RELEASE DATE:  July 1, 2002

PA NUMBER:  PAR-02-121 (See Replacement PAR-07-430)

(See Notice NOT-MH-06-120)
(See Notice NOT-MH-06-118 
Extending the expiration dates and change the cost limitations and application receipt dates)

EXPIRATION DATE:  October 26, 2006, unless reissued

National Institute of Mental Health (NIMH)

LETTER OF INTENT RECEIPT DATE:  August 1 2002, July 1 annually thereafter
APPLICATION RECEIPT DATE:  October 21, 2002, October 20 annually thereafter

This program announcement (PA) replaces PAR-98-057, which was published in the 
April 17, 1998 issue of the NIH Guide.


o  Purpose of this PA
o  Research Objectives
o  Mechanism of Support
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


The National Institute of Mental Health (NIMH) invites research center grant 
applications for Silvio O. Conte Centers for Neuroscience Research (CCNR).  The 
purpose of this program is to provide a unifying framework for the pursuit of 
basic neuroscience research relevant to mental health and mental illness.  A 
CCNR should conduct novel, integrative, and hypothesis driven research on a 
highly focused and well defined neuroscience question that is significant to the 
mission of NIMH.  It is expected that these Centers will encourage investigators 
representing a variety of disciplines, approaches or perspectives to bring to 
the field of mental health research the full range of expertise and advanced 
technologies available in the basic sciences.

In addition to the Silvio O. Conte Centers for Neuroscience Research, NIMH has a 
number of other center mechanisms with somewhat different programmatic goals.  
The purposes of these other mechanisms, and links to the relevant announcements, 
are summarized below:

o  Applicants who have all the elements expected of a Conte Center for 
Neuroscience Research or a Conte Center for the Neuroscience of Mental Disorders 
(see below) except for established collaborative research across participating 
laboratories, should consult (PAR-02-123) 
Silvio O. Conte Centers to Develop Collaborative Neuroscience Research,

o  Applicants interested in funding for a Center for the bi-directional 
translation of research between basic and clinical neuroscience investigations 
relevant to severe mental disorders should consider (PAR-02-122), Silvio O. 
Conte Centers for the Neuroscience of Mental Disorders 

o  Applicants interested in funding for a Center for research at the interface 
between basic behavioral research and neuroscience should see PAR-00-130, 
Interdisciplinary Behavioral Science Centers for Mental Health 

o  Applicants interested in funding for a Center that would foster research 
projects on the translation of basic behavioral research to mental disorders and 
public health applications should consider PAR-01-027, Translational Research 
Centers in Behavioral Science 

o  Applicants seeking to establish core infrastructure support for mental health 
services and interventions research are referred to PAR-01-089, Advanced Centers 
for Interventions and Services Research 
( and PAR-01-090, 
Developing Centers for Interventions and Services Research 
(, and

o  Those interested in a Center with a focus on HIV/AIDS should apply for 
funding through PAR-99-153, Core Support Program for Mental Health/AIDS Research 



As research produces ever greater levels of detail in each of the fields that 
collectively constitute the neurosciences, the ability of individual 
investigators to integrate approaches and disciplines is diminished.  Yet, the 
cutting edge of science is often defined across disciplinary boundaries and 
through the use of new technologies.  The Conte Centers for Neuroscience 
Research (CCNR) support highly interactive research projects addressing 
different aspects of a common set of research issues at different levels of 
biological organization and from different disciplinary, methodological and 
technological perspectives.  Such integrative approaches will provide unique 
opportunities to advance our understanding of factors that influence the 
development and function of the brain, offering new insights into brain-behavior 
relationships and mental illness.

Objectives and Scope

Each CCNR is designed to address a critical question of basic brain research 
through a multidisciplinary, well integrated, and highly focused research 
program.  A CCNR is characterized as follows:

o  The purpose of a CCNR is to address one hypothesis (or a small number of 
closely related hypotheses) in neuroscience that is specific, well focused, and 
significant to the mission of NIMH.

o  A CCNR should clearly demonstrate a high interdependence of projects and 
investigators, and solid evidence of integration and synergy across projects.

o  It is expected that a Center will be organized specifically to address 
innovative, creative, and potentially high risk/high impact research questions.  
Centers must rigorously test the proposed hypothesis and generate new ones.  It 
is expected that such research will advance neuroscience in fundamental and 
significant ways.

o  A CCNR should be based upon a highly integrated multidisciplinary approach 
which uses as many disciplines, perspectives, and approaches as are needed and 
appropriate to solve the research problem.  The best neuroscience laboratories 
and investigators using the most advanced technologies should be enlisted toward 
this end.

o  The Center mechanism may not be used as a substitute for individual grant 
support.  It is, therefore, expected that investigators participating in Centers 
will have independent, peer reviewed research support.  A Center must be viewed 
as a unique scientific opportunity to investigate leading edge research 
questions not currently being addressed.

o  The CCNR Director should have a demonstrated capability to organize, 
administer and direct the Center.  This individual should be the scientific 
leader of the Center, and thus must also head at least one of the projects, with 
a minimum total time commitment of 30 percent to the Center.

o  Investigators heading projects in a CCNR should be prominent scientists in 
basic neuroscience research who are at once leaders of their respective fields 
and actively involved in research.  Investigators with the qualifications to 
contribute to a unique enterprise such as a CCNR may be located in different 
geographic areas.  Therefore, collaborations among different institutions are 
encouraged, if scientifically appropriate.

o  A CCNR should provide opportunities for young investigators who have the 
potential for independent research careers to become skilled in the experimental 
strategies, approaches, and techniques of modern neuroscience research.  In 
addition, there should be close coordination between the Center and relevant 
predoctoral and/or postdoctoral research training programs of the participating 
institutions.  Special attention should also be given to the recruitment and 
training of minority students.

o  Each CCNR should provide outreach that makes the public aware of the 
importance and implications of the CCNR research for addressing basic 
neuroscience issues and their relationship to mental illness and mental health.

Research Topics

Silvio O. Conte Centers for Neuroscience Research are intended to support 
research in basic neuroscience relevant to the mission of NIMH.  Since 
appropriate research covers a wide swath of neuroscience, prospective applicants 
are referred to the website that describes research programs of the Division of 
Neuroscience and Basic Behavioral Science, which funds Conte Centers for 
Neuroscience Research.  The URL is  
Please note that although program staff are listed on the website, program 
inquires about CCNRs should be directed to the program staff listed under 


This PA will use the National Institutes of Health (NIH) center award mechanism 
(P50), which provides funding for multidisciplinary and multi-investigator 
approaches to the investigation of specific and complex research problems 
requiring the application of diverse expertise and methodologies.  As an 
applicant, you will be solely responsible for planning, directing, and executing 
the proposed center.

Applicants may request support for a period of up to five years, followed by a 
competitive renewal application for a second five year period.  The NIMH will 
not support individual Centers for longer than two consecutive funding periods.

Direct costs are limited to $1.5 million in any one year, this limit applies to 
new grants, their non-competitive continuations, and any subsequent competitive 
renewals.  Since the best scientific talent and resources are expected to be 
brought to bear on questions posed in each Center, and since these are often not 
all available at any single institution, projects constituting a given center 
may be based at multiple institutions.  In an effort to allow for such multi-
institutional involvement, for the purposes of this program announcement, 
Facility and Administrative (F&A) costs for consortium activity at collaborating 
institutions will not be counted against the $1.5 million limit to direct costs 
(but these costs should be delineated as instructed in form PHS 398 [rev. 

Competitive supplements will not be considered for these Center grants.  It is 
anticipated that individual projects, which are developed as outgrowths of a 
Center grant, will seek independent funding through mechanisms such as the 
research project grant (R01) mechanism.


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

Foreign institutions are not eligible for Center grants.

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.  Racial/ethnic minority individuals, women, and persons 
with disabilities are encouraged to apply as CCNR Directors and heads of 
projects or cores.


Sharing Data, Biological Material Resources, and Tools

Public Health Service (PHS) policy requires that investigators make unique 
research resources readily available to qualified individuals within the 
scientific community for research purposes following publication (the current 
NIH Grants Policy statement is dated March 1, 2001 and may be found at  The intent of this policy, 
however, is not to discourage, impede, or prohibit the organization that 
develops unique research resources or intellectual property from commercializing 
the products.

CCNRs marshal the very best researchers and resources for investigating 
neuroscience, and novel data, materials and tools, which can be difficult to 
develop under smaller mechanisms, are often the result.  Therefore, the NIMH 
requires applicants to develop detailed plans for the dissemination of data and 
materials generated through the Center through commercial or non-commercial 
means.  (It should be noted that even with non-commercial paradigms, the cost of 
developing such resources for distribution and the cost of distributing them may
be charged to those requesting them.)

The plan should be described in the Operational Plan for the CCNR, and the 
adequacy of the plan will be considered by NIMH staff in determining whether the 
grant should be awarded.  The initial review group will comment on the proposed 
plan for sharing and the adequacy of the plan is among the review criteria.  The 
sharing plan, as approved, after negotiation with the applicant when necessary, 
will be a condition of the award.


We encourage your inquiries concerning this PA 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 

o  Direct your questions about scientific/research issues and address the letter 
of intent to:

Laurie S. Nadler, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7194, MSC 9645
Bethesda, MD  20892-9645
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3563
FAX:  (301) 443-1731

o  Direct your questions about peer review issues to:

Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9608
Bethesda, MD  20892-9608
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-1340
FAX:  (301) 443-4720

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

Ms. Carol J. Robinson
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD  20892-9605
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3858
FAX:  (301) 443-6885


Prospective applicants are strongly encouraged to contact the program staff 
member listed under INQUIRIES as early as possible in the conceptualization of a 
possible application for a CCNR.

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, telephone number of the Principal Investigator
o  Names of other key personnel 
o  Participating institutions
o  Number and title of this PA

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 NIMH staff to estimate the potential review workload and to plan the 

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:

Laurie S. Nadler, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7194, MSC 9645
Bethesda, MD  20892-9645
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3563
FAX:  (301) 443-1731


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at in an interactive format.  
For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:

Application Format Guidelines

A major requirement for each Center is the conduct of multidisciplinary, 
integrative research on a single, highly focused research question (or a small 
number of closely related questions).  The application must describe the 
hypothesis to be tested, the goals of, and the approaches used in the Center.

In addition, the application should clearly articulate the reasons a Center 
approach is needed for the proposed work as well as the unique benefits that 
will accrue from a Center.  It should be emphasized that this center mechanism 
is not meant to be a substitute for individual grant support.  Therefore, the 
reasons that constituent projects require center support should be fully 

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 program announcement 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 
justification will be provided separately for each project and core (as 
described below), only items for which justification is not provided elsewhere 
should be presented in narrative here.

o  Biographical Sketches of Key Personnel - Biographical sketches should be 
provided for key personnel of the entire Center, and should be arranged 
alphabetically based on the individual"s 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 10 pages, for 
revised and resubmitted applications, a one-page introduction is allowed to 
describe changes from the previously submitted version):

Provide an overview of the entire proposed Center describing the central 
hypothesis to be tested and goals to be achieved.  Describe how the overall 
Center will achieve its major objectives.  Explain the proposed contribution of 
each of the projects and cores in achieving the objectives of the Center and how 
these components, especially the projects, relate to each other scientifically.

o  Evidence of Feasibility and Preliminary Findings (for new, Type 1, 
applications and amended Type 1 applications only, not to exceed 10 pages, for 
revised and resubmitted applications, a one-page introduction is allowed to 
describe changes from the previously submitted version)

Present evidence that the research team will be able to work together to 
accomplish the research proposed in the projects, present preliminary results, 
present evidence of competence in the areas proposed, etc.

If previously supported by an NIMH Silvio O. Conte Feasibility Center for 
Neuroscience Research, indicate the outcome of that specific activity as it 
relates to the application for the proposed Center support.

o  Progress Report (for competing renewal, Type 2, applications and amended Type 
2 applications only, not to exceed 3 pages for each project supported in the 
antecedent Center grant, for revised and resubmitted applications, a one-page 
introduction for the entire Progress Report is allowed to describe changes from 
the previously submitted version)

Describe the results of each of the projects supported in the previous CCNR 
grant and the manner in which those results and projects relate to the currently 
proposed Center application.  Describe the manner in which the Center mechanism 
provided synergy to the previously funded Center.

o  Operational Plan for Overall Center (not to exceed 11 pages, for revised and 
resubmitted applications, an extra one-page introduction is allowed to describe 
changes from the previously submitted version)

The working administrative and logistical arrangements, as well as the resource 
support necessary to implement the research, should be fully elaborated in the 
application.  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.

The plan for sharing data, biological material resources, and tools generated by 
the Center should also be included in this section.

o  Research Career Development and Outreach Plans (not to exceed 2 pages)

A description of the manner in which Center activities will provide 
opportunities for young investigators and how the proposed CCNR relates to 
existing training programs of participating institutions should be given.  Also, 
plans for disseminating information to the public regarding the activities of 
the Center should be given.

Information for Each Project or Core:

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

o  Cover Page - Information provided here should pertain specifically to the 
project or core.

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 10 pages for any one 
project, for revised and resubmitted applications, an additional one-page 
introduction for each project is allowed to describe changes from the previously 
submitted version.)

The research plan for each project should describe the specific aims, background 
and significance.  In these sections, the research question to be addressed and 
the hypothesis to be tested by the proposed research project should be highly 
focused and fully explained.  Full discussion is required on:  the status of 
current research efforts addressing the issue (both within the Center and 
elsewhere), the limitations of existing research strategies, why the particular 
research question lends itself to a multidisciplinary, integrative approach, and 
how the proposed project is to be linked and integrated with other proposed 
Center projects.

The research plan for each project should also include a description of the 
research design and methods.  This will not require extensive details for 
individual experiments.  Description of the experimental design should outline 
the strategies proposed to accomplish the specific aims of the project and
should include a discussion of the innovative aspects of the approach.  
Experimental procedures need not be spelled out in great detail if those 
procedures have already been extensively published and widely accepted by the 
scientific community, the methods to be used should be cited and referenced  
Any new methodology, however, and its advantage over existing methodologies, 
should be fully described.  Further, the feasibility of the proposed experiments, 
potential pitfalls, alternative approaches, if necessary, and relevance to 
Center goals should be discussed, as should plans for data sharing.

o  Descriptions of Individual Cores (Not to exceed 8 pages for any one core, for 
revised and resubmitted applications, an extra one-page introduction is allowed 
to describe changes from the previously submitted version.)

Describe how the core will contribute to the overall goals of the Center as well 
as which projects will be supported by the core and the manner in which that 
support will be rendered by the core.  The description of each core should 
clearly indicate the facilities, resources, services, and professional skills 
that the facility will provide to the proposed Center.

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).

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).

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 is not required 
for peer review).

o  Checklist

o  Personal Data on Center Director

SENDING AN APPLICATION TO THE NIH:  The title and number of this program 
announcement must be typed on line 2 of the face page of the application form 
and the YES box must be marked.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies in one package to:

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 

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD  20892-9609
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3367
FAX:  (303) 443-4720

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this PA.  If an application is received 
after that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in
response to this PA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The CSR 
will not accept any application that is essentially the same as one already 
reviewed.  This does not preclude the submission of substantial revisions of 
applications already reviewed, but such applications must include an 
Introduction addressing the previous critique.


Upon receipt, applications will be reviewed by CSR for completeness and by NIMH 
program staff to determine if they satisfy the objectives and requirements of a 
CCNR as outlined in this program announcement (excluding scientific or technical 
merit).  Applications that do not meet these objectives and requirements will 
not be accepted and will be returned to the applicant.

Applications that are complete and responsive will be evaluated for scientific 
and technical merit by an appropriate scientific review group convened by the 
NIMH in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will:

o  Receive a written critique and priority score
o  Receive a second level review by the National Advisory Mental Health Council


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.  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.

Criteria for scientific/technical review of CCNR applications will include the 

o  Intrinsic merit of the intellectual focus and research:  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, in addition, the research conducted 
must center around a highly focused and well-defined question.

o  Integration across projects:  the adequacy of the proposed Center to 
integrate across research projects so that activities in each project inform and 
advance the others

o  Appropriateness of the Center approach:  the need for and suitability of the 
Center approach, whether a Center approach will add significantly to what could 
be done through other modes of research support, in this respect, the 
integration and synergy of the projects are of utmost importance and should be 
explicitly described.

o  Research competence:  the capability and scientific credentials of the Center 
Director and constituent project directors and participating scientists, who are 
expected to be regarded by their peers as leaders in, and at the forefront of, 
their respective fields

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, devoting a minimum of 30 percent of his/her time to the 
Center, the Director must, by necessity, be the scientific leader of the Center.

o  Institutional commitment:  the nature and level of resource commitments from 
the home institution and from other participant institutions, and plans for 
interactions with the rest of the participating institutions

o  Appropriateness of management plans and arrangements:  the feasibility and 
adequacy of the organizational and administrative plans, the appropriateness of 
the budget, and the mechanisms to evaluate the Center"s progress

o  Appropriateness of the proposed plan to share data, biological material 
resources, and tools (the plan may use commercial and/or non-commercial 

o  Quality and appropriateness of the outreach and research career development 
components of the Center"s activities:  the adequacy of approaches used to 
disseminate information regarding the Center"s activities as they relate to 
public understanding of science and mental health and illness, 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

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your application 
will also be reviewed with respect to the following:

o  PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application

o  INCLUSION:  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.

o  BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research

The initial review group will make an overall recommendation for approval (and 
assign a priority score) or disapproval of the entire Center application.  Under 
some circumstances, it may be appropriate for the initial review group to 
recommend disapproval of one or more project(s).


To ensure a uniform review quality, all applications will be reviewed by a 
single review group, which will meet once per year.  In accordance with this 
objective, there will be one receipt date each year.  Applications received 
after this date will be returned to the applicant without review.

Letter of Intent Receipt Date:  August 1, 2002, July 1 annually thereafter
Application Receipt Date:       October 21, 2002, October 20 annually thereafter
Administrative Review:          November
Scientific Review:              April/May
Advisory Council Review:        May/June
Earliest Starting Date:         July


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


the policy of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported biomedical and behavioral 
research projects involving human subjects, unless a clear and compelling 
rationale and justification are 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 research involving human subjects should read the 
AMENDMENT "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 
(, a complete 
copy of the updated Guidelines is available at  
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.

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

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

NIH GRANTS POLICY STATEMENT:  The NIH Grants Policy Statement (NIHGPS) has been 
revised and reissued.  The provisions of the revised NIHGPS are effective for 
all funded NIH grants and cooperative agreements with budget periods beginning on or 
after March 1, 2001.  The revised NIHGPS is available at

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research on 
hESCs can be found at and at  Only research 
using hESC lines that are registered in the NIH Human Embryonic Stem Cell 
Registry will be eligible for Federal funding (see  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.

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

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

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

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

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance No. 93.242.  Awards are made under authorization of sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at and under Federal Regulations 42 CFR 
52 and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health Systems 
Agency review.

The PHS strongly encourages all grant and contract 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 

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

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