ADVANCED CENTERS FOR MENTAL HEALTH DISPARITIES RESEARCH (ACMHDR)

RELEASE DATE:  February 6, 2004

PA NUMBER:  PAR-04-060 (See Notice NOT-MH-06-120)

(Requirement restated and contact info updated, see NOT-MH-05-006)

EXPIRATION DATE:  May 12, 2006, unless reissued.

Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.242

LETTER OF INTENT RECEIPT DATE:  April 11 annually
APPLICATION RECEIPT DATE:  May 11, 2004; May 11, 2005; May 11, 2006

THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
o  Where to Send Inquiries
o  Submitting an Application
o  Supplementary Instructions
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THE PA

This PA replaces PA-96-007.

The purpose of this Advanced Centers for Mental Health Disparities Research 
(ACMHDR) initiative is to promote the enhancement of established research core 
infrastructures and investigator-initiated research aimed at understanding and 
ameliorating mental health disparities (defined below in next section).  All 
research areas supported by NIMH that are relevant to mental health disparities are 
appropriate as the central focus for ACMHDR research.  Research projects may 
include, but are not limited to, studies of mental health disparities of American 
Indians/Alaskan Natives, Asian Americans, African Americans, Hispanics, and Native 
Hawaiians and Pacific Islanders.  Studies of ethnic subpopulations within these 
broad categories are also encouraged.

RESEARCH OBJECTIVES

The principal objective of this program is to assist in the maintenance of and 
strengthen a research environment in which state-of-the-art research methodologies 
may be applied to an interdependent set of research projects and pilot research 
projects relating to a single major focus in mental health disparities research.  
The NIH defines health disparities as differences in the incidence, prevalence, 
mortality, and burden of diseases and other adverse health conditions that exist 
among specific population groups in the United States 
(http://www.nih.gov/about/hd/strategicplan.pdf).  Many disparities in mental health 
outcomes are highly associated with, but not necessarily limited to race, 
ethnicity, gender, and social conditions such as inadequate access to quality 
mental health care services.  For example, a principal finding cited in “Mental 
Health: Culture, Race, and Ethnicity -- A Supplement to Mental Health:  A Report of 
the Surgeon General”, is that racial and ethnic minorities bear a greater burden 
from unmet mental health needs and thus suffer a greater loss to their overall 
health and productivity.  More is known about the existence of disparities in 
access to healthcare and mental health services, and the differential rates of 
mental health diagnoses among racial and ethnic groups and their significance, than 
the reasons for the occurrence of those disparities.  The ACMHDR are specifically 
intended to support investigations of mental health disparities, with a strong 
emphasis on the reasons for the occurrence of those disparities, and are expected 
to produce findings that lead to outcomes that contribute to reducing the burden of 
mental health for all people.

For further assistance in defining mental health disparities and/or the populations 
to be served by the Center, please contact Dr. Michael Sesma under “WHERE TO SEND 
INQUIRIES.”  Further assistance in defining the research focus may be obtained by 
contacting the appropriate program official listed under “WHERE TO SEND INQUIRIES.”

Each ACMHDR should provide an environment of scientific excellence that will ensure 
the highest quality research and leadership in its particular area of 
investigation.  Through its research activities, the ACMHDR should demonstrate that 
it has a major impact on mental health disparities through (e.g.) publications, 
community involvement, and outreach efforts.  As a result of support from this 
program, it is expected that research projects developed by the ACMHDR 
investigators will later be supported by other research and research training 
grants from NIMH, private foundations, and from other research grant awarding 
sectors of the Federal government.  However, applicants who are seeking support for 
ACMHDR pilot projects are not expected to have current extensive additional 
research funding.

MECHANISM OF SUPPORT

This PA will use the NIH Specialized Center Grants (P50) award mechanism.  As an 
applicant, you will be solely responsible for planning, directing, and executing 
the proposed center.  This mechanism supports cores, research projects, and pilot 
research projects.  Research projects are expected to be fully developed and 
designed to test a research hypotheses in a definitive manner, similar to an R01 in 
scope.  Pilot research subprojects are for investigators who: (1) are new to the 
institution and have not had previous independent research support; (2) have 
academic responsibilities that have precluded pursuit of a research program; or (3) 
plan to make a change in their research direction that necessitates a fresh start 
in a new discipline relevant to mental health research.  The pilot research project 
is intended for faculty without current research support.  Therefore, investigators 
with significant current extramural support from other NIH mechanisms such as the 
R01 or research funding from another agency, are not eligible to submit pilot 
research projects.

Support for these advanced centers may be requested for an initial period of up to 
5 years, followed by a competitive renewal for an additional 5-year period.  Once 
awarded and during the term of the award, centers are subject to administrative 
review for performance, and are not transferable to another institution.  
Applicants may request up to $600,000 in direct costs per year, plus Facility and 
Administrative (F&A) costs.  Although the F&A costs associated with all contractual 
and consortium arrangements are considered as direct costs to the applicant 
organization, for the purposes of this program announcement, these will not count 
against the program direct costs cap of $600,000 per year.  However, these costs 
should be indicated as instructed on Form 398, rev. 5/01.

To qualify for support, a Center should consist of at least three research 
projects, which may include a pilot project(s) that are determined by expert review 
to be scientifically meritorious in relation to the career level of the project’s 
principal investigator.  Pilot projects, although not specifically required, are 
strongly encouraged to assist in the career development of mental health 
researchers.  Annual awards will be made subject to continued availability of funds 
and progress achieved.

This PA uses just-in-time concepts, but it uses only non-modular budgeting formats 
(see  http://grants.nih.gov/grants/funding/phs398/phs398.html.  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.

ELIGIBLE INSTITUTIONS

You may submit an application 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  Foreign institutions are not eligible for ACMHDR grants

Applicant institutions should demonstrate the capacity to become an advanced center 
through evidence of previous commitment of institutional resources, development of, 
or access to, a critical mass of mental health and/or mental health disparities 
researchers, the presence of substantial recent topical peer-reviewed publications 
in the research area chosen, and partnerships/cooperative efforts with other 
institutions.  Minority-Serving institutions such as (for example) Historically 
Black Colleges and Universities and Hispanic Serving Institutions are encouraged to 
apply.  Advanced centers should be a major national scientific resource with the 
ability to impact practice and public mental health policy.  They should 
demonstrate a capability to study questions among various populations in different 
community and practice settings.

For the purpose of this PA, the NIMH will not support more than one ACMHDR grant 
(P50) from the same applicant institution.  Institutions with similar or 
complementary active or pending support from other NIH sources are not precluded 
from applying for an ACMHDR.  For example, programs such as Project Export or 
Research Infrastructure in Minority Institutions (National Center for Minority 
Health and Health Disparities), Minority Biomedical Research Support program 
(National Institute of General Medical Sciences), Research Centers in Minority 
Institutions (National Center for Research Resources), and/or other minority 
student/faculty support programs from private or public funding agencies may also 
apply for this program.

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 as an ACMHDR.  Individuals from underrepresented racial and 
ethnic groups as well as individuals with disabilities are always encouraged to 
apply for NIH programs.

SPECIAL REQUIREMENTS

An ACMHDR must have the following: (a) strong intellectual leadership, at the 
administrative level and in each of the individual research projects.  This is 
characterized by a principal investigator and co-investigators who are able to 
demonstrate significant direct personal experience in a research project, clinical 
intervention, biomedical activity, public or private social service organizational 
function, or preventive intervention effort, with racial and ethnic minority 
groups, or other health disparity groups, in the related study area; (b) the 
availability of mental health researchers as co-investigators, especially members 
of racial and ethnic minority group(s) who have experience in mental health-
relevant research for that referenced group; and (c) the availability of promising 
junior researchers who are either graduate students or junior faculty.  The 
participation of minority investigators as consultants to the applicant institution 
will not be sufficient, in itself, to satisfy these requirements.

An ACMHDR must include a central conceptual focus for the research and involve 
strong, collaborative, synergistic relationships among the investigators, which 
will form the basis for further research and research training activities.  All 
activities must be interrelated to reflect an integrative ACMHDR rather than a 
loosely allied network of investigators.

An ACMHDR must be interdisciplinary, including, as appropriate, investigators from 
biological sciences (e.g., neuroscience, molecular biology, genetics) and the 
social and behavioral sciences (e.g., health economics, sociology, public health, 
epidemiology, psychiatry, nursing, social work, psychology, statistics, 
anthropology, and demography).

The principal investigator and investigators on research projects should be able to 
demonstrate competence in working with diverse populations and a history of working 
in the area of health disparities.  The participation of minority investigators as 
consultants will not be sufficient, in itself, to satisfy these requirements.

An effective evaluation plan, a required component of every ACMHDR program, should 
be able to demonstrate overall improvement of the institution’s research capacity.  
Therefore, the emphasis of evaluation activities is on self-study and on continual 
improvement of the institution's research capacity.  In the evaluation plan, 
applicants are expected to identify their goals and objectives, and to set 
milestones appropriate to developing the institution's current research 
infrastructure and research capacity.  The goals and specific objectives should 
relate to the overall goals of the ACMHDR program and to the institution's research 
development plans.  The evaluation plan must describe the procedures and methods 
that will be used to collect and analyze the type of data needed to assess the 
extent to which the proposed goals and objectives have been achieved.   The 
applicant should also provide information on the qualifications of the person(s) 
conducting the evaluation, the type of data to be collected, and the data 
collection schedule.  Thereafter, the program requires that annually (in annual 
progress reports), each institution assess progress made toward its own goals and 
specific objectives including milestones for accomplishment.  For an effective 
measure of progress by research project and pilot project investigators, the 
following data and information should be presented in subsequent annual progress 
reports for the former or current investigator; (1) name; (2) project title; (3) 
period of support; (4) number and type of competitive research support applications 
submitted; and (5) number and type of grants received.

If the applicant plans to involve another corporate entity (e.g., research 
institute, medical school, local government, etc.) in the functions of the ACMHDR, 
the following must be included:  (1) Description of the nature of the arrangements 
and lines of authority; (2) Letter(s) of agreement signed by the responsible 
officer of each associated organization stating that cooperation, research 
facilities, services, or other relevant assistance will be available on a 
continuing basis (Submit as an appendix to the application); and (3) Appropriate 
clearances from each associated organization that state that the proposed research 
meets that institution’s research review requirements (including Institutional 
Review Boards responsible for activities involving human subjects)

An ACMHDR must have access to the target populations or subpopulations in 
sufficient numbers to accomplish its research goals.  This access must be 
documented by letters of collaboration from relevant local and national groups.  An 
ACMHDR with a clinical focus must provide access to and appropriate levels of 
administrative control over sufficient inpatient and/or outpatient facilities to 
ensure availability of patients/clients for specific research projects.

Although funds from the ACMHDR grant may not be used to support formal research 
training activities, each ACMHDR should include a plan for providing opportunities 
for research training experiences in disciplines relevant to mental health.  An 
ACMHDR may take advantage of the Ruth L. Kirschstein National Research Service 
Award (NRSA) Fellowships and Institutional Research Training Grants, Research 
Scientist Development Awards for support of appropriate developing scientists, and 
Supplements for Underrepresented Minorities in Biomedical and Behavioral Research.  
Information on these mechanisms can be found at 
http://grants.nih.gov/training/extramural.htm. The ACMHDR Director is encouraged to 
contact NIMH program staff regarding application for these support mechanisms.

The ACMHDR will be required to submit detailed annual progress reports, including 
substantive information about research results to date, status of ongoing research, 
research plans for the next year, and any modification in long-term research plans.  
Presentation in scientific meetings and publication in refereed journals should be 
included.  Also, inventions reporting, financial status reports, final reports, and 
other reports are required to be filed in accordance with PHS policy.

Institutions with active or pending research infrastructure development support 
from other NIH sources such as Project Export or Research Infrastructure in 
Minority Institutions (National Center for Minority Health and Health Disparities), 
Minority Biomedical Research Support program (National Institute of General Medical 
Sciences, Research Centers in Minority Institutions (National Center for Research 
Resources, and/or other minority student/faculty support programs from private or 
public funding agencies may also apply for this program.  However, within the 
Operational Plan for the Overall Center the applicant institution must describe how 
the funds from this proposed advanced center program will complement these other 
awards.  Institutions must describe/explain any overlap in research 
aims/objectives.  In particular, the applicant must describe how the research and 
research-related activities (goals and objectives) supported by different programs 
will complement each other.  The application must also describe how administrative 
staff (secretarial assistance, administrative assistance) will be shared between 
this and other programs.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into four areas:  
mental health disparities and populations to be served, scientific/research, peer 
review, and financial or grants management issues:

o  Direct your questions about mental health disparities and populations to be 
served to:

Michael A. Sesma, Ph.D.
Office for Special Populations
National Institute of Mental Health
6001 Executive Boulevard, Room 8125, MSC 9659
Bethesda, MD  20892-9659
Telephone:  (301) 443-2847
Email:  msesma@mail.nih.gov

o  Direct your questions about scientific/research issues to:

Debra Babcock, Ph.D., M.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7178, MSC 9639
Bethesda, MD  20892-9639
Telephone:  (301) 443-1692
Email: dbabcock@mail.nih.gov

Ann Hohmann, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7146, MSC 9631
Bethesda, MD  20892-9631
Telephone:  (301) 443-4235
Email:  ahohmann@mail.nih.gov

Emeline Otey, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6180, MSC 9625
Bethesda, MD  20892-9625
Telephone:  (301) 443-1636
Email:  eotey@mail.nih.gov

o  Direct your questions about peer review issues to:

Michael Kozak, Ph.D.
Extramural Review Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9608
Bethesda, MD  20892-9608
Telephone:  (301) 443-1340
Email:  mkozak@mail.nih.gov

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

Rebecca Claycamp
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MS 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2811
Email:  rclaycam@mail.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 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 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 the appropriate program contact 
at the address listed under WHERE TO SEND INQUIRIES.

SUBMITTING AN APPLICATION

Applicants are strongly encouraged to contact the appropriate program contact 
listed under INQUIRIES with any questions regarding their proposed project and the 
goals of this PA.

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 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.

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 checked.

SUPPLEMENTARY INSTRUCTIONS

APPLICATION PAGE LIMITS:  The description of the Operations Plan, Research and 
Statistics Methods Cores, and the Administrative Core is limited to a total of 30 
pages; the research plans for the Research Projects are limited to 25 pages each; 
research plans for pilot projects are limited to 15 pages each.

The application must use PHS Form 398 and include the following components in the 
specified order:

Information for the Entire ACMHDR:

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

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

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 ACMHDR.  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 of the budget information section.

o  Biographical Sketches of Key Personnel - Biographical sketches must be provided 
for key personnel of the entire ACMHDR, and 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  Introduction - For revised and resubmitted applications, a introduction of not 
more than three pages addressing the concerns of the previous review is required.  
Refer to the PHS 398 instructions for revised applications.

o  General Description of the Overall ACMHDR.  This section should provide an 
overview of the entire proposed ACMHDR.  This must include a description of the 
central hypothesis to be tested and goals to be achieved.  This announcement 
requires an evaluation component for the ACMHDR.  Towards this end, the general 
description section must identify the objectives of the overall ACMHDR, how these 
will be achieved, how the outcomes will be evaluated, and the timeline (milestones) 
for their achievement.  This section must also specify the proposed contribution of 
each of the research projects in achieving the objectives of the ACMHDR and how 
these components relate to each other scientifically.

o  If previously supported by a Research On The Mental Health Of Minority 
Populations award, indicate the outcome (in less than 4 pages) of that specific 
activity as it relates to the application for the proposed ACMHDR support.

o  Operational Plan for Overall ACMHDR.  The 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 
must be included (documentation of these arrangements should be included in the 
"Letters of Support" section).  Additionally, the expected distribution of the 
award to each institution by percent of effort and percent of funds must be 
explained.  Also included in this section is the manner in which an external 
advisory board will advise the ACMHDR.  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 ACMHDR must also be included in this section.

o  Research Career Development and Outreach Plans.  A description should be 
provided of the manner in which ACMHDR activities will provide research career 
advancement opportunities for developing investigators.  An explanation should be 
provided of how the proposed Center relates to existing training programs of ACMHDR 
institutions.  In addition, the plans for disseminating information to the public 
regarding the activities of the ACMHDR should be an element of the overall ACMHDR 
program description.

The ACMHDR should enable investigators to conduct research and pilot studies and to 
formulate, develop, and test new hypotheses, methodologies, and data-gathering 
techniques.  Models for organization of a ACMHDR may vary, but they all must 
contain the infrastructure for implementing an overarching research plan and a plan 
that includes sophisticated, multidisciplinary, integrated pilot research projects.  
This infrastructure must provide, at minimum, an administrative core and a 
methodology and statistics core, as described below.

Administrative Core.  An ACMHDR must have a scientifically and administratively 
well-qualified director who has primary responsibility for the scientific 
leadership and administration of the research program and a strong administrative 
structure.  The description of the Administrative Core should include the following 
information:

o  Relationship to the applicant institution
o  Description of the administrative structure of the ACMHDR, including delineation 
of responsibilities and authorities of the ACMHDR Director and his/her assistants
o  Description of any committee whose role is advisory on specific aspects of the 
ACMHDR research program
o  Arrangements for planning, coordinating, facilitating, and evaluating the ACMHDR 
research projects and pilot research projects and development of Core resources
o  Procedures for coordinating and supervising the work of individual investigators
o  Procedures for coordinating specific studies conducted under the auspices of the 
ACMHDR
o  Personal Data (Biosketch) of the ACMHDR Director

Methods and Statistics Core.  Applicants should describe an organizational 
structure to provide on-site expertise in research design methodology, database 
management, psychometrics (if instrument development is to be included in the 
research activities), and statistical analysis to the investigators of the ACMHDR.

Research Projects and Pilot/Feasibility Research Projects.  A Center application 
must include at least three research projects, one or more of which may be pilot 
projects.  For each proposed individual project, all of the sections of the PHS 398 
application are required, including Specific Aims, Background and Significance, 
Preliminary Studies/Progress Report (if applicable), Research Design and Methods, 
Inclusion of Women and Minorities, and Children, and Protection of Human Subjects.  
An applicant must show the project is related to the central research focus of the 
ACMHDR.  Early phases of major studies (feasibility studies) may be supported by 
the ACMHDR.  Separate budgets and budget justifications for each research project 
are also required.

Selection of the specific research focus of research projects and pilot research 
projects must be justified in terms of:

o  Their concordance with research areas of interest to NIMH
o  The state of scientific knowledge
o  The feasibility of performing the proposed research (e.g., availability of 
measurement instruments, populations to study)
o  Access to the target minority groups or subgroups in sufficient numbers for 
meaningful analysis
o  The potential impact of the research on understanding and improving the mental 
health of the minority populations under study

The research plan should describe how the individual research projects and pilot 
research projects are linked to the central focus of the ACMHDR.  Applicants should 
also describe the types of further programmatic steps that might be taken in future 
years to build upon early findings.  In addition, a statement should be included 
describing relevant, current and planned research, training, and service grant 
support that will be available to the ACMHDR.

The research plan for each project must include a description of the research 
design and methods.  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 ACMHDR goals should be discussed, as 
should plans for data sharing.

o  Human Subjects - For each individual activity or project and core involving 
human subjects, describe the plans for protection of subjects from research risks.  
Clinical research projects must also include a description of plans for the 
inclusion of women, minorities, and children, as described in the PHS 398 
application instructions (rev. 5/2001). The plan should clearly describe any novel 
efforts designed to recruit and retain women, minorities, and children in the 
research project.

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

Budget

Budgets for the ACMHDR administrative core, methods and statistical core, and 
individual research projects and pilot research projects should be presented 
separately and each must be fully justified.  In addition, the travel budget 
request should include funds for the ACMHDR Director and one other key professional 
staff member to attend an annual meeting with other ACMHDR directors and NIMH staff 
in the Washington, DC area.

o  Information should be presented on cash and in-kind support, if any, for the 
ACMHDR by the applicant institution.  In-kind support may include such items as 
university supported faculty and graduate students who will participate in the 
program to supplement the core staff, funding of joint tenure-line appointments for 
ACMHDR staff, office space, supplies, and equipment.

Allowable Costs

Allowable costs include salaries of personnel responsible for the management of the 
ACMHDR, including the ACMHDR Director, support for resources shared across research 
projects and pilot research projects through the coordinating ACMHDR, such as 
equipment and personnel to provide research design and statistical consultation, 
data base management services, reference services, or scientific administrative 
services.  Expenses clearly related and necessary to conduct the research projects, 
and support for individual pilot research projects at the developmental stage, 
which can include salaries, supplies, travel, special consultations, and 
publication costs, direct costs that can be specifically identified with the pilot 
research project.  Only costs required by the research may be requested for 
research-related treatment, rehabilitation, or prevention services and programs

In addition, funds can be used to support research participant recruitment and 
retention activities for all populations, especially activities to ensure 
appropriate participation by women, children and adolescents, elderly and other 
traditionally understudied populations, such as racial and ethnic minorities and 
people in rural areas.  Those Centers that will conduct clinical trials may request 
funds to support the establishment of a Data and Safety Monitoring Board for those 
trials.  Funds may also be used for travel, salaries, meeting expenses, 
subcontracts and paying consultants.  Applicants are referred to the General 
Clinical Research Center program at the NIH/National Center for Research Resources 
(http://www.ncrr.nih.gov/clinical/cr_gcrc.asp) as a potential resource for 
inpatient and outpatient facility costs.

Grant funds may not be used for establishing, adding a component to, or operating a 
treatment, rehabilitation, or prevention/intervention service program or for formal 
research training activities.

The ACMHDR grant is neither expected nor intended to cover all of the costs of a 
successful Center.  NIMH expects and encourages the institution and personnel 
attracted to an ACMHDR to actively seek and compete for additional funding.

APPLICATION RECEIPT DATES:  Applications submitted in response to this program 
announcement will be accepted at the application receipt dates listed in the 
heading of this PA.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:  
Applications requesting $500,000 or more in direct costs for any year must include 
a cover letter identifying the NIH staff member within one of NIH institutes or 
centers who has agreed to accept assignment of the application.

SUBMITTING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of the 
application, including the Checklist of the documents included, 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:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD  20892-9663
Bethesda, MD  20817 (for courier/express service)

APPLICATION PROCESSING:  Applications must be received on or before the application 
receipt date listed in the heading of this PA.  The 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 a substantial revision of an 
unfunded version of an application already reviewed, but such application must 
include an Introduction addressing the issues raised in the previous 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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established PHS 
referral guidelines.  Appropriate scientific review groups convened in accordance 
with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) 
will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications will:

o  Undergo a selection process in which only those applications deemed to have the 
highest scientific merit, generally the top half of 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 Mental Health Council

REVIEW CRITERIA

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

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

Your 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, you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

REVIEW OF OVERALL ACMHDR

In carrying out the scientific and technical merit review of the overall ACMHDR, 
the initial review group will take into account:

SIGNIFICANCE:  Does this ACMHDR and its associated research projects address an 
important mental health disparities topic?  If the aims of the application are 
achieved, will scientific knowledge of mental health disparities be advanced?  Will 
the effect of the center and its affiliated studies in addressing mental health 
disparities be significant?

APPROACH:  Is there adequate rationale to support the importance of a center 
approach as opposed to other mechanisms (e.g., individual R01, R21, R03 
applications)?  Does a conceptual and theoretical framework focused on a major 
topic in mental health disparities research inform the center organization and 
infrastructure development? Is the concept of a center on mental health disparities 
research fulfilled, including:  (a) an integrated theme bringing together a multi- 
or interdisciplinary team of investigators in a common mission of studying mental 
health disparity topics, (b) development of a pooled, core database or access to 
research participants that can yield results beyond that accomplished with 
individual projects alone, (c) attraction of established investigators and 
development of collaboration among investigators with diverse backgrounds and areas 
of expertise, (d) a research mentorship component designed to guide new 
investigators through the pathways of research training and career development 
mechanisms, and (e) a process for stimulation and evaluation of new pilot study 
proposals for the investigation of mental health disparities?  Is the approach for 
the center adequately developed, well integrated, and appropriate to the general 
aims of the center?  Does the applicant acknowledge potential problem areas and 
consider alternative tactics?  Are collaborations across sites well justified and 
reasonable to carry out the research activities?  Are the plans for evaluation of 
ACMHDR progress towards measurable objectives well conceived and appropriate? What 
is the feasibility and the likelihood of success of the application as defined by 
the stated goals, measurable objectives, anticipated milestones and/or outcomes, 
and the evaluation plan.

INNOVATION:  Does the center propose to develop novel concepts, approaches, 
measures or methods in the development and assessment of mental health disparities 
research?  Are the aims original and innovative? Does the ACMHDR extend existing 
approaches or develop new methodologies or technologies that will facilitate 
development of focused research efforts?  Does the ACMHDR propose to study 
populations/groups which have a paucity of data and information in comparison to 
other segments of the U.S. population? 

INVESTIGATOR:  Are the ACMHDR director and other senior investigators at the 
forefront of their respective fields? Do they have the experience and authority 
necessary to organize, administer and direct the center?  Is the investigator's 
research competence continuing to improve?

ENVIRONMENT:  Does the scientific environment of the center contribute to the 
probability of success? Does the center take advantage of unique features of the 
scientific environment or employ useful collaborative arrangements?  Is the center 
able to gain and sustain access to a representative range of people in a broad set 
of academic and community settings?  Is there evidence of institutional support?  
Are the collaborating sites chosen for the center appropriate for  addressing the 
research questions proposed?  If applicable, does the distribution of the budget 
among multi-site institutions reflect a partnership between developed research 
institutions and developing research institutions?

REVIEW OF RESEARCH PROJECTS AND PILOT RESEARCH PROJECTS 

The initial review group will take into account these factors when conducting the 
scientific and technical merit review of the research project and pilot research 
project applications:

SIGNIFICANCE:

o  Does this study address an important problem in mental health disparities? 
o  If the aims of the application are achieved, will scientific knowledge be 
advanced? 
o  Will there be a significant impact of these studies on the concepts or methods 
that contribute to the reduction of health disparities? 
o  For pilot subprojects: Is it likely that the research proposed in the pilot 
projects would yield data useful as the basis for a more sophisticated independent 
research support application (e.g., Career Development (K), Exploratory Research 
Grants (R34), Small Research Grant Program (R03), Exploratory/Developmental 
Research Grant (R21) (where applicable), a research project in an advanced center, 
or an R01)?  

APPROACH:

o  Are the conceptual framework, design, methods, and analyses of data adequately 
developed, well integrated, and appropriate to the aims of the project? 
o  Does the applicant acknowledge potential problem areas and consider alternative 
methods/approaches? 
o  Is the literature review critical and current, including identification of gaps 
in the knowledge? 
o  For pilot projects: Are the proposed aims achievable and reasonable for a pilot 
project?

INNOVATION:

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

INVESTIGATOR:

o  Is the investigator appropriately trained and well suited to carry out this 
work? 
o  Is the work proposed appropriate to the experience level of the principal 
investigator and other researchers (if any)? 
o  Has the investigator been productive in documenting his/her research findings in 
refereed-reviewed journals? 
o  Has the investigator's productivity been commensurate with previous research 
support? Is the investigator's research competence continuing to improve?

ENVIRONMENT:

o  Does the scientific environment in which the work will be done contribute to the 
probability of success? 
o  Do the proposed experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? 
o  Is there evidence of institutional support? 
o  If resources are not available, are there plans to acquire, or gain access to, 
the necessary resources to conduct the research?

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:

Quality and appropriateness of the outreach and research career development 
components of the Center’s activities:  Are approaches used to disseminate 
information regarding the Center’s activities as they relate to public 
understanding of science and mental health and illness adequate? Are 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 likely to be effective?
 
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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
 
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 will be 
assessed.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to be 
used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL CONSIDERATIONS

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct costs in 
any year of the proposed research are expected to include a data sharing plan in 
their application.  The reasonableness of the data sharing plan or the rationale 
for not sharing research data will be assessed by the reviewers.  However, 
reviewers will not factor the proposed data sharing plan into the determination of 
scientific merit or priority score.

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

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds with 
all other recommended applications.  The following will be considered in making 
funding decisions:

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

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:  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 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.  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://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.

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 PA 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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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