RELEASE DATE:  September 24, 2003

PA NUMBER:  PA-03-175 

EXPIRATION DATE:  January 21, 2006, unless reissued.

Department of Health and Human Services (DHHS)


National Institutes of Health (NIH) 


National Institute on Drug Abuse (NIDA) 



o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


This PA seeks investigator-initiated applications for research that builds on 
the initial goals of the RFA DA-99-003 and PA-00-115, "Genetics of Drug 
Addiction Vulnerability," which were to identify chromosomal regions involved 
in addiction and addiction vulnerability (including addiction to, or 
dependence on, stimulants, narcotics, nicotine, benzodiazepines, 
barbiturates, cannabis, hallucinogens and/or poly drug abuse). Once 
chromosomal regions are identified, the natural progression of the research 
is to identify the gene and gene variants responsible for the initial 
localization of the chromosomal region.  The objectives of this PA, then, are 
to build on, encourage and support innovative research from investigators who 
have, or can obtain access to data and resources to conduct fine mapping of 
chromosomal regions and quantitative trait loci (QTL) involved in addiction 
vulnerability and/or can uncover genetic variants within those regions to 
assess their association with addiction vulnerability.  Mapping 
susceptibility genes for common, complex diseases like addiction are 
difficult, in part, due to the tenuous correlations between genotype and 
phenotype.  For this reason, applicants must demonstrate the availability of 
well-characterized families with addiction and/or well-characterized genetic 
animal models of addiction in which linkage has already been demonstrated.  
Successful applicants are encouraged to take part in the NIDA Genetics 
Consortium through the NIDA Center for Genetic Studies.

In addition, this PA encourages the development of proposals to fine map 
quantitative trait loci (QTLs) and ENU induced mutations in mice and rodents 
associated with responses to substances of abuse.  Many of these QTLs span 
large regions, where the underlying genetic variant(s) responsible for the 
QTL remains unknown.   Knowledge of the complete sequence of the mouse and 
human genomes, the use of congenic, consomic, and transgenic strains, and the 
use of gene expression profiling to map genetic variants that control gene 
expression now make it possible to fine map QTLs involved in responses to 
substances of abuse. These studies may be informative for human candidate 
gene studies of addiction.

Wide distribution to the scientific community of the methods and data 
resulting from this program is essential to establishing validity of 
molecular targets identified.  Wide distribution will also facilitate the 
rapid transfer of technology for the development of diagnostic tools and 
treatment interventions for addiction disorders.

For additional NIDA funding opportunities in genetics, refer to the NIDA 
Genetics Workgroup homepage



Drug addiction is a genetically complex disease in which many genes and many 
environmental factors interact.  Identification of the gene variants 
associated with substance abuse disorders will greatly facilitate the 
characterization of the contributions that genes and environment play in the 
development of substance abuse disorders.  Since there has been progress in 
determining chromosomal regions that show linkage to certain drugs of abuse 
(for review, see Uhl et al, Trends in Genetics, 2002 18(8):420-5), and to the 
extent the necessary resources are accessible to investigators, now is an 
opportune time for research to gradually move from initial chromosomal 
localization towards gene identification.  Therefore, the next step is to 
generate fine maps of these chromosomal regions to the level of the gene and 
the variations within those genes.  

Fine mapping these very large (megabase) regions, in which there may be 
hundreds of biologically plausible candidate genes, is cumbersome.  For this 
reason, applicants should: 1) focus on a specific drug of abuse, 2) focus on 
specific well-explained phenotypes associated with that drug, and 3) consider 
combining several approaches to strengthen and expedite the identification of 
relevant genes and gene variants (for example, traditional positional mapping 
approaches combined with gene expression profiling in post-mortem human brain 
tissue).  Association studies in candidate genes and haplotype analyses are 
also favorable approaches in identifying relevant genes and variants.

Fine mapping QTLs and/or chemically induced mutations in mice has been made 
possible by the development of consomic and congenic strains, and knowledge 
of the sequence of the mouse genome.  Combining QTL analyses with gene 
expression profiling will help in the identification of gene variants 
responsible for QTLs or induced mutations in mice associated with responses 
to drugs of abuse, and may assist in the development of strategies for 
identifying candidate genes for substance abuse disorders in humans. 

Research Scope

This initiative is primarily intended to support follow-up research conducted 
under the RFA DA-99-003 and PA-00-115 and to solicit applications to fine 
map the gene(s) and gene variants to chromosomal regions shown to be 
associated with addiction and addiction vulnerability, and then to 
demonstrate that the variation in the gene(s) is associated with addiction.  
Thoughtful documentation on the use of heritable phenotypic definitions and 
high statistical rigor is vital.  Applicants who are seeking to link 
chromosomal regions to substance abuse disorders or addiction phenotypes or 
to recruit new subjects for identifying gene variants for addiction 
vulnerability should respond to PA-03-155, "Molecular Genetics of Addiction 
Vulnerability."  Fine mapping QTLs affecting drug response in rodents is also 
within the scope of this PA.

The types of projects supported by this initiative include but are not 
limited to:

o Gene Identification - Some addiction vulnerability traits have been linked 
to multiple regions of the genome.  Research is needed to identify specific 
genes and polymorphisms within those genes that lie within these linkage 
regions.  Prioritizing a candidate gene list combined with other, more high-
throughput approaches, is encouraged.

o Association Studies – Specific gene variants have been shown to be more 
strongly associated with addiction phenotypes (ex., withdrawal).  Validation 
of existing studies is an essential component in identifying addiction-
associated variants.  Testing candidate variants and haplotype variants is 
encouraged.  Particular attention to phenotype definition and statistical 
limitations must be clearly addressed.

o Gene x Environment and Gene x Gene Interactions – Candidate chromosomal 
regions identified by linkage studies may not account for the variability in 
addiction.  Thus, studies examining gene x environment and gene x gene 
interactions are also encouraged.

o Mouse Models – A number of mouse models have provided important genetic 
clues through identification of QTLs or ENU induced mutations that can then 
be further fine mapped and extrapolated to humans by syntenic localization.  
Mouse models with careful attention to phenotype definition are needed to 
refine QTLs and identify genes associated with addiction.

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 states that investigators must 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 (PRINCIPLES AND GUIDELINES FOR 
in the Federal Register,  
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 PA to develop and 
propose detailed plans for sharing the data and materials generated through 
the grant.

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) 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, 3) a timetable specifying when various elements of the database 
(e.g., diagnostic, assessment, or genetic data) will be available for 
distribution.  Investigators are encouraged to use the data management 
resources of the NIDA Center for Genetic Studies to comply with these 
expectations.   For more information about NIDA's policy concerning sharing 
of research resources and data dissemination see NIDA Human Molecular 
Genetics Research: Frequently Asked Questions (FAQs)  

In addition NIDA expects mouse resources, rat resources, or any other 
research resources generated with the aid of NIH funding to be distributed in 
a timely fashion and shared with the scientific community.  Investigators 
submitting an NIH application must include a concise plan addressing the 
timely distribution of these resources, unless the proposed research will not 
generate such resources.

The NIDA Genetics Consortium (NGC)

The nucleus of the NIDA Genetics Consortium (NGC) are investigators who have 
been awarded grants under the RFA, "Genetics of Drug Addiction Vulnerability" 
(DA-99-003) as well as those who have modified their projects to conform to 
the guidelines listed in that RFA to use the resources provided by the NIDA 
Center for Genetics Studies.  The NIDA Center for Genetics Studies is a 
resource for creating databases, cell lines, and DNA samples, and for wide 
distribution of the data and DNA to the scientific community.   After a 
proprietary period, the NIDA Center for Genetics Studies will, upon proper 
application and approval, distribute both the data and DNA samples to 
qualified researchers.   

Clinical data and DNA from projects of investigators belonging to the NIDA 
Genetics Consortium will begin to be available for analysis in July 2005.  
The process for gaining access to this resource is described in the following 
document (Frequently Asked Questions About the NIDA Center For Genetic 
Investigators interested in knowing what research projects participate in the 
NIDA Genetics Consortium (NGC) should see  Members of 
the NGC meet two times a year to discuss issues related to the molecular 
genetics of addiction vulnerability.


This PA will use the NIH research project (R01) award mechanism.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  

This PA uses just-in-time concepts.  It also uses the modular budgeting as 
well as the non-modular budgeting formats (see  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular budget format.  Otherwise 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  


You may submit (an) application(s) 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
o Faith-based or community-based organizations


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 underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   


Principal Investigators and key personnel as appropriate are expected to 
adhere to the NIDA Data Sharing Plans and participate in the NIDA Genetics 
Consortium.  Funds for travel to the meeting should be requested in the 


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

o Direct your questions about scientific/research issues to:

Joni L. Rutter, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 435-0298
Fax:  (301) 443-594-6093

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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847


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 The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 is available at 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at  Application 
deadlines are also indicated in the PHS 398 application kit.

requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail.  Applicants request direct costs in $25,000 modules.  
Section C of the research grant application instructions for the PHS 398 
(rev. 5/2001) at 
includes step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at

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 NIH program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from NIH staff that NIH 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 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five 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)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at  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.


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  Appropriate scientific review groups 
convened in accordance with the standard NIH peer review procedures 
( will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an appropriate advisory council or board.  


The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to 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 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority 
score.  For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 

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?

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?

INNOVATION: Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

INVESTIGATOR: Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?

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?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

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).
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).

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.  


SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct 
costs in any year of the proposed research are expected to include a data 
sharing plan in their application. The reasonableness of the data sharing 
plan or the rationale for not sharing research data will be assessed by the 
reviewers. However, reviewers will not factor the proposed data sharing plan 
into the determination of scientific merit or priority score.

BUDGET: The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.


Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities


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. 

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: 

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or 
more in direct costs in any single year are expected to include a plan for 
data sharing or state why this is not possible. 
Investigators should seek guidance from their institutions, on issues related 
to institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers will 
consider the data sharing plan but will not factor the plan into the 
determination of the scientific merit or the priority score.

the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is 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 "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 
a complete copy of the updated Guidelines are available at  
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) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 

The NIH maintains a policy 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 is available at 

policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 

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

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.

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 
( 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

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.   Furthermore, 
we caution reviewers 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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  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 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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