DEVELOPMENTAL CENTERS FOR TRANSLATIONAL RESEARCH ON THE CLINICAL 
NEUROBIOLOGY OF DRUG ADDICTION
 
RELEASE DATE:  April 30, 2004
 
RFA Number:  RFA-DA-05-003 (This RFA has been reissued, see RFA-DA-06-006)

EXPIRATION DATE:  November 18, 2004

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

COMPONENT OF PARTICIPATING ORGANIZATION:  
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: October 18, 2004
APPLICATION RECEIPT DATE:  November 17, 2004  
 
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 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 

The National Institute on Drug Abuse (NIDA) invites applications to 
support the development of translational research centers on the 
neurobiology of drug abuse that have a strong clinical/human 
neurobiology focus and the capability to integrate preclinical/animal 
studies that will serve to directly inform the direction of the 
clinical research.  Advances in the technological armamentarium that 
can now be brought to bear on questions concerning the acute and 
chronic effects of drugs of abuse, the factors that influence addiction 
liability, the neurobiological alterations that may lead to abuse and 
addiction, and the effects of intrinsic and extrinsic influences on the 
course of treatment and relapse now make it possible to pose very 
specific questions on the nature of drug effects in the human nervous 
system.  Despite technical advances, however, the spectrum of 
approaches that can be used in preclinical investigations renders 
animal research much more suitable for mechanistic studies of the 
neurobiology of drug abuse. This funding opportunity announcement   is 
designed to encourage teams of investigators to propose the development 
of research programs with a primary focus on clearly defined issues in 
drug abuse and addiction in clinical populations that can 
simultaneously be investigated in animal models with the aim of, 
ultimately, using the preclinical findings to refine and direct the 
clinical research. It is expected that the centers funded through this 
RFA will be well positioned to compete for funding through a subsequent 
funding opportunity announcement for larger centers for Translational 
Research on Drug Addiction. 
 
RESEARCH OBJECTIVES 

Background:

Animal models have yielded very important data on the neurobiological 
mechanisms of addiction and have been extremely useful in elucidating 
some of the mechanisms of addiction and abuse at the basic molecular, 
cellular, and systems levels.  Recent clinical studies, with the advent 
of advances in areas such as structural, functional and chemical 
imaging and human genetics have provided new insights into the 
neurobiological changes caused by drug exposure and the factors that 
influence those changes. Most frequently, animal investigations and 
human investigations proceed on parallel tracks and, while clinical and 
preclinical findings may inform one another, the integration of the two 
is only rarely accomplished in a setting that has their integration as 
an explicit goal and an infrastructure to support that effort.  A need 
exists in the drug abuse field for integrative/translational research 
centers capable of both clinical and preclinical investigations that 
are driven by the clinical questions and issues.  This RFA represents a 
first step in addressing this need. 

Understanding drug abuse and drug addiction is an incredibly complex 
problem; to achieve a true understanding of any single facet of the 
problem will require an interdisciplinary and integrative research 
approach that employs a range of disciplines, levels of analysis and 
methodologies.  The centers supported by this RFA would have as their 
primary focus human/clinical drug abuse issues and take advantage of 
the methodologies and investigative approaches available for use in 
preclinical studies, but not available for use in human studies for 
technical/design/feasibility/ethical reasons, to inform the directions 
of the clinical investigations and refine the clinical questions.  For 
example, neuroimaging studies now provide an important opportunity to 
advance significantly our understanding of the areas of the brain, and 
to a limited extent, the processes involved in drug addiction. 

Neuroimaging studies in humans, however, can only provide very indirect 
information concerning the alterations induced by abused drugs at the 
cellular, molecular, genetic, or even the connectional level. It is 
expected that centers competing successfully for funding through this 
RFA will propose a program of research that has, as its focus, a well 
defined clinical question that will be investigated at multiple levels, 
taking advantage of model systems that offer methodological advantages 
that have the potential to yield results that can be directly 
translated into the clinical investigations.

Finally, it is expected that the centers established following award to 
successful applicants will serve as a venue for training junior 
investigators in the clinical and preclinical neurobiology of drug 
abuse and in multidisciplinary approaches to scientific investigation.

Objectives and Scope:

The primary aim of this RFA is to support early stage development of 
interdisciplinary teams of investigators dedicated to the study of the 
impact of drug exposure, abuse, and addiction on the human brain and to 
position these teams to compete successfully for Centers for 
Translational Research on the Clinical Neurobiology of Drug Addiction 
that will be established in a future initiative.  Successful 
applications will demonstrate a strategy for the development of a 
Developmental Center that will provide both a structure for the support 
of the team’s goals and a strong scientific rationale for both the 
composition of the team and the role of the team members.

Proposed centers must be comprised of an Administrative Core and at 
least three, but no more than five, scientific projects.  At least one 
of the scientific projects must propose to conduct clinical research 
and at least one must conduct preclinical (non-human) research.  Since 
clinical drug issue(s) must define the central theme of each center, it 
needs to be demonstrated that the proposed preclinical project(s) 
directly relate(s) to the clinical component.  High risk/high impact 
research that might be especially well investigated using the 
collaborative approach that the center organization is designed to 
foster is encouraged. However, the way in which such projects will 
directly contribute to achieving the overall scientific aims of center 
must be clearly detailed. The interdependence and integration of all of 
the projects in pursuit of the central clinical question must be 
clearly described.

The investigators directing each of the projects are expected to be 
among the leaders in their respective fields. The Developmental Center 
mechanism may not be used as a substitute for individual grant support.  
Scientists named as Project Directors of the scientific projects, 
therefore, are expected to have independent, peer-reviewed, research 
support.

It may be that one or more of the scientists best suited to address the 
scientific questions central to the proposed center is not sited at the 
center’s administrative home.  Given the current facility of 
communication and information exchange, such collaborations among 
different institutions are encouraged if deemed the optimal way for 
achieving the goals of the proposed center.  In those instances in 
which project investigators are geographically separated, it is 
imperative that a detailed plan for feasibility, regular communication, 
and coordination among the projects be delineated.

The Director of the Developmental Center should have a demonstrated 
capability to organize, administer and direct the center.  It is 
expected that the Director will serve as the scientific, as well as 
administrative, leader of the center.  To that end, the Center Director 
must function as the Director of the Administrative Core and must serve 
as the Project Director of one of the scientific projects and devote a 
minimum of 20% effort overall to the center.     

If appropriate to the scientific aims of the proposed center, support 
for core facilities should be requested.  As with the scientific 
projects, it is expected that the investigators that lead the cores 
will also be prominent in their respective fields.  The contribution 
that each of the cores will make to the overall goals of the proposed 
center, and their integration into the overall structure of the center, 
should be clearly described.

The proposed center should provide opportunities for young 
investigators who have the potential for independent research careers 
to gain skills and experience in state-of-the-art approaches to 
research in drug abuse and addiction.  To achieve this aim, it is 
expected that relationships be developed between the center and the 
relevant pre- and postdoctoral training programs at the participating 
institutions.

Areas of Scientific Interest:

The following areas are illustrative of the topics that address the 
mission of the National Institute on Drug Abuse and should not be 
considered as being either comprehensive or exclusive of other areas.

The neurobiological processes leading to abuse and addiction – what 
brain processes, structures and circuits are affected by abused drugs; 
how are these altered over the time course of exposure; is there an 
exposure threshold beyond which addiction is inevitable and what 
factors determine that threshold?

The cognitive neuroscience of addiction – what facets of executive 
function are affected by drug exposure and how are they altered along 
the pathway to addiction, how is the neurobiological circuitry 
implicated in cognitive functions such as reward, inhibitory control, 
impulsivity, etc. affected by exposure; can cognitive measures be used 
to predict vulnerability to abuse and addiction or to predict treatment 
outcome?  

The developmental neuroscience of drug abuse – how are the effects of 
drug exposure influenced by the developmental epoch in which exposure 
occurs; are there specific developmental time points in which exposure 
is more or less likely to lead to addiction; what are the developmental 
neurobiological factors that affect addiction liability; how are 
processes such as the development of tolerance; the emergence of 
withdrawal symptoms, or the efficacy of treatment affected by duration 
of exposure and developmental timeframe?

The treatment of drug abuse and addiction – what are the 
neurobiological bases of treatment effects; how do behavioral and 
pharmacological treatments interact with brain processes; what are the 
neurobiological effects of different behavioral and/or pharmacological 
treatment approaches; what are their neurobiological mechanisms; can 
neurobiological changes induced by treatment be used to predict 
treatment success or the optimal course of treatment?

The interaction of drug abuse and HIV/AIDS – does drug exposure 
influence the time course and severity of the neurobiological effects 
of HIV infection; does HIV infection, and its psychological effects; 
alter the neurobiological effects of drug exposure; does antiretroviral 
treatment affect abuse or addiction liability?

Extrinsic and intrinsic influences on addiction and abuse – what are 
the interactions between drug exposure and comorbid psychological, 
psychiatric, or developmental conditions; are there demonstrable 
genetic influences on the effects of abused drugs; how do personal and 
social factors (e.g., stress) affect drug abuse and addiction 
liability; can intrinsic (e.g., genetic factors, gender) and/or 
extrinsic (e.g., stress) factors explain individual differences in the 
effects of abused drugs? 

MECHANISM OF SUPPORT
 
This RFA will use the NIH P20 award mechanism, which provides support 
for developing collaborative teams of high caliber investigators using 
diverse scientific approaches to the investigation of a highly focused 
research problem.  Applicants may request support for only one period of 
up to three years; direct costs requested may not exceed $500,000 in any 
one year.  In an effort to allow for multi-institutional involvement, 
for the purposes of this RFA , facility and administrative (F&A) costs 
for consortium activity at collaborating institutions will not be 
counted against the $500,000 limit to direct costs (but these costs 
should be delineated as instructed in form PHS 398.

The applicant 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 for this RFA is June 2005.  

This RFA uses just-in-time concepts.  The instructions for non-modular 
budget research grant applications should be followed.  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

NIDA intends to commit approximately $2,000,000 in FY 2005 to fund 2 to 
3 new grants in response to this RFA. An applicant may request a 
project period of up to 3 years and a budget for direct costs of up to 
$500,000 per year. 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 NIDA provides support for this program, awards 
pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications.  
 
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:
   
o 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 institutions/organizations
o Faith-based or community-based organizations
 
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 his/her 
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

Principal Investigators will be required to attend an annual meeting in 
the Washington, DC metropolitan area.  The travel budget should 
therefore reflect appropriate allocation for this activity.  The purpose 
of these annual meetings will be to share scientific information, assess 
progress, identify and solve common methodological problems, and 
identify new research opportunities.
 
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:

L. R. Stanford, Ph.D.
Division of Treatment, Research, and Development
National Institute of Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4232, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 402-3869
FAX: (301) 443-6814
Email:  lstanfor@mail.nih.gov

o Direct your questions about peer review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland  20892-8401
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 270, MSC 8403
Bethesda, MD  20892-8403
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gf6s@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 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 – DA-05-003
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland  20892-8401
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.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:

Application Format Guidelines

The primary purpose of this initiative is to support early stage 
development of interdisciplinary teams of investigators dedicated to the 
study of the impact of drug exposure, abuse, and addiction on the human 
brain. The application must clearly describe the hypotheses to be 
tested, the goals of the proposed research plan, and the approaches used 
in the Center.

The application should utilize PHS Form 398 and include the following 
components in the specified order:

Information for the Entire Center:

o  Face Page (noting this RFA in Item 2) - Information provided here 
should pertain to the entire Center.

o  Description, Performance Sites, and Key Personnel (Form Page 2) - 
Information provided here should pertain to the entire Center.

o  Table of Contents (Form Page 3)

o  Budget Information (Form Pages 4 and 5) - Categorical figures should 
be provided to reflect the budget of the overall Center.  Since detailed 
budget justifications will be provided separately for each project and 
core, only items for which a narrative justification is not provided 
elsewhere should be described here.

o  Biographical Sketches of Key Personnel - Biographical sketches should 
be provided for key personnel of the entire Center, with the Principal 
Investigator being first.  Other key personnel should be arranged 
alphabetically based by surname.

o  Resources - Resources described here should be restricted to those 
not described separately for the individual projects and cores (as 
described below).

o  General Description of the Overall Center (not to exceed 7 pages) - 
Provide an overview of the entire proposed Center describing the central 
research theme and the goals to be achieved.  Describe how the overall 
Center will achieve its major scientific objectives and how the Center 
organization will foster the development of collaborative research 
efforts.  Explain the proposed contribution of each of the projects and 
cores in addressing the central research question, how the components 
relate to each other scientifically, and how they will benefit from the 
establishment of the center.  The proposed interactions and 
collaboration across projects and cores should be described in detail. 

o  Preliminary Findings (not to exceed 3 pages) – Briefly present 
preliminary results directly relevant to the proposed research and 
evidence of experience and expertise in the areas of investigation 
proposed.  If applicable, describe briefly the history of interactions 
of the investigators whose collaborative efforts will be developed in 
the proposed center. 

o  Administrative Core(s) and other Operational Plans (not to exceed 8 
pages) – In this section the operation of the Administrative Core, 
including the working administrative and logistical arrangements, as 
well as the resource support necessary to implement the research, should 
be fully elaborated. Plans for the overall and day-to-day management of 
the proposed center should be included, including the roles and 
responsibilities of the Center Director, Principal Investigators of the 
projects and cores, and other personnel with administrative and 
management responsibilities, should be described. Methods and means for 
the establishment and maintenance of effective communication and 
integration of the center components, at both the scientific and 
managerial level, should also be detailed.  When multiple institutional 
sites are involved, a detailed description of the cooperative 
administrative arrangements should be included (documentation of these 
arrangements should be included in the "Letters of Support" section). 
Also included in this section is the manner in which an external 
advisory board will advise the Center.  Prospective board members should 
not be chosen or contacted prior to a funding decision and therefore 
should not be named.

o  Research Career Development (not to exceed 2 pages)- A description of 
the manner in which Center activities will provide opportunities for 
young investigators and how the proposed center relates to existing 
training programs of participating institutions should be given
Information for Each Project or Core:

For each project or core, the information should be arranged in the 
following order:

o  Cover Page - Information provided here should pertain specifically to 
the project or core and should include the title of the core and the 
name and title of the PI.
o  Description, Performance Sites, and Key Personnel (Form Page 2) - 
Information provided here should pertain specifically to the project or 
core.

o  Budget Information (Form Pages 4 and 5) - Detailed budget information 
should be provided for each project or core, with a narrative 
justification given for all budget items.

o  Resources - Resources should be described for each project or core.

o  Research Plan for Individual Projects (not to exceed 15 pages):

The research plan for each project should describe the specific aims, 
background and significance and preliminary results.  In this section, 
why the particular research question is best addressed by a 
multidisciplinary, integrative, collaborative research approach and how 
the proposed project is to be linked and integrated with other proposed 
Center projects and laboratories should be described in detail.

The description of the research design and methods should not include 
extensive detail on individual experiments.  Instead, the general 
strategies to be used in addressing the aims of the project should be 
described, with appropriate citations for those experimental procedures 
and techniques that have been previously published and validated.  New 
methodologies should be more completely described, especially those 
adopted to take advantage of the collaborative aspects of the center. 
For all investigative approaches, feasibility, potential pitfalls, 
alternative approaches, if necessary, and  relevance to the scientific 
goals of the center should be discussed.

o  Descriptions of Individual Cores (Not to exceed 8 pages):

The ways in which the core will contribute to the overall goals of the 
Center should be described. The description of each core should clearly 
indicate the facilities, resources, services, and professional skills 
that the facility will provide to the proposed Center as well as the 
projects that will be served by the core.

o  Human Subjects - For each individual project and core involving human 
subjects describe the plans for protection of subjects from research 
risks, as well as plans for the inclusion of women, minorities and 
children, as described in the PHS 398 application instructions (Rev. 
5/2001).  This information does not count against the page limitations

o  Vertebrate Animals - For each individual project and core involving 
vertebrate animals, provide a detailed description and justification for 
the use of animals as described in the PHS 398 application instructions 
(rev. 5/2001).  This information does not count against the page 
limitations.

Other Information:

o  Literature Cited - This section should include and compile literature 
cited throughout the application.

o  Letters of Support from Institutions and Collaborators - Also 
included in this section should be assurances from Institutional Animal 
Care and Use Committees and/or Institutional Review Boards (though the 
latter are not required at peer review).

o  Checklist applies to entire application

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

Director – DA-05-003
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland  20892-8401
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov
 
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 NIDA. Incomplete and/or nonresponsive 
applications will not be reviewed.  

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by NIDA 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 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 evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals. The 
scientific review group will address and consider each of the following 
criteria in assigning the application’s overall score, weighting them 
as appropriate for each application. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The application does not need to be strong in all categories to be 
judged likely to have major scientific impact and thus deserve a high 
priority score.  For example, an investigator may propose to carry out 
important work that by its nature is not innovative but is essential to 
move a field forward.

Criteria for scientific/technical review of the proposed Center 
applications will include the following:

o  Intrinsic merit of the intellectual focus and research:  the focus on 
clearly defined issues in drug abuse/addiction in clinical populations; 
the overall quality, scientific merit, and innovation of the research to 
be done; the likelihood that the work will lead to fundamental advances 
within the field, to new discoveries, and/or to new technological 
developments; evidence of a range of disciplinary levels of analyses and 
methodologies.

o  Integration across projects and collaboration across laboratories:  
the adequacy of the proposed Center to integrate across research 
projects including preclinical and clinical approaches so that 
activities in each project inform and advance the others; the adequacy 
of the proposed collaborative activities to provide synergy to the 
proposed Center.

o  Appropriateness of the Center approach:  the need for and suitability 
of the collaborative research approach; how the collaborative approach 
will add significantly to what could be done through other modes of 
research support.

o  Research competence:  the capability and scientific credentials of 
the Center Director, project directors and other participating 
scientists; evidence of multidisciplinary and interdisciplinary 
expertise.

o  Center Director credentials:  ability of the Center Director to 
organize, administer, and direct the Center and, in addition, head at 
least one of the proposed projects; a Center Director will devote a 
minimum of 20 percent of his/her time to the Center.  The Director must 
be the scientific leader of the Center and a recognized leader in the 
field.

o  Institutional commitment:  the nature and level of resource 
commitments from the home institution and from other participant 
institutions.

o  Appropriateness of management plans and arrangements in the 
Administrative Core:  the feasibility and adequacy of the organizational 
and administrative plans; the appropriateness of the budget and the 
mechanisms to evaluate the Center's progress; the use of an external 
advisory board.

o  Quality and appropriateness of research career development components 
of the Center's activities:  the likely effectiveness of approaches to 
attract and involve young investigators and students who show potential 
for significant future contributions and independent research careers in 
the work of the Center.

Criteria for scientific/technical review of the proposed projects and 
cores will include the following:

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 the study well integrated into the 
project as a whole?

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?  For preclinical projects:  How well 
does the project relate to the clinical issues and theme of the 
proposed center?  For cores:  How well is the need for this core 
justified?  How well does the core contribute to the purpose of the 
Center?

INNOVATION:  Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?

INVESTIGATOR:  Is the investigator appropriately trained and well 
suited to carry out this work?  Is the investigator recognized as a 
leader in the field?  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?  Is there evidence of 
interdisciplinary and multidisplinary collaboration?

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 REVIEW CONSIDERATIONS

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 18, 2004
Application Receipt Date:  November 17, 2004
Peer Review Date:  February/March 2005
Council Review:    May 2005
Earliest Anticipated Start Date:  June 2005

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 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on 
Humane Care and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), 
as mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the 
USDA Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated 
with reference to the risks to the subjects, the adequacy of protection 
against these risks, the potential benefits of the research to the 
subjects and others, and the importance of the knowledge gained or to 
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide 
for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA: 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 this is not 
possible. 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.

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. 

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://stemcells.nih.gov/index.asp and 
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).   It is the responsibility of the applicant to 
provide, in the project description and elsewhere in the application as 
appropriate, the official NIH identifier(s) for the hESC line(s)to be 
used in the proposed research.  Applications that do not provide this 
information will be returned without review. 

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON 
DRUG ABUSE:  Researchers funded by NIDA who are conducting research in 
community outreach settings, clinical, hospital settings, or clinical 
laboratories and have ongoing contact with clients at risk for HIV 
infection, are strongly encouraged to provide HIV risk reduction 
education and counseling.  HIV counseling should include offering HIV 
testing available on-site or by referral to other HIV testing service 
for persons at risk for HIV infection including injecting drug users, 
crack cocaine users, and sexually active drug users and their sexual 
partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS:  The National Advisory 
Council on Drug Abuse recognizes the importance of research involving 
the administration of drugs to human subjects and has developed 
guidelines relevant to such research.   Potential applicants are 
encouraged to obtain and review these recommendations of Council before 
submitting an application that will administer compounds to human 
subjects.  The guidelines are available on NIDA's Home Page at 
www.nida.nih.gov under the Funding, or may be obtained by calling (301) 
443-2755.

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).  

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.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 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92.  All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a 
facility) in which regular or routine education, library, day care, 
health care, or early childhood development services are provided to 
children.  This is consistent with the PHS mission to protect and 
advance the physical and mental health of the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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