PHARMACOTHERAPY FOR COMORBID ALCOHOL AND DRUG USE DISORDERS
RELEASE DATE: February 24, 2004
PA NUMBER: PA-04-067
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. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date for these
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms
expires on the date indicated below. Other mechanisms relating to this announcement
will continue to be accepted using paper PHS 398 applications until the stated
expiration date below, or transition to electronic application submission. 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 for AIDS and
non-AIDS applications thereafter. Applications relating to R33 and R34 activities
must be in response to NIH Institute/Center (IC)-specific announcements.
EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006
EXPIRATION DATE for All R01 Applications: January 30, 2007, unless re-issued.
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.273 (NIAAA) and
93.279 (NIDA)
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 Supplementary Instructions
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
o References
PURPOSE OF THIS PA
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the
National Institute on Drug Abuse (NIDA) are seeking research grant
applications on pharmacological treatment for patients with alcohol use
disorder (AUD) and a comorbid substance use disorder (SUD). Substance
use disorder may include the abuse/dependence of heroin, prescription
narcotics, cocaine, methamphetamine and other stimulants,
hallucinogens, sedative hypnotics, marijuana, and other substances of
abuse. Alcoholic abuse/dependent patients may have a co-occurring
nicotine dependence, but must also meet the criteria for other types of
SUD. Research on the specific treatment needs of this population is in
early stages, and thus well-designed studies are needed. In
particular, it is important to understand how the effects of treating
one disorder affects the outcome for the other disorder. The
intervention strategy to treat one or both comorbid conditions might
depend on the type of comorbidity as well as the subtype of comorbid
AUD/SUD patient. In addition, applications can include the utilization
of human laboratory paradigms to screen potential medications for
subsequent phase 2 and 3 trials as well as to determine the actions of
the medications for the treatment of comorbid AUD and SUD. All
applications submitted in response to this program announcement should
be conducted in humans. In addition, all applicants are encouraged to
evaluate the interactions among alcohol, the abused substance and the
medication under investigation.
RESEARCH OBJECTIVES
Background
Alcohol abuse and dependence commonly occurs in subjects who suffer
from SUD and patients with AUD often have SUD, for example, as many as
90 percent of cocaine addicts have a problem with alcohol in both
treatment and community settings. Patients suffering from both
disorders often have poorer treatment outcome and are more likely to
drop out of treatment. Unfortunately, effective pharmacological
treatments have yet to be established for the various conditions of
comorbid AUD and SUD.
In developing effective treatment strategies for each substance of
abuse, one may need to take into account the physiological and
psychological alternations that can occur from a drug-alcohol
interaction. For example, ingestion of alcohol and cocaine can produce
a new metabolite, cocaethylene, which can increase craving as well as
increased heart rate.
Some progress has been made in treating patients with a concurrent
alcohol and cocaine dependence. Carroll et al. (1998) reported that
disulfiram combined with outpatient psychotherapy enhanced treatment
retention and increased the duration of abstinence from both alcohol
and cocaine use. In a preliminary report, it was found that supervised
disulfiram reduced both alcohol and cocaine intake in patients dually
diagnosed with cocaine dependence and alcohol abuse/dependence.
Interestingly, naltrexone at doses of 50 mg/day has been reported
ineffective in treating comorbid alcohol and cocaine use disorders.
Nevertheless, in a preliminary report in 1999, alcohol and cocaine
dependent patients treated with higher doses of naltrexone (150 mg/day)
reduced both their frequency and amount of alcohol and cocaine intake.
Studies are underway to test the efficacy of 150 mg of naltrexone daily
and also to evaluate the effectiveness of the combination of naltrexone
and disulfiram in this population.
Little research has been conducted on alcoholics with a comorbid opioid
addiction. In an early study it was reported that disulfiram given to
alcoholic methadone patients reduced their alcohol intake. However,
new studies are needed to test newer medications such as buprenorphine
for opioid dependence and naltrexone and acamprosate for alcoholism.
In summary, research to evaluate effective combined pharmacological and
behavioral treatments for patients diagnosed with AUD and SUD is in
very early stages. The purpose of this program announcement is to
stimulate state-of-the-art research to evaluate promising
pharmacological treatments across a wide population of comorbid AUD and
SUD subjects.
Specific Areas of Interest
A wide variety of research opportunities exist for advancing the
treatment of this understudied population. Research topics include,
but are not limited to:
Evaluate the efficacy of established and novel pharmacological agents
for AUD patients with a comorbid SUD.
Evaluate pharmacotherapies for the treatment of AUD and SUD in patients
with other co-morbid psychiatric disorders.
Appropriate combination and sequencing of pharmacological and
behavioral therapies for patients suffering from concurrent AUD and SUD
disorders is needed. In addition, optimal dosage and duration of
treatment needs to be established for each medication.
Determine the optimal integration of pharmacological agents with
behavioral therapies for concurrent AUD and SUD.
Determine if outcome of pharmacological treatment of AUD patients
suffering from comorbidity is different than that of non-comorbid
patients or different as a function of gender.
Establish if the treatment of AUD or SUD improves or affects the
outcome for the other comorbid psychiatric disorder.
Determine if treatment for AUD and SUD should be conducted
simultaneously or sequentially.
Determine if the chronology of onset of the comorbid condition (e.g.,
primary versus secondary AUD) can influence treatment outcome and alter
treatment strategy.
Evaluate pharmacological treatments for comorbidity in special
populations including minorities, women, the elderly, adolescents, and
those in the criminal justice system.
Develop techniques to enhance treatment compliance in patients with
comorbid AUD and SUD.
Identify factors influencing the safety and clinical efficacy of
medications for the treatment of AUD and SUD, using human laboratory
behavioral pharmacology paradigms. Prior to beginning phase 2 clinical
trials potential medications can be screened in the laboratory to
determine the following: 1) the medication's impact to reduce craving
and/or to diminish the negative symptoms of addiction; 2) likelihood of
adverse events, especially in the presence of alcohol; 3)
pharmacokinetics for medication combinations; and 4) optimal dosing
regimens. Studies are sought which develop and expand use of these
human laboratory paradigms.
MECHANISM(S) OF SUPPORT
This PA will use the NIH research project grant (R01) small grant (R03)
and Exploratory/developmental grant (R21) award mechanism. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project. The total project period for a research
project grant (R01) application submitted in response to this Program
Announcement may not exceed 5 years.
This PA uses just-in-time concepts. It also uses the modular budgeting
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 budget format.
Otherwise follow the instructions for non-modular budget research grant
applications. 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 institutions/organizations
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with 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.
SPECIAL REQUIREMENTS
The issue of safety of the three-way interaction of alcohol, the abused
substance and the medication under investigation should be addressed in
the application. The application should demonstrate (through pilot
studies and /or citations of published data or presentation of
unpublished data) that no serious adverse events would be expected from
the co administration of alcohol, the abused substance and the
medication under investigation. Serious adverse events (SAEs) are
defined as any medical occurrence that results in death; is life-
threatening; requires inpatient hospitalization or prolongation of
existing hospitalization; creates persistent or significant
disability/incapacity, or a congenital anomaly/birth defects.
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 two areas: scientific/research and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Charlene E. Le Fauve, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane
Bethesda, MD 20892-9304
For express mail use:
Rockville, MD 20852-1705
Telephone: (301) 402-9401
Fax: (301) 443-8774
Email: clefauve@NIAAA.nih.gov
Ivan D. Montoya, M.D., M.P.H.
Medications Research Grants Branch
Division of Treatment Research and Development
National Institute on Drug Abuse
6001 Executive Blvd.
Bethesda, MD 20892-9551
Phone: (301) 443-8639
Fax: (301) 443-2599
e-mail: imontoya@mail.nih.gov
o Direct your questions about financial or grants management matters
to:
Judy Fox (formerly Simons)
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane
Bethesda, MD 20892-9304
(For express mail use:
Rockville, MD 20852-1705)
Telephone: (301) 443-2434
Email: jsimons@mail.nih.gov
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131 MSC 9541
Bethesda, Maryland 20892-9541
Telephone: 301-443-6710
E-mail: gfleming@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 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.
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.
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 BUDGET GRANT APPLICATIONS:
Applications requesting up to $250,000 per year in direct costs must be
submitted in a modular budget grant format. The modular budget 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 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
unfunded version 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. 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 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 evaluate
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application’s overall score, weighting them
as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high
priority score. For example, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
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).
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 REVIEW 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 more than $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.
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 No. 93.273 (NIAAA) and 93.279 (NIDA), 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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