ANCILLARY STUDIES TO NIMH MULTI-SITE CLINICAL TRIALS

Release Date:  May 17, 2000 (see addenda NOT-MH-01-005, NOT-MH-00-009, NOT-MH-00-012)

PA NUMBER:  PAR-00-095

National Institute of Mental Health

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.

PURPOSE

The National Institute of Mental Health (NIMH) recently issued four contracts 
to support multi-site clinical trials in schizophrenia, Alzheimer’s disease, 
bipolar disorder, treatment resistant depression, and adolescent depression.  
Information about these trials is available on the NIMH website at 
http://www.nimh.nih.gov/studies/index.cfm.  NIMH invites investigator-
initiated research project applications for ancillary studies that extend the 
utility of the national resource created in these trials.  The purpose of 
ancillary studies is to promote innovative lines of scientific inquiry 
regarding the understanding and treatment of mental disorders.  Ancillary 
studies may use subjects recruited in a trial; may be an expansion into a new 
(related) population at some or all of the clinical sites participating in 
the trial; or may simply share methods and measures with the trial.  
Ancillary studies must not interfere with the objectives of a trial, and each 
trial has an Ancillary Study Committee to review the appropriateness of 
proposed projects.  The website for each trial contains ancillary study 
policies and procedures.  Current participation in a trial as a principal 
investigator, co-investigator, consultant, or clinical site investigator is 
not a prerequisite for submission of an ancillary study application.

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 Program Announcement 
(PA), Ancillary Studies to NIMH Multi-Site Clinical Trials, is related to the 
priority areas of Mental Health and Mental Disorders.  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 are not eligible 
for the Small Grant (R03) mechanism.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators.

MECHANISM OF SUPPORT

This PA will use the following research grant mechanisms:  Small Grants 
(R03), Exploratory/Developmental Grants (R21), Research Project Grants (R01), 
and Collaborative R01s for Clinical Studies of Mental Disorders.  The Small 
Grant (R03) provides two years of funding with a maximum of $50,000 direct 
costs for each year.  The Exploratory/Developmental Grant (R21) provides up 
to three years of funding with up to $125,000 in total direct costs annually, 
and is intended for pilot testing of interventions and other aspects of 
intervention development.  The Research Project Grant (R01) provides up to 
five years of funding that is commensurate with the science proposed.  
Collaborative R01s for Clinical Studies of Mental Disorders (CSMD) support 
research that requires multiple sites and Principal Investigators.

For all competing R03 and R21 applications, and R01 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.  R01 applications 
that request more than $250,000 in any year must use the standard PHS 398 
(rev. 4/98) application instructions.

Small Grants (RO3s), Exploratory/Developmental Grants (R21), and 
Collaborative R01s for Clinical Studies of Mental Disorders, have special 
eligibility requirements, application formats, and review criteria.  
Applicants are strongly encouraged to consult with program staff (listed 
under INQUIRIES) and to obtain the appropriate additional announcements for 
those grant mechanisms.  These can be found at:
http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html (R03); 
http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html (R21); 
http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html (Collaborative 
R01s).

RESEARCH OBJECTIVES

BACKGROUND

The National Institute of Mental Health (NIMH) has made a major commitment to 
support treatment research that directly affects and improves public health.  
This “effectiveness” model is a relatively new approach for mental health 
treatment researchers, whose studies in the past have either been clinical 
trials focused on short term efficacy and regulatory issues, or studies of 
systems of care and service utilization.  NIMH has issued contracts for four 
large-scale multi-site clinical trials:  (1) Systematic Treatment Enhancement 
Program for Bipolar Disorder (STEP-BD) to investigate strategies for managing 
bipolar disorder, (2) Clinical Antipsychotic Trials of Intervention 
Effectiveness (CATIE) to study the effectiveness of the new atypical 
antipsychotics in schizophrenia and Alzheimer’s disease, (3) Sequenced 
Treatment Alternatives to Relieve Depression (STAR*D) to develop algorithms 
for managing resistant depression, and (4) Treatment of Adolescents with 
Depression Study (TADS).  Information about the objectives of each of these 
trials, detailed study protocols, and participating investigators and sites 
can be found at http://www.nimh.nih.gov/studies/index.cfm.

The trials supported by these contracts address fundamental questions about 
the day-to-day care of people with mental illness.  However, despite their 
size and the level of NIMH’s commitment, they will not be able to answer all 
relevant issues.  They are only a beginning, and one of NIMH’s goals in 
funding these contracts is to develop an infrastructure to facilitate and 
foster investigator-initiated research grants that focus on understanding the 
nature and course of illness and on improving treatment in the community.  
This Program Announcement invites research project applications that make use 
of the infrastructures developed in the NIMH clinical trial contracts.  The 
scope of these projects could range from small pilot studies to multi-site, 
multi-principal investigator collaborative research projects.  NIMH is 
particularly interested in fostering projects by new investigators, as well 
as translational research studies that apply basic science findings in a 
clinical setting.  Ancillary studies might use subjects recruited in the 
trials, or might be an expansion into a new (related) population at the 
clinical sites participating in the trial, or might simply share data, 
methods and resources with the trials.  The distinguishing feature of an 
ancillary study is that it either requires the resources of a trial to 
achieve its goals, or that this involvement and interaction with a trial 
significantly enhances the ancillary study’s efficiency or scientific value.
 
Current participation in a trial as a principal investigator, co-
investigator, consultant, or clinical site investigator is not a prerequisite 
for submission of an ancillary study application (although these 
investigators can also propose ancillary studies).  Since ancillary studies 
may involve close interaction with trial participants or personnel, it is 
important that the projects be coordinated.  In particular, ancillary studies 
must not interfere with the objectives of the trial, and an ancillary study 
must be approved by the trial before NIMH will consider funding an 
application.  Each trial has established an Ancillary Study Committee (ASC) 
to review proposed projects for appropriateness prior to submitting an 
application to NIMH or other potential funding sources.  The ASC will also 
serve as a point of initial contact for investigators interested in an 
ancillary study, and will help formulate methods and develop budgets.  Each 
Trial ASC has established its own policies and procedures, which can be 
obtained via http://www.nimh.nih.gov/studies/index.cfm.

There are currently four multi-site NIMH clinical trials for which ancillary 
studies may be considered:

(1) Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD): 
The overall goal of this project is to improve treatment of bipolar disorder 
by identifying optimal treatments for normalizing mood and preventing 
recurrence, as well as providing answers to a host of important questions 
confronting clinicians who treat bipolar disorder.  The primary objectives 
are 1) developing a registry of bipolar patients treated in diverse settings 
by a network of clinicians following common clinical practice guidelines; 2) 
determining the most effective strategies for treatment of the depressed 
phase of bipolar illness; and 3) determining which maintenance strategies 
most effectively prevent recurrence of affective episodes.

(2) Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE):  The 
projects includes two separate trials with a common administrative and 
operational core, studying the new atypical antipsychotics in people with 
schizophrenia and people with Alzheimer’s disease.  The primary objectives of 
the schizophrenia trial are to determine the cost effectiveness of the new 
atypical antipsychotics compared to conventional agents and to determine the 
differential effectiveness of the new atypical antipsychotics compared to one 
another.  The primary objective of the Alzheimer’s disease trial is to study 
the effectiveness of the new atypical antipsychotics in managing psychosis 
and severe agitation in people with Alzheimer’s disease.

(3) Sequenced Treatment Alternatives to Relieve Depression (STAR*D):  The 
overall goal of this project is to develop and evaluate clinical strategies 
for improving outcomes for outpatients with treatment resistant depression in 
both primary care and specialty settings.  The primary objectives are (a) to 
determine which "next step" treatments are acceptable to depressed patients 
who have failed previous treatments, and provide maximal clinical benefit 
with minimal side effects; (b) studying how well these “next step” treatments 
prevent subsequent relapses; and (c) providing estimates of the relative 
costs effectiveness and benefits of these treatments.

(4) Treatment of Adolescents with Depression Study (TADS): This project 
compares the effectiveness of different treatment modalities in 12-17 year 
old patients with major depressive disorder.  In this multi-site trial, a 
total of 432 teens will be randomized to either pharmacotherapy with 
fluoxetine, cognitive-behavioral therapy, combined cognitive-behavioral 
therapy plus fluoxetine, or clinical management with placebo medication.  
Treatment continues for up to 9 months, depending on clinical response, with 
a post-treatment follow-up of 12 months.

EXAMPLES

Examples of appropriate ancillary studies include (but are not limited to) 
the following (please note that NIMH’s interest in these topics does not 
guarantee approval by a trial’s ASC):

o  Developing and testing specific treatment interventions for patients who 
are screened for a trial but do not meet the entry criteria, or who reach a 
study end-point.

o  Studying treatment effects on additional outcome variables not included in 
the initial trial protocol.

o  Investigating potential moderators and mediators of treatment effects 
(including side effects) not already included in the trial protocol 

o  Follow-up assessments of patients who have completed a trial.

o  Population pharmacokinetics of drugs used in a trial.

o  Development of pharmacogenetic databases using samples and data from trial 
subjects.

o  Coordination with existing or new brain banks by characterizing patients 
ante-mortem, securing patient and family permission, and collecting post-
mortem brain tissue.

o  Investigations with neuroimaging measures of brain function (PET, SPECT, 
MRI, MRS) to identify, characterize, and validate biomarkers that predict 
treatment response, non-response, or placebo response.

o  Investigations with neuroimaging measures of brain function (PET, SPECT, 
MRI, MRS) to identify the sites and therapeutic mechanisms of action of 
different psychotropic drugs.

o  Investigation of illness state, treatment, service use, and outcomes in 
persons excluded from a trial because of risk of suicide.

o  Development of interventions to manage suicidality in persons excluded 
from a trial due to risk for suicide.

o  Determining patient, provider and encounter factors that may enhance or 
detract from the effective delivery of interventions.

o  Assessing and testing methods to more quickly and effectively synthesize 
and incorporate results from a trial into clinical practice.

o  Characterizing system and organizational factors/processes that interfere 
with clinical care of subjects in a trial.

o  Investigating and optimizing procedures for assessing capacity and 
obtaining informed consent in trial participants.

o  Examining stigma and its effects in trial subjects.

o  Examining ethnicity, cultural, and socioeconomic factors that influence 
outcome in trial participants, including their effects on help-seeking 
behavior, formation of therapeutic alliances, and adherence to treatment.

o  Investigations of basic behavioral processes (e.g., cognition, emotion, 
motivation, personality, social cognition) to identify how these processes 
are altered in disorder and/or predict treatment response, non-response, or 
placebo response.

o  Investigations of the effects of atypical antipsychotics on metabolism and 
endocrine function.

o  Investigations of the effects of the new atypical antipsychotics on 
cardiovascular physiology.

o  Investigations of the effects of sex hormones on antidepressant treatment 
response in patients demonstrating treatment resistant depression.

o  Development and refinement of psychosocial interventions to enhance 
adherence to antidepressant medication or psychotherapy regimens in patients 
demonstrating treatment resistant depression.

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 subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 
23, No. 11, March 18, 1994 available on the web at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

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

An ancillary study application must provide written proof of approval from a 
trial’s Principal Investigator and its Ancillary Study Committee (ASC) or 
Executive Committee both before NIMH accepts it for scientific review, and 
again before an award is made.

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

For all competing R03, R21 and R01 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.  Applications that request more than $250,000 in any year 
must use the standard PHS 398 (rev. 4/98) application instructions.

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 key 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 key 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.
- 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.

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact 
Institute program staff before submitting the application, i.e., as plans for 
the study are being developed.  Furthermore, the application must obtain 
agreement from Institute staff that the Institute will accept the application 
for consideration for award.  Finally, the applicant must identify, in a 
cover letter sent with the application, the staff member and Institute who 
agreed to accept assignment of the application.

This policy requires an applicant to obtain agreement for acceptance of both 
any such application and any such subsequent amendment.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html

Any application subject to this policy that does not contain the required 
information in a cover letter sent with the application will be returned to 
the applicant without 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 three signed photocopies in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

At the time of submission, two additional copies of the application must be 
sent to:

Henry Haigler, Ph.D.
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609

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 NIMH.  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 assigned to the Institute.  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 encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding issues related to the trials as well as scientific 
issues related to programs in the Division of Services and Interventions 
Research to:

John K. Hsiao, M.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD 20892-9635
Telephone:  (301) 443-1185
FAX:  (301) 594-6784
Email:  jhsiao@helix.nih.gov 

Direct inquiries regarding scientific issues related to programs in the 
Division of Mental Disorders, Behavior, and AIDS to:

Bruce Cuthbert, Ph.D.
Division of Mental Disorders, Behavior, and AIDS 
National Institute of Mental Health
6001 Executive Boulevard, Room 6184, MSC 9625
Bethesda, MD 20892-9651
Telephone:  (301) 443-3728
FAX:  (301) 443-4611
Email:  bcuthbert@mail.nih.gov 

Direct inquiries regarding scientific issues related to programs in the 
Division of Neuroscience and Basic Behavioral Sciences to:

Steven Zalcman, M.D.
Division of Neuroscience and Basic Behavioral Sciences
National Institute of Mental Health
6001 Executive Boulevard, Room 7177, MSC 9639
Bethesda, MD 20892-9639
Telephone:  (301) 443-1692
FAX:  (301) 443-4822
Email:  szalcman@mail.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
Email:  Diana_Trunnell@nih.gov 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.242.  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 PHS grants policies and Federal 
Regulations 42 CFR 52, 45 CFR 66  and 45 CFR 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, and 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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