NIDA NEUROPROTEOMICS RESEARCH CENTERS (NIDA NPRCs)

RELEASE DATE:  April 28, 2003 (see addendum NOT-DA-03-006)

RFA NUMBER:  DA-04-004

National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.279 

LETTER OF INTENT RECEIPT DATE:  September 24, 2003
APPLICATION RECEIPT DATE:  October 24, 2003

THIS REQUEST FOR APPLICATIONS (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 on Drug Abuse is requesting applications for the 
support of Neuroproteomics Research Centers (NPRCs).  These Centers 
should be built around scientific themes that address questions 
relevant to the mission of the National Institute on Drug Abuse.  The 
Centers will support already existing neuroscience research, provide 
training in proteomics technologies and develop new proteomics 
technologies.  The objective of this program is to provide technical 
and administrative support for proteomics Centers in order to increase 
the accessibility of the Centers to neuroscience researchers at 
institutions with a demonstrated need for such a resource, to develop 
new or improve existing proteomics technologies that would be applied 
to the analysis of tissues of the nervous system and promote sharing of 
information with the scientific community.  

While Centers should be at institutions that have extensive ongoing 
neurobiology research, they will not be restricted to working solely 
with investigators from their own institution.  The objectives in 
establishing these Centers are to: (1) provide neurobiologists with the 
ability to benefit from proteomics experiments, (2) build a cadre of 
proteomics experts who will develop expertise in analyzing neural 
tissues, and (3) develop new or improve existing proteomics 
technologies as they relate to neurobiology or tissues of the nervous 
system.

This announcement does not support the purchase of large pieces of 
equipment ($100,000 +).  Investigators may seek funding from the 
National Center for Research Resources at the NIH for the purchase of 
equipment. http://www.ncrr.nih.gov/rsrch_funding.asp

RESEARCH OBJECTIVES

Background:
Proteomics is generally defined as the study of the complement of 
proteins produced by a given tissue, cell or subcellular organelle 
under specific conditions.  The proteome is not simply a catalog of 
proteins, but also subsumes the post-translational modifications and 
relative quantities of proteins.  Ideally the entire proteome of a cell 
or tissue would be examined, but in reality one is only able to look at 
a subset of the proteome.  That subset is defined by either the 
investigator who selects a population of proteins based on some 
intrinsic or extrinsic characteristic, or by limitations of the 
technology or a combination of the two.  In spite of these limitations, 
proteomics is an extraordinarily powerful way to approach a scientific 
question in that proteomics experiments presuppose very little about 
the outcome of the experiment.  As the hypotheses of proteomics 
experiments are much broader than those of traditional experiments, 
results from proteomics experiments can generate new hypotheses or help 
guide current ideas.  Furthermore, as a more global analysis of a 
system, proteomics lends itself to the identification of multi-
component systems such as mechanistic pathways and signal transduction 
cascades. By monitoring changes in the proteome that occur with a given 
disease or treatment, one may gain insight into the mechanisms of 
health and disease.  

Current technology requires a significant financial and educational 
investment to obtain, manage and interpret high quality data. Thus, it 
is not feasible or practical for individual investigators to establish 
such a resource for use by their laboratory alone.  Furthermore, 
information gathered from a single proteomics experiment provides a 
wealth of information for subsequent hypothesis-driven experiments.  By 
providing a shared facility, a greater number of neuroscience 
researchers will have the opportunity to benefit from these 
information-rich experiments.  Whenever possible, applicants are 
encouraged to build the Center around a specific neuroscience theme 
that will facilitate integration and synergy among the Center's 
collaborators. In addition to the collaborative efforts of the Centers 
with the neuroscience community, the scientific cores are expected to 
develop new technology that will improve the analysis of samples 
relevant to neuroscience research.

This announcement focuses on supporting Centers that will assist 
neuroscientists in identifying additional targets and markers toward 
which future research can be directed.

Areas of Scientific Interest - 

A Center should be thematically integrated.  Each project should 
benefit from the other components of the Center.  The Center components 
may include, but are not limited to:

o   Long-term changes in CNS associated with substance abuse to identify 
proteins that may be involved in molecular mechanisms of relapse
o   The use of proteomics to identify common cellular mechanisms 
triggered by different substances of abuse
o   Studies directed toward understanding signal transduction in cells 
of the CNS and how the cascades differ with exposure to drugs of 
abuse
o   Studies designed to identify possible therapeutic target proteins 
for the treatment of drug abuse
o   Changes in CNS associated with HIV/AIDS and/or HCV infection and the 
effects of drugs of abuse on disease progression, pathology and 
treatment
o   Studies directed toward understanding neural plasticity such as 
proteomics on the post-synaptic density, dendrites and presynaptic 
terminals of neurons from various states of drug exposure
o   Proteomics of cytoskeletal proteins in neurons and glia involved in 
mediating the addictive process 
o   Proteomics of the effect of drugs of abuse on regulating 
extracellular matrix proteins and adhesion molecules
o   Studies on the proteomics of drug-induced neurotoxicity or 
neuroprotection
o   Studies defining how drugs of abuse affect the processes of 
exocytosis and endocytosis
o   Studies directed toward understanding the effects of drugs of abuse 
on development 
o   Proteomic approaches to identifying peptides and proteins secreted 
by glia in response to drugs of abuse
o   Studies to evaluate effects of therapeutics for substance abuse
o   Proteomic analysis of the proteins involved in mRNA trafficking in 
neurons and glia
o   Proteomics of neuronal and glial transcription factors and chromatin 
regulation
o   Studies that identify molecular changes in the proteome that 
correlate with changes in behavior
o   Studies of genetic effects on the proteome of CNS cells or tissue
o   Proteomics as a diagnostic or prognostic tool for CNS diseases
o   Proteomics of membrane proteins
o   Analysis of lipid raft and caveolae using proteomic approaches

Additionally, given the scientific evidence on sex differences in 
genetic factors of drug abuse, NIDA encourages the evaluation of data 
to determine if there are sex differences in the proteomes analyzed.

Areas of Interest in Technology Development -

It is recommended that a Center focus its technology development 
efforts on select aspects of technology that capitalize on the 
strengths of the research team.  Areas of interest in proteomics 
technology development include, but are not limited to:

o   Methods to improve analysis of low copy number proteins
o   Methods that improve the quality of absolute or relative 
quantitative data 
o   Methods that increase dynamic range of analysis
o   Methods that allow functional analysis of a proteome
o   Methods that improve in situ proteomic analysis 
o   Development of new separations technology including isolation of 
cellular or subcellular components from neural samples
o   Development of new, high throughput technology for analyzing 
protein-protein interactions 
o   Improved methods or software for the analysis of complex mixtures
o   Development of technology for real time proteomics in culture 
systems
o   Development of "turn-key" technology such as protein chips for 
neuroproteomics
o   Improvements in the analysis of traditionally difficult proteins 
such as very acidic, very alkaline or hydrophobic proteins
o   Development of software or hardware that will increase efficiency 

Evaluation Of Progress Following Grant Award -

Among the criteria used for evaluation of progress are the following:

o   Number and quality of publications on which this grant is cited each 
year, whether or not the Center PI is listed as a co-author 
o   New technology developed by the Center 
o   New technology implemented by the Center
o   Overall benefit to the neuroscience community
o   Sharing of data and resources with the neuroscience community

MECHANISM OF SUPPORT

This RFA will use NIH Center Core grant (P30) award mechanism.  As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  
Future unsolicited, competing-continuation applications based on this 
project will compete with all investigator-initiated applications and 
will be reviewed according to the customary peer review procedures.  
The anticipated award date is July 2004.  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 will support the establishment of Neuroproteomics Research 
Centers (P30) at institutions with a demonstrated need for such a 
Center.  Each application at a minimum must contain the following:  a 
protein separations core, a protein identification core, a 
bioinformatics core and an administrative core.  Each core, except the 
administrative core, will be required to devote no less than 20 percent 
effort and no more than 40 percent effort to technology development for 
the improvement of the analysis of samples relevant to neuroscience.  
Technology development will be one of the criteria on which the 
competitive and noncompetitive renewal will be assessed.

The Center must be able to demonstrate that it will collaborate with at 
least two other funded projects (e.g. R01 grants) and these projects 
must be described in summary form in the application. The projects need 
not be limited to researchers at the applicants' institutions.

This RFA uses just-in-time concepts.  This program does not require 
cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
  
FUNDS AVAILABLE
 
NIDA intends to commit approximately $2.5 million in FY 2004 to fund 1 
to 3 new and/or competitive continuation grants in response to this 
RFA. An applicant may request a project period of up to five years.   
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 NIDA 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. At this time, it is not 
known if this RFA will be reissued.

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
  hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based or community-based organizations

To be eligible, the application must list qualified personnel to 
implement proteomics experiments.  The institutions must have a 
neuroscience constituency with substantial ongoing research in the 
various subdisciplines of neuroscience.  The Center must be able to 
demonstrate that it will collaborate with at least two other funded 
projects (e.g. R01 grants) and these projects must be described in 
summary form in the application. The projects need not be limited to 
researchers at the applicants' institutions, however large numbers of 
collaborators from distant institutions are discouraged.

The applicant must clearly demonstrate how a proteomics research core 
Center would enhance the individually funded projects and improve 
programmatic coherence, synergy, and integration.  Applicants must 
demonstrate the potential for the continuation of funding of the 
individual projects included in the Center application, and each 
project must have at least two years of funding remaining at the time 
of submission.  Pilot projects will not be supported under the P30 
mechanism.

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.   

To be eligible, a PI must have the technical background and the 
administrative skills needed to operate a proteomics Center.  The 
applicant must have substantial experience in the experimental design, 
implementation and interpretation of proteomic data.  The applicant 
must be able to devote no less than a total of 25 percent effort to the 
Center.

SPECIAL REQUIREMENTS 

Key to a successful Center is the implementation of a well-designed 
management plan.   Internal and external advisory boards are 
recommended for providing guidance regarding administrative issues that 
arise when managing a Center with multiple users.  It is also important 
that at least one member of the Center work closely with the Center 
project PIs after data is generated.  While this requires more time on 
the part of Center personnel, it ultimately lends itself to a more 
productive environment.  The complexity of proteomics data and the 
statistical analysis needed for some experiments requires much more 
interaction between the proteomics research team and the neuroscience 
research team.  

In addition to the science addressed in the application, the PI should 
consider the following questions:

Communication:
How will Center project PIs interact with the individual cores, if at 
all?  At what stage of the experimental design will the Center director 
or core directors work with the Center users?  Who will be responsible 
for various aspects of data analysis (e.g. interpretation of technical 
data or statistical interpretation of large data sets)?  What will the 
format be for joint review of the data by the Center members and the 
Center users?  How will the efforts of the various core components be 
coordinated?   How will the cores and the core leaders interact and 
communicate with one another? How will the PIs participating in the 
Center be informed about guidelines and expectations?  How will 
summarizing progress and potential problems be communicated to P30 
participants?  Will the Center do anything to foster communication 
and/or collaboration among Center users?

Administration:
How will the Center recruit users and prioritize projects?  Who will 
advise the Center regarding the merit of the biological questions being 
asked by the various Center users?  How will new administrative 
functions be developed?   How will progress be assessed? What are the 
plans for regularly scheduled seminars/meetings/progress reports? How 
will these meeting be used to train junior investigators? How will 
ongoing strategic planning for the Center be conducted?  How will the 
director ensure proper budget management and necessary oversight?  How 
will the Center ensure proper regulatory guidelines are followed: Human 
Subject/IRB approval if human subjects are used?

Data Sharing:
How will data be annotated, managed, archived and queried?  How will 
Center users access their own data (e.g. via intra- or internet 
connection or through local computers)? Will the users be able to 
manipulate the data and if so are there software licensing issues?  
Will the format of the data be raw or summarized?  How and when will 
the data be shared with the scientific community?  How will the Center 
enforce data sharing obligations?  NIDA strongly encourages full and 
open access to well annotated data from control/normal samples.

Also see data sharing requirements under ADDITIONAL CONSIDERATIONS.

Advisory boards:
Are the administrative functions of the internal advisory and external 
advisory boards well developed?  What is the expertise of the external 
advisory board?  What are the functions of the external advisory board?  
How will progress and problems be communicated by the director to 
members of external advisory board before each meeting with the 
external advisory board?  
What will be the frequency and regularity of the meetings among core 
heads and internal advisory board?  What will be discussed? How will 
conflicts be resolved within the Center? How will the core directors 
work with the internal/external advisory boards to draft guidelines of 
Center operations and oversight?

Technology:
Are the aims for technical development appropriate for nervous system 
tissue samples?  How  will quality control be maintained? How many 
proteomics experiments are anticipated per year? How will new issues in 
neuroproteomics be identified? How frequently will the directors of the 
Center interact with the office of technology transfer and their 
institutions about issues surrounding intellectual property? 

Scientific Cores:
How will technology developed in one core affect the other cores in the 
Center?  What are the qualifications of the core directors?  Do any of 
the core directors have a history of collaboration with one another?  
Do any of the core directors have a history of collaboration with 
prospective Center users and if so how will that affect prioritization 
of projects?  

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:

Christine Colvis, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Rockville, MD 20852 (for express or courier service)
Telephone:  (301) 435-1323
Fax:  (301) 594-6043
Email:  [email protected]

o Direct your questions about peer review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for express or courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  [email protected]

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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  [email protected]

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

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

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows NIDA 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:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for express or courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email: [email protected]

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

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
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. 

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.  While the investigator may 
still benefit from the previous review, the RFA application is not to 
state explicitly how.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NIDA.  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 NIDA in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 
will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council on 
Drug Abuse.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  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, 
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?  Is there evidence that the proposed 
neuroproteomics Center is needed?  If the aims in the technology 
development are achieved, how will the neuroscience community benefit?

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of 
the project?  Do you acknowledge potential problem areas and consider 
alternative tactics?  Are weaknesses acknowledged and alternative 
approaches considered?

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?  If other proteomics labs or facilities already exist at 
the principal investigator's institution, how will this Center differ 
and how will the facilities interact if at all?   If other proteomics 
labs or facilities already exist at the principal investigator's 
institution, why is there a need for an additional proteomics resource?

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 core leaders?

ENVIRONMENT:  Will the PI's institution cover the cost of equipment 
maintenance?  Does the scientific environment in which the work will be 
conducted contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Do the 
members of the external advisory committee seem appropriate?  Is the 
described role and extent of involvement of an external advisory 
committee sufficient?

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:

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 CONSIDERATIONS 

DATA SHARING: The adequacy of the proposed plan to share data.

The NIH expects and supports the timely release and sharing of final 
research data from NIH-supported studies for use by other researchers.  
Starting with the October 1, 2003 receipt date, investigators 
submitting an NIH application seeking $500,000 or more in direct costs 
in any single year are expected to include a plan for data sharing or 
state why data sharing is not possible.  Applicants are encouraged to 
discuss their data sharing plan with their program contact at the time 
they negotiate an agreement with the Institute/Center (IC) staff to 
accept assignment of their application as described at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.  
Applicants are reminded that agreement to accept assignment of 
applications over $500,000 must be obtained at least six weeks in 
advance of the anticipated submission date. Reviewers will not factor 
the proposed data-sharing plan into the determination of scientific 
merit or priority score. Program staff will be responsible for 
overseeing the data sharing policy and for assessing the 
appropriateness and adequacy of the proposed data-sharing plan.  Full 
content of the final NIH statement on sharing of research data may be 
found at http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-03-032.html.

Also see Data Sharing under SPECIAL REQUIREMENTS

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:  September 24, 2003
Application Receipt Date:  October 24, 2003
Peer Review Date:  January/February 2004
Council Review:  May 2004
Earliest Anticipated Start Date:  July 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.
o Geographic balance 

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research 
components involving Phases I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the 
policy of the NIH that women and members of minority groups and their 
sub-populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health 
of the subjects or the purpose of the research. This policy results 
from the NIH Revitalization Act of 1993 (Section 492B of Public Law 
103-43).

All investigators proposing clinical research should read the "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_
2001.htm.  The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS:  The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at 
http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).   It is the responsibility of the applicant to 
provide the official NIH identifier(s)for the hESC line(s)to be used in 
the proposed research.  Applications that do not provide this 
information will be returned without review. 

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

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

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:   
The Department of Health and Human Services (DHHS) issued final 
modification to the "Standards for Privacy of Individually Identifiable 
Health Information", the "Privacy Rule," on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 
Those who must comply with the Privacy Rule (classified under the Rule 
as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on "Am 
I a covered entity?"  Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts 
can be found at http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-03-025.html

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
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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