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

SECONDARY ANALYSIS OF EXISTING ALCOHOL EPIDEMIOLOGY DATA SETS

Release Date:  September 25, 2001

PA NUMBER:  PA-01-140 (This PA has been reissued, see PA-05-088)

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) invites 
applications to support the secondary analysis of existing data sets with the 
goal of enhancing our understanding of patterns of alcohol consumption and 
the epidemiology of alcohol-related problems. 

Research grants for the Secondary Analysis of Existing Alcohol 
Epidemiology Data Sets are intended to provide support for studies that 
more fully utilize currently available data sets to increase our 
understanding of the incidence, prevalence and etiology of alcohol 
related problems and disorders in the population, as well as the risk 
and protective factors associated with them. Data used in secondary 
analyses may be obtained from current or past investigator-initiated 
research activities or from other public or private sources. Research 
that employs analytic techniques which demonstrate or promote 
methodological advances in alcohol-related epidemiologic research is 
also of interest. 

Research objectives of this program announcement include, but are not limited 
to:  (1) studying patterns of alcohol consumption and the distribution of 
alcohol-related problems in the population as a whole and in specific sub-
populations, (2) studying risk and protective factors for alcohol-related 
problems in the population as a whole and in specific subpopulations,  (3) 
elucidating disparities among racial/ethnic groups with respect to alcohol 
consumption and alcohol-related problems, (4) understanding the natural 
history, course, and short- and long-term outcomes of alcohol consumption.

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), Secondary Analysis of Existing Alcohol Epidemiology Data Sets, 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 support research through the National Institutes of Health (NIH) 
Research Project grant (R01) and the 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 research project grants (R01s) may request support for up to 5 years.  
Exploratory/developmental grants (R21) are limited to 3 years and $100,000 
per year in direct costs.  Facilities and Administrative (F&A) costs will be 
awarded based on the negotiated rate at the time of the award. Applicants 
without extensive preliminary data are urged to submit applications for this 
PA using the exploratory/developmental grant mechanism. 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
 
The National Institute on Alcohol Abuse and Alcoholism seeks to expand 
knowledge about patterns of alcohol consumption and the epidemiology of 
alcohol-related problems through the use of secondary analysis of existing 
data, where appropriate data sets and analytic techniques are available.  The 
specific objectives of this announcement on the Secondary Analysis of 
Existing Alcohol Epidemiology Data Sets are to provide support for (a) 
analyzing previously collected data that would advance -- in cost effective 
ways -- scientific knowledge of alcohol-related epidemiology, or (b) applying 
new approaches to analyze current data sets that would benefit from further 
exploration.  Grants under this announcement are not intended as a means for 
carrying out currently ongoing data analysis nor for the maintenance and 
distribution of data sets.
 
BACKGROUND
 
Epidemiologic research projects typically generate data with potential 
utility beyond the specific hypotheses and questions that they were designed 
to address. Often data are not fully analyzed, especially when unexpected 
research questions emerge after the end of the project’s funding period.  
Analyzing such existing data sets can therefore provide a cost-effective 
means to test specific hypotheses that have not been adequately examined. The 
further analysis of existing research data may also be prompted by a need to 
confirm new findings or to aid in the development of new research questions.  

Also appropriate for secondary analyses are relevant cross-sectional and 
longitudinal survey data collected by Federal, State, and local government 
agencies. Secondary data analyses of these data may serve as an economical 
alternative to expensive and time-consuming new data collection projects.  A 
few examples of such publicly available data sets are: the National 
Longitudinal Alcohol Epidemiologic Survey (NLAES) conducted by NIAAA, the 
National Longitudinal Survey of Youth (NLSY) conducted by the U.S. Department 
of Labor, the National Adolescent Student Health Survey, a cooperative 
project of the U.S. Department of Health and Human Services, Public Health 
Service, Office of Disease Prevention and Health Promotion, Centers for 
Disease Control and Prevention, and the National Institute on Drug Abuse, the 
National Health and Nutrition Examination Survey (NHANES) conducted by the 
National Center for Health Statistics (NCHS), the National Health Interview 
Survey conducted by NCHS, the National Household Survey on Drug Abuse 
conducted by the Substance Abuse and Mental Health Services Administration, 
and the National Mortality Followback Survey conducted by NCHS.  

In addition to the examination of specific research hypotheses, existing data 
sets may also be used to cross-validate exploratory analyses in ongoing 
studies, to test complex statistical models, and in special circumstances to 
provide comparison groups for experimental studies.  Meta-analysis, in which 
results from multiple studies may be compared or combined, is considered to 
be a form of secondary data analysis for the purpose of this program 
announcement.  Moreover, secondary analysis is appropriate for many types of 
data, including qualitative information, and may also cover the integration 
of quantitative and qualitative data. 

AREAS OF RESEARCH INTEREST

Alcohol epidemiology is the study of the distribution in the population of 
alcohol-related problems and disorders.  Research in this area includes the 
investigation of patterns of alcohol consumption and of the incidence, 
prevalence and etiology of alcohol-related problems and disorders in the 
population as a whole and in specific subpopulations.  It also includes 
studies that enhance our knowledge about risk and protective factors 
(personal, environmental and genetic) for alcohol-related problems, and how 
these factors may vary and/or interact in various populations and/or be 
affected by other factors such as family history, education, health status, 
socio-economic status and occupation.

More specifically, this general area includes, but is not limited to: (a) the 
epidemiology (causes, course and outcomes) of alcohol-related problems 
including alcohol use disorders among the general population and among 
special populations, for example, youth, racial/ethnic groups, women and the 
elderly, (b) the relationship of alcohol consumption and alcohol use 
disorders to other psychiatric disorders and conditions, (c) the relationship 
of alcohol consumption to the development, course, and outcomes of physical 
illnesses, including heart disease, cancer, liver disease and HIV/AIDS, (d) 
the study of prenatal exposure to alcohol, including the epidemiology of 
fetal alcohol syndrome (FAS) and alcohol-related neurodevelopmental disorders 
(ARND), and (e) the role of alcohol in intentional and non-intentional injury 
and death including homicide, suicide, and vehicular and other accidents.

Applicants may conduct secondary analyses relevant to alcohol-related 
epidemiology using large, nationally representative data sets or smaller, 
regional or locally based data sets. As mentioned above, many data sets in 
the public domain which contain items relevant to alcohol consumption and 
alcohol-related problems have not been fully analyzed. Appropriate data sets 
include those collected or coordinated by agencies of the Federal Government 
(e.g., surveys carried out by the National Center for Health Statistics and 
the Centers for Disease Control and Prevention), various State governments, 
and regional or local governments. Applicants may also secure access to other 
data sets that may or may not be in the public domain, such as those 
collected under research grant funds, sponsored by private entities (e.g., 
philanthropic foundations, motor vehicle administrations, or commercial 
businesses) or originally collected for purposes other than research (e.g., 
health care, criminal justice or insurance data). 

The Alcohol Epidemiologic Data Directory is a resource document that lists 
data sets of potential relevance to this announcement.  It is available on 
NIAAA’s website at the following address: 
http://pubs.niaaa.nih.gov/publications/datasys.htm or from an NIAAA 
contractor: CSR Incorporated, Suite 200, 1400 Eye Street, NW, Washington, 
D.C. 20005, 202/842-7600.  The information provided for each data set 
includes: title, sponsoring agency, contact person, survey design/purpose, 
methodology, sample size, alcohol variables, other variables and limitations.

Examples of general types of secondary analyses that may be considered within 
the scope of this announcement are given below. This list is illustrative and 
not exhaustive, prospective proposals need not be limited by these examples.  
Scientific considerations and the potential benefit of the proposed analyses 
should guide any proposed research. 

o   New analyses of past or current studies: Appropriate analyses include: 
those which explore overarching initial hypotheses further but which are 
significant enough to justify a new stand-alone analytic research project, 
and those which investigate hypotheses beyond those tested in the original 
study.

o   Large sample or multiple sample comparisons: Investigators may use large 
archival data sets with identified subgroups or multiple data sets for 
comparison with one another. For example, an investigator may obtain two or 
more data sets for the development and testing of integrated research 
hypotheses for multiple cohorts, different genders, or different ethnic 
groups. 

o   Methodology development: Single or multiple data sets may be used to 
demonstrate new or improved research designs, measurement techniques, or 
analytic approaches.  For example, researchers may wish to develop new 
analytic techniques for longitudinal designs that take into account 
transitions in alcohol and other drug use behaviors over time, or use 
existing data to undertake the simulation of complex systems for predicting 
the use of alcohol or the emergence of alcohol-related problems at an 
individual, group, or community level. 

o   Developmental Projects: Investigators might examine the feasibility of 
using certain types of data records or certain kinds of data sets for 
answering alcohol-related epidemiologic research questions, particularly if 
these types of data have not been widely used to address alcohol-related 
hypotheses.  Examples include abstracting from medical encounter records, and 
analyzing general health or criminal justice data. 

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 subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), 
a complete copy of the updated Guidelines 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 strongly 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 both 
any such application and any such subsequent amendment. Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award. It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers 
and NIH staff.  The research grant application form PHS 398 (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 Advisory Council. 

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.

o  The adequacy of the proposed plan to share data, if appropriate.

AWARD CRITERIA
 
Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.

INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.  Direct inquiries regarding 
programmatic issues to:
 
Vivian B. Faden, Ph.D.
Acting Chief, Epidemiology Branch
Division of Biometry and Epidemiology
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 514, MSC 7003
Bethesda, MD  20892-7003
Telephone:  301-594-6232
FAX:  301-443-8614
E-mail:  vfaden@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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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