This Program Announcement expires on October 5, 2004 unless reissued.

COST RESEARCH ON ALCOHOL TREATMENT AND PREVENTION SERVICES

Release Date:  September 6, 2001
 
PA NUMBER:  PA-01-137

National Institute on Alcohol Abuse and Alcoholism
 
THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER 
YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 
(REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks 
applications for research projects that will advance knowledge about the cost 
of treating and preventing alcohol problems.  Applications are sought for 
cost analysis studies, cost effectiveness studies, cost benefit studies, and 
cost offset studies.  The announcement also invites studies that improve the 
methods used to measure the costs of treatment and prevention interventions.  
Studies of costs and outcomes of specific interventions are encouraged, as 
are studies of the costs and outcomes of categories of interventions (e.g., 
inpatient versus outpatient).  Studies to improve the methodologies of 
estimating costs and of comparing costs to outcomes are also encouraged.

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 Program Announcement 
(PA), Adoption of Alcohol Research Findings in Clinical Practice, 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 
grant (R01) and exploratory/developmental grant (R21) award mechanisms. 
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  Applications for R01s may 
request support for up to 5 years.  Facilities and Administrative (F&A) costs 
will be awarded based on the negotiated rate at the time of the award.  More 
detailed information on the R21 mechanism can be found at 
http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html. 
Exploratory/developmental grants cannot be renewed: however, a no-cost 
extension of up to one year may be granted prior to expiration of the project 
period.  Investigators are encouraged to seek continued support after 
completing an exploratory/developmental grant project through a research 
project grant (R01).

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. 
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

Two considerations establish the importance of evaluating both costs and 
outcomes of alcoholism treatment and prevention interventions.  First, 
resources available for the treatment of alcohol problems are typically in 
short supply.   Hence, any money spent for unnecessary or ineffective 
treatment reduces the amount that could be used more effectively.  Second, 
effective treatments need to be preserved against the pressures of cost 
containment.  In an era that gives close scrutiny to all medical care costs, 
cheaper therapies will displace more expensive ones unless research provides 
evidence that the higher costs of some therapies are justified by better 
outcomes.

Several varieties of cost research are described in the paragraphs below.  
All of these, as well as other types of cost research, are encouraged under 
the terms of this announcement.

Cost analysis is the most basic form of cost research.  It concerns the 
accurate measurement of costs.  Given that most studies rely on charges for 
services rather than on true costs (opportunity costs) of services, there is 
room for improvement.  In addition, the measurement of cost is not well 
developed for publicly-funded treatment, despite the significant size of this 
treatment sector.

Cost effectiveness studies compare the costs of treatments to their outcomes.  
For example, one might compare the costs of obtaining a successfully-treated 
client across two treatment interventions.  Noteworthy varieties of cost 
effectiveness studies are those that measure outcomes in terms of quality 
adjusted life years (QUALYS; Patrick and Erickson 1993; Spilker 1990) and 
disability adjusted life years (DALYS; Murray 1996).  Such studies are also 
encouraged under the terms of this announcement.

Cost benefit studies measure both costs and outcomes in monetary units.  This 
is achieved by estimating monetary values for mortality, morbidity, and other 
outcomes such as improved productivity.

Cost offset analyses are, in fact, partial cost benefit analyses in which 
future medical care costs are the only outcomes measured.  Historically, cost 
offset research has formed the largest part of the cost research undertaken 
in the alcohol field (Holder and Blose 1986; 1992; Holder and Shachtman 1987; 
Goodman et al. 1997; Jones and Vischi 1979).  

No one study can be expected to provide a complete answer to the question:  
“Which treatments provide the best outcomes for the costs incurred?”  
Progress will more likely be made through the accretion of results from many 
individual studies, each analyzing some specific treatment program.  
Accordingly, this announcement invites analyses of the costs, cost 
effectiveness, cost benefits, and cost offsets of specific treatment 
programs.

Some studies might be more ambitious and attempt to draw conclusions about a 
class or a category of treatment programs.  For example, past studies have 
compared the relative costs and outcomes of inpatient versus outpatient 
treatment (see Finney et al. 1996; Institute of Medicine 1990; Miller and 
Hester 1986; and Office of Technology Assessment 1983).  Other comparisons of 
interest are those between more intensive versus less intensive programs, 
longer versus shorter programs, and programs with stronger versus weaker ties 
to ancillary services, primary medical care, or aftercare services.

As the case of inpatient care for more severely dependent alcoholics 
indicates, the balance between cost and outcome can vary by patient 
characteristics.  Studies of these variations are encouraged.  Such studies 
could focus on population subgroups (defined by ethnicity, gender, or age) or 
on patient characteristics (such as severity of dependence, presence of 
psychiatric comorbidities, and level of social support).

Scientific progress is also furthered by improvements in methodology.  Two 
important methodological contributions to cost research have been made in 
recent years, but neither has been widely applied to the study of alcohol 
treatment.  The first is a set of standardized guidelines for conducting cost 
effectiveness studies.  These guidelines (Gold et al. 1996) were developed 
for the PHS for use across its constituent agencies, including the NIH.  This 
announcement encourages research that applies these guidelines to the study 
of alcohol treatment or identifies areas where the recommended general 
approaches to measuring costs and outcomes are problematic in this specific 
application.  The second development is the Drug Abuse Treatment Cost 
Analysis Program (French 1995; French et al. 1997).  Though originally 
developed to measure treatment costs for drug abuse, this system could easily 
and profitably be applied to alcohol treatment as well.

A number of other methodological developments could also help improve the 
field.  These include improvements in using administrative data sets for 
research purposes, the development of  methods to study of persons who change 
health plans or insurers frequently, and methods to study those who combine 
plan-financed with out-of-plan services.
 
Studies of the cost of providing parity in insurance benefits between 
substance abuse treatment and treatment for other health conditions are also 
encouraged (Sing et al. 1997).  Some states, such as Vermont, have enacted 
legislation requiring such parity, and the Federal Government has established 
parity for all persons insured by the Federal Employees Health Benefits 
(FEHB) program.  However, the cost consequences of these policy initiatives 
are unknown.

Although the research examples described in this announcement have 
concentrated on the cost and outcomes of alcohol treatment, there is a 
parallel need for cost studies of prevention activities.  Such research was 
identified as a priority by the Subcommittee on Health Services Research, 
National Advisory Council on Alcohol Abuse and Alcoholism, which recommended 
that the Institute encourage studies to “measure the effectiveness and cost-
effectiveness of alcohol prevention in reducing the utilization of health 
care services.” (NIAAA 1997; p. 49).  Unfortunately, this objective has not 
yet captured the attention of the research community.  Accordingly, such 
studies are expressly invited here.

Summary

The research encouraged by this PA is expected to increase scientific 
knowledge about the cost of treating and preventing alcohol abuse and alcohol 
dependence.  It will also increase knowledge of the effectiveness and 
benefits of alcohol treatment and prevention in comparison to cost so that 
the cost effectiveness and cost benefits of treatment and prevention can be 
better estimated and understood.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided 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 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 are 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 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 was published in the NIH Guide for 
Grants and Contracts, 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 the policy.

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.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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.

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.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants and will be accepted at the standard application 
deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable PDF format. Although applicants are encouraged to begin using the 
5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to 
accept applications prepared using the 4/1998 revision until January 9, 2002. 
Beginning January 10, 2002, however, the NIH will return applications that 
are not submitted on the 5/2001 version.  For further assistance contact 
GrantsInfo, 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 
Institute or Center who agreed to accept assignment of the application.

This policy requires an applicant to obtain agreement for acceptance of the 
original application as well as any subsequent revisions.  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 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  Applicants are permitted, 
however, to use the 4/1998 revision of the PHS 398 for scheduled application 
receipt dates until January 9, 2002.  If you are preparing an application 
using the 4/1998 version, please refer to the step-by-step instructions for 
Modular Grants available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.  Additional 
information about Modular Grants is also available on this site.

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. Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures. As part of the initial merit review, all 
applications will receive a written critique and undergo a process in which 
only those applications deemed to have the highest scientific merit, 
generally the top half of applications under review, will be discussed, 
assigned a priority score, and receive a second level review by the 
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 method? 
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 will also be reviewed with respect to the following:

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

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.
o  The adequacy of the proposed protection for humans or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

Additional consideration pertinent to the review of Exploratory/Developmental 
Grant (R21) applications:

Pilot feasibility studies may contain little or no preliminary data.  Review 
should focus on whether the rationale for the study is well developed and 
whether the proposed research is likely to generate data that will lead to a 
regular research project grant or full-scale clinical trial.  Adequate 
justification for the proposed work may be provided through literature 
citations, data from other sources, or investigator-generated data.

AWARD CRITERIA

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

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Mike Hilton, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 Executive Blvd., MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-8753
FAX:  (301) 443-8774
Email:  mhilton@willco.niaaa.nih.gov

Direct inquiries regarding fiscal matters to:

Judy Simons
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Blvd., MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-2434
FAX:  (301) 443-0788
Email:  jsimons@willco.niaaa.nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.273. 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 and contract 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, and 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.

REFERENCES

Backer TE.  Drug Abuse Technology Transfer.  DHHS Publication No. (ADM) 91-
1764, Rockville, MD: National Institute on Drug Abuse, 1991.

Backer TE.   “Research utilization and managing innovation in rehabilitation 
organizations.”  Journal of Rehabilitation, 54:18-22, 1988.

Brown BS.  “From research to practice: The bridge is out and the water’s 
rising.”  Pp. 345-365 in Levy JA, Stephens RC, and McBride DC, Advances in 
Medical Sociology, Volume 7.  Greenwich, CT: JAI Press, 2000.

Center for Substance Abuse Treatment.  Improving Substance Abuse Treatment: 
The National Treatment Plan Initiative.  DHHS Publication No. (SMA) 00-3479, 
Rockville, MD: Center for Substance Abuse Treatment, Substance Abuse and 
Mental Health Services Administration, 2000.

Dunn WN and Holzner B.  “Anatomy of an emergent field.”  Knowledge in Society 
1:3-26, 1988.

Finney, L.W.; Hahn, A.C.; and Moos, R.H.  The effectiveness of inpatient and 
outpatient treatment for alcohol abuse:  The need to focus on mediators and 
moderators of setting effects.  Addiction 91(12):1773-1796, 1996.

Glaser EM, Ableson H, and Garrison KN.  Putting Knowledge to Use.  San 
Francisco, CA: Jossey-Bass, 1983.

Goodman, A.D.; Nishiura, E.; and Humphreys, R.S.  Cost and usage impacts of 
treatment initiation:  A comparison of alcoholism and drug abuse treatments.  
Alcoholism:  Clinical and Experimental Research  21(5):931-938, 1997.

Green LW, Gottleib NH, and Parcel GS.  “Diffusion Theory Extended and 
Applied.”  Pp. 91-117 in Ward WB (ed.) Advances in Health Education and 
Promotion.  Greenwich, CT: JAI Press, 1987.

Lamb S, Greenlick MR, and McCarty, D. (eds.).  Bridging the Gap Between 
Practice and Research: Forging Partnerships with Community-Based Drug and 
Alcohol Treatment.  Institute of Medicine.  Washington, DC: National Academy 
Press, 1998.

Christopher J.L. Murray.  Rethinking DALYs.  Pp. 1-98 in Christopher J. L. 
Murray and Alan D. Lopez.  The Global burden of Disease:  A Comprehensive 
Assessment of Mortality and Disability from Diseases, Injuries, and Risk 
Factors in 1990 and Projected to 2020.  Cambridge: MA, Harvard University 
Press, 1996

National Institute on Drug Abuse.  Reviewing the Behavioral Science Knowledge 
Base on Technology Transfer.  NIH Publication No. 95-4035.  Rockville, MD:  
National Institute on Drug Abuse, National Institutes of Health, Public 
Health Service, 1995.

National Institute on Alcohol Abuse and Alcoholism.  Improving the Delivery 
of Alcohol Treatment and Prevention Services: A National Plan for Alcohol 
Health Services Research.  NIH Publication No. 97-4223.  Rockville, MD: 
National Institute on Alcohol Abuse and Alcoholism, National Institutes of 
Health, Public Health Service, 1997.

Oldenburg B, Hardcastle DM, and Kok G.  “Diffusion of Innovations.”  Pp. 270-
286 in Glantz K and Lewis FM (eds.).  Health Behavior and Health Education.  
San Francisco, CA: Jossey-Bass, 1997.

Rogers EM.  Diffusion of Innovations.  New York: Free Press, 1983.

Weisner C, Mertens J, Parthasarathy S, Moore C, Hu TW, Hunkeler E, and Selby 
J.  “Outcome and cost of alcohol and drug treatment in an HMO: Day hospital 
versus traditional outpatient.”  Health Services Research, 35:791-810, 2000.

Zaltman G, Duncan R, and Holbek J.  Innovations and Organizations.  New York: 
Wiley, 1973.

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