RELEASE DATE:  September 9, 2002

PA NUMBER: PA-02-164

EXPIRATION DATE:  September 30, 2005, unless reissued.

National Institute on Drug Abuse (NIDA)


o Purpose of the PA
o Research Objectives
o Mechanism(s) 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


The National Institute on Drug Abuse (NIDA) encourages research on the 
economics of HIV/AIDS services that are utilized in conjunction with drug 
abuse treatment and/or prevention services. The catastrophic medical expenses 
and premature disability due to AIDS can have a devastating impact on the 
well-being of the afflicted individual. Society also experiences numerous 
negative consequences from the HIV/AIDS and indeed some nations are 
experiencing health system failures.  Furthermore, persons with HIV/AIDS also 
face other blood borne infections, and of particular concern, is hepatitis C 

Public health experts maintain that in order to achieve declines in AIDS 
incidence and deaths, HIV-infected persons must seek testing earlier in the 
course of their disease, receive and adhere to treatment, and follow 
prevention guidelines. Research to achieve these goals must involve an 
economic component concerned with the economic behavior of consumers, 
providers, government agencies, and third party payers.  Applications are 
sought that would employ the methods of economic analysis to pressing 
problems in the financing and delivery of HIV/AIDS services and drug abuse 
treatment and/or prevention services. 

This program announcement is related to other NIH announcements in this 
general subject. Investigators interested in economic factors, should refer 
to PA-01-013, "Economics of Drug Abuse Treatment and Prevention Services," 
published in the NIH Guide on November 7, 2000. Investigators interested in 
natural history, epidemiology, etiology, pathogenesis, prevention, and 
treatment of drug abuse and drug abuse aspects of HIV/AIDS and associated 
infectious diseases, refer to PA-01-023, "Drug Abuse Aspects of HIV/AIDS and 
Other Infections," published in the NIH Guide on November 30, 2000. 
Investigators interested mainly in mental health aspects of HIV infection 
should refer to PA-95-001 "Economic Evaluation in HIV and Mental Disorders 
Prevention," October 2, 1998.  In many cases, building an economic research 
project on an intervention already under study or a completed study of an 
intervention would be beneficial. 


Summary.  Health economic research has the goal to inform society about 
fundamental issues in the production and distribution of health.  The public 
health interventions of drug abuse treatment and prevention have critical 
roles in saving lives, preventing diseases, and reducing the economic burden 
of diseases. The research descriptions below are examples to guide potential 
applicants to determine whether a given scientific topic may be appropriate 
for this announcement. The examples are illustrative only and investigators 
should always feel free to propose their own study ideas.

Background. As of December 2000, there were 774,467 cases of AIDS reported in 
the United States and its territories, and 448,060 Americans were recorded to 
have died from AIDS since the epidemic began in the early 1980s. In 1999, the 
Centers for Disease Control estimated that 800,000 to 900,000 persons in the 
U.S were living with HIV or AIDS. In recent years, there has been a marked 
decline in AIDS incidence and deaths. This began in 1996 and continued into 
1998 and was associated with the widespread use of potent combination 
antiretroviral therapies. However, the rates of decline in AIDS incidence and 
deaths slowed during the latter part of 1998 and 1999. Reported through June 
2001, 331,518 persons were living with AIDS in the United States and its 
dependencies.  In 1999, the numbers of cases and deaths each quarter 
stabilized or fluctuated slightly in most populations and geographic areas. 
Much more ominous has been the disproportionate distribution among minority 
groups. During the 1990s, the epidemic shifted steadily towards a growing 
proportion of AIDS cases in African-Americans and Hispanics as well as women, 
and towards a decreasing proportion in men who have sex with men, although 
this group remains the largest single exposure group. African-Americans and 
Hispanics, for whom AIDS rates have been markedly higher than whites, have 
been disproportionately affected since the early years of the epidemic. In 
absolute numbers, African-Americans have outnumbered whites in new AIDS 
diagnoses and deaths since 1996, and in the number of people living with AIDS 
since 1998.

Injection drug use is a critical vector for HIV transmission to the extent 
that more than 24 percent of AIDS cases were amongst injection drug users, 
their sexual partners, and their offspring in December 2000.  Further data 
indicate that "black, not Hispanic" and "Hispanic" groups have a 
disproportionately higher rate of injecting drug use associated with AIDS 
cases. HIV counseling and testing services provided in conjunction with drug 
abuse treatment, especially methadone maintenance, reduce risky behaviors and 
infections.  Costs associated with these reductions are often not captured in 
studies of cost-effectiveness or cost-benefit analysis.

In less developed countries, the impact of HIV/AIDS has been devastating.  In 
some African nations up to 10 percent of the population may be infected with 
HIV.  Death rates have been rising, health systems disrupted, demographic 
patterns drastically altered, and country economic growth rates curtailed.  
The high cost of therapeutic interventions as compared to per capita gross 
domestic product is a major policy concern that challenges the usual economic 
calculus of international patent rights and incentives to research, develop, 
and eventually market anti-HIV drugs.  Economics is often called "the science 
of choice" and the economic evaluation of alternatives in the HIV/AIDS crisis 
will challenge the skills of economists and other scientists to respond to 
the research needs. 

Research Studies.   Researchers are encouraged to develop rigorous designs 
for studies of the economics of HIV/AIDS services and drug treatment and/or 
prevention services.  Studies are sought on: (1) financing, including health 
insurance and/or payment mechanisms; (2) alternative delivery systems and 
managed care; (3) cost-benefit, cost-effectiveness, and cost-utility 
analysis; (4) cost of services and economic burden of the disease; and (5) 
methodological research.   

Financing.  Within the United States, financing for HIV prevention and 
treatment services is derived from Federal, State, and local government funds 
and also private sector funds from health insurance, consumer out-of-pocket 
expenditures, and charity.  The scientific inquiry into financing of health 
care services requires normative and positive economic analysis on allocation 
and distribution issues.  Because different levels of government are involved 
in public financing, fiscal federalism is a central issue.  Distribution 
issues must be addressed for the indigent that are at risk or have HIV/AIDS 
as well as for funding strategies for service delivery. Analysis of both 
public and private provision of health insurance coverage for HIV/AIDS 
services is essential to financing studies.  Furthermore, payment mechanisms 
for HIV/AIDS services and drug treatment and prevention services affect the 
allocation and distribution of the financing and provision of care by private 
and public health care organizations.  In addition, international aspects of 
financing have numerous issues.  The financial burden of providing services 
may overwhelm development plans for some economies and the drug abuse and 
medical treatment infrastructure may also be under intense stress.

Alternative Delivery Systems and Managed Care.  The efficient and equitable 
provision of HIV/AIDS services requires studies in alternative delivery 
systems and managed care.  A behavioral health care organization, usually for 
profit, often administers the mental health, alcohol, and drug abuse 
treatment benefits in private and public insurance plans.  Specific HIV/AIDS 
medical clinics and practices have developed with service needs for patients 
beyond medical treatment. Clinical services must sequence the treatments for 
hepatitis A, B, and C infections as well as HIV and drug use, which challenge 
the organizational and management structures of the health care system.  
Integration of HIV services and drug abuse treatment and prevention services 
remains a challenge to the delivery system for which economic factors are 
deemed of considerable importance. Furthermore, management of such services 
may require the design of new incentives, contracts, and regulations and as 
such will require studies of outcomes on patients, programs, and systems.  
Economic evaluation of well-defined managed care systems on quality, access, 
outcomes, and costs of service delivery must be done with consideration of 
the HIV/AIDS service component.  Managed care effects on clinical decision-
making and on the structure and function of the treatment provider 
organization also generates considerable interest. 

Cost-Benefit, Cost-Effectiveness, and Cost-Utility Analysis.  Studies of the 
economic costs and benefits of HIV/AIDS services and drug abuse treatment 
and/or prevention services are encouraged.  Cost-benefit, cost-effectiveness, 
and cost-utility analyses are collaborative activities involving multi-
disciplinary research teams.  For the general population, as well as HIV/AIDS 
patients, economic evaluation of innovative drug abuse treatment or 
prevention services as well as their effectiveness in real-world settings 
must be stimulated. Cost-effectiveness studies are useful in comparing novel 
treatment or prevention technologies to a standard treatment or prevention 
technology.  Examples of such cost-benefit or cost-effectiveness studies 
include comparing drug abuse treatment integrated with HIV/AIDS services and 
prevention services to the general, adolescent, and high-risk populations and 
current drug abuse treatment services.  International public health programs 
require rigorous economic evaluation of alternative treatment and prevention 
services in order to maximize donor and host country use of resources. 

Cost of Drug Abuse Treatment and Prevention Services.  Costs are separately 
highlighted to indicate the importance of valuing and producing health care 
services in drug abuse treatment and prevention organizations as well as care 
where HIV/AIDS clinical treatment is provided. Improved measures of costs are 
needed for management decisions that will assist clinical and program 
treatment staff as well as local, state and national health policy makers.  
For scientific research, measures of costs must be improved both conceptually 
and operationally so that precise costs may be determined.  Cost-of-illness 
studies of HIV/AIDS have examined costs of medical treatment although many 
other economic factors may be identified.  At the system level, research on 
unit service costs must be encouraged in order to achieve pricing of service 
delivery for innovative and standard services.  For programs and systems, 
conceptualizing and measuring the relationships among accounting costs, 
marginal costs, average costs, and total costs in programs and systems have 
received little attention.  Research in these areas is needed so that a 
precise measurement of service costs can be established for economic analysis 
of multi-product production and cost functions of services. Economics of 
scale and scope have not been studied and should be examined with management 
and organizational factors considered.  

Methodological Research.  Research is encouraged that will develop and test 
the application of new methods of economic analysis in services research for 
HIV/AIDS and drug abuse treatment and/or prevention.  There is a need for 
improved assessment of economic efficiency and equity.  Health insurance 
theory and practices associated with HIV/AIDS patients and drug abuse 
treatment services will require additional study. New statistical methods 
associated with economic analysis of treatment or prevention studies may be 
developed. Simulation models of health intervention strategies, decision 
theories, methodologies for cost-benefit, cost-effectiveness, and cost-
utility analysis may be advanced.  Distribution theory and health disparity 
studies may require additional methodological development.


This PA will use the National Institutes of Health (NIH) research project 
grant (R01), exploratory/developmental grant (R21), and small grant (R03) 
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 R01 application submitted in response to this PA may 
not exceed 5 years.  For R21 applications, the project period cannot exceed 3 
years and $100,000 in direct costs in each of those years.  For R03 
applications, the project period cannot exceed 2 years and $50,000 in direct 
costs in each of those years.  Applicants are strongly encouraged to read the 
R21 and R03 announcements, which specify the goals and guidelines for each 
program ( and 

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


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
o Faith based or community based organizations


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


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:

William S. Cartwright, Ph.D.
Services Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd, Room 4222
Bethesda, Maryland 20892-9565
Telephone:  301-443-4060	
Fax:  301-443-6815
E-mail:  WC34B@NIH.GOV

Jean-Craft Comolli, B.S.N., M.B.A.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Blvd, Room 5194
Bethesda, Maryland 20892-9593
Telephone:  301-402-0630
Fax 301-594-6566

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

Gary Fleming, J.D., M.A.
Chief, Grants Management Branch
National Institute on Drug Abuse, NIH
6001 Exeuctive Boulevard, Room 3131
Bethesda, Maryland  20892-9541
Telephone:  301-443-6710
Fax:  301-594-6849
E-mail:  GF6S@NIH.GOV


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

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

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

Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

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

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

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at 

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

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

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


Applications submitted for this PA 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:

o Receive a written critique
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 second level review by the appropriate national advisory council 
or board

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your 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, you 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 your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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?  Do you acknowledge potential problem areas and consider alternative 

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

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

(5) ENVIRONMENT:  Does the scientific environment in which your 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 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  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.

INCLUSION:  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.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

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


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

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


involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 

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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(; a complete 
copy of the updated Guidelines are available at  
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) all 
applications or proposals and/or protocols must provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting analyses, 
as appropriate, by sex/gender and/or racial/ethnic group differences.

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.

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

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

Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at

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

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 services.  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

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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.279, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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 described at and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92 

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

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