RESEARCH ON ADHERENCE TO INTERVENTIONS FOR MENTAL DISORDERS
RELEASE DATE: April 21, 2003
PA NUMBER: PA-03-111 (This PA has been reissued, see PA-06-324 for R01 applications)
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. Parent R03 (PA-06-180) and R21 (PA-06-181)
funding opportunity announcements have been issued for the submission date of
June 1, 2006 and submission dates thereafter. Applications relating to R33 and R34
activities must be in response to NIH Institute/Center (IC)-specific announcements.
EXPIRATION DATE: March 02, 2006
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.242
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 OF THIS PA
This PA replaces PA-00-016.
Maximal benefits from treatment or preventive interventions will not be
achieved if individuals discontinue those interventions before completion.
Even if a protocol is completed, less than full adherence to one or more of its
components can also limit the benefits. An example of the consequences of
nonadherence to treatment regimens may be seen in statistics relating to
unipolar major depression. According to World Health Organization estimates,
unipolar major depression will become the second leading cause of disability
worldwide by the year 2020. Although effective treatments exist, large
segments of those who suffer from depression do not receive treatment. The
Agency for Healthcare Research and Quality estimates that, among those who do
receive treatment with available antidepressant medications, forty percent do
not complete the recommended 7-12 months regimen. Thus, the full benefit of
antidepressant medication therapy is not realized. Similarly, substantial
dropout rates from psychosocial and behavioral interventions for mental
disorders limit their public health impact. In addition to unipolar major
depression, bipolar disorder, schizophrenia, and anxiety disorders such as
obsessive-compulsive disorders are among the leading causes of disability
worldwide. Available interventions for these disorders could have greater
impact and relieve more suffering if adherence to them were improved.
This program announcement is intended to expand research on adherence and
behavior change that leads to improved adherence and/or improved mental health
outcomes. It should integrate findings from the basic behavioral sciences with
interventions for mental disorders, symptoms, or related disability, and with
findings from services research about the elements of care delivery systems that
facilitate or create barriers to improved adherence. Included are studies of
mechanisms and processes that enhance or interfere with adherence to preventive,
treatment, and rehabilitative interventions. The interventions may be
pharmacological, behavioral, or psychosocial. Emphasis is on the development
of innovative approaches to adherence and behavior change, especially models of
interventions to improve adherence. A well-articulated, empirically based
conceptual framework is therefore essential in applications solicited under
this announcement. Applications that also include a detailed plan for initial
tests of a conceptual model, or which test the feasibility of implementing an
efficacious intervention in an existing health care delivery system are
especially encouraged.
One commonly used definition of adherence is: The degree to which a patient or
client's behavior is consistent with an agreed-upon mode of treatment. However,
the definition of "adherence" or "behavior change" might well vary depending
upon the nature and scope of the particular problems under study. Clear
conceptual and operational definitions and psychometrically sound measures
that are consistent with these definitions are essential in this research.
Definitions of "adherence" or "behavior change" might address, for example,
the completeness and frequency with which a client engages in behavioral or
psychosocial components of an intervention protocol, or the extent to which a
client takes medications at the dosage and frequency prescribed. Other
definitions and measures could focus on provider behaviors, intervention
strategies or on aspects of the patient provider relationship.
Increased understanding of the mechanisms and processes underlying individuals'
decisions to adhere or not to adhere to interventions for mental disorders,
their symptoms, and related disability, would enhance our ability to develop
models of interventions to modify those mechanisms and processes to increase
adherence. Although many theoretical models have been developed to describe
the processes of adherence and behavior change, their potential has not been
fully exploited to guide the design of pharmacological, behavioral and
psychosocial interventions. Progress in applied public mental health could be
accelerated significantly by building on fundamental research in the behavioral
and biomedical sciences related to motivation, persuasion, attitude change,
decision-making, perception, self-efficacy, social cognition and other
interpersonal processes, initiation and sustainment of behavior change,
personality factors, family and community support, and the character of
alliances between providers and clients. Therefore, investigation of the
utility of such theoretical models remains an important challenge.
Applications examining mechanisms and processes underlying provider strategies
and behaviors that enhance recruitment, retention, and adherence are also
encouraged. Other areas of interest under this program announcement include
research on approaches to decreasing stigma related to mental disorders and
increasing adherence to interventions; studies of ways in which various
informed consent procedures and other issues related to research ethics can
facilitate or hinder adherence to interventions; and the development of
reliable and valid measures for all the above areas.
The importance of adherence to the outcome of preventive, treatment, and
rehabilitative interventions is well recognized, but it has often been treated
simply as a nuisance variable in research. Adherence must be regarded as a
central focus in all research that attempts to develop or test models of
interventions for mental disorders, symptoms, and related disability.
RESEARCH OBJECTIVES
The need for research is urgent across a range of topics germane to adherence
to interventions for mental disorders, symptoms, and related disability. This
program announcement will encourage grant applications for research in a number
of critical areas, including, but not limited to:
o Cross-cutting principles of motivating adherence and behavior change in
studies aimed at developing models of preventive, treatment, and rehabilitative
interventions and innovative strategies to enhance adherence to them;
o Methods of adherence and behavior change that promote incremental change over
time to sustain the benefits of intervention;
o The relationship of adherence to intervention response throughout the course
of the intervention;
o How competing theories of adherence and behavior change complement each
other, such as studies simultaneously varying motivation source, degree of
self-efficacy, stage of change, social reinforcement, or norms;
o How differential patterns of adherence to various components of combined
interventions influence outcomes;
o Identifying the general principles of motivation (e.g., intrinsic or
extrinsic motivation) most effective in encouraging adherence, and identifying
the emotions, attitudes, states, or beliefs (e.g., negative emotions such as
fear, or positive attitudes such as an enhanced self-image or an appeal to an
ideal self) that are most centrally associated with adherence behaviors;
o Studies of various theory-based interventions for improving adherence in
various under-served or high-risk/special-need populations across the
life-course;
o Strategies containing sub-components that address different adherence-
related behaviors separately, e.g., a project with multiple sub-studies that
investigate different aspects of a theory for their relevance to different
behaviors;
o Studies of how factors underlying adherence or behavior change in one domain,
for example, interventions aimed at HIV disease, other sexually transmitted
diseases, Hepatitis C and tuberculosis, might inform adherence to interventions
aimed at mental disorders;
o Studies of factors underlying provider strategies and behaviors that enhance
recruitment, retention, and adherence;
o Developing and validating measurements of adherence to pharmacological,
behavioral, or psychosocial interventions, including blood and urine levels,
self-reports, clinicians' observations, pill counts, remote or automated
sensing devices, etc.;
o Clarifying the characteristics of study participants that may contribute to
adherence and non-adherence, such as age, gender, ethnicity, level of education,
occupation, marital status, parental status, socioeconomic status, sexual
orientation, religion, personality traits, personal and/or cultural beliefs
about health, the nature of their disorder, or their treatments, and the
presence of co-morbid mental illness;
o The health provider/client alliance and communication patterns, and how these
processes affect adherence;
o Studies of interventions and service models that aim to increase client
involvement in preventive, treatment, and rehabilitative decisions as a way of
improving adherence;
o Studies that examine the impact of organizational, management, integration,
or financial features of the mental health delivery system that may facilitate
or create barriers to improved adherence and/or more productive health
provider/client alliances;
o Community and clinical epidemiological studies that assess the relative
impact of the competing explanatory domains that are associated with adherence,
such as the relative impact of intra-psychic phenomena, behavioral cues and
reminders, the health provider/client alliance, or the features of the health
care delivery system;
o Research on approaches to decreasing stigma related to mental disorders and
increasing adherence to interventions, including studies of self stigma, stigma
among providers, families and significant others, the social context of stigma,
as well as studies of individuals who are stigmatized; or
o Research on the potential positive and/or negative impact of various
informed-consent procedures and other issues related to research ethics on
interventions aimed at mental disorders, including issues such as capacity to
make informed consent, adequacy of informed consent content and procedures,
efforts to identify and reduce therapeutic misconceptions, the impact of
wash-out protocols, and the feasibility and adequacy of connect by proxies.
MECHANISM(S) OF SUPPORT
This PA will use the NIH Small Research Grant Program (R03), NIH
Exploratory/Developmental Research Grant Award (R21), and Research Project Grant
(R01) award mechanism(s). As an applicant, you will be solely responsible for
planning, directing, and executing the proposed project.
The Small Grant (R03) provides two years of funding with a maximum of $50,000
direct costs for each year. Information on the requirements for the NIH Small
Grant may be obtained at
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html.
The Exploratory/Developmental Grant (R21) provides two years of funding with a
maximum of $275,000 direct costs over the entire budget period; it is intended
for pilot testing of interventions and other aspects of intervention
development. The Research Plan may not exceed 15 pages. Information on the
requirements for the NIH Exploratory/Developmental Grant may be obtained at
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html.
The Research Project Grant (R01) provides up to five years of funding that is
commensurate with the science proposed.
This PA uses just-in-time concepts. It also uses the modular budgeting format.
(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. 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(s) if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
o Faith-based or community-based organizations
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 to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
William Riley, Ph.D.
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6226, MSC 9623
Bethesda, MD 20892-9623
Telephone: (301) 435-0301
FAX: (301) 480-2920
Email: wiriley@mail.nih.gov
Junius Gonzales, M.D.
Division of Services Research and Clinical Epidemiology Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 7141, MSC 9631
Bethesda, MD 20892
Telephone: (301) 443-3364
FAX: (301)443-4045
Email: jgonzale@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Brian Albertini
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6135, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-0004
FAX: (301) 443-6885
Email: ba18b@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) 710-0267,
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 on or
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.
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. 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, an investigator may propose to carry out important
work that by its nature is not innovative but is essential to move a field
forward.
SIGNIFICANCE: Does this study address an important problem? If the aims of the
application are achieved, how will scientific knowledge be advanced? What will
be the effect of these studies on the concepts or methods that drive this field?
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?
INNOVATION: Does the project employ novel concepts, approaches or methods? Are
the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?
ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. (See criteria included in the section
on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans
to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the research
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
DATA SHARING: The adequacy of the proposed plan to share data.
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
MONITORING PLAN AND DATA AND SAFETY 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 "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 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.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under 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.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.
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