This Program Announcement expires on December 15, 2003, unless reissued.

DRUG ABUSE ASPECTS OF HIV/AIDS AND OTHER INFECTIONS

Release Date:  November 30, 2000

PA NUMBER:  PA-01-023

National Institute on Drug Abuse
 (http://www.nida.nih.gov)

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) supports research on the natural 
history, epidemiology, etiology, pathogenesis, prevention, and treatment of 
drug abuse and drug abuse aspects of HIV/AIDS and other infectious agents 
[e.g., hepatitis B virus (HBV), hepatitis C  virus (HCV), other sexually 
transmitted diseases (STDs), and tuberculosis (TB)]. AIDS was first 
recognized as a growing epidemic among men who have sex with men (MSM) and 
injection drug users (IDUs) and their sexual partners in the early 1980s.  
While considerable scientific progress has been made since then in 
understanding, preventing, and treating the intertwined epidemics of drug 
abuse and HIV/AIDS, much remains unknown or poorly understood today.  
Emerging drugs of abuse, such as the club drugs ecstasy, GHB, ketamine, and 
methamphetamine, as well as more potent supplies of heroin, cocaine, and 
marijuana, are rapidly changing the profiles of populations at risk.  In the 
United States, over 48,000 women have been diagnosed with AIDS attributed to 
injection drug use, and more than a third of AIDS cases in adult/adolescent 
women diagnosed from July 1998 through June 1999 reported injection drug use 
as their risk exposure.  Racial and ethnic minority populations of both 
genders have been deeply affected by drug abuse, HIV/AIDS, and other 
infectious diseases in recent years, with new HIV infections continuing at an 
alarming rate in the U.S. and in other nations.  This PA seeks to stimulate a 
range of investigator-initiated studies to advance the scientific knowledge 
base on drug abuse aspects of HIV/AIDS and other serious infections.  
Researchers are invited to address diverse and cross-cutting issues in 
multiple disciplines, including virology, etiology, therapeutics and 
vaccines, ethnography and epidemiology, and the behavioral and social 
sciences. 

HEALTHY 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 PA, "Drug Abuse 
Aspects of HIV/AIDS and Other Infections," is related to one or more of the 
priority areas.  Potential applicants may obtain a copy of "Healthy People 
2010" at http://www.health.gov/healthypeople/.

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 use the National Institutes of Health (NIH) research project 
(R01), small grant (R03), and exploratory/developmental (R21) award 
mechanisms.  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 for the R01, two years for the R03, and three years for the R21.

RESEARCH OBJECTIVES

Background and Significance			

In the early 1980s, HIV and AIDS were first identified in the U.S. among MSM, 
IDUs, and the sexual partners of IDUs.  It later became clear that the same 
risk behaviors for HIV (i.e., injecting drug use and unprotected sex) are 
associated with other blood-borne and sexually transmitted infections, such 
as HBV and HCV, and with the spread of TB.  Sharing syringes and other 
equipment for drug injection is a primary route of HIV transmission, yet 
injection drug use contributes to the spread of HIV/AIDS beyond the circle of 
those who inject; e.g., to persons who have sex with an IDU and to children 
born to HIV-infected mothers who acquired the infection from sharing needles 
or having sex with an infected IDU.  IDU-associated AIDS accounts for a 
larger proportion of cases among women than among men.  Since the epidemic 
began, 59% of all AIDS cases among women have been attributed to injection 
drug use or sex with partners who inject drugs, compared with 31% of cases 
among men.  Racial and ethnic minority populations in the U.S. have 
experienced a disproportionate burden of HIV/AIDS cases, most profoundly from 
IDU-associated AIDS.  In 1998, IDUs accounted for 36% of all AIDS cases among 
both African American and Hispanic adults and adolescents, compared with 22% 
of all cases among White adults/adolescents.

Since the start of the epidemic, injection drug use has directly or 
indirectly accounted for more than 36% of the AIDS cases in the U.S., and the 
trend continues today.  The Centers for Disease Control and Prevention (CDC) 
reports that 15,024 (31%) of the 48,269 new cases of AIDS in the U.S. in 1998 
were associated with injection drug use.  IDUs also have one of the highest 
HBV seroincidence rates compared to other risk groups, and at least 60% of 
incident HCV cases are among IDUs.  Acquisition of HBV and HCV can occur 
rapidly following initiation of injection, with reported prevalence rates of 
50% for HBV and 65% for HCV among persons injecting for less than one year.  
Co-infections of HBV, HCV, and HIV often cluster in IDUs and are endemic 
among experienced IDUs.  IDUs are at very high risk for pneumonia, septic 
pulmonary emboli, and TB.  In 1998, for example, CDC estimated that 50% of 
HIV-infected persons with TB had injection drug use as an HIV exposure.  
Other infectious diseases pose major risks to IDUs, including Human T-
Lymphotropic Viruses (HTLV) and hepatitis D virus (HDV).  Combined HBV and 
HDV infection is associated with hepatitis outbreaks and high mortality among 
IDUs.  IDUs are at risk for other serious health complications, such as 
rhabdomyolysis and delirium, as well as a variety of bacteremic infections, 
including endocarditis, skin/soft tissue infection, mycotic aneurysm, septic 
arthritis, septic thrombophlebitis, respiratory infections, and 
osteomyelitis.  Risks for these infections are particularly high among IDUs 
exposed to infected blood from multiperson use of syringes and other 
injecting equipment.

Noninjecting drug use, particularly the use of crack cocaine, is another 
major transmission risk for HIV and other infectious diseases.  Research has 
shown that crack smokers may be three or more times more likely to be 
infected with HIV than non-smokers.  The context of risk, including crack use 
and drug-for-sex exchanges or risky, unprotected sex with multiple partners, 
is significantly associated with the rapid spread of HIV through drug and sex 
networks.  Age-discrepant relations also have implications for HIV 
transmission; young women and adolescents who use crack and other drugs are 
at high risk for HIV infection at an early age, especially when they use 
drugs and have sex with older, HIV-infected partners.  

Largely because of substantial gains in early diagnosis and therapeutic care, 
there are now more people living with HIV in the U.S. than ever before.  
Moreover, today’s HIV prevention programs have benefited considerably from 
the empirical knowledge accrued over more than 15 years of NIDA-supported 
research on preventing the spread of HIV and other infections among drug 
users.  While the number of new HIV infections in the U.S. has declined 
significantly from the 150,000 a year in the late 1980s, there are still an 
estimated 40,000 new infections every year.  In addition, the CDC estimates 
that, of the 900,000 people currently living with HIV in the U.S., up to a 
third are unaware that they have the infection.  Today, the profile of the 
individual at risk in the U.S. is largely urban and involves multiple and 
simultaneous risk-taking behaviors, including injecting and noninjecting drug 
use (particularly use of crack cocaine), unprotected sex with multiple 
partners, and exchange of sex for drugs or money.

The intertwined epidemics of drug abuse, HIV/AIDS, and other infectious 
diseases have evolved over time.  HBV and HCV have become more prevalent in 
injecting and noninjecting drug-using populations, as have drug-resistant 
strains of gonorrhea and TB.  HCV is now considered an opportunistic 
infection in HIV-positive persons, according to the U.S. Public Health 
Service (1999).  An estimated 80% of HIV-infected persons in the U.S. today 
are co-infected with HCV. Although no vaccine is available for HIV or HCV, 
epidemiological data on the HBV vaccine indicate that successful immunization 
of injecting and noninjecting drug users is possible. Multidisciplinary, 
biomedical, and behavioral research is critically needed today to address the 
public health challenges of these intertwined, drug use-associated epidemics 
in all ethnic and racial groups, adolescents and young adults, and persons of 
all sexual orientations.

Areas of Interest

NIDA seeks multi-disciplinary, cross-cultural research studies on drug abuse 
aspects of HIV/AIDS, other blood-borne and sexually transmitted infections, 
and TB.  Included are studies that inform our understanding of the causes and 
consequences of differentials in HIV-associated risks, morbidity, and 
mortality in men and women, adolescents and adults, and in majority and 
minority populations.  Researchers are encouraged to utilize and integrate 
complementary methodological approaches in their study designs, including 
epidemiology, ethnography, behavioral and prevention science, virology, and 
clinical medicine.  

This PA envisions a range of national and international research projects 
within and across the priority areas for NIH research on HIV/AIDS 
(http://www.nih.gov/od/oar/index.htm), including but not limited to the types 
of studies and issues described below.

Natural History and Epidemiology

o  Studies of the epidemiology and natural history of HIV and blood-borne 
infections, STDs, and TB in injecting and noninjecting drug users and their 
sexual partners, including studies of women, racial and ethnic minorities, 
specific subpopulations (e.g., adolescents and young adults, runaways, street 
youth, men who have sex with men and use drugs), and the risk, peer, and 
social networks of drug users and their sexual partners.  Studies are 
encouraged to understand potential cofactors and mediators of these diseases, 
their progression, and their outcomes in active drug users.

o  Studies of new and  improved approaches to access and recruit hard-to-
reach, active drug users to participate in biomedical and behavioral 
interventions to reduce drug use-related risk behaviors, disease 
transmission, comorbidity, and mortality.  Researchers are encouraged to 
develop new strategies to link community-based outreach to drug users with 
referrals and access to services for HIV counseling and testing, diagnostic 
screening for other diseases, drug treatment, and medical care.

o  Research involving the development and evaluation of (a) new study 
protocols, sampling and survey methods, and biostatistical techniques; and 
(b) rapid diagnostic assays to measure and monitor drug abuse and sex-related 
risk behaviors; seroincidence and seroprevalence rates for HIV, HBV, HCV, 
other blood-borne and sexually transmitted infections, and TB; and disease 
progression and outcomes.

Etiology and Pathogenesis

o  Studies of viral and host mechanisms involved in the transmission, 
establishment, and spread of HIV in IDUs, noninjecting drug users, and their 
sexual partners, including research on the mechanisms by which viral 
hepatitis, STDs, and other infections may influence HIV transmission in drug 
users.  Research is encouraged to identify the etiologic and interactive 
biologic, behavioral, environmental, sociocultural, and gender-related 
factors that determine the relative transmission efficiency of HIV and other 
diseases in diverse populations of drug users and others at risk.

o  Studies that define the role of drugs of abuse and related compounds 
(including adulterants and contaminants of drugs of abuse) or drug abuse 
treatment medications on susceptibility, onset, and progression of HIV 
disease, latent HIV infection, pharmacotherapy-resistant HIV strains, AIDS-
associated opportunistic infections, TB, and other blood-borne and sexually 
transmitted diseases in drug-abusing populations.

o  Research on drug abuse-related risk factors associated with nutritional, 
metabolic, endocrine, and gastrointestinal disorders and their underlying 
pathophysiology in persons infected/co-infected with HIV, HIV/AIDS-associated 
opportunistic infections, TB, viral hepatitis, and other blood-borne and 
sexually transmitted infections.

o  Basic and clinical research on the neuropathogenesis of HIV and the 
relationship of nervous system infection to disease progression in drug 
users, including studies of the relationship(s) of virologic, host, 
pharmacologic, and environmental factors to HIV-associated central nervous 
system dysfunction and AIDS dementia complex. 

Therapeutics

o  Clinical trials research which reflects the changing demographics of drug 
abuse, HIV/AIDS, TB, viral hepatitis, and other blood-borne and sexually 
transmitted infections, including studies that recruit and retain multi-
ethnic/racial populations of injecting and noninjecting drug users, their 
sexual partners, and their children in the evaluation of potential therapies 
for the treatment of drug abuse, HIV infection, serious HIV-associated 
complications, and other diseases.

o  Basic and applied research to advance therapeutic entities and strategies 
to prevent and treat HIV, HIV/AIDS-related complications, and potential co-
infections in drug users and their sexual partners.  Of interest are studies 
of drug interactions among commonly used treatments for HIV and HIV-related 
disease and other substances that may be used by HIV-infected drug users 
(such as drug addiction treatment medications and over-the-counter drugs).  
Investigators are encouraged to evaluate the acceptability and use of new 
compounds (e.g., topical microbicides and other agents) to reduce and prevent 
sexual transmission of HIV and other infectious diseases in high-risk, 
sexually active, drug-using populations.

o  Studies that select and investigate biologic markers, surrogates, and/or 
other outcomes to evaluate the safety and clinical efficacy of new agents and 
approaches in the treatment of HIV-associated opportunistic infections and 
neurologic complications of HIV disease in injecting and noninjecting drug 
users. In particular, clinical research is needed to develop and evaluate 
interventions that facilitate better adherence to therapies among drug users 
infected with HIV and other diseases in drug abuse treatment.

o  Studies of adherence to multidrug regimens in HIV-infected injecting and 
noninjecting drug users, including the development of improved methods to 
assess adherence to therapeutic regimens in this diverse and changing 
population.  Better methods are also needed to compare and validate adherence 
measures in the context of linked HIV care/drug abuse treatment services for 
HIV-infected drug users, and to evaluate the impact of improved adherence on 
the clinical effectiveness of HIV care/drug abuse treatment (and, 
potentially, of therapeutic regimens for other infectious diseases, such as 
HBV and HCV).

Vaccines

o  Basic research to advance the design and development of candidate vaccines 
and other biomedical interventions to prevent the spread of HIV in at-risk, 
drug-using populations, including studies that, for example, monitor and 
model effects on immune activation from drug abuse and STDs in HIV-infected 
and seronegative injecting and noninjecting drug users and their sexual 
partners.

o  Basic virologic and immunologic research to model, develop, and evaluate 
safe and effective HIV vaccine strategies and passive immune interventions to 
interrupt HIV transmission from mother to infant, with special focus on high 
risk, sexually active and/or pregnant women who use drugs or are the sexual 
partners of IDUs.

o  Epidemiologic and behavioral research to monitor changes in the risk 
behaviors and HIV seroincidence rates of persons participating in vaccine 
clinical trials and to improve methods for identifying and evaluating 
emerging risk groups likely to participate in HIV vaccine efficacy trials. 
Behavioral and biomedical intervention studies are needed to improve the 
recruitment, adherence, and retention of high-risk populations in HIV vaccine 
efficacy trials and to minimize potential adverse social, economic, 
behavioral, and legal consequences of participation.

o  Multidisciplinary research to improve the design and efficiency of HIV 
vaccine efficacy studies involving high-risk drug-using populations, 
including research to establish and  strengthen linkages between HIV vaccine 
preparedness and other prevention and treatment research activities (e.g., 
research on HIV outreach interventions that integrate counseling and testing 
for HIV with screening and medical services for viral hepatitis and other 
STDs, and with referrals and access to drug abuse treatment). 

Behavioral and Social Sciences Research

o  Research to design and test single components (and/or their combinations) 
of prevention interventions for HIV and other diseases in sexually active, 
drug-using populations, including evaluation studies to determine the 
effectiveness, cost-effectiveness, and sustainability of interventions in 
demographically and culturally diverse community contexts.  This may include 
developing interventions that have linkages to a variety of ancillary 
services (e.g., rapid diagnostic assays, HIV counseling and testing, and 
medical and drug treatment) or that are adapted to special populations, such 
as drug injecting women, the sex partners of drug injectors, or men who use 
drugs and have sex with men.

o  Interdisciplinary research on the behavioral, cultural, and social 
determinants of injection drug use and risky sex as they relate to the 
transmission of HIV and other infections.  Studies are needed to understand 
the diverse and dynamic contexts of risk associated with the transmission of 
blood-borne infections and STDs, including HIV.  Such studies may address, 
for example, relationships between peer influences, beliefs about gender 
roles, the composition of social networks, and transitions from noninjecting 
to injecting drug use or from unsafe drug use and unsafe sex.

o  Intervention studies to improve outreach, recruitment, adherence, and 
retention of HIV-infected drug users, especially hard-to-reach IDUs, in 
clinical trials on HIV/AIDS and drug abuse prevention and treatment.  
Research is encouraged on improving strategies to prevent and minimize 
adverse social, psychological, and physical consequences of HIV/AIDS and drug 
abuse addiction, including the stigmatization so often associated with these 
diseases.

o  Research that advances qualitative and quantitative methodologies in 
behavioral and social science investigations of drug abuse, HIV/AIDS, and 
other infectious diseases.  This may include studies to: improve measurement 
instruments for special populations (e.g., HIV-infected drug injecting women, 
prisoners); refine techniques for measuring the social mixing patterns of 
high-risk networks; develop outcome measures and indicators for evaluating 
the social impact of HIV prevention interventions; and formulate new 
strategies that facilitate multisite, intercultural, and international 
research projects.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS - 
UPDATED AUGUST 2, 2000

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 1993 
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines is available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

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.  
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 Contract, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning these policies.

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 the 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 IDUs, crack cocaine users, and sexually active drug users and their 
sexual partners.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated 
in the application kit.  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, email: GrantsInfo@nih.gov.

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact the 
Institute or Center (IC) program staff before submitting the application; 
i.e., as plans for the study are being developed.  Furthermore, the 
application must obtain agreement from the IC staff that the IC will accept 
the application for consideration for award.  Finally, the applicant must 
identify, in a cover letter sent with the application, the staff member and 
IC that agreed to accept assignment of the application.  This policy requires 
an applicant to obtain agreement for acceptance from both for any such 
application and any such subsequent amendment.  Refer to the NIH Guide for 
Grants and Contracts, March 20, 1998 at  
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

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 NIH 
staff.  The research grant application form PHS 398 (revised 4/98) is to be 
used in applying for these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

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

o 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.

o 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.

o 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.

o 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 all 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 facilities and administrative) 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 all personnel, 
and their 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.

o 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.

o 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 title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  An appropriate scientific review group, 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 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 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?

(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 
support?

In addition to the above criteria, in accordance with NIH policy, all 
applications also will 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.  Plans for the recruitment and retention of subjects also will 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.

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 priorities.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Elizabeth Lambert, M.Sc. or
Helen Cesari, M.Sc.
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) 402-1933 or 402-1918
FAX:  301-443-4100
Email:  HC30X@nih.gov or  EL46i@nih.gov

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX :  (301) 594-6847
E-mail: 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 sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered 
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92.  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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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