Full Text DA-96-002
 
STRATEGIC PROGRAM FOR INNOVATIVE RESEARCH ON COCAINE ADDICTION
PHARMACOTHERAPY
 
NIH GUIDE, Volume 25, Number 9, March 22, 1996
 
RFA:  DA-96-002
 
P.T. 34

Keywords: 
  Drugs/Drug Abuse 
  Addiction 
  Treatment, Medical+ 
  Neurotransmitters 
  Receptors 

 
National Institute on Drug Abuse
 
Letter of Intent Receipt Date:  May 13, 1996
Application Receipt Date:  June 13, 1996
 
PURPOSE
 
This Request for Applications (RFA) will support innovative,
integrated preclinical and clinical research to identify potential
compounds and validate novel approaches that are safe and effective
short-term (to reduce and stop cocaine use) and long-term (to prolong
abstinence) pharmacotherapies for the treatment of cocaine addiction.
A Strategic Program for Innovative Research on Cocaine Addiction
Pharmacotherapy (SPIRCAP) can focus its therapeutic research
activities on, for example, modulating specific receptor sites,
(e.g., the dopamine transporter, D3 receptor, a serotonin receptor,
etc,) or neurotransmitters that are believed to be involved in
cocaine addiction, or on development of biologically based
anti-cocaine medications, such as antibodies, enzymes, and catalytic
antibodies, or other approaches with the potential for effective
therapies.  Studies supported by this RFA should have a truely novel
or innovative approach.  The SPIRCAP Program thus complements
existing, more traditional, preclinical and clinical programs for the
development of cocaine treatment medications, managed by the
Medications Development Division of the National Institute on Drug
Abuse (NIDA) (e.g., the Medications Development Research Centers
(MDRC, P-50)), the medicinal chemistry synthesis contracts, and the
preclinical medications testing contracts.
 
Of greatest significance, each SPIRCAP will form a collaborative
enterprise between preclinical and clinical scientists in the
conceptualization and proof-of-concept of an identified therapeutic
strategy.  This will entail interactive research and information
exchange between preclinical and clinical investigators in order to
ensure effective development and refinement of the therapeutic
concept.  The Group must, therefore, possess the expertise necessary
to (1) evaluate the proposed strategy in preclinical systems, and (2)
conduct pilot clinical study(ies) using the proposed therapeutic
approach.  A SPIRCAP should be dedicated to the expedited transition
of ground-breaking research from advanced preclinical findings to
clinical application in developing an anti-cocaine medication.  A
SPIRCAP is encouraged to include investigators from academic,
non-profit, and commercial (pharmaceutical, chemical, or
biotechnological companies) organizations.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Strategic Program for Innovative Research on Cocaine Addiction
Pharmacotherapy (SPIRCAP), is related to the priority areas of
tobacco, alcohol, and other drugs, and HIV infection.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0 or Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic for-profit and non-profit
organizations, private and public, such as universities, colleges,
hospitals, laboratories, units of State or local governments, and
eligible agencies of the Federal government.  Racial/ethnic minority
individuals, women and persons with disabilities are encouraged to
apply as Principal Investigators.
 
MECHANISM OF SUPPORT
 
Awards will be made as cooperative agreements (U19s).  The
cooperative agreement is an assistance mechanism in which substantial
NIDA programmatic involvement with the recipient during the
performance of the planned activity is anticipated.  The nature of
NIDA staff participation is described in SPECIAL REQUIREMENTS - Terms
and Conditions of Award.  The awardee will be responsible for the
planning direction, and execution of the proposed project and
interrelated activities. All applications must consist of at least
three interrelated projects conducted by at least three independent
research laboratories, e.g., a preclinical laboratory, a clinical
laboratory, and a laboratory from a pharmaceutical or biotechnology
company.  For the purpose of this RFA, two (or more) projects within
a single company will not be considered independent.  Similarly, two
(or more) projects within the same academic department will not be
considered independent.  The involvement of laboratories from
commercial (pharmaceutical, chemical, or biotechnological companies)
organizations as part of the project is encouraged.  This limitation
on the number of independent projects from the same academic or
private sector organization is intended to increase the diversity and
multidisciplinary expertise available to the Group from other than
the parent institution or organization.  While no maximum number of
projects is stipulated, it has been observed that when a
multidisciplinary grant or award exceeds six component projects the
program becomes less coordinated and more difficult to manage.
 
This RFA is a one-time solicitation.  If by the end of the third year
of the award, the NIDA has not announced its intent to re-issue the
RFA, awardees should contact NIDA program staff and consider
submitting investigator-initiated (R01) applications which will
compete with all investigator-initiated applications and be reviewed
according to the customary peer review procedures.  All policies and
requirements that govern the grant program of the U.S. Public Health
Service (PHS) and the National Institutes of Health (NIH) apply.
 
FUNDS AVAILABLE
 
NIDA has set aside $2.0 million total costs for the first year of
funding.  This level of support is dependent on the receipt of a
sufficient number and diversity of applications of high scientific
merit.  Two to three awards are anticipated for project periods up to
four years.  However, support beyond the second year of each SPIRCAP
will be determined by NIDA staff based, in part, on the
recommendations of an external ad hoc committee, convened to evaluate
accomplishments and determine whether or not stated goals have been
met.
 
Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the size of individual
awards will vary also.  Awards are subject to a first year limit of
$1.0 million in total costs (direct plus indirect costs).  Budget
requests should be carefully justified and commensurate with the
complexity of the project.  Although this program is provided for in
the financial plans of the NIDA, awards pursuant to this RFA are
contingent upon the availability of funds for this purpose.
Applications in excess of $1.0 million total cost will be returned
without review, unless a waiver has been granted by the SPIRCAP
Program Director, Dr. Betty Tai, in advance of submission. (address
listed under INQUIRIES).
 
RESEARCH OBJECTIVES
 
Background
 
The NIDA and the PHS are currently supporting comprehensive
extramural and intramural projects aimed at the elucidation of
processes susceptible to the action of cocaine and the mechanisms
through which cocaine affects the fundamental brain processes, and
for developing safe and effective behavioral and pharmacological
therapies to treat cocaine addicts.  Notwithstanding these efforts,
no pharmacotherapeutic approaches yet been proven effective.  To
address this critical deficiency, NIDA has made the development of an
anti-cocaine medication its number one priority.  The sense of
urgency is prompted by the fact that cocaine abuse and dependence
affect all segments of our society with devastating personal, social,
and public health consequences.  National surveys indicate that more
than 23 million Americans have used cocaine at some time in their
lives and more than 1.3 million are current cocaine users.  Cocaine
use is associated with potentially life-threatening cardiovascular
effects; sex-for-crack exchanges that are spreading the AIDS virus
among both drug-abusing and non-drug-abusing populations; possible
damage to the health and development of infants born to women who
abuse cocaine during pregnancy; and violence and neighborhood
disintegration related to the cocaine marketplace.
 
In recent years, the scientific information base on the neurobiology
of cocaine addiction has expanded and the number of technological
breakthroughs has increased significantly.  Advances in molecular
biology, medicinal chemistry, immunology and neuroscience of cocaine
addiction have been made: genes for the dopamine and serotonin
receptors have been cloned, novel cocaine congeners of varying
affinities and pharmacokinetics properties have been synthesized and
evaluated, animal models that permit the study of behavioral features
of cocaine addiction in the laboratory are available, relationship
among protein function and regulation, brain structures, functions
and behavioral end points, and how cocaine affects these
relationships have been elucidated, basic brain mechanisms associated
with addiction behavior have been studied by clinicians, imaging
scientists and psychologists.
 
However, application of developments to clinical and treatment
activities has not been commensurate with this expansion.  There is a
need to apply these research advances to clinical research studies,
an effort that requires interdependent research activities involving
both preclinical and clinical investigators in the planning and
implementation of studies whose ultimate goal is an effective
pharmacotherapy for cocaine addiction.  A concerted effort to
mobilize the nation's combined basic and clinical scientific
expertise through SPIRCAP can accelerate advances in the development
of effective treatments for this brain disorder.
 
The SPIRCAP Program is specifically designed to support research for
the development of innovative hypothesis generating and
proof-of-concept pharmacological intervention and strategy for the
treatment of cocaine addiction.  The theme of this program
complements and balances present efforts pursued under existing NIDA
programs, including the Medication Development Research Centers
(MDRC), the various contracts managed by the Division's discovery
programs for the synthesis, testing and screening of potential
pharmacotherapeutics.
 
Research Goals and Objectives of the SPIRCAP Program
 
A.  The principal goals of this RFA are to (1) bring together
innovative, advanced preclinical research of sound scientific
rationale and clinical proof-of concept of an identified therapeutic
strategy for cocaine addiction; and (2) implement pilot clinical
studies of a therapeutic strategy.  In line with this objective, the
SPIRCAP Program will support projects with a common thematic goal for
which advanced preclinical data exist.  These efforts are to be
implemented through a concerted, interdependent Group effort by
components comprising the SPIRCAP Group.  A SPIRCAP can focus its
preclinical and clinical research activities on strategies directed
toward validating a "substitution" or "blocking" treatment concept or
the development of cocaine antibodies or anti-idiotype based vaccines
or other novel, innovative approaches.
 
B.  Applicants for SPIRCAP funding are expected to have an identified
strategy - based on creative, solid scientific rationale and
supported by advanced preclinical data - which is proposed for pilot
clinical evaluation.  Therapeutic strategies that require studies in
humans as well as preclinical studies to refine the clinical approach
are appropriate for funding under the SPIRCAP Program.  Each SPIRCAP
is a well-defined central research focus consistent with the research
objectives of the Program as stated in the RFA.  The following
approaches are provided as examples and are not intended to be
inclusive or restrictive:
 
Strategies that substantiate or refute the concept of
"substitution-agonist" and/or "antagonist" therapies.  Much of the
current approaches for the development of anti-cocaine medications
are modeled after the success of opioid addiction pharmacotherapies
(the methadone, LAAM and naltrexone) or the nicotine addiction
pharmacotherapies (the nicotine patch, gum, etc.), however, the
differences between these addictions warrant further validations of
such concepts.
 
Strategies that validate the utility of novel classes of compounds as
potential anti-cocaine medications, e.g., dopamine D1 antagonists,
SSRIs, or kappa opioid compounds.
 
Strategies that validate the utility of an anti-craving medication to
prevent relapse to cocaine addiction.
 
Strategies for the development of catalytic antibodies and anti-
idiotype based vaccines to treat cocaine addiction.
 
Strategies that validate the utility of compounds which interrupt
chronic cocaine use based on identified neurobiological and cellular
mechanisms that may promote repeated cocaine use.
 
Strategies that validate the utility of compounds that modifies
cocaine sensitization or tolerance to treat cocaine addiction.
 
C.  Applications should address advanced preclinical refinements of
the proposed strategy, evaluation and demonstration of therapeutic
benefit in laboratory animals, if applicable, and implementation of
pilot clinical studies.  The cyclic flow of information between
preclinical and clinical phases is critical for maximal refinement
and optimization of the proposed clinical modality, clinical
evaluation of the therapeutic concept, and ultimately, to accelerate
transition to clinical treatment.
 
D.  Studies required for the IND-targeted preclinical development
(formulation, toxicology) of proposed treatments are generally beyond
the scope of this RFA, but such development through private venture
capital is encouraged.  Alternatively, a Group may request that the
NIH assist in these developmental tasks using existing NIH/NIDA
contract resources.  The NIDA/MDD has the capacity for clinical
evaluation of therapies for cocaine addiction in its VA interagency
agreement.  It is envisioned that extended clinical studies of
treatments developed by a SPIRCAP group can be accommodated under the
clinical trial mechanisms available through Medications Development
Division.  Queries about these programs may be directed to Dr. Betty
Tai at the address listed under INQUIRIES.
 
E.  The Group's objectives and goals should be relevant to and
compatible with the NIDA Program missions and directions as stated in
this RFA.  Applicants should describe their plans to accommodate the
stated SPIRCAP Program requirements, criteria, and NIDA involvement.
 
F.  Applications that are not truely innovative or are covered by
other NIDA programs are excluded from this RFA.
 
G.  Relevance to other NIDA programs:  This RFA will support
innovative, integrated preclinical and clinical studies to validate
therapeutic concepts for cocaine addiction.  Other MDD/NIDA
initiatives involving only preclinical studies for novel intervention
strategies address (1) preclinical animal models development; (2)
early preclinical discovery of new drugs and therapeutic approaches
for the treatment of cocaine addiction.  SPIRCAP applicants must
ensure that no overlap exists between the specific aims proposed
under this RFA and those proposed under any of the other initiatives
referenced above, if applicable.
 
SPIRCAP applicants from an institution receiving government funds
under General Clinical Research Center (GCRC), Medication Development
Research Center (MDRC), should describe how these programs are
integrated with the proposed studies, and ensure that no scientific
and budget overlap exists with the SPIRCAP proposal.
 
DEFINITIONS
 
ADMINISTRATIVE CORE - An administrative facility that provides
central operations and support for the overall management of the
cooperative agreement and services shared by the Group as a whole.
The Administrative Core should have a budget separate from that of
the Principal Investigator's research project, but should be
administered by the Principal Investigator's organization.  The
Administrative Core will have in its budget for each year travel
expense to support its SPIRCAP Steering Committee members to attend
scheduled Steering Committee meetings.  The Administrative Core will
be responsible for allocating required travel expenses to appropriate
members of the Group.  Only SPIRCAP-related travel will be supported
under this RFA; travel funds to other domestic or foreign meetings is
not provided under this RFA.  (For additional details of required
travel see SPECIAL REQUIREMENTS - TERMS AND CONDITIONS OF AWARD:  A.
and B.)
 
COOPERATIVE AGREEMENT - An assistance mechanism in which substantial
NIDA programmatic involvement is anticipated with the recipient
organization during the performance of the planned activity.
 
CORE COMPONENT - Laboratory facilities for equipment and services
which are shared by two or more projects of the SPIRCAP. Examples of
core components are:  biochemical, cell-based, and immunological
studies; animal model studies; pharmacology/toxicology studies;
scale-up synthesis of the therapeutic agent.  The core can be defined
as a facility laboratory with established techniques and assays which
performs a service function resulting in an economy of effort and
savings in the overall costs of the Group.  The core unit is to be
described with the same detail as the research projects to enable
evaluation of its scientific merit.
 
CORE LEADER - The leader of one of the Scientific or Administrative
Cores of the SPIRCAP.
 
GROUP - see SPIRCAP, below.
 
INVENTION - An innovative therapeutic approach that is or may be
patentable under Title 35 of the United States Code.
 
(SPIRCAP) STRATEGIC PROGRAM FOR INNOVATIVE RESEARCH ON COCAINE
ADDICTION PHARMACOTHERAPY - In this RFA the terms STRATEGIC PROGRAM
FOR INNOVATIVE RESEARCH ON COCAINE ADDICTION PHARMACOTHERAPY
(SPIRCAP) and "Group" are synonymous.  Each Group may consist of a
number of scientific investigators from academic and/or non-profit
research institutions as well as scientists from commercial
organizations, performing research on interdependent projects whose
central focus is development of effective clinical therapy for
cocaine addiction.  A CORE component cannot be used toward
fulfillment of the three research projects requirement.
 
NIDA SPIRCAP PROGRAM DIRECTOR - A Senior Scientist of the NIDA
extramural staff who coordinates NIDA's participation in the SPIRCAP
Program, oversees the operation of the entire SPIRCAP Program,
maintains the program stewardship duties and who ensures that the
SPIRCAP Program is consistent with the Medications Development
program and NIDA missions and goals.
 
NIDA SCIENTIFIC COORDINATORS - Scientists of the extramural staff of
the Medications Development Program, NIDA, who function as
collaborators with the Principal Investigators and Project Leaders
and who facilitate the partnership relationship between NIDA and each
Group.  Two Scientific Coordinators from the Medications Development
Program - one from the preclinical program area and one from the
clinical program or other related program area - will be assigned to
each Group by the SPIRCAP Program Director.  The Scientific
Coordinators are the immediate contact persons to the Group.
 
PRINCIPAL INVESTIGATOR - The person who assembles the SPIRCAP, who is
responsible for the performance of the Group as a whole and for that
of each of the Project Leaders, and who is responsible for submitting
the single application in response to this RFA.  The Principal
Investigator will coordinate Group activities scientifically and
administratively and should preferably be project leader of one of
the Research Projects of the Group.  The awardee (Principal
Investigator's) institution establishes and operates the Central
Operations Office that funds Group members and is legally and
fiscally accountable for the disposition of funds awarded.
 
PROJECT LEADER - The leader of one of the scientific research
projects of the SPIRCAP, who is responsible for the scientific
conduct of that project.
 
SPIRCAP GROUP STEERING COMMITTEES - Each SPIRCAP Group will form a
Steering Committee (SC) which is the primary coordination center of
the GROUP and will decide all major scientific/programmatic
decisions.  It will be composed of the Principal Investigator, the
Project leaders of the Group, the Chief of NIDA MDD Regulatory
Affairs Branch (non voting), the NIDA Scientific Coordinators (one
from the preclinical area and one from the clinical area), and other
non voting consultants (e.g., Scientists, relevant FDA and/or DEA
officials) as needed.  Only one NIDA Scientific Coordinator will
vote. The SC will have the following responsibilities and
authorities:  (1) develop a detailed plan and timetable to coordinate
the various research activities among the GROUP's various research
laboratories to ensure the preclinical concept/strategy will advance
into clinical studies in a timely fashion.  (2) Identify/allocate the
essential and additional studies or resources (toxicology,
formulation) required for the IND targeted preclinical medication
development activities which are not the scope of the study.  (3)
formulate strategies to successfully interact with the FDA, and/or
local IRBs, etc regarding the IND submission and quality control of
the studies (GLP, GCP, GMP, etc).  (4) develop policies on data
sharing, on access to data and materials and on publication
authorship. The SC will meet at least two but not to exceed four
times a year and will tele-conference when requested. (For additional
details on SC see SPECIAL REQUIREMENTS - TERMS AND CONDITIONS OF
AWARD: B.)
 
RESEARCH PROJECT - A discrete, specified, circumscribed project that
must relate to the overall theme (refinement and proof-of- concept of
high risk innovative pharmacological intervention and strategy for
the treatment of cocaine addiction) of the SPIRCAP.
 
SPECIAL REQUIREMENTS
 
Terms and Conditions of Award
 
NOTE:  Failure to abide by any of the Terms of Award pertaining to
awardee responsibilities stipulated in this Section may result in
withholding of funds by the NIDA until compliance with the Terms is
restored.
 
A.  Awardee Rights and Responsibilities
 
Specifically, the Principal Investigator defines the details for the
project within the guidelines of the RFA, retains primary authority
and responsibility for the plan, conduct, analyze and publish
results, interpretations and conclusions of their studies, and agrees
to accept assistance in coordination, cooperation, and participation
of NIDA staff in those areas of scientific and technical management
identified under C. NIDA staff responsibilities.
 
Awardee will participate on the SPIRCAP Steering Committee as
described under Collaborative Responsibilities.  Awardee will retain
custody of primary rights to their data developed under the award,
subject to rules formulated by the Steering Committee, and government
rights of access consistent with current DHHS, PHS, and NIH policies.
 
B.  Collaborative Responsibilities
 
Under the Cooperative Agreement, a partner relationship exists
between the awardee and NIDA.  In order to facilitate the
collaborative effort between the awardee and the NIDA extramural
staff, a Steering Committee for each SPIRCAP will be established.
 
Each SPIRCAP Steering Committee will be composed of:
 
1.  The Principal Investigator of the Group.
2.  The Project leaders of all preclinical and clinical projects.
3.  The Chief of the NIDA Regulatory Affairs Branch (or designee),
4.  The NIDA preclinical and clinical Scientific Coordinators,
5.  Additional non-voting consultants as needed
 
NIDA will have one vote and will not be serving as the Chair of the
Committee.
 
Each SPIRCAP Steering Committee will have the authority and
responsibility to:  (1) develop a detailed plan and timetable that
will ensure active and frequent interactions among the various
research laboratories and NIDA staff to expedite the  transition of
preclinical concept/strategy into clinical studies; (2) identify and
allocate all essential and additional studies or resources
(toxicology, formulation) required for the IND targeted preclinical
development that are not the scope of the study; (3) formulate
strategies to interact with FDA, and/or local IRBs, regarding the IND
submission and quality control of the study (GLP, GMP, GCP, etc); (4)
develop policies on data sharing, on access to data and materials and
on publication authorship.  The steering committee will meet two to
four times a year and tele-conference when requested by the Awardee
or by NIDA staff.
 
C.  NIDA Staff Responsibilities:  Nature of NIDA Participation
 
Assistance via a Cooperative Agreement differs from the traditional
research grant in that, in addition to the normal programmatic and
administrative stewardship responsibilities, the awarding component
(NIDA) anticipates substantial scientific and programmatic
involvement during performance of the research program.  NIDA will
work with each Group and will be represented by two NIDA Scientific
Coordinators, both members of the professional staff of the
Medications Development Program: one coordinator will be from the
Cocaine Treatment Discovery Program, and one coordinator will be from
the Clinical Cocaine Treatment Program or other related Programs.
NIDA SPIRCAP Scientific Coordinators will be voting members of the
SPIRCAP Steering Committee but will not hold the position of chair.
 
In light of the complex structure and research activities of the
SPIRCAP and the medications development goal of the SPIRCAP, NIDA
staff will provide technical assistance and advice in the area of
pharmaceutical regulatory science and in the area of information
management and project management to ensure effective and efficient
progress of the study.  Specifically, the responsibilities of NIDA
staff are three fold: (1) By means of their project management and
information management expertise to facilitate the effective
communication among study laboratories to ensure expedited transition
of ground-breaking research from advanced preclinical findings to
applied clinical mode.  (2) To provide pharmaceutical regulatory
advice and support to the GROUP by serving as liaison with the Food
and Drug Administration (FDA) and Drug Enforcement Administration
(DEA) regarding all relevant regulatory issues; serving as
consultants for the GROUP to prepare IND submissions and to conduct
studies that meet FDA standards (GLP, GMP, GCP) when needed.  (3) To
provide appropriate assistance, advice, and guidance in general by
participating in the design of Group activities; advising in the
selection of sources or resources; coordinating or participating in
collection and/or analysis of data and participating in the
preparation of publications but will not participate in the actual
implementation of the preclinical and clinical studies.
 
D.  Patent Coverage
 
Principal worldwide patent rights to an invention supported in whole
or part with Federal funds usually vest with the grantee/contractor
organization.  Under existing regulations 37 CFR 401,
grantee/contractor organization must promptly report all inventions
disclosed to them by their investigators to NIH Extramural Technology
Transfer Office.  A grantee can elect to retain title to any subject
invention, although such title is subject to an nonexclusive,
nontransferable, irrevocable, paid-up license to the government to
use, and license others to use, the invention for Government
purposes.  If the grantee does not elect to retain title, the
Government may do so.  Moreover, the Government retains march-in
rights that require the patent holders to license others in certain
circumstances such as when the licensee has not taken effective steps
within a reasonable time to achieve practical application of an
invention or to alleviate a health and safety need.
 
E.  Arbitration Process
 
Inasmuch as certain activities require approval by NIDA staff during
performance of this Cooperative Agreement - specifically, reports
intended for inclusion in IND's and Clinical Brochures,
redistribution of materials received from the Government, and
dissemination of research findings resulting from the use of these
materials - NIDA will establish an arbitration process to resolve any
differences of opinion between the awardee and NIDA, on scientific
and programmatic matters.  An arbitration panel, composed of one
Group designee, one NIDA designee, and a third designee with
expertise in the relevant area and chosen by the other two, will be
formed to review any scientific or programmatic issue that is
significantly restricting progress. These special arbitration
procedures in no way affect the awardee's right to appeal an adverse
action in accordance with PHS regulations at 42 CFR Part 50, Subpart
D, and HHS regulations at 45 CFR Part 16.
 
The special "TERMS AND CONDITIONS OF AWARD: " described in this
Section are in addition to, and not in lieu of, otherwise applicable
OMB administrative guidelines, HHS grant administration regulations
at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH grant
administration policies.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990. The new policy contains some new
provisions that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research", which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.
 
Investigators may obtain copies from these sources or from the
program staff or contact person listed under INQUIRIES.  Program
staff may also provide additional relevant information concerning the
policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by May 13, 1996, a letter
of intent that includes a descriptive title of the overall proposed
research; the name, address, telephone number, and institution of the
Principal Investigator; names of prospective Project Leaders, other
key investigators, and their respective institutions; title, project
leader, and institution for each component research project, and  the
number and title of the RFA in response to which the application may
be submitted.  Although the letter of intent is not required, is not
binding, and is not a factor in the peer review of the application,
the information it contains is helpful in planning for the review of
applications.  It allows NIDA staff to estimate the potential review
workload and to avoid conflict of interest in the review process.
 
The letter of intent is to be sent to:
 
Director
Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Rm 10-42
Rockville, MD  20857
Telephone:  (301) 443-2755
 
APPLICATION PROCEDURES
 
This RFA requires the submission of a single application for the
proposed SPIRCAP.
 
o  The individual research projects comprising the SPIRCAP are
subject to the same format and page limitations as a research project
grant application.  The research grant application form PHS 398 (rev.
5/95) is to be used in applying for these cooperative agreements.
Applications kits are available at most institutional offices of
sponsored research and may be obtained from the Grants Information
Office, Office of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/435-0714, email:
girg@drgpo.drg.nih.gov.  The title and number of this RFA must be
typed in Item 2 on the face page of the application.
 
o  The special requirements of this RFA also necessitate certain
modification.  The Introductory Section should apply to the proposed
SPIRCAP as a whole with respect to the overall theme, goals,
objectives, and overall research plan. The Introductory Section, not
to exceed three pages, should contain any additional information
about the proposed Principal Investigator or his/her institution as
evidence of capability to carry out the scientific and administrative
duties required in this RFA and the functions of the Central
Operations Office.
 
The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, to ensure the identification of the
application with this RFA the "YES" box must be marked in item 2 of
the face page of the application form and the title and number of
this RFA typed.  Applications that are not received as a single
package from the Principal Investigator and that do not conform to
the instructions contained in PHS 398 (rev. 5/95) application kit
will be judged non-responsive and will be returned to the applicant.
 
The completed original, including the checklist, and three legible
copies must be sent or delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH, MSC-7762,
6701 ROCKLEDGE DRIVE, ROOM 1040
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for courier/overnight services)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Director
Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Rm 10-42
Rockville, MD  20857
Telephone:  (301) 443-2755
 
Applications must be received by  June 13, 1996.  If an application
is received after this date, it will be returned to the applicant
without review.  If the application submitted in response to this RFA
is substantially similar to a grant application already submitted to
the NIH for review, the applicant will be asked to withdraw either
the pending application or the new one.  Simultaneous submission of
identical applications will not be allowed, nor will essentially
identical applications to be reviewed by different review committees.
This restriction is superseded by an NIH policy permitting concurrent
submission of a duplicate R01 and a component of a multi-project
application.  The NIH policy however, further stipulates that should
both the R01 and the multi-project application be considered for
funding, the R01 will be relinquished in favor of the multi-project
application.
 
REVIEW CONSIDERATIONS
 
A.  Review procedures
 
Applications will be reviewed by the Division of Research Grants for
completeness and by NIDA staff to determine administrative and
programmatic responsiveness to this RFA; those judged to be
non-responsive will be returned to the applicant without review.
 
Applications with first year total costs (direct and indirect) in
excess of $1.0 million will be returned without review unless the
applicant has received a written waiver from the NIDA to exceed this
amount (see FUNDS AVAILABLE, above).
 
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by NIDA in accordance with NIH peer review
procedures.  As part of the initial merit review, all applications
will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit,
generally the top half of applications under review, will be
discussed, assigned priority score, and receive a second level review
by the National Advisory Council of NIDA.
 
B.  Review Criteria
 
Applicants are encouraged to submit and describe their own ideas
about how best to meet the goals of the cooperative study and their
specific objectives, and are expected to address issues identified
under SPECIAL REQUIREMENTS of this RFA.
 
The review group will assess the scientific and technical merit of
the proposed study plans and related factors:
 
o  Relevance of proposed research to the goals of the RFA;
 
o  Significance and originality of the proposed research;
 
o  Appropriateness and adequacy of the proposed research approach,
methodology, and plans to address special requirements;
 
o  Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  Availability of the resources necessary to perform the research;
 
o  Appropriateness of the proposed budget and duration in relation to
the proposed research;
 
o  Appropriateness of proposed methodology and demonstrated
willingness to work as part of the cooperative study and with NIDA
Collaborating Scientists;
 
o  Adequacy of provisions for the protection of human subjects; and
 
o  Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the specific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.
 
AWARD CRITERIA
 
Applications recommended for further consideration by an appropriate
Advisory Council will be considered for funding based on the
following factors:
 
o  Overall scientific and technical merit of the proposal as
determined by peer review;
 
o  Significance and originality of the proposed research;
 
o  Appropriateness of budget estimates;
 
o  Compatibility of research and data analytic approaches,
administrative structures, and other features to make a successful
cooperative study a reasonable likelihood;
 
o  Program priorities; and
 
o  Availability of funds.
 
Schedule
 
Letter of Intent Receipt Date:  May 13,1996
Application Receipt Date:       June 13, 1996
Scientific Review Date:         August 1996
Council Meeting Date:           September 1996
Earliest Award Date:            September 30, 1996
 
INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applications is
welcome.
 
Direct inquiries regarding programmatic issues to:
 
Betty Tai, Ph.D.
Medications Development Division
National Institute on Drug Abuse
Parklawn Building, Room 11A-55
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-3318/1428
FAX:  (301) 443-2599
Email:  BTAI@NIH.GOV
 
Direct inquiries regarding fiscal matters to:
 
Gary Fleming, J.D., M.S.
Grants Management Branch
National Institute on Drug Abuse
Parklawn Building, Room 8A-54
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-6710
Email:  gfleming@aoada1.ssw.dhhs.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the catalog of Federal Domestic
Assistance No. 93.279.  Awards are made under the authority of the
Public Health Service Act, Title IV, Part A (Public Law 78- 410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grant policies and Federal Regulations 42 CFR Part 52 and
45 CFR Parts 74 and 92.  This program is not subject to the
intergovernmental review requirements of Executive Order 122372 or
Health Systems Agency review.
 
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 of early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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