RESEARCH ON CO-MORBID MENTAL AND OTHER PHYSICAL DISORDERS

RELEASE DATE:  January 22, 2002

PA NUMBER:  PA-02-047 (This program announcement has been replaced by PA-05-018)

EXPIRATION DATE:  November 22, 2004.

PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Institute of Mental Health
 (http://www.nimh.nih.gov/)

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 Where to send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE THIS PA

This PA replaces PA-99-071.

A range of research studies has demonstrated that many individuals suffer 
from mental and other physical disorders at the same time.  The suffering 
experienced by individuals as a result, and the cost to the nation in lost 
productivity and health expenditures, is magnified well beyond the suffering 
and costs associated with either mental or other physical disorders alone.  
For example, compelling scientific data show that depression co-morbid with 
heart disease increases mortality beyond heart disease alone.  Other examples 
of co-morbid mental and other physical disorders include anxiety disorders 
and cancer, panic disorder and asthma, post-traumatic stress disorder and 
chronic physical disability caused by serious injury, and schizophrenia and 
diabetes. Co-morbid disorders occur across the lifespan, from early childhood 
through the oldest segments of our population, including those with terminal 
physical disorders.  Yet the scope and nature of co-morbid mental and other 
physical disorders remains largely unknown.  Limited reliable and valid 
national or statewide epidemiological data on the incidence and prevalence of 
these co-morbid disorders exist.  Little is known about the mechanisms that 
link co-morbid mental and other physical disorders, particularly mechanisms 
that have a relatively large influence on the development of these co-morbid 
disorders and can also be modified through intervention.  Thus, our ability 
to intervene to prevent or treat adverse co-morbid mental and other physical 
outcomes is limited. 

The overall purpose of this program announcement is to expand and to refocus 
NIMH-supported studies on co-morbid disorders, including, but not limited to, 
areas traditionally known as "behavioral medicine" or "health psychology." Of 
interest are epidemiological studies that elucidate the frequency and 
distribution patterns of co-morbid mental and other physical disorders across 
gender, racial/ethnic minority groups, and the lifespan, studies of 
biological, behavioral, and psychosocial risk and protective processes 
underlying co-morbid mental and other physical disorders to clarify which 
processes have the greatest relative influence on the development of these 
disorders and can potentially be modified through intervention, 
investigations to discover potentially modifiable biological substrates that 
link co-morbid mental and other physical disorders, including research on, 
neurotransmitters, neuropeptides, neuromodulators, hormones and other 
proteins, neural circuits, and neural systems (to include nervous, endocrine, 
and immune system pathways, e.g., the hypothalamic-pituitary-adrenal axis), 
initial tests of innovative pharmacological, behavioral, psychosocial, or 
environmental interventions, research on the efficacy, effectiveness, long-
term outcome and safety of preventive, treatment, and rehabilitative 
interventions across the lifespan, clinical trials and intervention studies 
targeting functional and symptomatic outcomes adapting pharmacological, 
psychosocial, behavioral, or environmental approaches individually or in 
combination, studies to improve the recruitment and retention of individuals 
with co-morbid disorders in real-world practice settings, and research on the 
impact of separate organizational systems and different financing mechanism 
for mental and other physical disorders.  Within these broad research areas, 
emphasis on better understanding basic behavioral processes is encouraged, 
including processes such as motivation, decision-making, adherence, emotion, 
cognition, and social interactions between health care providers and consumers.

Descriptive studies (e.g., epidemiology, risk and protective factors 
research) elicited by this program announcement MUST HAVE CENTRAL AND 
EXPLICIT RELEVANCE TO MENTAL DISORDERS, SYMPTOMS, OR RELATED DISABILITY as 
reflected in the title, abstract, theoretical framework, specific aims, 
measures, and analyses.  Intervention studies—including prevention, 
treatment, and rehabilitation-- elicited by this announcement should 
PRIMARILY TARGET MENTAL DISORDER OUTCOMES that are co-morbid with other 
physical disorders.  Examples include preventing or treating mood or anxiety 
disorders in people with another physical disorder.  Interventions may be 
pharmacological, behavioral, psychosocial, environmental, or a combination of 
these approaches.

Investigators primarily interested in another physical disorder outcome or 
investigators interested in treating a mental disorder (i.e., depression) to 
improve adherence to a regimen for another physical disorder (i.e., heart 
disease or diabetes) should seek funding from the NIH Institute or Center 
focused on that particular physical disorder.

Research on improving adherence to interventions aimed at mental disorders 
per se are supported by the NIMH through PA-00-016, "Research on Adherence to 
Interventions for Mental Disorders" at 
http://grants.nih.gov/grants/guide/pa-files/PA-00-016.html.

RESEARCH OBJECTIVES

SUMMARY

The NIMH encourages studies on the co-occurrence and co-morbidity of mental 
disorders with other physical disorders.  An important goal of this program 
announcement is to identify potent, modifiable risk and protective factors 
amenable to intervention, and to translate the results of such studies into 
initial tests of theory-driven prevention and early intervention strategies.  
Risk and protective factors include biological, psychosocial, behavioral, and 
environmental contributors to co-morbid disorders.  The program announcement 
encourages research on the efficacy, effectiveness, long-term outcome and 
safety of preventive, treatment, and rehabilitative interventions across the 
lifespan, clinical trials and intervention studies targeting functional and 
symptomatic outcomes adapting pharmacological, psychosocial, behavioral, or 
environmental approaches individually or in combination, studies to improve 
the recruitment and retention of individuals with co-morbid disorders in real-
world practice settings, and research on the impact of separate organizational 
systems and different financing mechanism for mental and other physical 
disorders.  Major emphasis is placed on the identification of principles 
motivating and sustaining behavior changes critical to reducing the risk for 
co-occurring disorders.  Studies are particularly encouraged of mental 
disorders that are co-morbid with other physical disorders that are among the 
leading causes of morbidity and mortality in the United States, including 
heart disease, cancer, strokes, chronic obstructive pulmonary diseases, and 
diabetes, for example.  The Institute will, however, consider applications 
that focus on any combination of co-morbid mental and other physical disorder 
across the lifespan, it is incumbent upon the applicant to demonstrate the 
public health significance of the study by describing the severity and/or 
prevalence of the disorders studied.

Research applications solicited under this program announcement include, but 
are not limited to:

o  Studies of the incidence and prevalence of co-morbid mental and physical 
disorders/symptoms/related disability, especially epidemiological studies 
that elucidate potentially modifiable biological, behavioral, psychosocial, 
or environmental risk and protective processes

o  Investigations to discover potentially modifiable biological substrates 
that link co-morbid mental and other physical disorders, including research 
on neurotransmitters, neuropeptides, neuromodulators, hormones and other 
proteins, neural circuits, and neural systems (to include nervous, endocrine, 
and immune system pathways, e.g., the hypothalamic-pituitary-adrenal axis)

o  Proposals to discover potentially modifiable behavioral, psychosocial, or 
environmental risk and protective factors, including studies of motivation, 
decision-making, cognition, emotion, and social interactions between health 
care providers and consumers

o  Proposals to develop models of co-occurring mental and other physical 
disorders that specify the mediators and moderators responsible for 
translating risk into co-morbidity over time, or for protecting from risk 
over time

o  Tests of etiological models through experiments that probe the causal role 
of risk factors and presumed mediators and moderators of risk, including 
initial tests of innovative interventions.  Interventions may be prevention, 
treatment, rehabilitation, pharmacological, behavioral, psychosocial, or 
environmental factors

o  Studies of stress where depression or anxiety disorders/symptoms are a 
central and explicit aspect of the conceptualization and measurement of 
"stress"

o  Studies to strengthen the diagnosis and assessment of co-morbid mental and 
physical disorders, including the development of new measures to improve 
reliability and validity, especially in real-world practice settings 

o  Research on the kinds of individuals with co-morbid disorders seen in the 
general health care sector, especially primary care and emergency rooms, as 
well as on the types, quality, and effectiveness of mental health services 
delivered in that sector

o  Studies to clarify why and how the demands of treating other physical 
disorders interfere with care for mental disorders, especially in primary 
care settings

o  Examinations of the impact of treatment for another, secondary physical 
disorder on a primary or co-occurring mental disorder

o  Studies to determine whether people with mental disorders receive fewer 
medical services (e.g., cardiac assessments) for physical complaints, and, if 
so, why

o  Studies to determine whether health care costs for people with co-morbid 
mental and other physical disorders are greater than such costs among people 
with only one type of disorder, and to determine whether this is true even if 
those with co-morbid mental and other physical disorders receive fewer 
medical services (e.g., cardiac assessments) for physical complaints, and, if 
so, why

o  Investigations of the role of sub-clinical symptoms in the development and 
modulation of co-morbid disorders

o  Examinations of how treatments and services delivered in both the general 
and mental health sectors can be used to understand the needs and clinical 
characteristics of people with sub-syndromal conditions who also have other 
physical disorders

o  Studies using innovative methodologies (e.g., decision analysis) to 
examine and improve the clinical management of people with co-occurring 
mental and other physical disorders

o  Studies of referral patterns from the general health care sector to the 
mental health sector and barriers to referral for patients with co-occurring 
disorders – rates, processes, and effect on patient outcomes, as well as 
strategies to overcome those barriers

o  Research on the impact of different reimbursement approaches on the use of 
general health vs. mental health services and implications for services, 
quality of care and outcomes of people with co-occurring disorders

o  Research on existing or innovative models linking or integrating mental 
health services with the general health sector especially for people with 
severe mental disorders and other co-occurring physical disorders

o Studies of pain and co-morbid mental disorders

o  Examinations of self-management and behavior change strategies for co-
morbid mental and other physical disorders across the lifespan

o  Studies to elucidate risk and protective processes associated with co-
morbid mental and other physical disorders in those with chronic conditions 
that start as early development problems (e.g., mental retardation and 
autism) or chronic, late life problems such as dementia or infirmity

o  Studies to examine which of these risk and protective processes might be 
modified through preventive and treatment interventions, and how they might 
be most feasibly modified to prevent or alleviate co-morbid mental and other 
physical disorders

o Studies of co-morbid mental and other physical disorders at the end of life

MECHANISM OF SUPPORT

This PA will use the NIH Small Grant (R03), Exploratory/Developmental Grant 
(R21), and Research Project Grant (R01) award mechanisms.  As an applicant, 
you will be solely responsible for planning, directing, and executing the 
proposed project.  The Small Grant (R03) provides up to two years of funding 
with a maximum of $50,000 direct costs for each year.  The Exploratory/ 
Developmental Grant (R21) provides up to three years of funding with a 
maximum of $100,000 direct costs for each year, it is intended for pilot 
testing of interventions and other aspects of intervention development.  
Should funding levels for these grant mechanisms increase subsequent to the 
release of this program announcement, applicants may apply for the higher 
levels.  The Research Project Grant (R01) provides up to five years of 
funding that is commensurate with the science proposed.

Applications are encouraged under this announcement to develop and initially 
test innovative interventions.  The Exploratory/Developmental Grant for 
Mental Health Interventions (R21) is the appropriate  grant mechanism for 
this work.  Because such research is by definition exploratory and 
developmental, extensive preliminary data or studies are not expected for  
R21 applications.  For details, please see 
http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html.

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats 
(see http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, 
if you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for 
non-modular research grant applications.

Potential applicants are also encouraged to study co-morbid mental and other 
physical disorders by applying for Career Development Awards (the K Awards), 
which primarily provide salary support for full-time research.  Program 
announcements describing in detail the various Career Development Awards may 
be found at http://www.nimh.nih.gov/grants/career.htm.  Potential applicants 
interested in other award mechanisms are strongly encouraged to consult with 
program staff listed under INQUIRIES.

ELIGIBLE INSTITUTIONS

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

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

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o  Direct your questions about scientific/research issues to:

Peter Muehrer, Ph.D.
Co-Morbidity Research Program
Health and Behavioral Science Research Branch
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6189, MSC 9615
Bethesda, MD  20892-9615
Telephone:  301/443-4708
FAX:  301/480-2920
Email:  pmuehrer@mail.nih.gov

Junius J. Gonzales, M.D.
Services Research and Clinical Epidemiology Branch
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7146, MSC 9631
Bethesda, MD  20892-9631
Telephone:  301/443-3364
FAX:  301/443-4045
Email:  jgonzale@mail.nih.gov

Debra J. Babcock, Ph.D., M.D.
Division of Neuroscience & Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7178, MSC 9639
Bethesda, MD  20892-9639
Rockville, MD  20852 (FedEx, UPS, etc.)
Telephone:  301/443-1692
FAX:  301/402-4740
Email:  dbabcock@mail.nih.gov

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

Diana S. Trunnell
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  301/443-2805
FAX:  301/443-6885
Email:  Diana_Trunnell@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email:  GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular grant format.  The modular grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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.   

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study,

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award, and,

3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five 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)

APPLICATION PROCESSING: Applications must be received by or mailed before the 
receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.

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 application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
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 Receive a written critique
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 second level review by the appropriate national advisory council 
or board
	
REVIEW CRITERIA

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

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  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.

(1) Significance: Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced? 
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) Approach: Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation: Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?

(4) Investigator: Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5) Environment: Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional support?

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

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.

INCLUSION:  The adequacy of plans to include subjects from both genders, 
minorities and their subgroups, and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated.  (See Inclusion Criteria included in the 
section on Federal Citations, below)

BUDGET:  The reasonableness of the requested budget and the requested period 
of support as it relates to the proposed research.

OTHER REVIEW CRITERIA:

Additional considerations pertinent to the review of NIMH Small Grant 
(R03) applications:

o  Because the research plan is limited to 10 pages, a Small Grant 
application may not have the same level of detail or extensive discussion 
normally found in an R01 application.  Review emphasis should be placed on 
conceptual framework and general approach to the problem, with less emphasis 
on methodological details.

o  Pilot/feasibility studies contain little or no preliminary data.  Review 
should focus on whether the rationale for the study is well developed and 
whether the proposed research is likely to generate data that will lead to a 
regular research project grant or full-scale clinical trial.  Adequate 
justification for the proposed work may be provided through literature 
citations, data from other sources, or investigator-generated data.

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

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

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

All investigators proposing clinical research should read the 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 
(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.

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

Applicants may wish to place data collected under this RFA (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.  Reviewers are 
cautioned 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.health.gov/healthypeople/.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance No. 93.242 (NIMH) and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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 
http://grants.nih.gov/grants/policy/policy.htm 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.

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



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