Release Date:  December 16, 1999

RFA:  DA-00-005

National Institute on Drug Abuse

Letter of Intent Receipt Date:  February 29, 2000	
Application Receipt Date:  	  March 29, 2000



The National Institute on Drug Abuse (NIDA) requests applications for 
research projects in the basic behavioral, cognitive, and neurosciences that 
can address the complex relationship between drug abuse and addiction and 
HIV/AIDS transmission and progression.  Basic research is needed to 
characterize the antecedent variables and processes, such as psychosocial and 
emotional factors and decision processes, associated with increased risk for 
contracting HIV/AIDS and to determine the neurological, immunological, 
behavioral, and cognitive consequences potentially caused by combined effects 
of the virus, drugs of abuse, drug abuse pharmacotherapies, and/or anti-HIV 
medications.  HIV can cause a cascade of neuroimmune processes that have 
profound and potentially toxic effects on the brain.  Because drugs of abuse 
can also have adverse effects on neuronal and immune function and, in some 
cases, can cause cell death, it is important to characterize the changes in 
neuronal and neuroimmune function and the related cognitive and behavioral 
changes associated with disease progression and drug abuse.  In addition, the 
recent development of anti-HIV medications requires adherence to complex 
medication regimens.  It is important, therefore, to understand the basic 
cognitive and behavioral processes associated with treatment compliance, the 
influence of drug abuse and addiction on these fundamental processes, and 
changes in brain function associated with level of adherence.   Overall, 
basic research in these areas will lead to a better understanding of the 
effects of HIV/AIDS and drugs of abuse on behavioral, cognitive, and brain 
function, which will aid in the development and refinement of treatment and 
prevention interventions.  


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, “BASIC 
DRUG ABUSE,” is related to the priority area of alcohol and other drugs.  
Potential applicants may obtain a copy of “Healthy People 2000” at


Applications may be submitted by domestic and foreign for-profit and non-
profit organizations, public and private, 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.  Awards to foreign institutions under R-series awards are 
generally limited to
3 years.


The mechanisms of support will include the investigator-initiated research 
project grant (R01), small grant (R03), and exploratory/developmental (R21) 
grant.  In addition, competitive supplements to add a research component to 
an existing grant will be eligible.  Applicants are advised to contact NIDA 
program staff listed under INQUIRIES for additional information and specific 
application procedures. 

For research in methods development, the R03 or R21 mechanisms are 
particularly appropriate. The small grants (R03) are limited to 2 years and 
exploratory/developmental (R21) grants are limited to 3 years.  Both are non-
renewable and limited in direct cost amount per year (R03, $50,000; R21, 
$100,000).  The R03 mechanism gives funding priority to newer, less 
experienced investigators, investigators at institutions without well-
developed research traditions and resources, or experienced investigators 
wishing to change research directions or test new methods or techniques.  The 
R21 mechanism is intended to encourage exploratory research projects with 
sound methodology and strong rationales in underdeveloped research areas of 
drug abuse, such as the areas covered in this RFA.  Investigators may also 
choose to include methods development as one component within any of the 
other mechanisms.  Responsibility for the planning, direction, and execution 
of the proposed project will be solely that of the applicant.  Specific 
information on individual research mechanisms can be obtained from the NIDA 
home page at

Support may be requested for a period of up to 5 years for R01 grants and 
shorter periods of time for the other mechanisms.  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 vary also.  Modular budgeting 
procedures apply for grants under $250,000.  See for further 
information about modular budgets. 

The anticipated award date is September 30, 2000.  This RFA is a one-time 
solicitation.  Future unsolicited competing continuation applications will 
compete with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures.  Applications judged to be 
nonresponsive to the RFA will be returned to the applicant.


It is anticipated that 10-12 awards may be funded in FY2000 at a total cost 
of $2 million.



It is well established that drug abuse is a major risk factor for contracting 
HIV/AIDS.  In the context of drug abuse and addiction, research is needed to 
enhance our understanding of the behavioral and cognitive antecedent 
variables associated with HIV transmission.  Basic behavioral and cognitive 
science research can enhance our understanding of the complex 
interrelationship between drug abuse and addiction, impulsive and risk-taking 
behaviors, and decision-making processes that can lead to contracting the 
virus.  Basic behavioral and cognitive science research using either animal 
models or involving human volunteers that examines fundamental aspects of 
risk behavior and related decision processes is encouraged.  However, the 
applicant would need to provide a clear statement indicating how proposed 
research might advance the understanding of reducing risk behaviors 
associated with injection drug use and other drug abuse related risky 
behaviors associated with HIV transmission.  Understanding these fundamental 
processes will lead to a better understanding of decisions, attitudes, 
beliefs, and behaviors involved in unsafe needle sharing and in risky sexual 
encounters, for example.  Once these fundamental processes are understood, 
steps can be taken to modify or reduce their occurrence.  Information gained 
from basic research in this area will aid in developing and refining 
prevention interventions.

Little is known about potential neuropathological, and neuroimmune changes 
produced by the combination of the virus and drugs of abuse.  In addition, 
research is needed to determine (1) the effects of the various combinations 
of anti-HIV medications, drug abuse pharmacotherapies, and drugs of abuse on 
behavioral, cognitive, neurological, and disease processes; (2) how virus 
exposure, anti-HIV medications and drugs of abuse, and/or drug abuse 
pharmacotherapies affect behavioral, cognitive, neural development, and 
immune system following prenatal exposure; and (3) how the virus progresses 
in the central nervous system and how this disease progression affects drug 
seeking, subjective effects of drugs of abuse, or drug withdrawal.  
Approaches using animal models of HIV [e.g., transgenic animal models, SIV, 
FIV, severe combined immunodeficient (SCID) mice, or other animal models 
related to HIV/AIDS] would be most appropriate for studying the consequences 
of HIV/AIDS progression and drugs of abuse on basic behavioral, cognitive, 
and brain function.  For the study of neural and neuroimmune processes, in 
vitro models would also be appropriate.  For some aspects of this research, 
less invasive studies involving human volunteers may also be appropriate.    

Recent advances in effective treatment for the HIV/AIDS virus often involve 
strict and complex anti-HIV medication regimens.  Research is needed to 
determine the fundamental behavioral and cognitive processes that underlie 
and may ultimately optimize adherence to anti-HIV medication regimens.  
Importantly, basic research is needed in order to assist in the development 
of effective behavioral and cognitive strategies and approaches to improve 
adherence to medication regimens in substance abusing or substance-abuse 
treatment populations.   Basic behavioral and cognitive science research does 
not need to directly study adherence to medications, but rather could study 
fundamental behavioral and cognitive processes that may have potential 
application to the design and development of anti-HIV medication adherence 
protocols.  Basic research is also needed to determine how drug abuse and/or 
drug abuse pharmacotherapies, and level of adherence to retroviral 
medications, influence or modulate behavioral, cognitive, neural, and 
neuroimmune processes.  Information gained from basic research will prove 
valuable for developing and refining rehabilitation and treatment 

Illustrative examples of research within the scope of this RFA are outlined 
below.  The following examples serve as a guide and are not meant to subsume 
all research topics that would be appropriate under this RFA.

-  Identify and determine the importance of antecedent variables, such as 
drug use patterns, episodes of craving, attitudes toward injection drug use 
and HIV/AIDS, and psychosocial and emotional factors that lead to increased 
(or reduced) risk taking, impulsivity, and discounting as they relate to 
contracting HIV/AIDS.

-  In the context of drug abuse and addiction, develop basic behavioral and 
cognitive approaches or interventions that may improve compliance and 
adherence to anti-HIV medication regimens.

-  Characterize the cognitive and behavioral deficits associated with the 
combined effects of drug abuse and HIV/AIDS progression, and explore and 
evaluate the effects of cognitive and behavioral rehabilitation procedures on 
reversing these deficits.

-  Using animal models of HIV, study changes in neural, and cognitive 
function, and/or behavior, as a function of infection progression, its 
interaction with drugs of abuse, and environmental factors (e.g., social 
hierarchy, exposure to acute or chronic stress)

-  Assess combined effects of anti-HIV medications and drugs of abuse and/or 
pharmacotherapies (e.g., methadone) on basic cognitive, behavioral, and 
neural function.

-  Use animal models of HIV (e.g., SIV, FIV, transgenic animal models, or 
other animal models as they relate to HIV/AIDS) to determine the effects of 
the infection on drug self- administration and subjective effects of drugs of 

-  Assess the effects of prenatal exposure to anti-AIDS medications and drugs 
of abuse on behavioral and cognitive performance, neural development, and the 
immune system.

-  Study the neuro-toxic interactions associated with drugs of abuse and HIV 
and/or other appropriate lentiviruses.

-  Examine the effects of drugs of abuse and viral action on the regulation 
and expression of chemokines and cytokines, and their relevance to 

-  Study the apoptotic actions of HIV, especially its effects on lymphocytes, 
macrophages, and glia, and determine if drugs of abuse modulate these 

-  Study the role of drugs of abuse on macrophage transport of HIV-type 
lentiviruses to target sites.


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 are 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 were published in the Federal Register on March 28, 1994 (FR 
59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, 
Number 11, March 18, 1994.  Investigators also may obtain copies of the 
policy from the program staff listed under INQUIRIES.  Program staff may also 
provide additional relevant information concerning the policy.


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 


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 under "What's 
New" or may be obtained by calling (301) 443-2755.


Prospective applicants are asked to submit by February 29, 2000, 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 the RFA in response to which the application is being submitted.  A
letter of intent is not required, is not binding, and does not enter into the 
review of a subsequent application.

The letter of intent is to be sent to:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538


Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98).  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, 

When applying under mechanisms other than the R01, the applicants should 
obtain a copy of the relevant announcement from the Grants Management Branch 
at NIDA (301-443-6710), or NIDA's home page (  These 
announcements contain instructions for the preparation of grant applications 
that must be strictly adhered to, as well as other useful information.  


The modular grant concept establishes specific modules in which direct costs 
may be requested, as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award.  It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers, 
and Institute staff.  The research grant application form PHS 398 (rev. 4/98) 
is to be used in applying for these grants, with the modifications noted 


Modular Grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $250,000 per year.  (Applications that 
request more than $250,000 direct costs in any year must follow the 
traditional PHS 398 application instructions.)  The total direct costs must 
be requested in accordance with the program guidelines and the modifications 
made to the standard  PHS 398 application instructions described below:

PHS 398

FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative  (F&A) costs] for the initial 
budget period.  Items 8a and 8b should be completed indicating the Direct and 
Total Costs for the entire proposed period of support.

of the PHS 398.  It is not required and will not be accepted with the 

categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page (see for sample 
pages).  At the top of the page, enter the total Direct Costs requested for 
each year.  This is not a Form page.

Under Personnel, list key project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation 
language salary cap and the NIH policy for graduate student compensation in 
developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (Direct 
plus F&A) for each year, each rounded to the nearest $1,000.  List the 
individuals/organizations with whom consortium or contractual arrangements 
have been made, the percent effort of key personnel, and the role on the 
project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is 
included in the overall requested Modular Direct Cost amount.  Include the 
letter of intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at:

- Complete the educational block at the top of the Form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last 3 years; and
- List selected peer-reviewed publications, with full citations.

CHECKLIST - This page should be completed and submitted with the application.  
If the F&A rate agreement has been established, indicate the type of 
agreement and the date.  All appropriate exclusions must be applied in the 
calculation of the F&A costs for the initial budget period and all future 
budget years.

The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review. 

The RFA label available in the PHS 398 (rev. 4/98) 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.  The RFA number must be typed on the 
label as well.

The sample RFA label is available at: has been modified to 
allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies in one package to:

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
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547 
Rockville, MD  20852 (courier/delivery service)

Applications must be received by March 29, 2000.  If an application is 
received after that date, it 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. This does not preclude the submission of 
substantial revisions of applications already reviewed, but such applications 
must include an introduction addressing the
previous critique.


Applications will be reviewed for completeness by the CSR and for 
responsiveness by NIDA.  Applications judged to be incomplete and/or non-
responsive to the RFA will be returned to the applicant without further 
consideration.  Applications that are complete and responsive 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 a priority score, and receive a 
second level review by the National Advisory Council on Drug Abuse.  Small 
grant applications (R03) do not receive a second-level Council review.

Review Criteria

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 discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered 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 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 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?

(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?  (For the R21 mechanism, a strong rationale and 
conceptual framework are normally sufficient for establishing the feasibility 
of a project, in lieu of extensive preliminary data.)

(3) 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?

(4) 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)?

(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 

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

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research, or justification for exclusion.  Plans for the recruitment and 
retention of subjects will also be evaluated.

o The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o The adequacy of the proposed protection for humans, animals, or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.


Letter of Intent Receipt Date:  February 29, 2000
Application Receipt Date:       March 29, 2000
Peer Review Date:               Summer 2000
Council Review:                 September 2000
Earliest Start Date:            September 30, 2000


Award criteria that will be used to make award decisions include:  scientific 
merit (as determined by peer review), availability of funds, and programmatic 


Inquiries concerning this RFA are encouraged.  The opportunity to clarify 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

David Shurtleff, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 443-1887
FAX:  (301) 594-6043

Applicants who may be interested in applying topics in this RFA to clinical 
issues may contact:

Sander Genser, M.D., M.P.H.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD  20892-9593
Telephone:  (301) 443-1801
FAX:  (301) 443-6566

Direct inquiries regarding fiscal matters to:

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

Direct inquiries regarding review matters to:

Teresa Levitin, Ph.D.
Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538


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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