This Program Announcement expires on June 1, 2004, unless reissued.

HIV TREATMENT ADHERENCE RESEARCH

Release Date:  March 20, 2001

PA NUMBER:  PA-01-073 (The R01 portion has been reissued 
as PA-07-338, the R03 as PA-07-339, the R21 as PA-07-340 and R34 as PAR-07-341)

National Institute of Mental Health
 (http://www.nimh.nih.gov)
National Institute of Drug Abuse
 (http://www.nida.nih.gov)
National Institute of Alcohol Abuse and Alcoholism
 (http://www.niaaa.nih.gov)

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  THIS PA INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA.

THIS PROGRAM ANNOUNCEMENT REPLACES PA-97-070

PURPOSE

The efficacy of combination antiretroviral medication therapies (ART) for the 
treatment of HIV-disease is now well documented.  Combination therapies can 
inhibit viral replication and reduce viral load to a point where viral particles 
are undetectable in the blood of infected individuals.  Significant and 
sustained suppression of HIV replication is associated with improved clinical 
outcomes.  
        
However, these benefits are only tenable when adherence to precise dosing 
schedules is rigorous and other treatment requirements are closely followed.  
Partial or poor adherence can lead to the resumption of rapid viral replication, 
poorer survival rates, and the mutation to treatment-resistant strains of HIV.  
Both domestically and internationally, behaviorally based interventions will 
continue to be integral to the success of any medication advances and their 
health outcomes.  Therefore, understanding and enhancement of ART treatment 
adherence remains a critical goal for the individuals receiving treatment, for 
those providing treatment, for public and private health officials who are 
responsible for making treatment available, and for the public health at-large.  

In response to this pressing need, scientists and practitioners have made 
significant gains in ART adherence research.  For example, progress has been made 
to simplify dosing regimens, to ameliorate aversive medication side effects, to 
improve access to health care, to facilitate behavior changes to avoid re-
infection with HIV or other STDs, and to intervene with consumer and provider 
characteristics (e.g., increase self-efficacy, remove barriers to adherence, 
treat psychosocial factors that can impair adherence), in order to advance 
treatment adherence to an acceptable level.  However, as the HIV pandemic and 
treatment rapidly evolves, the goals of ART adherence research must also evolve 
to build on scientific advances and the changing needs of those affected by HIV. 

This Program Announcement (PA) identifies gaps in the understanding of ART 
adherence, and encourages studies to address the role of adherence through all 
phases of treatment and illness, the need to broaden the scope of interventions 
to enhance treatment adherence, and the importance of tailoring methodological 
and intervention advances to the special needs and context of affected 
populations.  Emphasis is on the development of innovative approaches to 
adherence and behavior change, especially models of interventions to improve 
adherence.  Approaches based on basic behavioral principles such as cognition, 
emotion, decision-making, motivation, social interaction, and cultural context 
are particularly encouraged.  A well-articulated and empirically based 
conceptual framework is essential in applications solicited under this 
announcement.          

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, HIV TREATMENT ADHERENCE RESEARCH, 
is related to one or more of the priority areas of the NIH Strategic Plan for 
HIV-Related Research, i.e., to improve treatment adherence and quality of life 
among infected individuals.  Potential applicants may obtain a copy of "Healthy 
People 2010" at:  http://www.health.gov/healthypeople/. 

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of the 
Federal government.  Foreign institutions may apply for the R01 mechanism, but 
are not eligible for small grants (R03).  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) individual research 
project grant (R01) and small grant (R03) mechanisms.  Responsibility for the 
planning, direction, and execution of the proposed project will be solely that 
of the applicant.  The total project period for an application submitted in 
response to this PA may not exceed 5 years for the R01 award, and 2 years for 
the R03.

Special instructions and information for the Small Grant (R03) mechanism, 
generally applicable to NIMH, NIAAA, and NIDA, are available in the NIH Guide 
for Grants and Contracts at:  
http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html.  
Because small grants have special eligibility requirements, 
application formats, and review criteria, applicants are strongly encouraged to 
consult with NIMH, NIAAA, or NIDA program staff (See INQUIRIES).  R03s are 
limited to 2 years of support at a maximum of $50,000 direct costs per year, and 
are not renewable thereafter.

For all competing applications requesting up to $250,000 direct costs per year, 
specific application instructions have been modified to reflect “MODULAR GRANT” 
and “JUST-IN-TIME” streamlining efforts being undertaken at NIH.  More detailed 
information about modular grant applications, including a sample budget 
narrative justification pages and a sample biographical sketch, is available via 
the Internet at:  http://grants.nih.gov/grants/funding/modular/modular.htm.  
Applications that request more than $250,000 in any year must use the standard 
PHS 398 (rev. 4/98) application instructions.

RESEARCH OBJECTIVES

Background

The efficacy of combination therapy with antiretroviral drugs (ART) has 
dramatically altered the landscape of HIV treatment.  Treatment with protease 
inhibitors and other antiretroviral drugs can inhibit virus replication and 
reduce virus load to undetectable levels.  Significant and sustained suppression 
of HIV replication is associated with improved clinical outcomes.

However, benefits of combination medication regimens require careful adherence 
to precise dosing schedules and other dosing requirements.  Poor treatment 
adherence can allow the virus to resume its characteristic rapid replication, 
providing the opportunity to generate resistant mutant strains no longer 
responsive to available antiretroviral drugs.  Widespread transmission of 
resistant HIV strains is becoming an increasingly serious public health concern 
in the United States and throughout the world.

There has been a widespread response to the need for adherence studies.  More 
than 150 abstracts on this topic were presented at the 12th International AIDS 
meeting in Geneva in 1999, and findings are being presented with greater 
frequency in peer-reviewed journals.  This literature, combined with prior 
theory and research on other chronic disease conditions (e.g., diabetes), has 
informed good working models for HIV treatment adherence.  In general, 
understanding of adherence has focused on the individual or the “consumer.”  For 
example, depressive symptomatology and substance abuse problems are often 
associated with poor ART adherence.  However, despite a growing body of evidence 
regarding the influence of mental health factors on adherence (e.g., severe 
mental illnesses, substance abuse, high stress levels), only about 40 percent of 
HIV treatment locations offer on-site mental health treatment, and fewer offer 
drug or alcohol treatment.

Innovative, effective interventions are needed to facilitate behavior change, 
improve ART adherence, and prevent treatment relapse among persons at high risk 
for acquiring and transmitting the infection, including the severely mentally 
ill and both injecting and non-injecting drug users.  Although persons with 
severe mental illness are at enhanced risk for HIV, very little is known about 
their ART adherence and such issues as interactions of ART medications with 
psychoactive medications.

Relatively few ART adherence studies have addressed the provider or “system” 
level, which includes integrated service delivery, staff training, economic and 
sociocultural barriers, or other structural factors that affect access and 
adherence to ART.  Investigators should attempt to broaden the scope of 
interventions to enhance treatment adherence.  For example, there is evidence 
that treatment providers may make decisions about when and with whom to start 
utilizing ART methods (to assess a consumer’s likelihood of adequate adherence) 
without being fully aware of reliability and validity issues.  Assessment tools 
are available, but translational studies are needed to illuminate how best to 
implement research findings for provider use.  Regarding provider/consumer 
relationships, a better understanding is needed regarding how effective 
alliances are facilitated among providers, consumers, and their family and/or 
friends.  More needs to be known about what basic behavioral principles foster 
these alliances or partnerships, with the aims of improving the process, 
effective treatment, and outcomes of HIV disease.  

Studies are needed to better understand the antecedents and correlates of 
adherence throughout the phases of treatment and disease.  Adherence related 
factors are not expected to be similar across disease stages.  Pre-ART 
interventions may, for example, address different mechanisms than interventions 
coincident with ART initiation and maintenance.  Very different issues are 
likely to be important with individuals who have been on ART for years.  For 
many, HIV disease has become more of a chronic condition and other lifestyle 
concerns may become more immediate and important (e.g., employment, medical 
care, day-to-day stressors, dyadic and sexual relationships, complacency about 
infectivity, drug and alcohol use).  Understanding the effects and interactions 
of these and other behavioral, social, and environmental factors on an 
individual’s attitudes, beliefs, and motivations toward ART adherence will help 
in the development of improved interventions for ART adherence across the stages 
of HIV infection and disease.  

Research issues related to directly observed therapy (DOT) highlight the 
importance of environmental factors and their effects on adherence.  A few 
studies have shown that DOT results in better adherence and treatment outcomes.  
However, little is known about the effectiveness of this treatment strategy when 
individuals make environmental transitions (e.g., change their living 
arrangements), when medical condition improves or worsens, or when the treatment 
regimen changes.  For example, DOT has been used successfully in correctional 
settings with HIV-positive inmates, but researchers have rarely followed 
participants longitudinally upon return to the community to evaluate how, 
whether, and for how long these individuals connect to post-incarceration 
services and adhere to ART without DOT.  Similar issues arise in the transition 
of consumers from inpatient to outpatient care, when individuals move to 
different housing, geographic location, or to new treatment providers.

Qualitative findings also suggest that not all non-adherence is unintentional.  
Some investigators have begun to examine the effects of scheduled periods of 
drug “holidays” (“intermittent ART”).  Even short drug “holidays” have been 
linked to rapid viral rebound, but the evidence is less clear regarding a loss 
in general immune response or the development of drug resistance.  Cyclic use of 
ART is desirable for many HIV-infected persons who want periods of being drug 
free, however, more research is needed to understand the risks and consequences 
of episodic adherence or on the development of HIV resistant strains.  In 
addition, little is known about characteristics that may contribute to adherence 
or non-adherence decision-making, such as personality traits, attitudes, stigma, 
and self-esteem.  Moreover, as secondary HIV prevention (prevention targeting 
those already living with HIV) becomes more of a national and international 
priority, it is important to understand how adherence to medication regimens is 
correlated with adherence to other health risk behavior practices, such as 
practicing safer sex or harmful alcohol or drug abuse. 

In summary, understanding the factors influencing adherence and development of 
effective interventions are critical for improved clinical outcomes among 
persons on ART.  Access to health care and difficulties in managing and 
sustaining complex treatment regimens for HIV are challenges for many who are 
hard to reach and underserved, as well as for providers.  For example, 
engagement of drug abusers into HIV care through accessible programs, such as 
primary care linked with methadone treatment, has demonstrated reduced morbidity 
and improved survival, nevertheless, providers may consider drug abusers as high 
risk candidates for ART.  Because there has been an under-representation of hard 
to reach individuals, such as drug abusers and persons with comorbid conditions, 
in clinical studies of HIV therapies, there are few data on potential risks of 
drug interactions and toxicity in these populations.  For example, interactions 
between illicit drugs and HIV therapies, as well as pharmacotherapies for 
substance abuse, mental health conditions, and other diseases, may cause 
morbidity, influence adherence, and reduce the effectiveness of HIV treatment.  
Appropriate sample selection is especially critical in these areas, because it 
is important that the field does not advance with an understanding only of 
adherence among study participants who may already tend to be more adherent.  
The ability to draw generalizations from study findings and the power to detect 
post-intervention changes will be limited without attention to this issue.  That 
is, some of the factors that may be related to poor adherence to medication and 
appointments (i.e., language barriers, difficulties accessing medical care, 
childcare needs, substance use, fear of stigmatization, and a host of other 
contextual factors) may also be barriers to research participation.

This PA seeks a broad range of research on HIV treatment adherence, including 
but not limited to the following:

o  Research on the relationship(s) among disease stage, individual difference 
characteristics, treatment response, and adherence is related to treatment 
outcomes throughout the course of the treatment, illness, and intervention(s), 
identify points where different types of adherence interventions can have the 
greatest impact

o  Research to expand understanding of the mechanisms by which factors 
associated with adherence and non-adherence, such as depression and substance 
use, influences adherence related behavior, risk studies of the factors 
underlying individuals" decisions to adhere or not to adhere should link 
directly to development and testing of interventions to modify those mechanisms

o  Research on treatment provider-caregiver-consumer alliances, how these 
interrelationships affect adherence to complicated medication regimens, and 
identification of the active ingredients of effective alliances

o  Studies of beneficial and deleterious behavior risk changes that occur as a 
result of HIV therapy and of the factors that influence long-term therapeutic 
effectiveness, development of viral resistance, disease progression, and medical 
outcomes in high-risk individuals

o  Research to improve the effectiveness of staff training in consumer education 
to promote adherence
        
o  Studies to develop, adapt, and assess theory-based interventions for 
improving adherence among underserved, high risk, or special need populations 
(e.g., persons with severe mental illness, incarcerated individuals, active drug 
and alcohol users, adolescents)

o  Research to understand how integrated service delivery systems contribute to 
effective consumer adherence, especially when environmental transitions are 
addressed
        
o  Studies on the effectiveness, toxicities, and pharmacologic interactions of 
antiretrovirals with drug abuse treatment medications for drug abusers, ongoing 
illicit drug abuse, and pharmacotherapeutic medications for dually-diagnosed 
individuals

o  Research to refine measurement of ART adherence (e.g., studies that account 
for the myriad of biological and health behavioral that can influence CD4 count 
and viral load, in the context of treatment and adherence interventions, to 
identify appropriate intervention outcomes)  
       
o  Research on the effectiveness of improving adherence through consumer 
education using a variety of health-related informational modules, a variety of 
modalities (including groups involving families, friends, significant others), 
repetition of information, and follow-up educational sessions, computers, etc. 

o  Research on economic and other structural barriers or facilitators to ART, 
and studies of the relationships between these factors and adherence in the 
context of other competing demands

o  Studies of how factors underlying adherence or behavior change in other 
chronic diseases might inform adherence to ART

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 biomedical and behavioral 
research projects involving human subjects, unless a clear and compelling 
rationale and justification are provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research.  This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), 
a complete copy of the updated Guidelines are available at:  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require:  a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit.  Application kits are available at most institutional 
offices of sponsored research and from the Division of Extramural Outreach and 
Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 
7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, Email: 
GrantsInfo@nih.gov.  Applications are also available on the World Wide Web at: 
http://grants.nih.gov/grants/forms.htm.

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

The modular grant concept establishes specific modules in which direct costs may 
be requested as well as a maximum level for requested budgets.  Only limited 
budgetary information is required under this approach.  The just-in-time concept 
allows applicants to submit certain information only when there is a possibility 
for an award.  It is anticipated that these changes will reduce the 
administrative burden for the applicants, reviewers and Institute staff.  The 
research grant application form PHS 398 (rev. 4/98) is to be used in applying 
for these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to a 
total direct cost request of $250,000 per year.  (Applications that request more 
than $250,000 direct costs in any year must follow the traditional PHS 398 
application instructions.)  The total direct costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

PHS 398

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total 
Direct plus Facilities and Administrative (F&A) costs] for the initial budget 
period.  Items 8a and 8b should be completed indicating the Direct and Total 
Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 
of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required and 
will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page.  (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.)  At the top of the page, enter the total direct costs requested for each 
year.  This is not a Form page.

o  Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should be 
provided.  However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the nearest 
$1,000.  List the individuals/organizations with whom consortium or contractual 
arrangements have been made, the percent effort of all personnel, and the role 
on the project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is included 
in the overall requested modular direct cost amount.  Include the Letter of 
Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual"s qualifications for a specific 
role in the proposed project, as well as to evaluate the overall qualifications 
of the research team.  A biographical sketch is required for all key personnel, 
following the instructions below.  No more than three pages may be used for each 
person.  A sample biographical sketch may be viewed at: 
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page,
- List position(s) and any honors,
- Provide information, including overall goals and responsibilities, on research 
projects ongoing or completed during the last three years, and,
- List selected peer-reviewed publications, with full citations.

o  CHECKLIST - This page should be completed and submitted with the application.  
If the F&A rate agreement has been established, indicate the type of agreement 
and the date.  All appropriate exclusions must be applied in the calculation of 
the F&A costs for the initial budget period and all future budget years.

o  The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information is 
necessary following the initial review.

The title and number of the program announcement must be typed on line 2 of the 
face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the 
Checklist, and 5 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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened by NIH in accordance with the 
standard NIH peer review procedures.  As part of the initial merit review, all 
applications will receive a written critique and undergo a process in which only 
those applications deemed to have the highest scientific merit, generally the 
top half of applications under review, will be discussed, assigned a priority 
score, and 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 the 
application in order to judge the likelihood that the proposed research will 
have a substantial impact on the pursuit of these goals.  Each of these criteria 
will be addressed and considered in assigning the overall score, weighting them 
as appropriate for each application.  Note that 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.

(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 methods?  
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?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include 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.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  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.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

INQUIRIES

Inquiries are strongly encouraged.  The opportunity to clarify any issues or 
questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Christopher M. Gordon, Ph.D.
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6199, MSC 9619
Bethesda, MD 20892-9619
Telephone:  (301) 443-1613
FAX:  (301) 443-9719
E-Mail:  cgordon1@mail.nih.gov

Kendall Bryant, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-8820
FAX:  (301) 443-8774
E-Mail:  Kbryant@willco.niaaa.nih.gov

Elizabeth Lambert, M.Sc. 
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD  20892-9593
Telephone:  (301) 402-1933 
FAX:  (301) 443-4100
E-Mail:  EL46i@nih.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX:  (301) 443-6885
E-Mail:  Diana_Trunnell@nih.gov

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
E-Mail: gf6s@nih.gov

Linda Hilley
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-0915
FAX:  (301) 443-3891
E-Mail:  LHilley@willco.niaaa.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.242 (NIMH), 93.279 (NIDA), and 93.273 (NIAAA).  Awards are made under 
authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-
410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under 
NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.  This 
program is not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and 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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