SUPPLEMENTS FOR THE STUDY OF DRUG ABUSE AND HIV/AIDS

Release Date:  February 10, 2000

PA Number:  PAS-00-058

National Institute on Drug Abuse

THIS PROGRAM ANNOUNCEMENT (PA) USES THE “MODULAR GRANT” AND “JUST-IN-TIME” 
CONCEPTS.  IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION 
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO 
THIS PA.

PURPOSE

The National Institute on Drug Abuse (NIDA) announces the availability of 
funds to supplement existing federal research project grants for the study of 
issues related to drug abuse and HIV/AIDS.  Funding will be available through 
competing supplements.

HEALTH PEOPLE 2010

The Public Health Services (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 Program Announcement 
(PA), Supplements for the Study of Drug Abuse And HIV/AIDS,” is related to 
one or more of the priority areas.  Potential applicants may obtain a copy of 
“Healthy People 2010,” at http://odphp.osophs.dhhs.gov/pubs/hp2000.

ELIGIBILITY REQUIREMENTS

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.

MECHANISM OF SUPPORT

This PA will supplement the National Institutes of Health (NIH) research 
project grant (R01) award mechanism only.  Responsibility for the planning, 
direction, and execution of the proposed project will be solely that of the 
applicant.  The total project period for an application submitted in response 
to this PA may not exceed five years or the life of the parent grant (i.e., 
the grant being supplemented), whichever is less.

FUNDS AVAILABLE

NIDA will set aside $500,000 total cost for this program for FY 2000.

RESEARCH OBJECTIVES

Background

The HIV/AIDS epidemic has demonstrated an increasing association with drug 
abuse, through transmission of HIV by contaminated drug injection equipment, 
high-risk sexual behavior with an infected drug user, and perinatal exposure 
of newborns from infected drug-abusing mothers. 

With this Supplement Announcement, NIDA plans to continue to develop a strong 
multidisciplinary research program in response to the complex challenges of 
drug abuse and HIV/AIDS. The Supplement Program is designed to encourage and 
enhance interactive, multidisciplinary collaborative projects involving 
researchers with primary foci both within and outside the area of drug abuse. 

Areas of Interest

In an effort to improve and expand its research on drug abuse-related aspects 
of HIV/AIDS, NIDA will consider requests from current NIDA grantees and those 
with grants from other NIH components to expand and/or enhance ongoing 
research that includes drug use-related HIV/AIDS issues. The primary intent 
of this Program is to encourage grantees who have not focused on drug use-
related HIV/AIDS issues to do so, thus recognizing that drug abuse/dependence 
and HIV/AIDS are two diseases that often co-occur and interact and that they 
must be prevented and treated together and in parallel. Projects that 
currently focus solely on either AIDS-related or drug abuse issues are 
encouraged to strengthen efforts in the complementary area. Thus, grantees 
are encouraged to examine for HIV/AIDS relevance ongoing drug abuse research 
projects that may not have been designed to examine AIDS-related issues. 
Similarly, those doing AIDS research, but who have not investigated how drugs 
of abuse may act within their area of investigation, are encouraged to think 
about these issues and consider submitting an application. 
Current areas of NIDA supported drug use research that are considered 
HIV/AIDS related include those listed below, as well as crosscutting areas of 
relevance; i.e., racial/ethnic factors, underrepresented or minority status, 
socioeconomic and cultural factors, gender differences, and issues that are 
unique to women and to men.  For example, gender-related research has shown 
that women's HIV viral loads are not the same as men's, raising the issue of 
whether women may need earlier interventions with anti-viral therapies. 
Another example may be a field such as genetics in which the rapid 
development of knowledge, as well as technology (e.g., gene chip arrays, 
quantitative trait locus analysis), may be broadly applicable to a number of 
research areas. As relevant data emerge from laboratory, community-based, and 
clinical HIV/AIDS research, investigators are urged to include these and 
other crosscutting perspectives in their research designs and analyses, where 
appropriate. 

Natural History and Epidemiology

o  International and/or national studies of the epidemiology and natural 
history of infectious diseases commonly transmitted by drug injection and/or 
sexual behavior and/or other behaviors associated with drug use (e.g., 
hepatitis A, B and C; Sexual Transmitted Diseases (STDs); Tuberculosis; and 
HIV).

o  Studies of interactions among chronic drug use and the treatment of HIV 
and comorbid mental disorders and other infectious diseases, including 
studies of health seeking behaviors.
 
o  Studies of the incidence and prevalence of HIV infection and AIDS, 
including monitoring the trends in HIV infection and AIDS-related diseases 
among specific subpopulations such as adolescents, women, minorities, and 
sexual partners and newborns/children of drug abusers.
 
o  Research on the natural history of HIV/AIDS, including the natural history 
of the dynamics of HIV and other blood-borne infectious disease transmission 
in sexual and drug-using risk networks.

o  Research on the transmission, incidence, prevalence, and natural history 
of pharmacotherapy-resistant HIV/AIDS in drug-using populations.
 
o  Research on the nature and extent of HIV risk behaviors and factors that 
affect the propagation of HIV and other diseases in at-risk populations.

o  Research to develop improved study protocols, research designs, interview 
and measurement instruments, and biostatistical techniques to detect, 
measure, and characterize HIV risk behaviors (drug use and unsafe sexual 
practices) in adolescent and adult populations.

o  Studies of the nature, extent, and progression of drug use and abuse, 
which include assessment of knowledge and attitudes regarding HIV/AIDS and/or 
the incidence, prevalence, and nature of drug-related HIV risk behaviors.

Etiology and Pathogenesis

o  Studies to define interactions between drugs of abuse and the operation of 
secondary messenger pathways effecting lymphocyte or monocyte function.

o  Studies to define the role of drugs of abuse and related compounds or drug 
abuse treatment medications on susceptibility, onset, and progression of HIV 
disease, including studies to identify latent HIV infection and 
pharmacotherapy-resistant HIV strains in drug abusing populations.

o  Research on the pharmacokinetics and pharmacodynamics of drugs of abuse as 
factors with an impact on susceptibility, onset, progression, and treatment 
of HIV disease.

o  Studies to further develop and utilize experimental models to study the 
effects of drugs of abuse on the pathogenesis of central nervous system 
lentivirus infections.

o  Studies to investigate the role of drugs of abuse and related endogenous 
substances and other biological and environmental factors in modulating HIV-
induced neuroAIDS.

o  Studies to identify and elucidate the role of drug abuse on immune 
susceptibility and the development and progression of AIDS-related 
opportunistic infections; e.g., “smoking” drugs of abuse and bacterial 
pneumonias.

o  Studies of nutritional, metabolic, endocrine, and gastrointestinal 
disorders and their underlying pathophysiology in HIV-infected drug abusers.

o  Research on adulterants/contaminants of drugs of abuse and their roles in 
the etiology, pathogenesis, and natural history of HIV/AIDS and associated 
illness in drug abusers.

o  Studies of the role of patterns of drug abuse in HIV/AIDS progression 
among women; e.g., in perinatal transmission of HIV and the effects on the 
fetal and neonate nervous system, immune system, and placenta.

o  Studies of the effects of drugs of abuse and drug treatment medications on 
immune function that may increase our knowledge of the immune dysfunction 
characteristic of HIV infection.

o  Studies of how drugs of abuse may modulate the immune system through the 
hypothalamic-pituitary axis and other parts of the central nervous system.

o  Basic and clinical research on neurobiologic, neurologic, 
neuropsychological, and psychiatric consequences of drug abuse that have 
relevance for understanding the natural history of HIV/AIDS-related dementia 
in drug users.

o  Studies of dual function receptor systems; e.g., opioid, with activation 
receptors of immune cells and subsequent induction of immune cell responses, 
including cytokine responses and other host factors.

Therapeutics

o  Research to improve access to health services provided to and long-term 
therapeutic strategies designed for HIV-infected drug users, their sexual 
partners, and their children, including studies of:

a.  Strategies to improve adherence with HIV medication regimens (e.g., 
simultaneous or co-located drug abuse and HIV treatment);

b.  Recruitment and retention of HIV-infected drug users into drug abuse and 
HIV/AIDS treatment;

c.  Delivery of linked medical and drug abuse prevention and treatment 
services through drug abuse treatment programs and/or other preventive and 
health services delivery programs (e.g., mobile van services); and 

d.  Strategies to improve the methods in and adherence to disease prevention, 
detection, and treatment programs (e.g., tuberculosis, hepatitis B and C, 
STDs, and other infectious diseases). 

o  Evaluation of the safety, efficacy, and acceptability of new agents and 
approaches, including alternative and complementary therapies (e.g., 
chemopreventive treatment with micro- and macronutrients such as vitamins and 
trace elements), in the treatment of wasting syndrome, growth failure, and 
other complications of HIV infection in drug users.

o  Research that investigates interactions between approved and 
investigational medications for drug addiction and HIV pharmacotherapies. 

o  Research on the development, dynamics, prevention, and treatment of 
pharmacotherapy-resistant HIV strains in drug abusing populations.

o  Research to test the feasibility of enhancing recruitment of HIV-infected 
drug users, their sexual partners, and infants into HIV/AIDS-therapeutics 
clinical trials, including very hard-to-reach risk groups and 
underrepresented racial and ethnic minority subpopulations.

Vaccines

o  Research on improving behavioral and/or biomedical methods to deliver HIV 
and other infectious disease vaccines to adolescent and adult drug using 
populations.

o  Research to recruit injection and non-injection drug users at high risk of 
HIV infection into clinical trials of vaccines, including developing specific 
strategies to study children, adolescents, and adults.

o  Investigation of how drugs of abuse may affect or modulate cofactors for 
HIV transmission.  Those cofactors include, for example, vaginal/cervical 
epithelium changes during puberty; hormonal changes during pregnancy; and use 
of contraceptives, hormonal replacement therapy, or steroids.

o  Studies of the genital tract immune system and inflammatory activity that 
might compromise integrity of the genital tract or inductive ability of 
vaccines. Studies of drugs of abuse and genital mucosal inflammation induced 
by drug use behaviors, which facilitate HIV transmission in injection and 
non-injection drug users.

o  In collaboration with institutions and communities being targeted, explore 
behavioral and social issues and prevention activities that might have a 
substantial impact on the design or conduct of a trial, including:

a. Evaluation of other biomedical and behavioral interventions that could 
prove of benefit in decreasing the incidence of HIV infection in the 
populations identified for future vaccine efficacy trials and assessment of  
their potential impact on the evaluation of vaccine efficacy;

b. Conduct of behavioral research in populations at high risk for HIV 
infection to determine, for example, appropriate risk-reduction interventions 
and to estimate risk behavior and recruitment, adherence, and retention 
strategies pertinent to the design and execution of a successful efficacy 
trial, especially for populations that have been historically 
underrepresented in clinical trials;

c. Determination of possible adverse social, economic, behavioral, or legal 
consequences of participation in clinical trials and development of  broadly 
applicable strategies for mitigating potential harm; 

d. Determination of optimal methods of achieving informed consent for vaccine 
efficacy trials; and

e. Evaluation of ethical issues and challenges, and the behaviors and conduct 
of health care workers, peer counselors, outreach workers, and prevention 
scientists in performing drug use and HIV-related studies.

Behavioral and Social Sciences Research

o  Research to develop, evaluate, and disseminate prevention strategies to 
reduce the incidence of drug-use related HIV infection, including high risk 
drug use-associated sexual behaviors (e.g., among adolescents, in perinatal 
transmission in drug-abusing mothers, and in commercial sex work).  Such 
research may include, but is not limited to:

a. Community-based behavioral and social intervention studies to stop or 
reduce the reuse and sharing of needles and unsafe sexual behaviors among 
injection drug users, crack cocaine users, and methamphetamine users and 
their sexual partners;

b. Behavioral studies on multicomponent prevention and intervention 
strategies, such as improving compliance with barrier methods, vaccine 
regimens, and HIV therapeutics;

c. Studies to develop and enhance prevention of HIV among high risk 
adolescents and youth, including ethnographic and epidemiologic studies of 
runaways and street children at risk for initiating drug use and injecting 
drug use and/or for exchanging sex for money, drugs, or subsistence; and

d. Development of new or improved HIV-risk and drug-use risk screening 
questionnaires that are developmentally appropriate for use with specific 
target populations in diverse settings (e.g., among street youth and 
adolescents, in communities of older adults, and among ethnic and cultural 
subgroups) and that serve as valid and reliable predictors of immediate and 
future exposure to HIV and other infectious diseases where preventive 
interventions do not occur.

o  Studies of the determinants and correlates of HIV risk behaviors and risk 
behavior change among adolescents who have initiated or recently transitioned 
to injecting drug use and who engage in unsafe sex in association with their 
drug use.

o  Studies of simultaneous and serial treatment interventions for drug 
dependence and comorbid conditions that meet the following criteria: 
 
a. Determines the efficacy or effectiveness of psychosocial and/or 
pharmacological treatment interventions for drug dependence and have a high 
probability of leading to reductions in transmission of infectious diseases 
associated with drug use; e.g., HIV, viral hepatitis, and other medical 
consequences of drug use and addiction (e.g., pneumonitis, osteomyelitis, 
cutaneous abscesses and cellulitis, hypertension, bacterial endocarditis, and 
diabetes mellitus);  

b. Reduces the risks of acquiring or transmitting HIV and other blood-borne 
infections among drug users who are in or out of drug treatment and at risk 
for HIV or HIV seropositive; 

c. Includes the assessment of drug use injection and non-injection practices 
and/or sexual AIDS risk; 

d. Evaluates HIV risk reduction counseling being provided either (1) during 
the course of the study or (2) as part of the intervention under study.
 
o  Studies of the impact of HIV/AIDS on the drug abuse treatment delivery 
system and on the HIV/AIDS services provided within drug treatment programs, 
including those provided under managed care.
 
o  Studies of the cost, cost-benefit, and cost-effectiveness of interventions 
to reduce HIV risk behaviors and prevent the transmission of HIV and other 
blood-borne infections.

o  Studies of the organization and management of services for HIV-positive 
drug abusers, including studies of the barriers to service access and 
utilization and strategies for overcoming them.

o  Studies of the organization and management of drug use and medical 
services provided by mobile care systems (e.g., vans) as a method for 
improving the effectiveness of community-based outreach, prevention, and 
health care access.

o  Research to enhance the effectiveness of other community-based HIV 
prevention interventions, such as studies to enhance entry and retention of 
new initiates to injecting drug use, persons at risk of transitioning to 
injecting drug use, and high-risk non-injecting drug users into drug abuse 
treatment and prevention programs. 

o  Research to inform and improve our understanding of behavior change, the 
maintenance of behavior change, and risk avoidance and relapse prevention 
relative to the prevention of drug use-related HIV transmission. 

Information Dissemination

o  Research on mass media and other education strategies focused on AIDS and 
drug abuse in children (ages 8-12), adolescents, adults, racial/ethnic 
groups, and gender specific groups.

o  Studies of HIV and drug use prevention strategies for community-based 
organizations, health care service providers, practitioners, and other 
clinical and public health professionals involved in HIV prevention, risk 
reduction, and/or drug abuse and HIV/AIDS treatment that targets high risk 
and hard-to-reach community populations.

Research Ethics

o  Studies of the ethical, legal, and social interactions and resulting 
issues related to research on HIV/AIDS and drug abuse in diverse settings 
(i.e., the community, the street setting, or in the clinic).  Investigators 
are referred for general topic areas and more background information to the 
program announcement:  Research on Ethical Issues in Human Studies (PA-99-
079).

International Research Collaboration 

o  Research support for collaborative national and international research 
with a focus on drug abuse-related links to HIV/AIDS. International 
collaborative research may involve, for example, any of the above areas (e.g, 
etiology and pathogenesis, natural history/epidemiology, vaccines, social and 
behavioral sciences, information dissemination, research ethics).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided 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 1983 
(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,” that were published in the Federal Register on March 28, 1994 (FR 
59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 
11, March 18, 1994 available on the web at the following URL address:  
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age 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.  
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 Contract, March 6, 1998, and is available at the following 
website:  http://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 the NIDA Home Page at http://www.nida.nih.gov/, or may be 
obtained by calling 301-443-2755.

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG 
ABUSE

Researchers funded by NIDA who are conducting research in community outreach 
settings, clinics, hospital settings, or clinical laboratories and have 
ongoing contact with clients at risk for HIV infection, are strongly 
encouraged to provide HIV risk reduction education and counseling. HIV 
counseling should include offering HIV testing available on-site or by 
referral to other HIV testing services.  Persons at risk for HIV infection 
include injection drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.

SPECIAL REQUIREMENTS

Budget/Administrative Issues
 
NIDA will set aside $500,000 total costs into this program for FY 2000.  
Applicants should request only what is necessary to do the proposed work and 
should request no more than $100,000 in direct costs.
 
Competing supplements are provided for expansion of a project's scope or the 
research protocol.  Supplements are treated as new applications for purposes 
of the review requirements and competition for funds and are reviewed in 
accordance with NIH standard procedures; i.e., peer review/council review.  
Competing supplement requests should be submitted to the Center for 
Scientific Review on the standard AIDS receipt date of  May 1, 2000. 
Applications submitted for the other NIH AIDS application receipt dates will 
not be considered for these funds and will compete for funds with other 
unsolicited applications.
 
Supplements may not exceed the stated life of the parent project.  Parent 
grants that would require or be in the status of no-additional-cost extension 
during the supplement period will not be eligible for supplementation.  
Supplements may not represent changes in the basic goals or intent of the 
project.  AIDS-related competing supplement requests to either non-AIDS or 
AIDS-related grants will receive expedited review, according to Section 301 
of the Public Health Service Act (42 USC241).

APPLICATION PROCEDURES

Supplement applications are to be submitted in 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)435-0714, 
E-mail: GrantsInfo@nih.gov. The kit contains detailed instructions on page 
limits, appendix material, and other matters related to preparation and 
submission of the application.

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

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 
below.

BUDGET INSTRUCTIONS

Applications will use the modular grant format, requesting direct costs in 
$25,000 modules, up to a total direct cost request of $100,000 per year.  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 $100,000) 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.

DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 
of the PHS 398.  It is not required and will not be accepted with the 
application.

BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete 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 http://grants.nih.gov/grants/funding/modular/modular.htm 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 role in 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 in 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:  http://grants.nih.gov/grants/funding/modular/modular.htm

- 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 three 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. 

Submit a signed typewritten original of the application, including the 
Checklist, and five signed photocopies 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)

As noted, to be eligible for consideration for these FY 2000 supplement 
funds, competing supplement applications must be received by May 1, 2000.

REVIEW CONSIDERATIONS

Applications that are complete will be evaluated for scientific and technical 
merit by an appropriate peer review group convened in accordance with the 
standard 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 
appropriate national advisory council or board.

Review Criteria

The goals of NIH-supported research are to advance the 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.

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 the study on the concept 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 concept, approaches, or method?  
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?

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

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

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

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

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  The following will be considered in making funding decisions: 
quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Sander G. Genser, M.D., M.P.H.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Rm. 5198, MSC 9593
Bethesda, MD  20892-9593
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-1801
FAX:  (301) 594-6566
Email:  sg73f@nih.gov

Direct fiscal inquiries to:

Gary Fleming, J.D.
Chief, Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Rm. 3131, MSC 9541
Bethesda, MD  20892-9541
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-6710
FAX: (301) 594-6849
Email:  gf6s@nih.gov

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, as amended by Sections 301 and 405 (42 USC 241 and 284) and are 
administered under NIH 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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