RESEARCH ON HIGH ALCOHOL CONTENT MALT BEVERAGES AND RELATED PRODUCTS Release Date: January 30, 2001 RFA: RFA-AA-01-003 National Institute on Alcohol Abuse and Alcoholism (http://www.niaaa.nih.gov/) Letter of Intent Receipt Date: April 16, 2001 Application Receipt Date: May 14, 2001 THIS (REQUEST FOR APPLICATIONS (RFA) USES THE MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA/PA. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks grant applications to conduct exploratory and developmental research on high alcohol content malt and wine specialty consumption as risk factors for alcohol- related health and social problems in racially, ethnically and economically diverse communities. The most popular of the malt beverages is known as malt liquor . For the purpose of this RFA, the beverages of interest are those with an alcohol content above 5 percent, often sold in similar containers as malt and wine cooler products having an alcohol content of 5 percent or lower. Previous studies of consumption patterns (quantity, frequency and type of beverage consumed) have often failed to consider these beverages. This has resulted in underestimates of the quantity of alcohol consumed and an imprecise understanding of what is considered a drink . The high alcohol content of these beverages, often about 7 percent or more, raises special concerns: 1) for their potential appeal to younger, often under-age drinkers, 2) because they are thought to be primarily, but not exclusively, marketed in predominantly urban minority communities, and 3) because promotional materials appear to target the minority youth market. Malt liquor is also relatively low cost per ounce of absolute alcohol and is often packaged in large-volume (40 ounce and larger), sometimes, non-recloseable, containers that encourage more immediate consumption. Community groups have alleged that these beverages are associated with faster consumption, a high blood alcohol content, and a more frequent loss of control and aggressive behavior than other, more standard alcoholic beverages. For example, one community passed a resolution that requests that off-sale outlet operators voluntarily withdraw the sale of malt liquor. The community has alleged, largely on the basis of citizen complaints, that malt liquor consumption contributes significantly to alcohol related problems in the community. Little research-based information is available about the association between the consumption of these beverages and the development of a spectrum of anti- social and risky behaviors. This RFA will support research that adds to our knowledge of the consumption patterns of these beverages and adverse health and social outcomes, if any. It is hoped that the results of this research will form the basis for the development of effective interventions and prevention approaches. 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 Request for Applications (RFA) RESEARCH ON HIGH ALCOHOL CONTENT MALT BEVERAGES AND RELATED PRODUCTS, 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 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. Foreign institutions are not eligible for exploratory/developmental grants under this RFA. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Exploratory/Developmental Research Grant (R21) award mechanism. Exploratory/Developmental Research Grants supported under this RFA may request up to $100,000 per year (direct costs) for up to three years. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The R21 awards are not renewable. However, we expect successful exploratory/developmental project awardees supported through this RFA to subsequently submit regular research project grant (R01) applications. Applications for competitive supplements to existing R01 research grants for up to $100,000 (direct costs) a year for up to three years may also be accepted. Applicants for a supplement to an existing grant should assure that the grant meets the requirements to be supplemented. The time frame for competing supplements cannot exceed the parent grant project period. Applicants should consult the program administrator before submitting a competing supplement application under this RFA. 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 This RFA is a one-time solicitation. The anticipated award date is September 28, 2001 FUNDS AVAILABLE The National Institute on Alcohol Abuse and Alcoholism plans to spend up to $1 million in FY 2001 to fund 7 to 10 new grants under this RFA. An applicant may request a project period of up to three years and a budget for direct costs of up to $100,000 per year for an R21 or a competitive supplement to an existing grant. Because the nature and scope of the research proposed might vary, it is anticipated that the size of each award will also vary. Although the financial plans of the Institute 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 applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Background Alcoholism and alcohol-related problems have an enormous impact on our society. Most adults can drink alcohol moderately and responsibly without complications. However, nearly 14 million Americans meet the medical criteria for a diagnosis of alcohol abuse or alcoholism. Although a dollar figure cannot adequately reflect the social and human devastation caused by these illnesses, it is estimated that the economic and health care costs to society from alcoholism and alcohol abuse are nearly $185 billion annually. Much of this cost is related to lost productivity, motor vehicle crashes, alcohol- related medical expenses and crime. Why some people who drink get into trouble from alcohol use, while many others do not, has been a central question in alcohol research. It is clear that there are genetic influences on an individual"s risk for alcoholism, but environmental influences are also key factors. African, Hispanic and Native Americans are at higher risk than whites for certain alcohol-related health and social problems and alcohol is the number one substance of abuse used by American adolescents and young adults. Research suggests that causal processes leading to alcohol use and abuse among youth do not necessarily differ across ethnic groups but prevalence of factors that affect development of risk does. Consumption of low cost per ounce, higher alcoholic content (5 percent or more) malt beverages and other often sweetened alcoholic beverages, especially among younger adolescents, is of concern because they may contribute to increased alcohol use and abuse and increased risk. These products are higher in potency than regular beer or wine coolers, which have alcohol contents of 5 percent alcohol or less and are usually sold in 12 ounce and smaller containers. KEY CONCEPTS, MEASURES, AND METHODS Issues surrounding higher alcohol content malt and wine specialties have been identified as areas where research-based information on possible associations with social, psychological, economic and other adverse consequences is lacking. Little research-based information exists to link outcomes specifically to consumption of these beverages, independent of other beverages. This request encourages applicants to consider a broad range of approaches and methods. Methods and approaches that the Institute believes will further this effort include: Case control, quantitative, qualitative, econometric, consumer behavior and longitudinal studies, surveys, natural experiments, event analyses, multivariate analyses and analyses of marketing practices and advertising content and sales. Rigorous studies of socially disruptive activities including fighting, missing school, risky sexual behaviors, accidents and violent behaviors are also of interest. Research is needed to determine: if these alcoholic beverages are more available in ethnically diverse communities, if levels of consumption are higher in these communities, if advertising, marketing and packaging contribute to higher consumption levels and what the adverse consequences might be, if any. The following areas illustrate suitable topics for research. While applicants are not limited to these themes, they are advised to consult with program staff on the relevance of their research plans to the RFA. A. Studies are needed to ascertain: 1) Prevalence - The evidence of problems directly or indirectly associated with consumption of these beverages - Definable pathways leading to consumption of these beverages. 2) User characteristics - The age, gender, ethnicity and product knowledge of consumers - Consumers terminology for this beverage - Awareness of its alcohol content and its influence on their decision to drink these beverages 3) The degree of harm - Provide demographic information on populations likely to consume these beverages versus populations that are likely to consume more traditional beer, wine or distilled spirits. - Compare product availability in selected communities. - Collect and analyze information on national marketing practices in minority communities. - Evaluate differences in consumatory practices and social settings of malt liquor and high alcohol content wine specialty drinkers and drinkers of comparable products such as beer. 4) Consequences/outcomes - Effects of consumption of these beverages on health, crime, violence and other adverse outcomes. - Compare outcomes in neighborhoods with similar demographics where these beverages are and are not sold. - Studies using biological measures to determine physiologic effects, studies of quantity and frequency of consumption, including blood alcohol concentrations, in comparison to other alcoholic beverages. 5) Drinking patterns - Prevalence of chugging and bingeing. Amounts typically consumed and relationship, if any, to socioeconomic status. - Consumers definition of a drink . - Youth trends in mixing malt liquor and other alcoholic beverages or drugs (e.g. blunts ). - Role of malt liquor as a gateway to drink other alcoholic beverages. - Consumer expectancies for different beverages, including malt liquor. - Consumers expectations of a different high from these beverages. - Drinker expectancies related to advertising. 6) Social Acceptability - Social norms regarding drinking in public vs. private. - Cultural differences among youth groups. - Differences in Hispanic and Native Americans as compared to African American youth and adult groups. - Presence of collective efficacy, the level of social control and/or willingness of individuals in a neighborhood to intervene in non-sanctioned behaviors. 7) Marketing strategies - Advertising promotional strategies specific for these beverages. - The potential of ads displaying images of strength and power to attract specific types of drinkers (male bias). Characterize the use of cultural icons to market these beverages (African, Native, Hispanic Americans). - Perceptions of these beverages among their drinkers. - The role of sponsorship (music, etc.) B. To Evaluate Policy Issues- Effects of changes in alcohol laws 1) Availability - Outlet-density differences for these beverages versus other alcoholic beverages (e.g., shelf space dedicated to such products). - Selling locations by geography and area. - Quantity of sales by location. - Effects of on-site versus off site outlets. - Issues regarding access by minors. - Control/zoning issues, including presence/absence of enforcement. - Data to support maintaining or changing policies regarding marketing/advertising of these beverages. 2) Price/Taxation - Effects of price and the relationship of statewide pricing to sales volume. - Price differences in products according to neighborhood/SES. - Effects due to container size for 40 ounce sometimes non-resealable containers. - Effects of price/taxation on consumption/outcomes. 3) Labeling/Definitions - Consumer awareness of the alcohol content of these beverages and influence of perceived alcohol content on consumer’s decision to drink malt liquor. SPECIAL REQUIREMENTS An annual meeting will be held in the Washington, D.C., area to facilitate the exchange of information and coordination among investigators. Applicants should include support for these required meetings as part of the overall budget request. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 to: RFA-AA-01-003 Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-4375 FAX: (301) 443-6077 by the letter of intent receipt date listed. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. 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 Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications for Exploratory/Developmental (R21) Grants and competing supplements will request direct costs in $25,000 modules, up to a total direct cost request of $100,000 per year for up to three years. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $100,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form 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 sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: RFA: AA-01-003 Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. If the application is not responsive to the RFA, CSR 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 next review cycle. 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, a process will be used by the initial review group in which applications 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council on Alcohol Abuse and Alcoholism. 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, animals 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. Additional consideration pertinent to the review of Exploratory/Developmental Grant (R21) applications: Pilot/feasibility studies may contain little or no preliminary data. Review should focus on whether the rationale for the study is well developed and whether the proposed research is likely to generate data that will lead to a regular research project grant or full-scale clinical trial. Adequate justification for the proposed work may be provided through literature citations, data from other sources, or investigator-generated data. Schedule Letter of Intent Receipt Date: April 16, 2001 Application Receipt Date: May 14, 2001 Peer Review Date: July, 2001 Council Review: September 18, 2001 Earliest Anticipated Start Date: September 28, 2001 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 concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ernestine Vanderveen, Ph.D. Office of Collaborative Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd, Suite 302, MCS 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2531 FAX (301) 480-2358 Email: tvanderv@willco.niaaa.nih.gov Direct inquiries regarding review issues to: Tony Beck, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd, Suite 409, MCS 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0913 FAX (301) 443-6077 Email: lbeck@mail.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd, Suite 504, MCS 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX (301) 480-3891 Email: lhilley@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 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, 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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