DRUG ABUSE ASPECTS OF HIV/AIDS AND OTHER INFECTIONS

RELEASE DATE:  October 10, 2003

PA NUMBER:  PA-04-007

January 17, 2007 - The R01 portion of this funding opportunity has been 
replaced by PA-07-307, which now uses the electronic SF424 (R&R) 
application for February 5, 2007 submission dates and beyond.

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. 
Replacement R03 (PA-06-310) and R21 (PA-06-309) funding opportunity announcements 
have been issued for the submission date of June 1, 2006 and submission dates 
for AIDS and non-AIDS applications thereafter.

EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: October 10, 2006

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:  
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATIONS: 
National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.279

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA  

The National Institute on Drug Abuse (NIDA) supports research on the natural 
history, epidemiology, etiology, virology and 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 infections (STIs), 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 (MDMA), GHB, ketamine, and 
methamphetamine, as well as more potent supplies of heroin, cocaine, and 
marijuana, are continually changing the profiles of populations at risk. 
Moreover, these drugs often contain adulterants, and are used in risky social 
contexts in combination with alcohol and other drugs, including Viagra, 
poppers, and tobacco. 

In the United States today, over 77,000 women have been diagnosed with AIDS 
attributed to injection drug use or sex with an IDU, and nearly a third of 
AIDS cases in adult/adolescent women diagnosed in 2001 reported injection drug 
use or sex with an IDU as their primary risks. 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. There are an 
estimated 800,000 to 900,000 people living with HIV in the U.S., with 
approximately 40,000 new HIV infections occurring every year. By race, more 
than half of new HIV infections in 2001 and deaths attributable to AIDS in 
2000 occurred among African Americans, although they represent only 13% of the 
U.S. population.

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, among others: 
virology, bacteriology, molecular epidemiology, etiology, therapeutics and 
vaccines, ethnography and behavioral epidemiology, mathematical modeling and 
simulations, and the behavioral and social sciences. 

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, 55% of all AIDS 
cases among women have been attributed to injection drug use or sex with 
partners who inject drugs, compared with 19% 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 2000, 
IDU-associated AIDS accounted for 26% of all AIDS cases among African American 
and 31% among Hispanic adults and adolescents, compared with 19% of all cases 
among White adults/adolescents.

Since the start of the epidemic, injection drug use has directly or indirectly 
accounted for more than a third (36%) of the AIDS cases in the U.S., and the 
trend continues today. The Centers for Disease Control and Prevention (CDC) 
reports that 11,635 (28%) of the 42,156 new cases of AIDS in the U.S. in 2000 
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 as 
well.  As with HIV, TB disproportionately affects minorities; 54% of active TB 
cases in 1999 were among African-Americans and Hispanics. Conditions that 
increase vulnerability to TB include injection drug use and poverty, as well 
HIV/AIDS. TB transmission is rampant in crowded shelters and prisons where 
people weakened by poor nutrition, drug addiction, and alcoholism are exposed 
to M. tuberculosis. 

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 bacterial 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 multi-person use of syringes and other injecting 
equipment.

Noninjecting drug use, particularly the use of crack cocaine, methamphetamine, 
and club drugs such as ecstasy or MDMA, GHB, and ketamine, is another major 
transmission risk for HIV and other infectious diseases.  For example, 
research has shown that crack smokers may be three or more times more likely 
to be infected with HIV than nonsmokers.  The context of risk, including crack 
and other drug use and drug-for-sex exchanges or risky, unprotected sex with 
multiple partners, is significantly associated with the rapid spread of HIV 
and other STIs 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 nearly two decades 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 no injecting drug use (particularly use of 
crack cocaine and other drugs), 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 non-injecting 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 
non-injecting drug users is possible.  Multidisciplinary, biomedical, and 
behavioral research is critically needed today to keep abreast of these 
continually changing and intertwined epidemics, as they affect all ethnic and 
racial groups, adolescents and young adults, and persons of all sexual 
orientations.

Areas of Interest

NIDA seeks multidisciplinary, cross-cultural, domestic and international 
research on drug abuse aspects of HIV/AIDS, other blood-borne and sexually 
transmitted infections, and TB.  Research of interest will inform our 
understanding of the causes, consequences, and differences 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 molecular epidemiology, ethnography and behavioral epidemiology, 
mathematical modeling and simulations, behavioral and prevention science, 
virology, bacteriology, 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 to characterize the risk factors and mechanisms of transmission of 
HIV, other blood-borne infections, STIs, and TB, and to guide strategies for 
prevention of transmission among injecting and non-injecting drug users, their 
sexual partners, and their risk, peer, and social networks, and among specific 
groups and subpopulations (e.g., racial/ethnic minority groups; adolescents, 
runaways, and street youth; drug-using women; drug-using MSM; drug abuse 
treatment clients; rural populations; and migrant drug users who follow 
circuit parties, are homeless, who move in and out of jails/prisons, or move 
to other geographical regions for work). 

o  Studies to identify and understand potential cofactors, mediators, and 
interactions of HIV and other diseases, their progression, and their outcomes 
in diverse groups (e.g., by HIV subtype, by socio-demographic factors) of 
active drug users.  Researchers are encouraged to identify and understand how 
antiretroviral therapies, adherence interventions, health disparities, and 
other biologic and behavioral factors influence HIV progression among drug 
users, as shown by virologic, immunologic, and clinical outcomes. 

o  Studies of new and improved approaches to access and recruit hard-to-reach 
cohorts of active drug users to participate in biomedical and behavioral 
interventions to reduce drug use-related risk behaviors, disease transmission, 
comorbidity, including drug-associated psychosis, and mortality.  Researchers 
are encouraged to develop or refine study protocols, sampling and survey 
methods, and 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.

Etiology and Pathogenesis

o  Studies of viral and host mechanisms involved in the transmission, 
establishment, and spread of HIV in drug users and their sexual partners, 
including research on the mechanisms by which viral hepatitis, STIs, and other 
bacteriological and virological infections may influence HIV transmission in 
these populations.  Research is encouraged to identify the etiologic and 
interactive biologic, behavioral, environmental, sociocultural, and race- and 
gender-related factors that determine the relative transmission efficiency of 
HIV and other diseases in diverse groups 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, other blood-borne and sexually 
transmitted diseases, and drug-associated mental health disorders 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 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 drug users. In particular, clinical 
trials research is needed to identify optimal and appropriate treatment 
modalities and interventions that facilitate therapeutic adherence among 
traditionally underrepresented populations, i.e., ethnic/racial minorities and 
hard-to-reach drug users infected with HIV and other diseases.

o  Studies of antiretroviral adherence among drug users infected or co-
infected with HIV and other diseases, including research to develop improved 
methods to assess adherence to therapeutic regimens; to compare and validate 
adherence measures in the context of linked services (e.g., medical care for 
HIV, HBV, HCV and drug abuse treatment) for infected drug users; and to 
evaluate the impact of antiretroviral therapy in the setting of viral 
hepatitis/STI and drug treatment.

Vaccines

o  Basic research to advance the design and development of candidate vaccines 
and other biomedical interventions to prevent the spread of HIV in drug users, 
including studies that, for example, monitor and model effects on immune 
activation from drug abuse and STIs in HIV-infected and uninfected 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 drug users 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 also needed to improve the 
recruitment, adherence, and retention of traditionally underrepresented 
populations (e.g., racial/ethnic minorities, women) 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 drug users, including studies that 
establish and strengthen linkages between HIV vaccine preparedness and other 
prevention and treatment research activities (e.g., community-based HIV 
outreach and education interventions that integrate counseling and testing for 
HIV with screening, counseling, medical services for viral hepatitis and other 
STIs, and referrals and access to drug abuse treatment). 

Behavioral and Social Sciences Research

o  Behavioral intervention research that addresses the initiation, 
sustainability, and renewal of HIV/AIDS risk reduction and prevention among 
drug users and their sex partners, including studies of the effectiveness, 
cost-effectiveness, and durability of intervention outcomes among 
demographically and culturally diverse populations and communities.  Studies 
are encouraged to design and test new community-based outreach interventions 
that are linked to a variety of ancillary services (e.g., rapid diagnostic 
assays, HIV counseling and testing, medical care for viral hepatitis/STIs, and 
drug treatment) or that are adapted to traditionally underrepresented or hard-
to-reach populations, such as racial/ethnic minorities, drug injecting women, 
the sex partners of drug injectors, and drug-using MSM.

o  Multidisciplinary research on behavioral, cultural, social, and economic 
risk factors and consequences of injection drug use, risky sex, and HIV and 
other infections among drug-using groups and populations that differ by 
socioeconomic status, geographic location (domestic/ international, 
urban/rural), gender, sexual orientation, age, and race/ethnicity.  Such 
studies may address, for example, contextual factors associated with risks of 
drug use, HIV, and other blood-borne infections and STIs, including health 
disparities, norms and attitudes about gender roles, the composition and 
stability of social networks, and peer and other influences related to 
transitions from noninjecting to injecting drug use or from safe to unsafe 
sex.

o  Studies to improve outreach, recruitment, and retention of HIV-infected 
drug users, especially hard-to-reach IDUs, in clinical trials on HIV/AIDS and 
drug abuse prevention and treatment.  Of particular interest are studies that 
identify and address determinants and complications of antiretroviral 
adherence; drug use relapse prevention; the co-occurrence of HIV and other 
infectious and co-morbid conditions (drug addiction, alcoholism, viral 
hepatitis, STIs, mental illness, homelessness); the stigmatization so often 
associated with these diseases; and the social and cultural contexts within 
which HIV-related risks, protective behaviors, and behavioral changes occur.  

o  Research that advances qualitative and quantitative methodologies in 
behavioral and social science investigations of drug abuse, HIV/AIDS, and 
other infectious diseases.  Included are studies to: improve measurement 
instruments for hard-to-reach and special populations (e.g., racial/ethnic 
minorities, drug-using women and MSM, prisoners, adolescents, and migrant drug 
users); advance understanding of the social, structural, and cultural factors 
that influence risk behaviors, behavioral norms, social mixing, and high-risk 
networks; model, simulate and forecast the epidemiology of HIV/STIs and drug 
abuse, and guide the development of new interventions that target vulnerable 
groups to address health disparities and avert new infections; develop new 
outcome measures and indicators for evaluating the costs, benefits, and social 
impact of HIV prevention interventions; and formulate new strategies that 
facilitate multisite, intercultural, and international research projects.

o  Operational and health services research to understand and improve 
barriers to, and facilitators of, the implementation of science-based 
HIV/AIDS interventions in drug abuse prevention and treatment settings.  
Included are studies of the organization, financing, management, access, 
delivery, cost-effectiveness, linkage, and coordination of services to 
prevent and treat HIV/AIDS and other medical consequences of drug abuse, as 
well as the quality, outcomes, and costs of those services.

MECHANISMS OF SUPPORT 

This PA will use the NIH research project (R01), the small grant (R03), and 
the exploratory/developmental (R21) award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project.  The total project period for an application submitted in 
response to this PA may not exceed five years for the R01 and two years for 
the R03 and R21.

This PA uses just-in-time concepts.  It also uses the modular budgeting as 
well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular budget format.  Otherwise follow the instructions 
for non-modular budget research grant applications.  This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Elizabeth Lambert, M.Sc.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD  20892-9593
Telephone:  (301) 402-1933
FAX:  (301) 480-4544
Email:  EL46i@nih.gov

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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse, NIH, DHHS
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD  20892-8403
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

The title, "Drug Abuse Aspects of HIV/AIDS and Other Infections," and number 
of the program announcement (PA-04-007) must be typed on line 2 of the face 
page of the application form and the YES box must be marked. 

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

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail.  Applicants request direct costs in $25,000 modules.  
Section C of the research grant application instructions for the PHS 398 
(rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html 
includes step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
   
1)   Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2)   Obtain agreement from IC staff that the IC will accept your application 
for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA that is essentially the 
same as one currently pending initial review unless the applicant withdraws 
the pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an unfunded version of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.   Appropriate scientific review groups 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

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

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

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 evaluate application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application's overall score, weighting them as appropriate for each 
application.

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

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project? Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

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

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

ENVIRONMENT: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?  

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

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS 

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research are expected to include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. (See 
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm.)

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

AWARD CRITERIA

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

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

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.  
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.    (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  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 clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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, clinical, 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 service for persons at risk for HIV infection 
including injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.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 of Council before submitting an application that will 
administer compounds to human subjects.  The guidelines are available on 
NIDA's Home Page at http://www.nida.nih.gov under the Funding, or may be obtained by 
calling (301) 443-2755.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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