GENETICS OF DRUG ADDICTION VULNERABILITY

Release Date:  September 15, 1998

RFA:  DA-99-003

P.T.

National Institute on Drug Abuse

Letter of Intent Receipt Date:  December 28, 1998
Application Receipt Date:  January 27, 1999

PURPOSE

This Request for Applications (RFA) solicits investigator-initiated applications
for research projects that identify genetic variation that increase vulnerability
to addiction, or dependence on, stimulants (e.g., cocaine and amphetamine),
narcotics (e.g., opiates), nicotine, benzodiazepines, barbiturates, cannabis,
hallucinogens and/or multiple drugs of abuse.  Thus, applications examining the
genetics of addiction vulnerability to both illicit and legal drugs of abuse are
relevant to this RFA.  Genetic approaches within the scope of this RFA are
linkage, linkage disequilibrium, and association studies.  Data may be collected
from the general population, population isolates, and/or recent admixed
populations.  Standard and novel methods of analysis for the identification of
genetic variation conferring vulnerability to a complex genetics disorder such
as drug addiction are highly encouraged.  The creation of new diagnostic
instruments is not within the scope of this RFA.  Investigators proposing such
a goal will be deemed unresponsive to this RFA.

Priority will be given to applications with sufficient statistical power to
identify genetic variations or chromosomal locations of the genetic variations
associated with increased addiction vulnerability.  Another priority
consideration is the speed at which data collection and genetic analysis take
place.  To achieve sufficient statistical power, efficient data collection, and
rapid genetic analysis, investigators may need to establish multidisciplinary and
multisite efforts.

Interested investigators are advised to discuss their plans with National
Institute on Drug Abuse (NIDA) staff and visit the NIDA Genetics Workgroup
homepage for more details: 
http://www.drugabuse.gov/about/organization/Genetics/about_genworkgroup/index.html". 
To facilitate the development of collaborations among drug addiction researchers
and scientists with expertise in genetics and molecular biology prior to the
submission of applications, a moderated bulletin board has been established on
the NIDA Genetics Workgroup home page.

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, Genetics of Drug Addiction
Vulnerability, is related to many priority areas.  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 and foreign for-profit and non-profit,
public and private organizations such as universities, colleges, hospitals,
laboratories, units of State and 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.  The collection
of clinically well characterized samples of sufficient size for linkage analyses
and for linkage disequilibrium mapping studies in genetically isolated
populations may be facilitated by the establishment of international consortia. 
Collaborations among U.S. scientists and scientists at foreign institutions are
encouraged, when scientifically appropriate.  In these cases, awards may be made
to foreign institutions or to domestic applications that include foreign
components.  Foreign institutions are not eligible for program project (P01)
grants.

MECHANISM OF SUPPORT

Applicants may apply for a regular research project (R01) grant or program
project (P01) grant.  The P01 mechanism supports broadly based multidisciplinary
research programs that have a well defined, central research focus or objective. 
An important feature is that the interrelationships of the individual
scientifically meritorious projects will result in a greater contribution to the
overall program goals than if each project were pursued individually.  The P01
consists of a minimum of three interrelated individual research projects that
contribute to the overall program objective.  To achieve sufficient statistical
power or needed expertise these projects may be located at more than one
institution.  This type of award can also provide support for certain shared
resources, termed cores, that provide funds for tasks common to two or more
projects within the award.  NIH limits the time period for P01 grants to 5 years.

The cover letter and abstract should indicate the type of mechanism for which the
applicant is applying.  Specific information on individual research mechanisms
can be obtained from the NIDA home page at http://www.nida.nih.gov/Funding.html.

FUNDS AVAILABLE

This RFA is a one-time solicitation.  It is anticipated that $7.0 million
(including direct and indirect costs) will be available for this initiative in
Fiscal Year 1999 and Fiscal Year 2000.  Funding in future years will be subject
to the availability of funds.

Because the nature and scope of the research proposed in response to this RFA may
vary, it is anticipated that the size of an award will also vary.  Responsibility
for the planning, direction, and execution of the proposed project will be solely
that of the applicant.  Awards will be administered under PHS grants policy as
stated in the PHS Grants Policy Statement.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications, and will be reviewed according to the customary peer review
procedures.

RESEARCH OBJECTIVES

Background

Evidence from adoption and twin studies, from genetic strains of rodents, and
from induced mutations in mice, suggests that heritability may play a role in
vulnerability to addiction.  The genetic variation underlying increased
vulnerability to drug addiction is as of yet unknown.  However, new scientific
opportunities may now make it possible to identify and characterize the genetic
variations that contribute to addiction vulnerability.  This knowledge will
improve diagnosis, prevention, and treatment of drug addiction.  By better
understanding the genetic factors involved in the addiction process, the
environmental contributions to this disease can also be better understood.

Significant advances in molecular and statistical genetics have now made it
possible to identify the etiology of a disease through genetic means without any
other biological knowledge.  The power of the genetic approach for neuroscience
is evidenced by the recent positional cloning of genetic variations associated
with many cases of Alzheimer's Disease and rare forms of Parkinson's Disease. 
Animal models of these genetic disorders are now being created using transgenic
technology.  These models provide a greater understanding of the underlying
biology of the disease.  These and related approaches are likely to have
applicability to the brain disease of addiction, even though no evidence
documents that it follows a strictly Mendelian pattern of inheritance in humans.

The challenge for the molecular genetics of addiction, like many other complex 
genetic disorders lacking simple patterns of Mendelian inheritance in humans, is
addressing the complexity of polygenic disorders with substantial environmental
influences.  Continued advances during the next 5-10 years will enhance the study
of the molecular genetics of addiction vulnerability.

SPECIAL REQUIREMENTS

1) Phenotype(s)

For purposes of recruitment, applicants are expected to select affected probands
and to define unaffected individuals on the basis of criteria documented as
significantly heritable by current twin and/or adoption studies.  Information
about drug use, quantity, frequency criteria, and diagnostic criteria (such as
the DSM-III-R or DSM-IV criteria) that have been shown to have significant
heritability in twin and/or adoption studies could provide one approach to
defining phenotypes of affected and unaffected individuals.  The rationale for
selecting unaffected as well as affected individuals must be clearly justified. 
Diagnoses should be established from clinical information obtained with
structured or semi-structured assessment instruments with high diagnostic
reliability, e.g., the Structured Clinical Interview for DSM-IIIR or IV (SCID),
the Psychiatric Research Interview for Substance and Mental Disorders (PRISM),
the Structure Clinical Assessment for Neuropsychiatry (SCAN), the composite
International Diagnostic Interview (CIDI), the CIDI-Substance Abuse Module (CIDI-
SAM), the Diagnostic Interview Schedule (DIS), and  the Alcohol Use Disorder and
Associated Disabilities Interview Schedule (AUDADIS).  The inclusion of other
phenotypic markers is highly encouraged.  The characterization of a phenotype is
to be based on sound scientific evidence and reasoning.  Examples of possible
phenotypes include specific diagnostic categorizations, presence or absence of
biological markers, or exhibition of unique individual traits, as well as
combinations of these or co-morbid conditions and other phenotypic markers.  The
creation of new diagnostic instruments is not within the scope of this RFA. 
Investigators proposing such a goal will be deemed unresponsive to this
announcement.

2) Subjects and Samples

Subjects may be recruited from treatment facilities, the general population,
genetically isolated populations, or from a recently admixed population to
implement case-control, nuclear family or extended pedigree research designs. 
Applications employing genome wide scan and/or association strategies are
encouraged.  The employment of innovative genetic models, pedigree structure, and
methods of analysis for the identification of genetic variations conferring
vulnerability to a complex genetics disorder such as drug addiction is highly
encouraged.  Applicants must justify the adequacy of the proposed target sample
size as feasible and adequate for the identification or localization of genetic
variation for the addictive disorder under study, given the assumptions
underlying the genetic model being used and the proposed methods of analysis.

3) Management

Since quality control and consistency across sites are of utmost importance,
applications that include multiple sites must describe a feasible mechanism for
scientific integration of research procedures, overall managerial and
administrative responsibilities, and cross site comparability of training to
assure reliability and quality control.  Likewise, a data management plan by a
single investigator at a single site using a R01 type mechanism should be
described.

4)Electronic Databases.

It is expected that applicants will have developed, or have access to, a high
quality, computerized database for data entry, storage, and analyses of large
amounts of data including clinical information, family structure, diagnostic
criteria, and genotype data.  As a condition of award, it is expected that the
Principal Investigator provide a plan for dissemination of these data as
described below.  The minimum data set for each subject must include unique
family and individual identification numbers (such that access to the database
will not reveal the true identity of the subjects), sex, date of birth,
ethnicity/geographical origin of ancestry (including, if possible, ethnicity of
both parents and grandparents), MZ/DZ twin status (if appropriate), DSM-IIIR and
DSM-IV diagnoses, quantity and frequency of peak lifetime use of all addictive
substances, age of onset, comprehensive clinical information with individual item
scores obtained through a structured interview, and other relevant phenotypic
data.  Other data may be included.  Associated with these data will be all
genotype information, including but not limited to, DNA marker names, allele size
in base pairs and corresponding frequencies, and relative map distances.  These
data will be widely distributed to the scientific community, according to a plan
proposed by the Principal Investigator and approved by NIDA.

5) Cell Lines and DNA Extraction

It is expected that investigators will obtain blood samples from all individuals
entered into the study and create immortalized cell lines, unless strong
scientific justification can be provided for exemption of the study design from
this requirement.  DNA is to be extracted from these lines for wide dissemination
to qualified investigators in the scientific community and for use in genetic
analysis in accordance with the Data Sharing Plan (see below).  Applicants may
request funds to defray the costs of this task.  Exemption from the requirement
of creating immortalized cell lines may be granted if scientifically justified.

6) Quality Control

Since quality control of data accuracy is essential to the execution of genetic
analyses, applicants are expected to provide details of how the data can be
verified and updated throughout the project.  The methods of verification are
also to be included in the Data Sharing Plan.

7) Molecular, Genetic, and Statistical Analysis

An existing resource available to investigators for genotyping is the Center for
Inherited Disease Research (CIDR) supported by a contract to Johns Hopkins
University by eight NIH institutes including NIDA.  CIDR was established in 1996
to provide high throughput of genotyping and statistical services for complex
genetic diseases to the scientific community at large.

Introductory no cost access to CIDR resources is available to investigators who
have been approved by the CIDR Access Committee (CAC) and are supported by one
of the eight, supporting NIH institutes (including NIDA).  Thus, projects
supported by this RFA are eligible for no cost access to CIDR resources following
CAC approval.  Investigators should request access to CIDR resources if needed
and obtain CIDR approval by April 1. Deadline for submission of applications
requesting CIDR access is November 1.  For more information about CIDR, see the
CIDR web site at http://www.cidr.jhmi.edu.  A detailed scientific plan for
conducting a high throughput genomic scan and statistical analysis at a central
facility is needed if approval to use the CIDR facility is not obtained.  The
proposed costs and time frame for genotyping are expected to be justified (e.g.,
comparable with the genotyping costs at CIDR or the average cost for a commercial
facility).

8) Data Sharing Plan: Dissemination of Data and Biological Materials

The sharing of biological materials, interview and other assessment data, and
genotype information (including software) in a timely manner has been an
essential element in the rapid progress that has been made in the genetic
analysis of human diseases.  PHS policy is that investigators make unique
research resources readily available for research purposes to qualified
individuals within the scientific community when first results based on these
resources have been published (PHS Grants Policy Statement in the July 12, 1996
issue of the NIH Guide to Grants and Contracts).  Accordingly, to address the
interests of the research community and government in promoting the science of
the genetic basis of drug addiction vulnerability, NIDA expects applicants who
respond to this RFA to develop and propose detailed plans for sharing the data
and materials generated through the grant.  It is expected that the information
to be shared will include all clinical, diagnostic, and pedigree structure
information, in addition to cell lines and DNA.

It is expected that the Data Sharing Plan will specify the following elements:
1) creation of comprehensive and verified databases that contain all clinical,
diagnostic, pedigree structure, and genotypic information collected and produced
by the grant, 2) establishment of cell lines (from which DNA will be extracted
and stored) from all protocol subjects from whom blood samples have been
obtained, 3) a mechanism or protocol by which all databases and biological
materials (DNA samples, cell lines) can be widely searched or distributed to
qualified investigators in the scientific community, 4) a timetable specifying
when various elements of the database (e.g., diagnostic, assessment, or genetic
data) will be available for distribution.

The Scientific Review Group will be asked to make an administrative comment on
the proposed plan for data sharing and access and, the adequacy of the plan will
be considered by NIDA in funding decisions.  The plan must be approved by NIDA
(after negotiation with the applicant if necessary) before an award will be made. 
NIDA staff will review implementation of the plan for each Application for
Continuation of Grant.  Failure in compliance may result in reduction of the
amount awarded in the Continuation of Grant.

9) Human Subjects Issues

Proper safeguards are required to protect the welfare and rights of subjects who
participate in genetic research.  Subjects who participate in research projects
funded under this RFA need to be fully informed of important issues such as data
collected from them will be included in a large database for research
distribution only after all information that can reasonably identify them is
removed.  Study participants must also be informed that their biological material
(DNA) will be stored and available to other researchers.  Subjects also need to
be informed that some qualified investigators who will have access to these
(unidentifiable) data may have commercial interests.  Some identifying
information may remain with Principal Investigators in their own research files,
in which case appropriate Informed Consent must be obtained from the subjects. 
Under circumstances of unique genotypes, it may be possible that enough
information eventually might be developed to allow individuals to be identified
and, consequently, become subject to any risk(s) that might arise as a result of
that identification.  Subjects must thus be informed about the risk of
identification.  Applicants should address any special human subject issues that
arise as a result of the proposed research.  (NIH is currently working to develop
a model consent form for human genetic research, and this will be provided to
applicants whose projects are funded under this RFA when it becomes available. 
This may then serve as a template that is subject to modification and/or approval
by local institutional review boards.)

10) Post Award Management

During the course of the project period, while the original approved scope of
work will be maintained, it is anticipated that technologies will improve and the
rate of progress and focus of work supported by the grant(s) may change. 
Accordingly, it is expected that the principal investigator(s) will be allowed
reasonable latitude, in consultation with program staff, to make necessary
adjustments in scientific direction to accommodate such changes.  Most
importantly, it is essential to the achievement of the study aims that subject
recruitment proceed as rapidly and efficiently as possible.  Thus, principal
investigators may need to be flexible in modifying recruitment strategies to
assure that the targeted sample size is achieved.  During the course of the award
period, the principal investigators will be invited to meet with NIDA program
staff in the Washington, D.C. area, to review scientific progress.  Other
scientists external to and knowledgeable about these studies may also be invited
to participate.  Budget requests should include travel funds for the principal
investigator to meet annually in the Washington, D.C. area.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.  This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).  All investigators proposing research involving human subjects
should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects
in Clinical Research," which have been published in the Federal Register of March
28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol.
23, No. 11, March 18, 1994.  Investigators also may obtain copies of the policy
from the program staff listed under INQUIRIES, who may also provide additional
relevant information.

NIH POLICY AND GUIDELINES ON THE 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 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:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS

The National Advisory Council on Drug Abuse recognizes the importance of research
involving the administration of drugs to human subjects and has developed
guidelines relevant to such research.  Potential applicants are encouraged to
obtain and review these recommendations before submitting an application that
will administer compounds to human subjects.  The guidelines are available on
NIDA's Home Page at http://www.nida.nih.gov under "What's New" or may be obtained
by calling (301) 443-2755.

LETTER OF INTENT

Prospective applicants are strongly encouraged to discuss their research
objectives with NIDA staff early in their planning process.  Prospective
applicants are asked to submit, by December 28, 1998, a letter of intent that
includes a descriptive title of the proposed research, the name, address, and
telephone number of the principal investigator, the identities of other key
personnel and participating institutions, and the number and title of this RFA. 
Although a letter of intent is not required, is not binding, and does not
influence the review of a subsequent application, the information that it
contains allows NIDA staff to estimate the potential review workload and avoid
conflict of interest in the review.

The letter of intent is to be sent to:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-42
Rockville, MD  20857
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95).  Application kits are available at most institutional offices of sponsored
research and may be obtained from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email:
[email protected].

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, the RFA title and
number must be typed on Item 2 of the face page of the application form and the
"YES" box must be marked.

Applications should state in a cover letter and in the Abstract Section which
mechanism (Regular Research (R01) or Program Project (P01) is being proposed.

Submit a signed original copy 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:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-42
Rockville, MD  20857

Applications in response to this RFA must be received by January 27, 1999.  If
an application in response to this RFA is received after that date, the
application will be returned to the applicant without review.  The Center for
Scientific Review (CSR) will not accept any application in response to this RFA
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 revisions of applications already reviewed, but such
applications must include an introduction responding to the previous critique. 
The applicants should also ensure that their revised applications respond to the
review criteria by which applications in response to this RFA will be evaluated.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and for
responsiveness to this RFA by NIDA staff.  Incomplete applications will be
returned to the applicant without further consideration.  If the application is
not responsive to the RFA, NIH staff will contact the applicant to determine
whether to return the application to the applicant or submit it for review in
competition with unsolicited applications at the next review cycle.

Applications that are complete and responsive to this RFA will be evaluated for
scientific and technical merit by a peer review group convened by the NIDA in
accordance to NIH procedures.  As part of the initial merit review, all
applications will receive a written critique and may undergo a process in which
only those applications deemed to have the highest scientific merit will be
discussed and assigned a priority score.  All applications will receive a second
level of review by the National Advisory Council on Drug Abuse.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  The
reviewers will comment on the following aspects of the application in their
written critiques to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of the criteria will
be addressed and considered by the reviewers in assigning the overall score
weighting them as appropriate for each application.  Note that the application
does not need to be strong in all categories to be judged likely to have a major
scientific impact and thus deserve a high priority score.  For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move the field forward.

(1) Significance:  Does this study address an important problem?  If the aims of
the application are achieved, how will scientific knowledge be advanced?  What
will be the effect of these studies on the concepts or methods that drive this
field?  Will the proposed study significantly advance knowledge about
identification of genetic variation that confers susceptibility to drug
addiction?  Is the scope of work for the molecular genetic studies focused
exclusively on efforts to establish the chromosomal locations of susceptibility
loci, and not focused on fine mapping, sequencing, or mutation analyses?

(2) Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?  Does the sample size have sufficient statistical power to
identify genetic variations or chromosomal regions that harbor genetic variations
conferring susceptibility to the disorder under investigation? Does the applicant
address potential problems in recruitment and consider alternatives? If multiple
sites are involved, is there adequate coordination and oversight among the
various groups?  Is phenotyping being done in a highly reliable, rigorous and
comprehensive fashion?  Is data collection reliable from site to site? Will
genotyping be accomplished in a rapid and cost-effective fashion?

(3) Innovation:  Does the project employ novel concepts, approaches, or method?
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?  Does the project foster
new analytic approaches for identifying chromosomal regions of interest?

(4) Investigator:  Is the investigator or are the investigators appropriately
trained and well suited to carry out this work?  Is the work proposed appropriate
to the experience level of the principal investigator and other researchers (if
any)?  Is there sufficient expertise in the area of drug addiction, molecular
genetics, statistics, and bioinformatics to carry out the data collection and
genetic analyses?

(5) Environment:  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence of institutional support?   Does
the applicant have access to sufficient resources to obtain the targeted sample
size?

6) Scalability: What is the likelihood that the data collected in the project
will be rapidly collected and available for analysis by a broad range of
qualified investigators?

7) Integration with other resources: Are comprehensive diagnostic assessment
instruments and currently available software utilized in the project?  Are
appropriate criteria used to select a minimum number of affected individuals with
the core phenotype, for the purpose of pedigree ascertainment?

8) Budget and duration: Are the proposed budget and duration appropriate in
relation to the proposed research? Are the costs and time frames for molecular
and statistical analyses generally comparable to those at CIDR and other high-
throughput genotyping facilities?

The review committee will also evaluate the provisions for the protection of
human and subjects, and the safety of the research environment as well as the
adequacy of plans to include both genders, minorities and their subgroups, and
children as appropriate for the scientific goals of the research.

Also, the committee will evaluate the Data Sharing Plan in n administrative note,
using criteria such as:  Will the applicant's data management plans permit
creation of a highly efficient and organized electronic database?  Will these
plans facilitate the creation of databases containing final best estimate
diagnostic data, family structure information, and clinical data that is
accessible to the scientific community? Will data provided to the data management
facility and cell repository be in a highly exportable format that will permit
rapid integration with comparable resources maintained by other investigators? 
Does the investigator's quality control plans assure that databases provided to
the scientific community are accurate and up-to-date, and that cell lines and DNA
samples are of high-quality?

Schedule

Letter of Intent Receipt Date:   December 28, 1998
Application Receipt Date         January 27, 1999
Peer Review Date                 April/May 1999
Council Review                   September 1999
Earliest Start Date              September 30, 1999

AWARD CRITERIA

Awards will be made on the basis of scientific and technical merit as determined
by peer review.  Other factors that will be used to make award decisions are:

o  Adequacy of plans to make all data and biological materials collected and
produced as a result of the proposed research widely accessible in a timely
manner to the biomedical research community

o  Programmatic considerations

o  Availability of funds

INQUIRIES

Written, telephone, and email inquiries concerning this RFA are strongly
encouraged.  NIDA staff welcomes the opportunity to clarify any issues or
questions from potential applicants.

Direct inquiries regarding programmatic issue to:

Jonathan D. Pollock, Ph.D.
Division of Basic Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A19
Rockville, MD 20857
Telephone:  (301) 443-6300
FAX:  (301) 594-6043
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A54
Rockville, MD  20857
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.279.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241
and 285), and administered under PHS grants policies and Federal Regulations 42
CFR 52 and 45 CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products.  In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.


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