INNOVATION IN MOLECULAR IMAGING PROBES 

RELEASE DATE:  July 22, 2004

RFA NUMBER:  RFA-RM-04-021  

EXPIRATION DATE:  October 23, 2004

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
The 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.  This RFA will be administered by the National 
Institute of Biomedical Imaging and Bioengineering on behalf of the NIH.

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.286

LETTER OF INTENT RECEIPT DATE:  September 22, 2004
APPLICATION RECEIPT DATE:  October 22, 2004  

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 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 Request for Applications (RFA) is part of the Molecular Libraries 
and Imaging (MLI) Initiative of the NIH Roadmap.  Molecular imaging has 
the potential to monitor both normal and abnormal biochemical and 
physiological parameters in individual patients.  A major road-block to 
clinical application of molecular imaging is the poor sensitivity, 
specificity and spatial localization of current imaging probes.  The 
purpose of this RFA is to encourage the development of new probes that 
will achieve one or two orders of magnitude (i.e., a factor of 10 to 
100) improvement in the ability to detect and image specific molecular 
events in vivo, and also have potential for clinical applications.  

This RFA solicits pilot and feasibility studies that explore novel and 
untested  high-risk  approaches to achieve this goal, rather than 
incremental technology development that is already supported by current 
NIH programs.  A team approach is encouraged, and chemists, physicists 
and engineers who are new to the NIH are strongly encouraged to 
participate in this program.   

RESEARCH OBJECTIVES

Background

Current methods for imaging humans provide predominantly anatomical 
information, or functional information at a macroscopic level.  
Molecular imaging is an emerging research area aimed at extending 
existing or novel methods to image specific molecular pathways in vivo, 
particularly those that are key targets in disease processes.  Unlike 
anatomical imaging, molecular imaging displays biochemical and 
physiological abnormalities underlying disease, rather than the 
structural consequences of these abnormalities. 

Potential clinical applications of molecular imaging include:

o monitoring cell therapies by tracking the survival, movement, 
engraftment and differentiation of injected or implanted cells and 
tissues
o monitoring gene therapies by reporting on gene expression and 
cellular function
o precise localization of tumors within organs, and detection of 
precancerous cells
o detection and tracking of bacteria and viruses throughout their 
infectious cycles in cells, tissues and organs; monitoring of cellular 
responses to infection
o tracking of circulating cells in the vasculature and tissues
o following the movement of cells in tissue injury and repair, 
inflammation, and metastasis
o imaging of cellular functions in organs and tissues by detecting 
trafficking and transport, adhesion and migration, differentiation, 
neurogenesis, cell cycle progression, stress responses and apoptosis
o detection of microenvironments contributing to pathology and 
monitoring of responses to injury, oxidative stress and hypoxia
o imaging of action potentials, membrane polarization, channel 
activity, synaptic transmission.  Neurochemical imaging  
o imaging intracellular molecular processes, intermolecular 
interactions, and signal transduction pathways.

Molecular imaging approaches are not used to their full potential in 
humans, either in research or clinical environments.  One reason is the 
poor sensitivity, specificity and spatial localization of molecular 
probes that can be used in humans.  Another reason is the relatively 
poor signal-to-noise and spatial resolution of most human molecular 
imaging techniques.  A third reason could be toxicity of the molecular 
probe.  Potential clinical applications of molecular imaging have, 
however, been widely recognized at recent workshops and meetings 
sponsored by the NIH and other agencies, and the development of 
molecular imaging approaches that can be used in clinical environments 
is an important goal of the NIH Roadmap process.  

Scope of Research

Contrast in molecular imaging is generated or enhanced by molecular 
probes reagents that are targeted to specific intracellular or 
extracellular molecules and either produce or alter signals that are 
detected by imaging devices.  Imaging of molecular probes in individual 
cells or small groups of cells in vivo will require contrast that is 
orders of magnitude better than current capabilities.  Responses to 
this RFA should propose long-term strategies to achieve one or two 
orders of magnitude improvement in the ability to detect and image 
specific molecular events in humans.  These improvements should result 
primarily from increases in the sensitivity and specificity of 
molecular probes, but could also include related improvements that 
result from increases in the signal-to-noise or spatial resolution of 
human molecular imaging devices.  

Applications that propose only to improve the signal-to-noise or 
spatial resolution of molecular imaging devices will be considered non-
responsive.  

Novel molecular imaging probes developed in applications submitted to 
this RFA should have a clear path to future clinical applications.  
However, clinical research need not be undertaken during the period of 
this grant.   

This RFA is specifically intended for innovative research of unproven 
feasibility, and will support projects that explore chemical and 
physical phenomena that may ultimately lead to new molecular imaging 
probes.   Investigators are encouraged to work closely with biologists 
and clinicians in order to address potential issues of toxicity and 
delivery that could complicate the clinical utility of new molecular 
imaging probes.

Novel molecular probes or imaging techniques that result from this RFA 
should eventually have broad applications to medical research and 
clinical care.  

MECHANISM OF SUPPORT

This RFA will use the R21 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-continuing applications based on this project will compete 
with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures.  The earliest 
anticipated award date is July 1, 2005.  Applications that are not 
funded in the competition described in this RFA may be resubmitted as 
NEW investigator-initiated applications using the standard receipt 
dates for NEW applications described in the instructions to the PHS 398 
application.  

This RFA uses just-in-time concepts.  It also uses the modular 
budgeting as well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular budget format.  
Otherwise follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in 
the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.  

FUNDS AVAILABLE

The NIH intends to commit approximately $3.3 million in FY 2005 to fund 
about seven new 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 $300,000 per year.  Indirect costs associated with 
consortia or subcontracts will not be considered as part of the 
$300,000 direct cost limit.  

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. 

ELIGIBLE INSTITUTIONS

You may submit an application if your institution is domestic and 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 Faith-based or community-based organizations
o Foreign institutions are not eligible to apply.

Applications from foreign institutions will not be accepted; however, 
participating collaborators at foreign institutions may be included 
through sub-contracts.

We welcome public-private partnerships, since academia and industry may 
have the complementary capabilities needed for development and 
commercialization of new technologies.

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 
under-represented racial and ethnic groups, as well as individuals with 
disabilities, are always encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

Sharing of Results.  All research resources (e.g., methods, tools, 
materials) and information (e.g. IND filing information) developed in 
these projects are expected to be made readily available to the 
scientific community for non-profit research purposes.  Applications 
should include a sharing plan that includes criteria, mechanisms, and 
timetables by which all the resources and information developed in the 
course of the project will be shared.  Sharing plans must be in accord 
with the NIH Grants Policy Statement 
(http://grants.nih.gov/grants/policy/nihgps/) and the Principles and 
Guidelines for Recipients of NIH Research Grants and Contracts on 
Obtaining and Disseminating Biomedical Research Resources: Final 
Notice, December 1999 
(http://www.ott.nih.gov/policy/rt_guide_final.html and 
http://ott.od.nih.gov/NewPages/64FR72090.pdf).  Applicants are invited 
to utilize NIH supported repositories to make reagents widely available 
to the scientific community.  The adequacy of the proposed sharing plan 
will be considered by NIH staff prior to award.  The proposed sharing 
plan, after negotiation with the applicant when necessary, will be made 
a condition of the award.

Grantees Meetings:  Principal Investigators are expected to attend an 
annual meeting, most likely in the Bethesda, MD region, organized by 
NIH.  Investigators must include travel to this meeting as part of the 
budget request and state a willingness to participate in this meeting. 

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Alan McLaughlin, Ph.D.
Division of Applied Science and technology
National Institute of Biomedical Imaging and Bioengineering
Building: Two Democracy Plaza, Room: 232
6707 Democracy Boulevard
Bethesda, MD  20892-5469
Telephone:  (301) 496-9321 
FAX: (301) 480-4973
Email: [email protected]

Linda Brady
Neuropharmacology and Drug Discovery/Clinical Therapeutics Program
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7185
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
Fax: (301) 402-4740
Email:  [email protected] 

Denis Buxton 
Heart Research Program
Division of Heart and Vascular Diseases
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Suite 9044
Bethesda, MD 20892-7940
Telephone: (301) 435-0516
Fax: (301) 480-1454
Email: [email protected] 

Daofen Chen
Channels, Synapses, and Circuits Research
National Institute of Neurological Disorders and Stroke
NIH Neuroscience Center, Room 2131
6001 Executive Boulevard
Bethesda, MD 20892-9523
Telephone: (301) 496-1917
Fax: (301) 402-1501
Email: [email protected]

James Deatherage
Cell Biology Branch
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.13J
Bethesda, MD 20892-6200
Telephone: (301) 594-3828
Fax: (301) 480-2004
Email: [email protected] 
Eleni Kousvelari 
Center for Biotechnology and Innovation
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN 18A
Bethesda, MD 20892
Telephone: (301) 594-2427
Fax: (301) 480-8318
Email: [email protected] 

Maren Laughlin
Metabolism Program
Division of Diabetes, Endocrinology and Metabolic Diseases
6707 Democracy Boulevard, Room 6101
Bethesda, MD 20892-5460
Telephone: (301) 594-8802
Fax: (301) (301) 480-3503
Email:  [email protected] 

Abraham Levy
Division of Biomedical Technology Research and Research Resources
National Center for Research Resources
6701 Democracy Boulevard, Room 970
Bethesda, MD 20892-4874
Telephone: (301) 435-0777
Fax: (301) 480-3659
Email:  [email protected] 

Bradley Ozenberger 
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9305
Telephone: (301) 451-4735
Fax: (301) 480-9305
Email:  [email protected] 

o Direct your questions about peer review issues to:

David T. George, Ph.D.
Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
Building: Two Democracy Plaza, Suite: 920, Room: 956
6707 Democracy Boulevard
Bethesda, MD 20892-5469 
Bethesda, MD 20817 for express/courier service
Telephone: (301) 496-8633 
FAX: (301) 480-0675
Email: [email protected]  

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

Nancy Curling
National Institute of Biomedical Imaging and Bioengineering
Building: Two Democracy Plaza, Suite: 920
6707 Democracy Boulevard
Bethesda, MD, 20892-5469
Telephone:  (301) 496-8633 
FAX: (301) 480-4974
Email: [email protected]

LETTER OF INTENT

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

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

A letter of intent is not required, is not binding, and does not enter 
into the review of a subsequent application. However, the information 
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, and should be sent to Dr. David T. George at the 
address listed under WHERE TO SEND INQUIRIES.    

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 D&B number can be obtained by calling (866) 
705-5711 or through the web site at http://www.dunandbradstreet.com/. 
The D&B 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:  All PHS 398 requirements should be 
followed, with the exception of items affected by the following 
instructions:

o The total page limit for the Research Plan (items a   d) may not 
exceed a total of 15 pages.  Items e-g (human subjects/vertebrate 
animals/sharing plan) do not count against the page limit.

o Preliminary data (published or unpublished) are not required, but may 
be included if available.  However, preliminary data 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 research group. 

o The only allowable items in the Appendix are original photographs or 
color images, provided that a photocopy (may be reduced in size) is 
also included within the 15-page limit of Items a-d of the research 
plan. No photographs or color images may be included in the appendix 
that are not also represented within the Research Plan.  Publications, 
manuscripts, abstracts, patents, or other printed materials are not 
permitted and, if present, will not be forwarded to the review panel.      

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2002) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step instructions for preparing modular grants.  Additional 
information on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.  

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked.  The RFA 
label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and 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 and 
all copies of the appendix material must be sent to Dr. David T. George 
at the address listed under WHERE TO SEND INQUIRIES.

APPLICATIONS 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 this 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 NIBIB and the Roadmap project team.  Incomplete 
and/or non-responsive applications will not be reviewed.
  
Applications that are complete and responsive to this RFA will be 
evaluated for scientific and technical merit by an appropriate peer-
review group convened by NIBIB in accordance with the review criteria 
stated below.  As part of the 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 of review by National Institute of Biomedical 
Imaging and Bioengineering Advisory Council.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments the 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.

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 concept, 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.  

o Since this RFA invites innovative research applications of unproven 
feasibility, the  Significance  and  Innovation  review criteria are 
especially important and should be emphasized.  

o Preliminary data are optional and will not be a major criterion at 
review.  Greater emphasis will be placed on the proposed strategy based 
on the combined insight, knowledge and experience of the research 
group, and on the potential impact of the proposed research.  
o Applicants need not have publications in the immediate research 
topics proposed in the application, but should have a record of 
accomplishment in relevant research areas to show they are capable of 
carrying out the proposed work.  

o Applicants should address the stated goal of developing new probes 
that will achieve one to two orders of magnitude improvement in the 
ability to detect and image specific molecular events in vivo, and also 
have potential for clinical applications.   

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 sub-groups), and children as appropriate for the scientific 
goals of the research will be assessed.  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:  All applications must include a data sharing 
plan (see  SPECIAL REQUIREMENTS  section).  The adequacy of the data 
sharing plan 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 will be 
assessed.  

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  September 22, 2004
Application Receipt Date:  October 22, 2004
Peer Review Date:  March 2005
Council Review: May 2005
Earliest Anticipated Start Date:  July 1, 2005

AWARD CRITERIA

Award criteria that will be used to make decisions include:

o Scientific merit (as determined by peer review)
o Level of innovation
o Relevance to program priorities and roadmap priorities
o Availability of funds

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTIONS:  Federal regulations (45CF46) 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 to be gained.  
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
 
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 is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: (a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and (b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex, gender and/or racial/ethnic group 
differences.  

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them.  All investigators proposing 
research involving humans 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://www.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 subjects 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  This policy announcement can be 
found 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 hESC’s can be found at http://stemcells.nih.gov/index.asp 
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-005.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 RFA 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).    

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 the 
question  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:  All applications and proposals for NIH 
funding must be self-contained within specified page limitations.  
Unless otherwise specified in an NIH solicitation, Internet addresses 
(URL s) 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.healthypeople.gov.  

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 of 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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