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) 710-0267, 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
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