies and hardware to maximize signal amplification

NHGRI, as a participant in this solicitation, is especially interested in 
technologies that fall under examples 3, 5, and 6 above, with emphasis on 
technologies that have a reasonable future potential to provide information 
regarding the dynamic presence, location, association, and/or activity of 
proteins.  

The participating Institutes strongly encourage potential applicants to 
discuss their ideas with Institute program staff and to send a letter of 
intent prior to submission to ensure that the application will be 
responsive to the mission and intent of this RFA.

Exploratory Center Grant Activities

Exploratory Center Grants will be expected to: 1) establish a 
collaboration that requires the interaction of a minimum of three to four 
investigators with different expertise spanning areas relevant to the 
development of the proposed technologies. These are likely to include 
investigators from the following areas: (i) molecular/cell biology, 
including delivery and targeting technologies; (ii) chemistry (especially 
synthetic organic chemistry and photochemistry); (iii) current cellular 
or molecular imaging methods; (iv) physical and engineering principles of 
the instrumentation used in cellular imaging; 2) establish a strategy for 
creating and testing new probes, including setting up the detection 
instrumentation and the model test system; and 3) develop methods for 
delivering probes into cells and targeting them to specific molecules.

Groups of investigators at different institutions are welcome to apply.

MECHANISM OF SUPPORT
 
This RFA will use NIH P20 Exploratory Center Grant mechanism. 
Applicants will be solely responsible for planning, directing, and 
executing the proposed project. The earliest expected award date is 
July 2004. It is anticipated that this RFA will be re-issued for a 
second time with a submission deadline in late 2004 and an expected 
award date in 2005. P20 Exploratory Grants will not be renewable, but 
rather are expected to lead to more mature projects that can attract 
other sources of funding. Plans for subsequent full-scale imaging 
centers are under discussion and will depend upon the resources 
available for this activity.

This RFA uses just-in-time concepts and the non-modular budgeting 
format (see http://grants.nih.gov/grants/funding/modular/modular.htm).

Proposals to develop technologies to advance other aspects of imaging, but 
are not specifically designed to achieve single molecule detection in vivo 
or to amplify probe sensitivity, should be submitted in response to NIH's 
bioengineering announcements:

http://grants.nih.gov/grants/guide/pa-files/PA-03-058.html
http://grants.nih.gov/grants/guide/pa-files/PA-02-011.html
 
FUNDS AVAILABLE
 
The participating ICs intend to commit approximately $7 million in FY 
2004 to fund seven to nine new P20 Exploratory Center Grants in 
response to this RFA. An applicant may request a project period of up 
to four years and a budget for direct costs of up to $500,000 per year. 
Costs for major items of equipment or indirect costs associated with 
consortium or sub-contractual arrangements will not be considered as 
part of the $500,000 direct cost limit. Because the nature and scope of 
the proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary. 
Although the financial plans of the Institutes include funds to support 
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 domestic institution has any 
of the following characteristics: 

o 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  

Applications from foreign institutions and for-profit organizations 
will not be accepted; however, participating collaborators can be at 
foreign institutions and for-profit organizations and may be included 
through subcontracts.
 
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 

It is essential that the P20 Exploratory Center Grant be used to 
support a true collaborative team effort. Participating investigators 
may be at the same or different institution as the PI. A significant 
contribution from a chemist is a requirement; it will be the 
responsibility of the Principal Investigator (PI) to demonstrate how 
the chemist and the other collaborators will be integrated into the 
project. Ideally, since a minimum of three to four investigators will 
be included, each investigator must have primary expertise in different 
areas covering (i) molecular/cell biology, (ii) chemistry (especially 
photochemistry and synthetic organic chemistry), (iii) cellular 
imaging, and (iv) physics, engineering, instrumentation. The role and 
level of effort of each investigator should be justified within the 
context of the specific aims. 

A plan should be presented for coordination of the efforts of the 
individual investigators. This should include how (and how often) the 
team will meet and a description of the anticipated flow of work 
between the PIs that indicates how they will interact to accomplish the 
aims. 

The NIH is interested in ensuring that the information about new methods, 
technologies, and reagents developed through this program become readily 
available to the research community. Applicants should develop and propose 
specific plans for sharing of data, materials, and resources, taking into 
consideration the guidance issued by NIH http://ott.od.nih.gov/ and 
http://grants.nih.gov/grants/policy/data_sharing. The plans for sharing of 
data, materials and resources must be approved by NIH staff prior to award. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants. Inquiries may fall into 
three areas:  scientific/research, peer review, and financial or grants 
management issues:

o Direct your questions about scientific/research issues to:

Catherine Lewis, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
Building 45, Room 2AS-13C
Bethesda, MD  20892-6200
Telephone:  (301) 594-0828
Email:  lewisc@nigms.nih.gov

Brenda Korte, Ph.D.
Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard – Suite 200
Bethesda, MD 20892-5469
Telephone:  301-451-4774
Fax:  301-480-4973
Email:  kortebr@mail.nih.gov

Adam L. Felsenfeld, Ph.D.
Program Director
Large-scale Sequencing
National Human Genome Research Institute
Building 31 Room B2B07
Bethesda, MD 20892-2033
Telephone:  (301) 496-7531
Email:  adam_felsenfeld@nih.gov

o Direct your questions about instrumentation and software to:

James F. Deatherage, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
Building 45, Room 2AS.13J
Bethesda MD 20892-6200
Telephone:  (301) 594-3828
Email:  deatherj@nigms.nih.gov

o Direct your questions about peer review issues to:

Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
Building 45, Room 3AN.12F
Bethesda, MD  20892-6200
Telephone:  (301)594-2881
Email:  sunshineh@nigms.nih.gov

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

Grace Olascoaga
Grants Management
National Institute of General Medical Sciences
Building 45, Room 2AN.32E
Bethesda, MD  20892
Telephone:  (301)594-5520
Email:  olascoag@nigms.nih.gov

Nancy Curling 
Acting Grants Management Officer 
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd., Suite 900
Bethesda, MD 20892-2077
Telephone:  301-496-9315
Fax:  301-480-4974
Email:  curlingn@mail.nih.gov

Ms. Jean Cahill 
Grants Administration Branch 
National Human Genome Research Institute 
Building 31, Room B2B34, MSC 2031
Bethesda, MD 20892-2031
Telephone:  (301) 402-0733 
FAX:  (301) 402-1951 
E-mail:  Jean_Cahill@nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows IC staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document. The letter of intent should be sent to:

Catherine Lewis, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
Building 45, Room 2AS-13C
Bethesda, MD  20892-6200
Telephone:  (301)594-0828
Email:  lewisc@nigms.nih.gov

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) 435-0714, Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS 

This research solicitation is for high-risk exploratory studies to 
explore the potential of possible new enabling technologies. Proof of 
principle may be lacking in the preliminary data prior to submission, 
and obtaining it should be one of the goals of the research. 
Nevertheless, a complete research and development pathway leading to 
single molecular event detection should be proposed. The strategy 
should address all the steps needed to assemble the components of a 
complete system including delivery into cells, targeting, reporting, 
and detection.  The timeframe for achieving the goals may be longer 
than five years; the proposal should present a plan for the first four 
years of support, but also address the longer term strategy. The total 
page limit for the sections "Background and Significance," "Progress 
Report and Preliminary Data," and "Research Design and Methods" is 15 
pages.

Specific Aims:
It is anticipated that the initial coordination, strategy discussions, 
and planning will require time during the first year of the project, 
primarily because the nature of the research will be new and the groups 
may not be fully formed. Thus, it will be acceptable to include 
planning as a legitimate first step (aim) and to defer much of the 
experimental work for years 2-4 of the project, if necessary. For 
groups that are already working well together, however, it will be 
possible to initiate experiments soon after the award is made.

Background and Significance:
It is expected that the proposed research activities may not have been 
initiated. In these cases, the rationale for the research strategy 
should be developed from the published literature and not necessarily 
the applicants' own publications.

Progress Report and Preliminary Data:
Develop and describe the scientific rationale. It is expected that many 
of the most promising ideas relevant to this RFA will be untested and 
that most applicants will not have carried out systematic preliminary 
studies on the design of new probes. Unpublished preliminary data may 
exist on a new approach but may be in a relatively crude form. For these 
reasons, preliminary data (published or unpublished) are not required, 
should be kept to a minimum, and will not be a major criterion for 
review. More emphasis will be placed on development of the proposed 
strategy based on the combined insight, knowledge and experience of the 
collaborators. Applicants should discuss the qualifications of the 
collaborators and the criteria for selecting any additional collaborators 
who would participate but have not yet been recruited.

Research Design and Methods:
The general approach should be described. An explanation should be 
provided for how this approach will lead to increased sensitivity in 
signal detection. Relevant literature to support the potential of the 
proposed approach should be cited. The proofs of principle that must be 
obtained should be described. In view of the long-term nature and 
anticipated difficulty of the goals, elements of risk in approach and 
research plans are expected and acceptable. Nevertheless, the potential 
difficulties and feasibility issues must be addressed. Where specific 
solutions to them have not yet been identified, more general strategies 
should be proposed.

A timeline for the project should be presented. This timeline should 
outline how the project's goals can be met within the time frame of the 
grant. Explicit, quantitative milestones should be presented, if 
possible. 

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten 
original of the application, including the Checklist, three signed 
photocopies, and all five copies of appendix material, 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:
 
Helen Sunshine, Ph.D.
Office of Scientific review
National Institute of General Medical Sciences
Building 45
45 Center Drive, Room 3AN.12F, 
Bethesda, MD  20892-6200
 
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 sponsoring ICs. Incomplete and/or non-
responsive applications will be returned to the applicant without 
further consideration.

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 NIGMS 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 discuss the 
following aspects of 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 these 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? Because the goal of this solicitation is 
to encourage technology that has the potential to have significant 
impact on improving the state of the art, this criterion will be 
especially important.

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? This criterion will be especially important for this 
solicitation since the goal is to encourage novel technology with the 
potential to improve imaging resolution by several orders of magnitude.  

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?) Since the purpose of this solicitation is to initiate new lines of 
inquiry, the applicant(s) need not have publications on the immediate 
research topic.  However, applicants should have a record of 
accomplishment in relevant research areas and a history of innovative 
discovery and creativity.

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:

Impact and the Acceptability of Risk:  The purpose of this announcement 
is to recruit active established investigators to form 
multidisciplinary collaborations and develop new lines of inquiry. It 
is expected that most of the proposed research activities have not yet 
been initiated in the applicants' laboratories, and in some cases may 
be so new that they are not yet underway anywhere. Thus, the nature of 
the projects may be untested and risky, and the success may be 
difficult to predict. Evaluation of the application's merit should be 
made on the basis of the rationale and potential impact and the track 
records of the investigators.

Technology Development:  It is expected that the major focus of the P20 
Exploratory Centers will be to develop technology with the goal of 
generating more sensitive imaging probes and imaging systems. Thus, the 
evaluation of merit will be based on the impact of the technology that 
is proposed. The biological aspects of the proposal will be secondary 
and will, for the most part, be used only to test the probes in the 
appropriate biological environments. The purpose will not be to 
discover new biological phenomena. 
 
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. 
Guidance issued by the NIH on the sharing of data, materials, and 
resources can be found at http://ott.od.nih.gov/ and 
http://grants.nih.gov/grants/policy/data_sharing. 

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: October 20, 2003
Application Receipt Date: November 20, 2003
Peer Review Date: March/April 2004
Council Review: May 2004
Earliest Anticipated Start Date: July 1, 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

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 
or more in direct costs in any single year are expected to include a 
plan for data sharing or state why this is not possible. See 
http://grants.nih.gov/grants/policy/data_sharing. Investigators should 
seek guidance from their institutions, on issues related to 
institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers 
will consider the data sharing plan but will not factor the plan into 
the determination of the scientific merit or the priority score.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom of 
Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, Internet 
addresses (URLs) should not be used to provide information necessary to 
the review because reviewers are under no obligation to view the 
Internet sites.   Furthermore, we caution reviewers that their anonymity 
may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance 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.


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