Structural Interventions, Alcohol Use, and Risk of HIV/AIDS

RFA Number: RFA-AA-05-003

Part I Overview Information
Department of Health and Human Services

Participating Organization:

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

Component of Participating Organization:

National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH) (http://www.niaaa.nih.gov/)

Announcement Type:
New

Update: The following update relating to this announcement has been issued:

Catalog of Federal Domestic Assistance Number(s): 93.273

Key Dates

Release Date: September 17, 2004
Letters Of Intent Receipt Date(s): November 19, 2004
Application Receipt Dates(s): December 16, 2004
Peer Review Date(s):February-March, 2005
Council Review Date(s): May, 2005
Earliest Anticipated Start Date: July, 2005
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: December 17, 2004

Due Dates for E.O. 12372 Not Applicable

Executive Summary

This RFA requests research on the effectiveness of structural interventions that reduce the risk of HIV/AIDS transmission by changing the environment of alcohol use. Although a variety of structural and environmental interventions have been employed successfully to reduce other drinking-related problems, there has been little research that extends such efforts into the realm of HIV/AIDS risk reduction. Approximately $2,000,000 will be awarded in FY 2005 in funding 5 to 7 new and/or competitive continuation grants in response to this RFA. This RFA is a one-time solicitation, and will use the NIH Research Project Grant (R01), Exploratory/ Developmental Grant (R21), and Small Grant (R03) award mechanisms. The acknowledged novelty of the research direction called for in this Announcement may make the R21 and R03 mechanisms particularly appropriate for many applicants. Eligible organizations include for-profit or non-profit organizations, public or private institutions (e.g., universities, colleges, hospitals), units of state and local governments, eligible agencies of the Federal government, domestic or foreign institutions, and faith-based or community-based organizations. Eligible principal investigators include any individual with the skills, knowledge, and resources necessary to carry out the proposed research. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply for NIH programs. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the disabled: TTY 301-451-5936

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(s) of Support
2. Funds Available

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Award Criteria
4. Reporting

Section VII. Agency Contact(s)
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

This RFA requests research on the effectiveness of structural interventions that reduce the risk of HIV/AIDS transmission by changing the environment of alcohol use. Although a variety of structural and environmental interventions have been employed successfully to reduce other drinking-related problems, there has been little research that extends such efforts into the realm of HIV/AIDS risk reduction.

1. Research Objectives

Background

The role played by alcohol consumption as a facilitator of HIV/AIDS infection risk has been the subject of much research. A relationship between alcohol use and HIV/AIDS risk has been documented among men who have sex with men (Koblin et al. 2003; Seage et al. 1998), urban minority groups (Morrison et al. 1998; Fort and Norris 1994); adolescents (Henry Kaiser Family Foundation 2001), HIV-seropositive individuals (Marks and Crepaz 2001), seriously mentally ill persons (Tucker et al. 2003), non-U.S. populations (Fritz et al. 2002; Mbulaiteye et al. 2000), and others.

Nevertheless, the putative link between alcohol use and involvement in HIV-risky sexual behaviors has not been without challenge (Weatherburn et al. 1993; Messiah et al. 1998; Liegh 1993; Tubman and Langer 1995; Leigh and Miller 1995; Weinhardt et al 2001). A growing body of evidence suggests that the relationship between drinking and risky sex is likely to be the result of a complex interaction among personality, situational, and behavioral factors, as well as the sexual experience of the partners (Temple et al. 1993; Cooper and Orcutt 1997).

In the course of this debate, it has become increasingly apparent that individual-level behavior change approaches are, by themselves, unlikely to be sufficient in halting HIV spread (e.g., Sterk 2002; Miller and Kelly 2002; DiClemente and Wingood 2003). As a result, some researchers and funding agencies have started to look closely at the possibility of reducing HIV spread through the implementation of structural changes (Wohlfeiler 2002; Mataure et al. 2002; Sumartojo et al. 2000; d'Crux-Grote 1996). Structural (sometimes termed "environmental") interventions for HIV have been defined: as ones "that attempt to directly or indirectly influence HIV transmission by modifying laws, regulations, policies, systems, and/or environmental factors (O'Leary et al. 2003); as "programs or policies that change the environments in which risk behavior occurs, without attempting to change knowledge, attitudes or social interaction patterns of the persons at risk" (Des Jarlais 2000); and as "interventions that work by altering the context within which health is produced or reproduced" (Blankenship et al. 2000).

Such interventions may take a number of forms. Blankenship and colleagues (2000) have identified two dimensions along which structural interventions can vary. For one thing, such interventions may locate the source of health problems in factors related to availability, acceptability, or accessibility. Availability interventions are rooted in the notion that health problems result from a lack of tools, behaviors, materials, or settings necessary to promote healthy outcomes (or, conversely, the excessive availability or these items). Acceptability interventions, based in the notion that public health is partly determined by that society’s cultural values and beliefs, alter social norms as a way of promoting public health. Accessibility interventions manipulate power and resources to promote public health. The target for the intervention constitutes the second dimension along which structural interventions can vary: that is, each of these intervention types may target the individual, the organizational/ institutional level, or the environmental (social, legal, and physical) level. In sum, then, this framework suggests no less than nine kinds of structural interventions.

A variety of structural interventions have been studied with regard to their effectiveness at reducing either alcohol consumption or various problems associated with drinking. Many of these are based on the substantial evidence that reducing alcohol availability can reduce alcohol consumption (Kuo et al. 2003; Skog 2000; Chaloupka et al. 1998; Rahkonen and Ahlstrom 1989). For instance, increasing the monetary price of alcoholic beverages, usually achieved through increasing taxes on alcoholic beverages (Chaloupka et al. 1998) reduces consumption and alcohol-related problems. Media-focused interventions can be regarded as structural-level approaches insofar as media affect the environment in which people live (Cohen and Scribner 2000). Evidence from a community trial suggests that training in media advocacy can increase electronic and print media coverage of news events generated by local individuals, resulting in greater public and leader attention paid to specific issues as well as to local policies aimed at reducing alcohol-involved injury (Holder and Treno 1997). Some structural approaches seek to change community policies by directly approaching those community-level policy makers who set local priorities for allocating resources and enforcing laws related to, for example, underage alcohol sales and bar/restaurant alcohol serving practices (Holder and Reynolds 1997). As some researchers have concluded that alcohol outlet density may be related to violent assaults in nearby areas when certain conditions prevail (Gorman et al. 1998; Treno et al 2001; Speer et al. 1998; Scribner et al. 1995, 1999; Alaniz et al. 1998), some research has examined the effects of local land use and zoning practices in reducing alcohol availability, consumption and related problems (Reynolds et al., 1997). Moreover, several studies (Johnsson and Berglund 2003; Saltz 1987) have found that alcohol server intervention programs can significantly reduce hazardous alcohol use among bar/restaurant patrons. Particularly germane to this RFA is a recent analysis that indicated that more restrictive state alcohol availability policies were associated with lower rates of gonorrhea among certain age groups (CDC 2000).

Thus, previous studies have manipulated a number of structural "handles" in attempting to reduce the problems associated with alcohol use. Many such projects have been supported by NIAAA. However, few of these alcohol-related structures have been examined for their potential in reducing the behavioral risks that lead to HIV/AIDS infection. Furthermore, while HIV/AIDS prevention approaches long have reported some success in altering community behavioral norms through the dissemination of relevant HIV/AIDS information and risk reduction techniques through high-risk social networks utilizing street outreach workers (Neaigus et al., 1990) and community peers (Broadhead et al., 1998; Kelly et al., 1992) as behavioral change endorsers, this Announcement seeks to stimulate adoption and/or evaluation of truly structural changes that can be expected to impact alcohol-related HIV/AIDS risk. These alterations in laws, regulations, programs, policies, systems, and environmental factors that influence the consumption of alcohol -specifically, how, who, when, where, how often, and how much alcohol is consumed -may also be examined for their effects in changing individual attitudes and perceptions related to alcohol-related HIV/AIDS risk. Potential applicants are particularly encouraged to examine the ramifications for HIV/AIDS risk of naturally occurring or already-announced changes in alcohol-related laws, regulations, programs or policies, specifically by evaluating the impacts of such changes against those observed in appropriate comparison sites/communities. In sum, then, this RFA attempts to move prevention science toward the investigation of the effects of structural or environmental interventions in altering drinking environments as a way of stemming alcohol-related HIV/AIDS risk behaviors and infection rates.

Areas of Research Interest

This RFA focuses on intermediate-level factors that directly affect the drinking environment. Hence, applications responsive to this announcement include, but are not limited to, attempts to reduce HIV/AIDS risk by changing -or by evaluating naturally occurring changes in--any of the following features of the alcohol consumption environment:

The above list is not intended to be exhaustive. Prospective researchers might well consider combining multiple strategies in their project (see Wallin et al., 2003; Holder et al., 2000). For example, one community-based approach aimed at preventing underage sales of alcohol combined elements of enforcement of underage sales laws, responsible beverage service training, and media advocacy (Grube, 1997).

While this RFA is primarily directed toward reducing alcohol-related risks, structural interventions may also be developed to improve secondary prevention among individuals who are already infected with HIV. These interventions may focus on increasing screening and identification of HIV+ alcoholics (often a hard to reach population), engagement and retention of this difficult-to-treat and often non-adherent group in AIDS treatment protocols, or developing new technologies to improve alcohol and HIV/AIDS treatment among these multiply-diagnosed persons to address medically significant end points, such as liver failure. Importantly, structural alterations may address the stigma endured by HIV-positive persons with drinking problems, particularly the manifold ways that felt stigma may hinder the retention of such persons in alcohol and HIV/AIDS treatment programs.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the NIH Research Project Grant (R01), Exploratory/Developmental Grant (R21), and Small Grant (R03) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.


2. Funds Available

The NIAAA intends to commit approximately $2,000,000 dollars in FY 2005 to fund 5 to 7 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html ) up to $500,000 dollars per year. 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 NIAAA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign institutions/organizations considering applying to this RFA must demonstrate an ability to conduct the proposed study in the designated setting(s) as well as an ability to meet government clearance requirements.

1.B. Eligible Individuals

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.

2. Cost Sharing

Cost sharing is not required.

3. Other-Special Eligibility Criteria

Section IV. Application Submission Instructions


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Subsection VI.2. Administrative and National Policy Requirements for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.


3. Submission Dates

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: November 19, 2004
Application Receipt Date(s): December 16, 2004
Peer Review Date: February-March, 2005
Council Review Date: May, 2005
Earliest Anticipated Start Date: July, 2005

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Dr. Ernestine Vanderveen, Ph.D., Chief
Extramural Project Review Branch, Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane
Room 3039
Bethesda, MD 20892
Telephone: (301) 443-2531
FAX: 301-443-6077
Email: tvanderv@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)


At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Ernestine Vanderveen, Ph.D., Chief
Extramural Project Review Branch, Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane
Room 3039
Bethesda, MD 20892
Telephone: (301) 443-2531
FAX:301-443-6077
Email: tvanderv@mail.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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

This initiative is not subject to intergovernmental review

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Award Criteria)
Although the financial plans of the NIAAA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.


6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

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

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting $500,000 or more in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and the data sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.


Section V. Application Review Information



1. Criteria

Administrative Criteria: Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. Incomplete applications will not be reviewed.

If the applications are not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the appropriate review cycle.

Not Applicable.

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAAA in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:
3. Merit 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. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

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

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

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

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

3.A. Additional Review Criteria:

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


Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See also Section VIII - Other Information.

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See also Section VIII-Other Information.

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed.

3.B. Additional Review Considerations

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

3.C. Sharing Research Data

1. Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing. Reviewers will assess the adequacy of the proposed plan for meeting the larger scientific goals as outlined in this Announcement.

3.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible
Reviewers will assess the adequacy of the proposed plan for meeting the larger scientific goals as outlined in this Announcement.


The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a summary statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Notification will be made electronically to the designated administrative/ institutional official.

2. Administrative and National Policy Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually:
http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Robert C. Freeman, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
Room 2073
5635 Fishers Lane
Bethesda, MD 20892
Telephone: (301) 443-8820
FAX:301-443-8614
Email: rfreeman@mail.nih.gov

2. Peer Review Contacts:

Ernestine Vanderveen, Ph.D. Chief
Extramural Project Review Branch, Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Room 3039
5635 Fishers Lane
Bethesda , MD 20892
Telephone: (301) 443-2531
FAX:301-443-6077
Email: tvanderv@mail.nih.gov

3. Financial or Grants Management Contacts:

Judy Fox, Chief
Grants Management Branch, Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Room 3023
Street Address
Bethesda , MD 20892
Telephone: (301) 443-4704
FAX:301-443-3891
Email: jfox@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing

Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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

Required Education on The Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

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

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

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

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


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