NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF MOOD DISORDERS OR 
NICOTINE ADDICTION (NCDDG-MD/NA)

RELEASE DATE:  October 16, 2003

PA NUMBER:  PAR-04-009

EXPIRATION DATE:  October 22, 2005

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov)

LETTER OF INTENT RECEIPT DATE:  January 15, 2004; September 23, 2004, 2005
APPLICATION RECEIPT DATE:  February 12, 2004; October 21, 2004, 2005

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242, 93.279, 93.273, 93.393

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  Where to Send Inquiries
o  Supplementary Instructions
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS PA

The intent of this solicitation is to invite applications from academic and 
pharmaceutical industry investigators interested in participating with National 
Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), the 
National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Cancer 
Institute in a National Cooperative Drug Discovery Group (NCDDG-MD/NA) Program to 
accelerate innovative drug discovery, the development of pharmacologic tools for 
basic and clinical research in mood disorders or nicotine addiction, and, in the 
case of mood disorders, the development and validation of models for evaluating 
novel therapeutics.  NIMH, NIDA, NIAAA, and NCI are interested in jointly advancing 
the discovery of new ligands because we anticipate that there are targets in common 
and overlap in the expertise that can be brought to bear.

The goal of the NCDDG-MD/NA Program is to establish long-term partnerships between 
NIH, academia, and industry that will advance the development and testing of new, 
rationally based mechanism of action medications and treatments for mental 
disorders and nicotine addiction.

Academic and/or pharmaceutical industry components of each NCDDG-MD/NA should 
contribute unique scientific expertise towards the common goal of translating basic 
science findings into innovative pharmacologic treatments for mental disorders and 
drug addiction.  Each partnership or group must consist of a multi-disciplinary 
team of scientists with appropriate expertise to address the development and 
evaluation of novel ligands, and the development of testing models where required.  
Scientists from both academia and pharmaceutical industry are encouraged to 
participate within an NCDDG-MD/NA.  Scientists from foreign institutions and NIH 
Intramural laboratories may participate in some aspects, as noted in other sections 
of this application.

The NCDDG-MD/NA Program is most appropriate for applications that include 
collaborations, Research Projects or core components from academia and the private 
sector (e.g., pharmaceutical, chemical, or biotechnological companies).  It is 
anticipated that the interaction of academic and non-profit research institutions 
with industry and NIH via the NCDDG-MD/NA model will:  1) accelerate the discovery 
of new therapeutics for mood disorders and nicotine addiction; 2) increase the 
availability of pharmacologic research tools for basic and clinical research; and 
3) facilitate the development and validation of models to evaluate novel 
therapeutics in mood disorders and nicotine addiction.

Small businesses without academic and/or industry partners are encouraged to 
respond to parallel Program Announcements:  Pharmacologic Agents and Drugs for 
Mental Disorders (SBIR Award) 
[ http://grants.nih.gov/grants/guide/pa-files/PA-02-027.html], 
Competing Continuation Awards of SBIR Phase II Grants for Pharmacologic 
Agents And Drugs for Mental Disorders 
[http://grants.nih.gov/grants/guide/pa-files/PA-02-173.html], 
Development of PET and SPECT Ligands for Brain Imaging (SBIR Award)
[http://grants.nih.gov/grants/guide/pa-files/PA-02-028.html], and Innovative 
Toxicology Models:  SBIR/STTR - Addendum to PA-02-075, Notice NOT-MH-02-005 
[http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-005.html].

RESEARCH OBJECTIVES

Background

Significant advances in neuroscience, genetics, and basic behavioral science, 
together with technological developments, have provided a rich knowledge base for 
understanding pathophysiology, identifying new molecular targets for drug 
discovery, and developing rational pharmacotherapies for the treatment of mood and 
substance abuse disorders.  With the wealth of potential new drug targets, the 
opportunity exists to accelerate the process of discovery to make quantum leaps 
toward novel and effective treatments for mood disorders (depression and bipolar 
disorder) and drug addiction.

NIMH recently convened a panel of experts to assess the state of the science and to 
identify opportunities and priorities in key areas of research relevant to mood 
disorders.  The following priorities identified in the area of pharmacologic 
treatment development for mood disorders are relevant to this PA:  1) development 
of neurochemical tools for understanding disease pathophysiology (e.g., expanding 
chemical repositories to increase the availability of imaging ligands and probes 
for basic and clinical research); 2) exploration, development, and evaluation of 
novel cellular, circuit-based, genetic, or pathophysiology-based models for drug 
development; and 3) facilitation of partnerships between NIMH, academia, and 
industry to support innovative approaches for drug discovery and the development of 
behavioral assays using the NCDDG-MD/NA model established by NCI.  The NIMH 
Strategic Plan for Mood Disorders Research is available at 
http://www.nimh.nih.gov/strategic/strategicplanmenu.cfm.

NIDA's interests are broadly consistent with the NIMH Strategic Plan (above), but 
with a particular interest at this time in drug discovery for nicotine addiction.  
The use of tobacco products is believed to be due in large part to addiction to 
nicotine, which acts through nicotinic cholinergic receptors (nAChRs).  In recent 
years there have been real advances in our understanding of the structure of the 
various subunits of these receptors, and of the ways in which the subunits combine 
to form diverse nAChR subtypes.  In particular, evidence suggests that the widely 
distributed alpha4/beta2 subtype plays a central role in nicotine addiction.  In 
addition, studies have suggested roles for other subtypes, for example the 
homomeric alpha7 nAChR and various complex heteromeric receptors that have been 
shown to modulate the release of addiction-relevant neurotransmitters, or are of 
interest because of their anatomical locations.  Establishment of a program to 
develop ligands that target nAChR subtypes is compelling for several reasons.  
First, the response of nAChRs to nicotine is complex and subtype dependent; this 
complexity may provide an opportunity to develop ligands that may be particularly 
useful in treating nicotine addiction.  Second, it is possible that ligands with a 
particular profile of action at nAChRs may be developed – for example, partial 
agonists, or ligands that target a particular state of the receptor –profiles that 
may ultimately be useful in developing molecules as medications for treatment of 
nicotine addiction.  Third, it is possible that ligands with a particular 
pharmacokinetic profile may be developed that would support their use in novel 
nicotine replacement devices.  In general, novel ligands developed for the nAChR 
target may afford greater specificity and safety in treatment.  Finally, ligands 
with a particular nAChR receptor profile will be of use as tools with which to 
advance knowledge of the basic processes of nicotine addiction.

In addition, there have been concrete advances in our understanding of the 
circuitry involved in nicotine addiction, in behavioral phenomena that associate 
with and/or modulate addiction, and in the effects of nicotine on CNS processes 
that may be associated with addictive behavior, such as learning and plasticity.  
Furthermore, knowledge of drug addiction in general suggests that processes such as 
stress may modulate addictive behaviors.  For many of these, evidence for the 
involvement of specific neurotransmitter systems and receptors exists; hence 
targets for ligand development exist.

Finally with respect to nicotine addiction, a number of valid cellular and animal 
models are currently available.  It is therefore expected that responsive groups 
will logically include a program to evaluate the efficacy of novel ligands in the 
appropriate models.  Examples of components of such a program could include, but 
are not limited to, tests of the ability of novel ligands to modulate cellular 
processes of plasticity in reward-relevant regions of the brain, assessment of the 
behavioral profile of nicotinic ligands in tests of reinforcement, relapse and 
withdrawal, and measurement of the effects of novel ligands on neurotransmitter 
release.

In light of the high comorbidity between alcohol and tobacco dependence, NIAAA is 
particularly interested in the discovery of new therapeutic agents with the 
potential to treat nicotine addicted alcoholics.  NIAAA is also interested in the 
development and validation of models to evaluate novel therapeutics for nicotine 
addiction.

The particular interest of NCI, Division of Cancer Prevention (DCP) is in the 
discovery and development of pharmacological agents for cessation of tobacco use.  
Nicotine addiction leads to the continual exposure of tobacco users to carcinogens 
and increases their risks of cancers.  The incidences of cancers of the lung, oral 
cavity, bladder, pancreas, and other organs are highly associated with tobacco use 
both in current and in former smokers.  Second hand exposure to tobacco smoke may 
also increase the risk of developing cancers.  This PA complements the Rapid Access 
to Preventive Agent Development (RAPID) program in the DCP that supports applied 
drug development for cancer prevention.  This PA also complements the NCI’s RFAs 
"Chemoprevention of Tobacco-Related Cancers in Former Smokers:  Preclinical 
Studies" and "Chemoprevention of Tobacco-Related Cancers in Former Smokers:  
Clinical Studies," as well as ongoing preclinical and clinical investigations of 
pharmacological agents to prevent, reverse, or delay the early stages of cancers.

The NCDDG-MD/NA Program will support broad, innovative, multidisciplinary, multi-
project approaches to the discovery of new, rationally based treatments for mood 
disorders and nicotine addiction.  Since the creative talents in the required 
scientific disciplines are rarely available in a single institution, a multi-
institutional, group approach involving academic, nonprofit, commercial, and/or 
industrial institutions is envisioned.  Academic and pharmaceutical scientists are 
strongly encouraged to form partnerships that take full advantage of their combined 
intellectual and material resources for drug discovery, lead optimization, and 
model development.  Further, the interaction of academic and non-profit research 
institutions with pharmaceutical industry and NIH is expected to facilitate 
subsequent development and marketing of new pharmacologic treatments, although 
these latter activities are not within the scope of this PA.  Molecular targets for 
drug discovery, and the sources and types of chemical entities to be investigated, 
will be selected by the applying group.  Both mechanism of action and disease-
oriented approaches are of interest.

Research Scope

The objective of this PA is to establish NCDDG-MD/NA Groups to conduct innovative, 
high impact research focused on the discovery and testing of chemical entities for 
novel molecular targets implicated in the pathophysiology of mood and nicotine 
addiction.  The NCDDG-MD/NA serves as a vehicle for pharmaceutical and academic 
scientists to pool intellectual and material resources for the translation of basic 
science findings into the conceptualization, discovery, and evaluation of new 
chemical entities.  Groups are encouraged to select molecular targets for drug 
discovery based on recent findings in basic and clinical neuroscience, genetics, 
and proteomics relevant to the understanding of mood disorders and nicotine 
addiction.  Research projects directed at identifying novel targets within 
signaling pathways involved in the regulation of emotion, reward, addiction, and 
cognition are encouraged.

NIMH is especially interested in drug discovery for bipolar disorder and 
depression, and in the development of novel cell, circuit, genetic, or 
pathophysiology based models for testing such drugs.  As noted above, NIDA, NIAAA, 
and NCI are interested in drug discovery for nicotine addiction.  Certain molecular 
targets may have relevance beyond nicotine addiction (e.g., pain, cognitive 
function).  At the present time, and for this initiative, NIDA, NIAAA, and NCI are 
not interested in the development of agents for these purposes; the sole target is 
nicotine addiction.  In addition, NIDA, NIAAA, and NCI are interested in research 
to develop and validate new models of nicotine addiction that will be predictive of 
treatment efficacy in humans who are addicted to tobacco products.  NIDA has an 
existing medication development program built around the dopamine system and 
further work in this area is NOT sought under this PA.

Molecular targets of high programmatic interest both in terms of novel therapeutics 
and research tools include, but are not limited to, the following:

o  Nicotinic cholinergic receptor (nAChR) subtypes, such as  alpha4/beta2, alpha7 
and its variants, alpha3-containing and other AChRs that have been implicated in 
nicotine reward, reinforcement and related processes such as withdrawal and relapse
o  Nicotinic ligands that target various states of the nAChRs
o  Receptors mediating the action of bupropion
o  Serotonin receptor subtypes, especially 5-HT2A selective antagonists, and 
ligands for 5-HT6 and 5-HT7
o  Metabotropic glutamate receptor subtypes
o  Neurokinin receptors, NK1, NK2, NK3
o  Corticotropin releasing factor receptors, CRH R1, CRH R2
o  Mood stabilizers
o  Intracellular targets:  BDNF, GSK-3B inhibitors, protein kinase inhibitors, 
transcription factors

Potential ligands of interest to NIMH, NIDA, NIAAA, and NCI might be identified by 
their receptor properties (e.g., partial agonists, agonists, or antagonists), 
solubility, pharmacokinetics, oral or CNS bioavailability, or other characteristics 
to support their use as research tools or candidates for drug development.

The identification of lead compounds and refining them for medication development 
is the principal aim of this initiative.  The use of chemical libraries, structural 
biology and computer modeling of molecular targets to screen for compounds with 
activity at selected targets are examples of responsive approaches.  If applicants 
do choose to synthesize compounds, they are encouraged to synthesize a small 
number, and to evaluate these compounds before making new analogs.  Extensive 
structure-activity-relationship studies are not encouraged.  Lead optimization 
using combinatorial chemistry or other innovative technologies is encouraged.

A program to evaluate the efficacy of novel ligands for nAChRs in valid cellular 
and animal models of nicotine addiction needs to be considered.  Such evaluation 
would logically address questions of the ability of the ligands to substitute for 
nicotine itself, to attenuate nicotine's reinforcing properties, as well as to 
measure the reinforcing properties of the novel ligands per se.

Responsive applicants may outline plans for the development and evaluation of 
cellular, circuit, genetic, or pathophysiology based models for validation of novel 
targets (preliminary proof-of-concept) for mood disorders, and drug discovery and 
the identification of compounds as potential candidates for drug development for 
mood disorders and nicotine addiction.  The discovery, development, and testing of 
new chemical identities as clinical candidates for treating mood disorders or 
nicotine abuse is a mandatory component of the NCDDG.

It is anticipated that the interaction of academic and non-profit research 
institutions with NIH and pharmaceutical industry will facilitate timely evaluation 
and development of clinical research tools, models, and novel therapeutics.

Note:  The development of analogs of established or well-studied agents for the 
treatment of mental disorders and/or substance abuse is not responsive to this PA.  
Subsequent studies required for development of new treatments (e.g., formulation 
development, large-scale production for clinical trials, or toxicology in support 
of Investigational New Drug (IND) applications, etc.) as well as early phase 
clinical trials, are beyond the scope of this PA.

Please contact program staff listed under Inquiries to determine program priorities 
and molecular targets of interest to NIMH, NIDA NIAAA, and NCI.

MECHANISMS OF SUPPORT

This PA will use the NIH U19 and U01 award mechanisms.  As an applicant, you will 
be solely responsible for planning, directing, and executing the proposed project.

This PA uses just-in-time concepts, however, it does not use modular budgeting 
formats.  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.

The NIH U19 and U01 are cooperative agreement award mechanisms.  In the cooperative 
agreement mechanism, the Principal Investigator retains the primary responsibility 
and dominant role for planning, directing, and executing the proposed project, with 
NIH staff being substantially involved as a partner with the Principal 
Investigator, as described under the section "Cooperative Agreement Terms and 
Conditions of Award."

ELIGIBLE INSTITUTIONS

You may submit (an) applications 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

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 under-represented racial and ethnic 
groups as well as individuals with disabilities are encouraged to apply for NIH 
programs.

DEFINITIONS

AWARDEE.  The institution to which the NCDDG-MD/NA award (U19 or U01) is issued.

CORE (ADMINISTRATIVE).  An administrative unit located at the Principal 
Investigator's institution that coordinates all NCDDG-MD/NA activities.  It is 
separately budgeted from the PI's Research Project (if any) and oversees support 
for activities pertinent to the NCDDG-MD/NA, such as travel for intra-group 
meetings.

CORE (SCIENTIFIC).  A separately budgeted scientific service component that 
provides essential facilities or services to two or more of the proposed Research 
Projects.  Core components typically use established procedures or protocols rather 
than generating new research.  An NIH intramural laboratory may participate as a 
Scientific Core.

CORE LEADER.  The director of a scientific core component who is responsible for 
the conduct of that core.

EXECUTIVE COMMITTEE.  An executive committee composed of the PI, Research Project 
Leaders, Core Directors, and NIH Coordinators will be established in each NCDDG to 
assist in monitoring and development of the scientific content and direction of the 
program.

NATIONAL COOPERATIVE DRUG DISCOVERY GROUP (NCDDG-MD/NA).  An NCDDG-MD/NA must 
include a Research Project to conceptualize, discover, and evaluate NEW CHEMICAL 
ENTITIES for the treatment of mood disorders (NCDDG-MD) and/or nicotine addiction 
(NCDDG-NA).  The Groups may also include Research Projects to:  1) generate 
pharmacologic TOOLS for basic and clinical research on mood disorders and nicotine 
addiction (e.g., drugs or radioligands for targets implicated in the 
pathophysiology of mood disorders or nicotine addiction; and/or 2) for mood 
disorders, develop and validate cellular, circuit, or pathophysiology based MODELS 
for evaluating novel therapeutics.  An NCDDG-MD/NA is encouraged to include high 
risk/high impact projects on drug discovery for mood disorders and/or nicotine 
addiction in one or more of the areas specified above:  NEW CHEMICAL ENTITIES 
(required), RESEARCH TOOLS, and/or MODELS (mood disorders only).

An NCDDG-MD/NA can apply using either the U01 or U19 mechanisms.  A Group of 
collaborators focused on one or two Research Projects without Cores should use the 
U01 mechanism.  Groups with three-to-five Research Projects as well as Core 
components should use the U19 mechanism.

The development and strengthening of partnerships between scientists from academia 
and the pharmaceutical industry is a highly desirable outcome of this PA and is 
strongly encouraged.  Pharmaceutical scientists are encouraged to actively 
participate as Principal Investigator, Project Leader, and/or key 
personnel/collaborators in one or more Research Projects within an NCDDG-MD/NA.  
Scientists from foreign institutions and NIH Intramural laboratories may 
participate as Project Leaders or as collaborators in Research Projects or 
scientific cores.

NIH COORDINATOR.  A scientist from the NIMH and/or NIDA, NIAAA, and NCI extramural 
program staff who has substantial involvement in the Group above and beyond normal 
program stewardship.  The Coordinator interacts scientifically with the Group and 
facilitates the role of NIMH and/or NIDA, NIAAA, and NCI as partner in the Group.  
The Coordinator will be appointed after award by NIMH and/or NIDA, NIAAA, and NCI 
based on the therapeutic focus area of the Group.

NIH PROGRAM OFFICIAL.  A staff member of NIMH and/or NIDA, NIAAA, and NCI who 
provides normal stewardship and guidance for the overall NCDDG-MD/NA Program within 
the NIMH, NIDA, NIAAA, and NCI and ensures that the NCDDG Program maintains its 
relevance to the NIMH, NIDA, NIAAA, and NCI mission for drug discovery and 
treatment development research.  The Program Official also may serve as an NIH 
Coordinator for a Group.

PRINCIPAL INVESTIGATOR.  The scientist who is designated by the applicant 
institution to direct the NCDDG-MD/NA.  The PI will assume responsibility and 
accountability to the applicant institution and to the NIMH and/or NIDA, NIAAA, and 
NCI for the performance and proper conduct of the NCDDG-MD/NA in accordance with 
the terms and conditions specified in this PA.  It is expected that the PI will 
contribute at least a 25% effort to the Group.  Foreign scientists and NIH 
intramural scientists may not be a Principal Investigator.

RESEARCH PROJECT.  A research component headed by a Project Leader within an NCDDG-
MD/NA with a separate, detailed research plan and budget.  Foreign institutions and 
NIH intramural laboratories may participate in a Research Project.

RESEARCH PROJECT LEADER.  A senior scientist with proven independent research 
capabilities who serves as director of one of the scientific Research Projects of 
the Group and is responsible for the scientific conduct of that program.  The 
Principal Investigator of the Group may be a Project Leader.  Foreign scientists 
and NIH intramural scientists may be Project Leaders.

SPECIAL REQUIREMENTS

A.  The NCDDG-MD/NA Program objectives and goals should be relevant to and 
compatible with the NIMH and/or NIDA, NIAAA, and NCI priorities for innovative drug 
discovery, development of pharmacologic tools for research, and, for NIMH, 
development and validation of models for mood disorders as specified in this PA.  
Applicants should describe their plans to accommodate the stated NCDDG-MD/NA 
requirements, criteria, and NIMH and/or NIDA, NIAAA, and NCI involvement.

B.  A proposed Group can consist of scientific collaborators focused on one or two 
Research Projects without Cores (U01 mechanism) or at least three Research Projects 
and Scientific and Administrative Core components (U19 mechanism).  It is 
anticipated that the Groups will include outstanding scientists from diverse 
scientific disciplines within neuroscience, neuropharmacology, neurobiology, 
medicinal chemistry, clinical neuroscience, mood disorders research, drug addiction 
research, radiochemistry, and pharmacokinetics into synergistic research teams 
without regard to institutional affiliation.

C.  A plan should be described for decision-making regarding identification and 
evaluation of promising drug candidates for development.

D.  Pharmaceutical partners should include key personnel who have authority within 
the company to allocate resources to ensure successful completion of the proposed 
discovery and development efforts.

E.  INTELLECTUAL PROPERTY AND PATENT RIGHTS FOR NEW CHEMICAL ENTITIES.  Since the 
discovery of new pharmacological treatments for mood disorders and nicotine 
addiction is a major objective of this effort and active involvement by 
pharmaceutical laboratories is encouraged and facilitated by the existence of 
adequate patent coverage, it is essential that applicants provide plans to assure 
the protection of intellectual property for NEW CHEMICAL ENTITIES for the treatment 
of mood disorders and/or nicotine addiction under this PA.

Successful applicants are required to supply the following confidential materials 
to the NIMH and/or NIDA, NIAAA, and NCI Program Officials listed under INQUIRIES.

1.  Each applicant Group must provide a detailed description of the approach to be 
used for obtaining patent coverage and for licensing where appropriate, in 
particular where the invention may involve investigators from more than one 
institution.  Procedures must be described for resolution of legal problems should 
they arise.  Your attention is drawn to the NIH Extramural Technology Transfer 
Policies and Documents [http://ott.od.nih.gov/NewPages/602-rev2.htm].

2.  A formal statement of Patent Agreement among all Group members and their 
institutions as well as a detailed description of procedures to be followed for 
resolution of legal problems which may develop, must be signed and dated by the 
organizational official authorized to enter into patent arrangements for each Group 
member and member institution.  The signed agreement must be submitted prior to 
award to Drs. Linda Brady and/or William Corrigall at the addresses provided under 
INQUIRIES.

3.  A plan must be developed for disposition of combinatorial and compound 
libraries generated in Research Projects focused on discovery of NEW CLINICAL 
ENTITIES as clinical candidates for drug development in conformance with TERMS AND 
CONDITIONS OF AWARD, Item 1. D, listed below.  The signed document must be 
submitted prior to award to Drs. Linda Brady and/or William Corrigall at the 
addresses provided under INQUIRIES.

4.  Prior to the award, the Principal Investigator and each Project Leader must 
provide a signed statement of acceptance of the participation of NIMH and/or NIDA, 
NIAAA, and NCI staff during performance of the award as outlined under "NIMH and/or 
NIDA, NIAAA, and NCI Staff Responsibilities" below.

Note:  Do NOT submit documents 1-4 above with the application.  However, awards 
will not be made until these documents are received and approved by NIMH and/or 
NIDA, NIAAA, and NCI.

F.  DATA SHARING PLAN FOR RESEARCH TOOLS AND MODELS TO EVALUATE THERAPEUTICS.  The 
NIH is also interested in ensuring that the RESEARCH TOOLS and MODELS developed 
through this PA become readily available to the scientific community for further 
research, development, and application, in the expectation that this will lead to 
knowledge of benefit to the public.  These TOOLS and MODELS are ones in which there 
are no intellectual property rights or patent position.  In these cases, it is 
expected that the Principal Investigator's Data Sharing Plan will include the 
following elements:

1) Description of mechanisms by which program-generated research resources related 
to RESEARCH TOOLS and MODELS (e.g., compounds, radioligands, synthesis protocols, 
analytical tools, IND filing information for clinical research tools) are 
distributed to qualified investigators in the scientific community; and 2) a 
timetable for distribution.  There should NOT be separate data sharing plans for 
each research component, but rather a single plan for the Group as a whole.

Applicants are invited to utilize NIH supported repositories such as the NIMH 
Chemical Synthesis and Drug Supply Program 
(http://www.nimh.nih.gov/mc/research.cfm) or the NIDA Drug Supply Program to make 
compounds available to the scientific community as research tools.  The sharing 
plan will be considered part of the scientific methodology for carrying out the 
research and, as such, the adequacy of the plan will be considered in determining 
funding priorities.  Reviewers will assess the adequacy of the proposed plan as 
detailed in the review criteria section.  The sharing plan as approved, after 
negotiation with the applicant when necessary, will be a condition of the award.

G.  An NIH intramural scientist may not serve as the Principal Investigator of an 
NCDDG-MD/NA but may participate in a Group as a Project Leader, Scientific Core 
Leader, collaborator, or consultant.  However, an Intramural scientist may not 
receive salary, equipment, supplies, or other remuneration from this PA.  The 
Intramural scientist must obtain written approval of his/her NIH Institute 
Scientific Director for the amount of resources that may be allocated to the 
project; this amount must be specified in the letter, and can not exceed $200,000 
in direct costs of intramural resources.  The approval must also specify that the 
conduct of the project will comply with the DHHS regulations for research involving 
human subjects (if applicable) and with the PHS policy on vertebrate animal 
research.  The participation of an intramural scientist is independent of and 
unrelated to the role of the NIMH and/or NIDA, NIAAA, and NCI Coordinator as 
described below in TERMS AND CONDITIONS OF AWARD.  For NCDDG-MD/NA applications 
that include NIH intramural components, the intramural resource level will be 
included in the total cost of the overall application.  The involvement of 
Intramural scientists needs to be consistent with NIH Policy.  
http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/ethical-conduct-toc.htm 

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD

The following terms and conditions will be incorporated into the award statement 
and provided to the Principal Investigator as well as the institutional official at 
the time of award.  Failure to abide by any of the Terms and Conditions of Award 
pertaining to awardee responsibilities stipulated in this Section may result in a 
reduction of funding, withholding of support, suspension or termination of the 
award.

These special Terms and Conditions of Award are in addition to and not in lieu of 
otherwise applicable OMB administrative guidelines, DHHS Grant Administration 
Regulations at 45 CFR parts 74 and 92, and other DHHS, PHS, and NIH Grant 
Administration policy statements.

1.  Cooperative Agreement Mechanism

The administrative and funding instrument used for this program is a cooperative 
agreement (U01 or U19), an "assistance" mechanism (rather than an "acquisition" 
mechanism) in which substantial NIH scientific and/or programmatic involvement with 
the awardee is anticipated during performance of the activity.  Under the 
cooperative agreement, the NIH purpose is to support and/or stimulate the 
recipient's activity by involvement in and otherwise working jointly with the award 
recipient in a partner role, but not to assume direction, prime responsibility, or 
a dominant role in the activity.  Consistent with this concept, the dominant role 
and prime responsibility for the activity resides with the Principal Investigator 
for the Group, although specific tasks and activities in carrying out these studies 
may be shared between the awardee and the NIH Coordinators assigned to the NCDDG-
MD/NA.  The tasks and activities are described more fully below.

Integration into the on-going program of the National Cooperative Drug Discovery 
Groups for the Treatment of Mood Disorders or Nicotine Addiction (NCDDG-MD/NA) is 
anticipated.  Principal Investigators and Research Project Leaders will be expected 
to attend an annual NCDDG meeting to review progress and share information among 
awardees.

2.  Awardee Rights and Responsibilities

a.  The Principal Investigator will have primary authority and responsibility to 
define objectives and approaches and to plan and conduct the proposed research.  
She/he will assume responsibility and accountability to the applicant organization 
and to the NIMH and/or NIDA, NIAAA, and NCI for performance and proper conduct of 
all research supported in the NCDDG-MD/NA, including the NIH intramural component, 
if applicable, in accordance with the Terms and Conditions of Award.  The Principal 
Investigator will be a member of the Executive Committee.

b.  Intramural research scientists participating as Research Project Leaders or 
collaborators have the same rights and responsibilities as other members of the 
Group.

c.  The Awardee Institution and/or Research Project Leader's Institution will 
retain primary custody of and have primary rights to data as specified under either 
the NIMH and/or NIDA, NIAAA, and NCI approved INTELLECTUAL PROPERTY PATENT RIGHTS 
AGREEMENTS FOR NEW CHEMICAL ENTITIES or the DATA SHARING PLAN FOR RESEARCH TOOLS 
AND MODELS TO EVALUATE THERAPEUTICS (described under SPECIAL REQUIREMENTS).  The 
Government, via the NIMH and/or NIDA Coordinator, will have access to data 
generated under this cooperative agreement and may periodically review the data 
consistent with current DHHS, PHS, and NIH policies.  Timely publication of major 
findings by the Group members is encouraged.  Publication or oral presentation of 
work done under this agreement will require appropriate acknowledgment of NIMH 
and/or NIDA, NIAAA, and NCI support, including the assigned cooperative agreement 
award number.

d.  Ownership of compound libraries and/or combinatorial libraries for drug 
discovery acquired during the course of the research rests with the Group.  Prior 
to award, the Group(s) must formulate a plan for final disposition of the compounds 
and ownership rights in the event that the compounds are transferred to other 
parties who make discoveries using them.  This plan is to be approved by NIMH 
and/or NIDA, NIAAA, and NCI.

e.  It is the intention that new chemical entities be fully evaluated as potential 
candidate drugs for mental health disorders and nicotine addiction or as potential 
research tools, after the Group has concluded its evaluation and before the 
compounds are transferred to other parties for evaluation in other therapeutic 
areas.  The Groups must follow the NIMH and/or NIDA, NIAAA, and NCI approved 
INTELLECTUAL PROPERTY PATENT RIGHTS AGREEMENTS FOR NEW CHEMICAL ENTITIES or the 
DATA SHARING PLAN FOR RESEARCH TOOLS AND MODELS TO EVALUATE THERAPEUTICS.

3.  NIMH and/or NIDA, NIAAA, and NCI Staff Responsibilities

During performance of the award, the role of the NIMH and/or NIDA, NIAAA, and NCI 
Coordinator is one of substantial involvement above and beyond the normal program 
stewardship role of a Program Official.  The Coordinator interacts scientifically 
with the Group and may provide appropriate assistance, including assisting in 
research planning, suggesting studies within the scope of the Group's objectives 
and research activities, presenting experimental findings to the Group from 
published sources or from relevant contract projects, participating in the design 
of experiments agreed to by the Group, participating in the analysis of results, 
and advising in management and technical performance.  The Coordinator(s) will be a 
member(s) of the Executive Committee.  In all cases, the role of NIMH and/or NIDA, 
NIAAA, and NCI will be to assist and facilitate and not to direct activities.

The NIMH/NIDA/NIAAA/NCI Coordinator(s) can recommend to their Institutes to utilize 
their drug development resources (e.g., CNS receptor screening, chemical synthesis, 
and toxicology services) in support of the NCDDG-MD/NA Group research activities if 
such resources are required on an occasional basis.  The following is a list of 
resources that are readily available and may be supplied if they become desirable 
during performance.  It is not anticipated that requests of services will be 
considered as a continuing need.

a.  Reference compounds for standardization of test systems, as analytical 
standards, and for related purposes.

b.  Data from testing conducted in resource contract laboratories.

c.  Laboratory testing capacity, whenever appropriate and possible, in NIMH's and 
NIDA's current contract based preclinical testing programs.  The Group is expected 
to provide sufficient test material for such testing.

d.  Additional needed resources such as test materials and information that may not 
otherwise be available to the Group.

The NIMH/NIDA/NIAAA Program Officials are responsible for normal stewardship and 
monitoring implementation of the Data Sharing Plan for Research Tools and Models 
for Evaluating Therapeutics.

4.  Collaborative Responsibilities

A governing Executive Committee composed of the PI, Research Project Leaders, Core 
Directors, and NIMH and/or NIDA, NIAAA, and NCI Coordinators will be established in 
each NCDDG to assist in monitoring and development of the scientific content and 
direction of the program.  The Executive Committee members will meet periodically 
to review progress, plan and design research activities, and establish priorities.  
The frequency of meetings, not fewer than two per year, will be determined by the 
Principal Investigator who will be responsible for scheduling the time and place 
(generally at one of the performance sites) and for preparing concise proceedings 
or minutes (two or three pages) which will be delivered to the members of the Group 
within 30 days of the meeting.

a.  The principal end products of NCDDG-MD/NA activities are expected to include:  
1) the discovery of new chemical entities, optimization of lead compounds, and the 
identification of clinical candidates for the treatment of mood disorders and/or 
nicotine addiction; as well as 2) research tools; and 3) preclinical models to 
evaluate novel therapeutics.  Subsequent toxicity and safety studies of drug 
candidates and clinical developmental work through other resources are encouraged.

b.  NIMH and/or NIDA, NIAAA, and NCI will retain the option to cross-file or 
independently file an application for an investigational clinical trial (e.g., an 
IND application to the United States Food and Drug Administration) of any clinical 
research tool or invention resulting from these NIMH and/or NIDA, NIAAA, and NCI 
supported cooperative agreements.  Reports of data generated by the Group or any of 
its members required for inclusion in IND applications and for cross-filing 
purposes shall be submitted promptly by the Principal Investigator to the NIMH 
and/or NIDA, NIAAA, and NCI Coordinator upon request.  Such reports shall include 
background information, methods, results, and conclusions.

5.  Arbitration

Any disagreement that may arise on scientific/programmatic matters (within the 
scope of the award, including the NIH intramural component), between the awardee 
and the NIMH and/or NIDA may be brought to arbitration.  An arbitration panel will 
be composed of three members:  one Group designee, one NIMH and/or NIDA, NIAAA, and 
NCI designee, and a third designee with expertise in the relevant area chosen by 
the two designees.  This special arbitration procedure in no way affects the 
awardee's right to appeal an adverse action in accordance with PHS regulations at 
42 CFR Part 50, Subpart D, and DHHS regulations at 45 CFR Part 16.

WHERE TO SEND INQUIRIES

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

o  Direct your questions about scientific/research issues to:

Linda Brady, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7185, MSC 9641
Bethesda, MD  20892-9641
Rockville, MD  20852-9641 (for express/courier service)
Telephone:  (301) 443-5288
FAX:  (301) 402-4740
Email:  lbrady@mail.nih.gov

William Corrigall, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute of Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 435-1324
FAX:  (301) 594-6043
Email:  wcorriga@nida.nih.gov

Joanne Fertig, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Room 505, MSC 7003
Bethesda, MD  20892-7003
Rockville, MD  20892 (for express/courier service)
Telephone:  (301) 443-0635
FAX:  (301) 443-8774
Email:  jfertig@niaaa.nih.gov

James A. Crowell, Ph.D.
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Room 2117, MSC 7322
Rockville, MD  20852-7322
Telephone:  (301) 594-0459
FAX:  (301) 402-0553
Email:  jcrowell@mail.nih.gov

o  Direct your questions about peer review issues to:

Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9608
Bethesda, MD  20892-9608
Rockville, MD  20852-9608 (for express/courier service)
Telephone:  (301) 443-1340
FAX:  (301) 443-4720
Email:  kozakm@mail.nih.gov

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

Carol Robinson
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118
Bethesda, MD  20892
Telephone:  (301) 443-3858
FAX:  (301) 443-6885
Email:  crobinso@mail.nih.gov

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131
Bethesda, MD  20892
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@mail.nih.gov

Judy Fox
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 504, MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-4704
FAX:  (301) 443-3891
Email:  jsimons@willco.niaaa.nih.gov

Ms. Eileen Natoli
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243 
Bethesda, MD  20892 
Telephone:  (301) 496-8791 
FAX:  (301) 496-8601
Email:  natolie@gab.nci.nih.gov

LETTER OF INTENT

Prospective applicants are requested to submit a letter of intent that includes the 
following information:

o  Descriptive title of the proposed research
o  Name, address, and telephone number of the Principal Investigator
o  Names of other key personnel
o  Participating institutions
o  Number and title of this PA

Although a letter of intent is not required, is not binding, and does not enter 
into the review of a subsequent application, the information that it contains 
allows IC staff to estimate the potential review workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning of this 
document, and should be sent to:

Linda Brady, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7185, MSC 9641
Bethesda, MD  20892-9641
Rockville, MD  20852-9641 (for express/courier service)
Telephone:  (301) 443-5288
FAX:  (301) 402-4740
Email:  lbrady@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) 435-0714, Email: 
GrantsInfo@nih.gov.

Potential applicants are strongly encouraged to contact NIMH, NIDA, NIAAA, and NCI 
program staff early in the planning process.

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 marked.

SUPPLEMENTARY INSTRUCTIONS

1.  SPECIFIC INSTRUCTIONS FOR PREPARING THE NCDDG-MD/NA AWARD U01 APPLICATION

In addition to the details described here for U01 applications, applicants also 
need to be aware of information described under SPECIAL REQUIREMENTS in this 
program announcement.

Applications must be complete at the time of submission.  Applicants are encouraged 
to organize the application by initially presenting the face page, the abstract 
page with key personnel, a table of contents, summary budget pages for the entire 
proposal, and other documentation pertaining to the entire project.  This should be 
followed by an introductory section of no more than ten pages that provides a 
General Description of the NCDDG-MD/NA.  The content requirements of this section 
are described in #3 below.

Following the General Description(s), each component (the Research Projects) should 
be presented individually with its accompanying individual budget and 
justification, biographical sketches, other support pages, and research plan.

For each Research Project component, there is a 25-page limit for the research plan 
(i.e., specific aims, background and significance, preliminary studies/progress 
report, and research design and methods), as indicated in the form PHS 398.  
Appendix material limits apply to each component separately, and appendices are 
limited to the contents specified in the form PHS 398.  They should be bundled 
separately, component by component.

For each individual Research Project, the research plan needs to address:

o  The major goals and objectives of the project and their relationship to the 
overall effort of the NCDDG-MD/NA.

o  The status of current research efforts, the limitations of existing approaches, 
and how the research questions posed relate to the objectives of the particular 
project and the NCDDG-MD/NA as a whole.

o  The feasibility of the proposed experiments, the advantages of new methodologies 
(if any), the potential pitfalls, alternative approaches, the means of assessing 
success of the research to meet the objectives of the project and the NCDDG-MD/NA 
as a whole.

2.  SPECIFIC INSTRUCTIONS FOR PREPARING THE NCDDG-MD/NA AWARD U19 APPLICATION

In addition to the details described here for U19 applications, applicants also 
need to be aware of information described under SPECIAL REQUIREMENTS in this 
announcement.

Applications must be complete at the time of submission.  Applicants are encouraged 
to organize the application by initially presenting the face page, the abstract 
page with key personnel, a table of contents, summary budget pages for the entire 
proposal, and other documentation pertaining to the entire project.  This should be 
followed by an introductory section of no more than ten pages that provides a 
General Description of the NCDDG-MD/NA.  The content requirements of this section 
are described below.

Following the General Description(s), each component (the Research Projects and 
cores, if any) should be presented individually with its accompanying individual 
budget and justification, biographical sketches, other support pages, and research 
plan.

For each Research Project there is a 25-page limit for the research plan (i.e., 
specific aims, background and significance, preliminary studies/ progress report, 
and research design and methods), as indicated in the form PHS 398.  Appendix 
material limits apply to each component separately, and appendices are limited to 
the contents specified in the form PHS 398.  They should be bundled separately, 
component by component.

For each individual Research Project, the research plan needs to address:

o  The major goals and objectives of the project and their relationship to the 
overall effort of the NCDDG-MD/NA.

o  The status of current research efforts, the limitations of existing approaches, 
and how the research questions posed relate to the objectives of the particular 
project and the NCDDG-MD/NA as a whole.

o  The feasibility of the proposed experiments, the advantages of new methodologies 
(if any), the potential pitfalls, alternative approaches, the means of assessing 
success of the research to meet the objectives of the project and the NCDDG-MD/NA 
as a whole.

For each core component, there is a 10-page limit.  If cores are required, the 
applicant must describe how each Core will contribute to the goals of the overall 
NCDDG-MD/NA as well as how each individual Research Project will draw upon a 
particular Core.  The description of each Core should clearly indicate the 
facilities, resources, services and professional skills that the facility will 
provide.  Moreover, clearly described information must be provided about how the 
collective operation of the Cores will be effected in a coherent manner.

3.  SPECIFIC INSTRUCTIONS FOR PREPARING THE GENERAL DESCRIPTION OF THE NCDDG-MD/NA

This section is to accompany both U01 and U19 applications.  The section must not 
exceed 10 pages, and should provide the following details:

o An overview of the proposed NCDDG-MD/NA Group, its central theme and goals; this 
overview should describe the general objectives, and explain the proposed 
contribution of each of the individual Research Projects and Cores (if any) towards 
achieving the objectives of the Group.  The administrative arrangements and 
research support should be described.  In particular, when more than one 
institutional site is involved, a detailed description and supporting documentation 
for the administrative arrangements must be included.  Detailed information on 
collaborations, facilities, and resources must also be provided.

o A clear description of how each component Research Project is required for the 
attainment of the NCDDG-MD/NA Program's objectives, including available 
professional and technical personnel to permit efficient and successful conduct of 
the proposed research, and description of the contribution of each to fulfillment 
of group objectives.  The name, organization, and scientific discipline of the 
Principal Investigator, Research Project Leaders, and other key personnel should be 
included.  A clear description of the interrelationships among the members of the 
group needs to be made.

o Evidence needs to be provided that each component Research Project and the Group 
as a whole have available facilities required for conduct of the proposed research.

o A plan to assure the maintenance of close collaboration and effective 
communication among members of the group that will include letters of commitment to 
this plan by all Research Project Leaders.  Include plans for scheduling group 
meetings, notifying group members (including the NIMH and/or NIDA, NIAAA, and NCI), 
and documenting and disseminating group meeting proceedings.

o Description of the steps that will be taken to ensure successful completion of 
the NCDDG-MD/NA's research should a key member leave the Group.

4.  SUPPLEMENTAL INSTRUCTIONS FOR NIH INTRAMURAL RESEARCHERS

NIH intramural researchers collaborating on an NCDDG-MD/NA must obtain the approval 
of his/her NIH Institute Scientific Director for participating under the terms and 
conditions of the pa.  A copy of that letter of approval must be provided in the 
application.

NIH intramural researchers submitting an Individual Research Project as a part of 
an NCDDG-MD/NA, must follow the procedures for Individual Research Projects as 
described above, with the following additional modifications.

o On the Face Page, fill out only items 1., 2., 3. (leave 3c. blank), 4., and 5.  
The remainder of the items should be left blank, and the application must not be 
signed by either the PI or an NIH Institute official.

o The Individual Research Project PI must obtain the approval of his/her NIH 
Institute Scientific Director for participating as a component of the NCDDG-MD/NA 
under the terms and conditions of the PA.  A copy of that letter of approval must 
be provided in the application.

o The Research Project component should NOT contain the "Other Support" pages.

o The individual budget pages should supply the time and effort for each project 
participant, but no other budget figures should be included.  The resources 
available for the Research Project and the research environment should be carefully 
described, but no budget figures should be included.  The NIH Institute Scientific 
Director, as part of the letter of approval for participation, must verify that no 
more than $200,000 direct costs of intramural resources will be allocated to the 
project described in the application, and provide assurance that the conduct of the 
project will comply with the DHHS regulations for research involving human subjects 
(if applicable) and with the PHS policy on vertebrate animal research.

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 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:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD  20892
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3367
FAX:  (301) 443-4720
Email:  jnoronha@mail.nih.gov

APPLICATION PROCESSING:  Applications must be received by the receipt dates listed 
on the first page of this PA.  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

Upon receipt, applications will be reviewed for completeness by the CSR and for 
responsiveness by the participating ICs.  Incomplete and/or non-responsive 
applications will be returned to the applicant without review.

Applications that are complete and responsive to the PA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by the 
NIMH in accordance with the review criteria stated below.  As part of the initial 
merit review, all applications will:

o  Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will be 
discussed and assigned a priority score
o  Receive a written critique
o  Receive a second level review by the NIMH and/or NIDA, NIAAA, and NCI 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.  Within this 
framework, the specific goals of this PA are drug discovery and preclinical 
evaluation of new drugs to treat mood disorders and nicotine addiction, the 
development of pharmacologic tools for basic and clinical research, and, for mood 
disorders, the development and validation of models for evaluating novel 
therapeutics.  In the written comments reviewers will be asked to evaluate the 
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.  Individual 
Research Projects and Cores within the NCDDG-MD/NA, as well as the NCDDG-MD/NA as a 
whole, will be evaluated.

REVIEW CRITERIA FOR THE NCDDG-MD/NA AS A WHOLE

1.  Significance.  Is the Group addressing an important problem?  If the aims of 
the application are achieved, what is the likelihood that it will produce a new 
candidate drug for development?  What will be the effect of these studies on the 
concepts or methods that drive this field?  To what degree does the proposed plan 
for discovery of novel drugs, research tools, and/or preclinical models support the 
needs for the targeted disease?

2.  Approach.  Are the conceptual framework, design, and methods adequately 
developed, well integrated, and appropriate to the aims of the project?  Are the 
scientific disciplines represented in Research Projects and Scientific Cores 
adequate to achieve the NCDDG-MD/NA Program objectives?  Does the applicant 
acknowledge potential problem areas and consider alternative tactics?  Are targets, 
screens, and preclinical models relevant to mood disorders and/or nicotine 
addiction?  If pharmaceutical partnerships are proposed, how will they facilitate 
the development and evaluation of candidate drugs, tools for clinical research, and 
model validation for testing therapeutics?

3.  Innovation.  Does the NCDDG-MD/NA employ novel concepts, approaches or methods?  
Are the aims original and innovative?  Does the NCDDG-MD/NA challenge existing 
paradigms, develop new research tools, models, methodologies, or technologies?  Is 
the target under investigation for drug discovery novel?  Will new paradigms for 
drug discovery emerge?

4.  Investigators.  Are the Principal Investigator, Research Project Leaders, and 
Core Leaders appropriately trained and well suited to direct or carry out this 
work?  Are the time commitments for each sufficient to achieve the goals?  To what 
extent do these investigators have complementary skills?  Will the Research Project 
Leaders and their key personnel contribute unique skills to the NCDDG-MD/NA?  Is 
the work proposed appropriate to the experience level of the key personnel and 
other researchers?  Has the Principal Investigator demonstrated leadership in 
development, implementation, and management of comprehensive research programs?

5.  Environment.  Does the technical and scientific environment in which the 
Research Projects will be done contribute to the probability of success?  Does the 
proposed work take advantage of unique features of the technical and scientific 
expertise and employ effective collaborations?  Is there evidence of institutional 
support and competence of the applying Institution to serve as the Administrative 
Core for the Group?

6.  Interaction.  Are there adequate plans for ensuring effective intra-Group 
communication, interaction, cohesiveness, and coordination among the PI, Research 
Project Leaders, and NIH Coordinators?  Do the investigators state their 
willingness to collaborate extensively and share information fully?  Do the 
investigators state their willingness to abide by the policies stated in the Terms 
and Conditions of the Cooperative Agreement?

7.  Data Sharing Plan.  How appropriate are the proposed plans for making research 
tools, synthesis protocols, analytical tools, preclinical models, IND filing 
information, or other resources generated under the project widely available to the 
scientific community?  Are the plans and timetable for distribution adequate for 
effective dissemination of the proposed resources?

REVIEW CRITERIA FOR RESEARCH PROJECTS

1.  Significance.  Does this study address an important problem?  If the aims of 
the application are achieved, how will scientific knowledge or technology 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, and methods adequately 
developed, well integrated, and appropriate to the aims of the project?  Are the 
scientific disciplines represented in Research Projects adequate to achieve the 
objectives?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  Is the plan to optimize lead structures adequate to ensure 
that the most efficacious drug will result?  If pharmaceutical partnerships are 
proposed, how will they facilitate the discovery and development of drugs and 
evaluation of research tools or models?

3.  Innovation.  Does the Research Project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new tools, methodologies, or technologies?

4.  Investigators.  Are the Research Project Leader and key personnel appropriately 
trained and well suited to direct or carry out this work?  Is the Project Leader's 
time commitment sufficient to achieve the goals?  Is the work proposed appropriate 
to the experience level of the key personnel and other researchers?  Have 
collaborations been established or consultants identified to provide the 
appropriate depth and breadth of expertise required for the project?

5.  Environment.  Does the technical and scientific environment in which the work 
will be done contribute to the probability of success?  Does the proposed work take 
advantage of unique features of the technical and scientific expertise and employ 
effective collaborations?

6.  Management of the Group.  Especially for the U19 mechanism, does the PI have 
previous experience of the ability to manage an integrated scientific enterprise?  
Do other members of the Group have experience that will facilitate achieving the 
desired research outcomes.

REVIEW CRITERIA FOR CORES

1.  The utility of the Core to the NCDDG-MD/NA.  Each Core must provide essential 
facilities or services to two or more Research Projects judged to have scientific 
merit.

2.  The quality of the facilities or services provided by the Core.

3.  The qualifications and experience of the personnel involved in the Core.

ADDITIONAL REVIEW CRITERIA

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

o  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

o  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).

o  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

BUDGET:  The review group will critically examine the budget requested for each 
Research Project, Core, and overall NCDDG-MD/NA and will recommend an appropriate 
budget and period of support.

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific and technical merit (as determined by peer review)
o  Availability of funds
o  Programmatic 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).

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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts on 
October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines is 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) all investigators must report 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:  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.

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.  This 
policy announcement is found in the NIH Guide for Grants and Contracts Announcement 
dated June 5, 2000, at the following website:  
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.  Reviewers are cautioned that their 
anonymity may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of "Healthy People 2010," a PHS 
led national activity for setting priority areas.  This PA is related to one or 
more of the priority areas.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople/.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health Systems 
Agency review.  Awards are made under authorization of Sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered under 
NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  
This program is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review.  All awards are subject to 
the terms and conditions, cost principles, and other considerations described in 
the NIH Grants Policy Statement.  The NIH Grants Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant 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.
 In the written comments reviewers will be asked to evaluate the 
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.  Individual 
Research Projects and Cores within the NCDDG-MD/NA, as well as the NCDDG-MD/NA as a 
whole, will be evaluated.

REVIEW CRITERIA FOR THE NCDDG-MD/NA AS A WHOLE

1.  Significance.  Is the Group addressing an important problem?  If the aims of 
the application are achieved, what is the likelihood that it will produce a new 
candidate drug for development?  What will be the effect of these studies on the 
concepts or methods that drive this field?  To what degree does the proposed plan 
for discovery of novel drugs, research tools, and/or preclinical models support the 
needs for the targeted disease?

2.  Approach.  Are the conceptual framework, design, and methods adequately 
developed, well integrated, and appropriate to the aims of the project?  Are the 
scientific disciplines represented in Research Projects and Scientific Cores 
adequate to achieve the NCDDG-MD/NA Program objectives?  Does the applicant 
acknowledge potential problem areas and consider alternative tactics?  Are targets, 
screens, and preclinical models relevant to mood disorders and/or nicotine 
addiction?  If pharmaceutical partnerships are proposed, how will they facilitate 
the development and evaluation of candidate drugs, tools for clinical research, and 
model validation for testing therapeutics?

3.  Innovation.  Does the NCDDG-MD/NA employ novel concepts, approaches or methods?  
Are the aims original and innovative?  Does the NCDDG-MD/NA challenge existing 
paradigms, develop new research tools, models, methodologies, or technologies?  Is 
the target under investigation for drug discovery novel?  Will new paradigms for 
drug discovery emerge?

4.  Investigators.  Are the Principal Investigator, Research Project Leaders, and 
Core Leaders appropriately trained and well suited to direct or carry out this 
work?  Are the time commitments for each sufficient to achieve the goals?  To what 
extent do these investigators have complementary skills?  Will the Research Project 
Leaders and their key personnel contribute unique skills to the NCDDG-MD/NA?  Is 
the work proposed appropriate to the experience level of the key personnel and 
other researchers?  Has the Principal Investigator demonstrated leadership in 
development, implementation, and management of comprehensive research programs?

5.  Environment.  Does the technical and scientific environment in which the 
Research Projects will be done contribute to the probability of success?  Does the 
proposed work take advantage of unique features of the technical and scientific 
expertise and employ effective collaborations?  Is there evidence of institutional 
support and competence of the applying Institution to serve as the Administrative 
Core for the Group?

6.  Interaction.  Are there adequate plans for ensuring effective intra-Group 
communication, interaction, cohesiveness, and coordination among the PI, Research 
Project Leaders, and NIH Coordinators?  Do the investigators state their 
willingness to collaborate extensively and share information fully?  Do the 
investigators state their willingness to abide by the policies stated in the Terms 
and Conditions of the Cooperative Agreement?

7.  Data Sharing Plan.  How appropriate are the proposed plans for making research 
tools, synthesis protocols, analytical tools, preclinical models, IND filing 
information, or other resources generated under the project widely available to the 
scientific community?  Are the plans and timetable for distribution adequate for 
effective dissemination of the proposed resources?

REVIEW CRITERIA FOR RESEARCH PROJECTS

1.  Significance.  Does this study address an important problem?  If the aims of 
the application are achieved, how will scientific knowledge or technology 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, and methods adequately 
developed, well integrated, and appropriate to the aims of the project?  Are the 
scientific disciplines represented in Research Projects adequate to achieve the 
objectives?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  Is the plan to optimize lead structures adequate to ensure 
that the most efficacious drug will result?  If pharmaceutical partnerships are 
proposed, how will they facilitate the discovery and development of drugs and 
evaluation of research tools or models?

3.  Innovation.  Does the Research Project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new tools, methodologies, or technologies?

4.  Investigators.  Are the Research Project Leader and key personnel appropriately 
trained and well suited to direct or carry out this work?  Is the Project Leader's 
time commitment sufficient to achieve the goals?  Is the work proposed appropriate 
to the experience level of the key personnel and other researchers?  Have 
collaborations been established or consultants identified to provide the 
appropriate depth and breadth of expertise required for the project?

5.  Environment.  Does the technical and scientific environment in which the work 
will be done contribute to the probability of success?  Does the proposed work take 
advantage of unique features of the technical and scientific expertise and employ 
effective collaborations?

6.  Management of the Group.  Especially for the U19 mechanism, does the PI have 
previous experience of the ability to manage an integrated scientific enterprise?  
Do other members of the Group have experience that will facilitate achieving the 
desired research outcomes.

REVIEW CRITERIA FOR CORES

1.  The utility of the Core to the NCDDG-MD/NA.  Each Core must provide essential 
facilities or services to two or more Research Projects judged to have scientific 
merit.

2.  The quality of the facilities or services provided by the Core.

3.  The qualifications and experience of the personnel involved in the Core.

ADDITIONAL REVIEW CRITERIA

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

o  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

o  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).

o  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

BUDGET:  The review group will critically examine the budget requested for each 
Research Project, Core, and overall NCDDG-MD/NA and will recommend an appropriate 
budget and period of support.

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific and technical merit (as determined by peer review)
o  Availability of funds
o  Programmatic 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).

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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts on 
October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines is 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) all investigators must report 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:  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.

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.  This 
policy announcement is found in the NIH Guide for Grants and Contracts Announcement 
dated June 5, 2000, at the following website:  
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.  Reviewers are cautioned that their 
anonymity may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of "Healthy People 2010," a PHS 
led national activity for setting priority areas.  This PA is related to one or 
more of the priority areas.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople/.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health Systems 
Agency review.  Awards are made under authorization of Sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered under 
NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  
This program is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review.  All awards are subject to 
the terms and conditions, cost principles, and other considerations described in 
the NIH Grants Policy Statement.  The NIH Grants Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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and Human Services (HHS)
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