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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)

Title: Secondary Analysis of Existing Alcohol Epidemiology Data (R21)

Announcement Type
This is a reissue of PA-06-557.

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PA-08-168

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4)weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.273

Key Dates
Release/Posted Date: May 23, 2008
Opening Date: September 16, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 8, 2011

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

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.

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), the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC) conducted by NIAAA; the National Longitudinal Survey of Youth (NLSY) conducted by the U.S. Department of Labor; the National Adolescent Student Health Survey (NASHS), 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 (NHIS) conducted by NCHS; the National Survey on Drug Use and Health (NSDUH) (formerly the National Household Survey on Drug Abuse (NHSDA), conducted by the Substance Abuse and Mental Health Services Administration; and the National Mortality Follow-back 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://www.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 appropriate topics include but are not limited to those listed below. Scientific considerations and the potential benefit of the proposed analyses should guide any proposed research.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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 support.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants may submit a resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).

Applicants may not submit a renewal application.

Applicants may submit more than one application, provided that each application is scientifically distinct.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)

Optional Components:

PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-domestic [non-U.S.] Entities)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from Foreign organizations must:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: September 16, 2008 (Earliest date an application may be submitted to Grants.gov) Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time(of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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